Indomethacin
Loading...Indomethacin Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
taking sedatives or tranquilizers.
avoid alcoholic drinks.
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away.
- for children under 12 years of age
- with any other product containing diphenhydramine, even one used on skin
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
taking sedatives or tranquilizers.
Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
for relief of occasional sleeplessness.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Indomethacin Manufacturers
-
Direct Rx
![Indomethacin Capsule, Extended Release [Direct Rx]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Indomethacin | Sam's West, Inc
adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor -
Avpak
Indomethacin | Avpak
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Proficient Rx Lp
Indomethacin | Laboratoires Clarins
• apply liberally 15 minutes before sun exposure
• apply to all skin exposed to the sun
• children under 6 months: Ask a doctor
• Sun Protection Measures.
Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating -
Blenheim Pharmacal, Inc.
Indomethacin | Blenheim Pharmacal, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Direct Rx
Indomethacin | Direct Rx
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
A-s Medication Solutions Llc
Indomethacin | A-s Medication Solutions Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
A-s Medication Solutions Llc
Indomethacin | A-s Medication Solutions Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
A-s Medication Solutions Llc
Indomethacin | A-s Medication Solutions Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
A-s Medication Solutions Llc
Indomethacin | A-s Medication Solutions Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Proficient Rx Lp
Indomethacin | Golden State Medical Supply, Inc.
Dose once daily. The dosage may then be increased after 2 to 3 weeks as needed to help achieve blood pressure goals. The maximum recommended dose is 20mg/25 mg
Switch Therapy
A patient whose blood pressure is not adequately controlled with benazepril alone or with hydrochlorothiazide alone may be switched to combination therapy with benazepril hydrochloride and hydrochlorothiazide tablets. The usual recommended starting dose is 10mg/12.5 mg once daily to control blood pressure.
Replacement Therapy
The combination may be substituted for the titrated individual components.
-
Contract Pharmacy Services-pa
Indomethacin | Contract Pharmacy Services-pa
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1.Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2.Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3.Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Stat Rx Usa Llc
Indomethacin | Stat Rx Usa Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Physicians Total Care, Inc.
Indomethacin | Physicians Total Care, Inc.
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extended-release capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give indomethacin extended-release capsules 75 mg with food, immediately after meals or with antacids to reduce gastric irritation.
Pediatric UseIndomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to extended-release Indomethacin Capsules (75 mg):
If indomethacin extended-release capsules is used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules is used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Rebel Distributors Corp
Indomethacin | Rebel Distributors Corp
Carefully consider the potential benefits and risks of Indomethacin and other treatment options before deciding to use Indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of Indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Amneal Pharmaceuticals
Indomethacin | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with ibuprofen tablets the dose and frequency should be adjusted to suit an individual patient's needs.
Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer Ibuprofen Tablets, USP with meals or milk.
Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease:
Suggested Dosage: 1200 mg-3200 mg daily (300 mg qid; 400 mg, 600 mg or 800 mg tid or qid).
Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk.
The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis.
The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGY for effects of food on rate of absorption). The availability of four tablet strengths facilitates dosage adjustment.
In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain.
In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.
Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
-
Hetero Drugs Ltd.,
Indomethacin | Hetero Drugs Ltd.,
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
-
Redpharm Drug Inc.
Indomethacin | Redpharm Drug Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Redpharm Drug Inc.
Indomethacin | Redpharm Drug Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS: Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75-150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days. Acute gouty arthritis.
Suggested Dosage:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Physicians Total Care, Inc.
Indomethacin | Physicians Total Care, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
1. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
2. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
G & W Laboratories, Inc.
Indomethacin | G & W Laboratories, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use Indomethacin Suppositories. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with Indomethacin Suppositories, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 50 mg suppositories for rectal use. THIS SECTION MAKES REFERENCE TO CAPSULE DOSAGE FOR GUIDANCE IN USING SUPPOSITORIES.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).Adult Use
Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendonitis).
Initial Dose:
75-150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Eon Labs, Inc.
Indomethacin | B. Braun Medical Inc.
The objective of nutritional management of patients with liver disease is the provision of sufficient amino acid and caloric support for protein synthesis without exacerbating hepatic encephalopathy.
The total daily dose of HepatAmine® depends on daily protein requirements and on the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements. Dosage should also be guided by the patient's fluid intake limits and glucose and nitrogen tolerances, as well as by metabolic and clinical response.
The recommended dosage is 80–120 grams of amino acids (12–18 grams of nitrogen) as HepatAmine® (8% Amino Acid Injection) per day. Typically, 500 mL of 8% HepatAmine® appropriately mixed with 500 mL of 50% dextrose supplemented with electrolytes and vitamins is administered over an 8–12 hour period. This results in a total daily fluid intake of approximately 2–3 liters. Patients with fluid restrictions may only tolerate 1–2 liters. Although nitrogen requirements may be higher in severely hypercatabolic or depleted patients, provision of additional nitrogen may not be possible due to fluid intake limits, nitrogen, or glucose intolerance.
In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose solutions are abruptly discontinued.
Fat emulsion coadministration should be considered when prolonged (more than 5 days) parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat free TPN.
The provision of sufficient intracellular electrolytes, principally potassium, magnesium, and phosphate, is required for optimum utilization of amino acids. Approximately 60–180 mEq of potassium, 10–30 mEq of magnesium, and 10–40 mmole of phosphate per day appear necessary to achieve optimum metabolic response. In addition, sufficient quantities of the major extracellular electrolytes sodium, calcium, and chloride, must be given. In patients with hyperchloremic or other metabolic acidoses, sodium and potassium may be added as the acetate salts to provide bicarbonate precursor. The electrolyte content of HepatAmine® must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently.
Pediatric UseUse of HepatAmine® in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).
Hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the superior vena cava. Initial infusion rates should be slow, and gradually increased to the recommended 60–125 mL/hr. If administration rate should fall behind schedule, no attempt to "catch up" to planned intake should be made. In addition to meeting protein needs, the rate of administration, particularly during the first few days of therapy, is governed by the patient's glucose tolerance. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of glucose levels in blood and urine.
For patients in whom the central venous route is not indicated and who can consume adequate calories enterally, 8% HepatAmine® may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution of 8% HepatAmine® with Sterile Water for Injection or 5%–10% dextrose to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is essential that peripheral infusion be accompanied by adequate caloric supplementation. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Care must be taken to avoid incompatible admixtures. Consult with pharmacist.
-
Dispensing Solutions, Inc.
Indomethacin | Dispensing Solutions, Inc.
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules and other treatment options before deciding to use Indomethacin Extended-Release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-Release Capsules 75 mg are available for oral use. Indomethacin Extended-Release Capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-Release Capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-Release Capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-Release Capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to sever ankylosing spondylitis; and moderate to sever osteoarthritis.
The following information is provided as background only and refers to immediate-released Indomethacin capsules (25 mg or 50 mg)
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREAS THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If Indomethacin Extended-Release Capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin Extended-Release Capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance. Indomethacin Extended-release Capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develops as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phrase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-Release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendonitis). Initial dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Rebel Distributors Corp
Indomethacin | Rebel Distributors Corp
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
-
Camber Pharmaceuticals
Indomethacin | Camber Pharmaceuticals
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Pd-rx Pharmaceuticals, Inc.
Indomethacin | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Indomethacin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules and other treatment options before deciding to use Indomethacin Extended-Release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-Release Capsules 75 mg are available for oral use. Indomethacin Extended-Release Capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-Release Capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-Release Capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-Release Capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to sever ankylosing spondylitis; and moderate to sever osteoarthritis.
The following information is provided as background only and refers to immediate-released Indomethacin capsules (25 mg or 50 mg)
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREAS THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If Indomethacin Extended-Release Capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin Extended-Release Capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance. Indomethacin Extended-release Capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develops as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phrase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-Release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendonitis). Initial dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Lake Erie Medical Dba Quality Care Products Llc
Indomethacin | Lake Erie Medical Dba Quality Care Products Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Paddock Laboratories, Llc
Indomethacin | Paddock Laboratories, Llc
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extendedrelease capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients,
but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give indomethacin extended-release capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use:Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use:Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg): If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. -
Glenmark Generics Inc., Usa
Indomethacin | Mylan Institutional Llc
The recommended dose based on controlled trials (see CLINICAL PHARMACOLOGY: Clinical Studies) is outlined in the Table below. Ibutilide infusion should be stopped as soon as the presenting arrhythmia is terminated or in the event of sustained or nonsustained ventricular tachycardia, or marked prolongation of QT or QTc.
Recommended Dose of Ibutilide Fumarate Injection Patient Weight Initial Infusion
(over 10 minutes) Second Infusion60 kg (132 lb)
or moreOne vial
(1 mg ibutilide fumarate)If the arrhythmia does not terminate within 10 minutes after the end of the initial infusion, a second 10-minute infusion of equal strength may be administered 10 minutes after completion of the first infusion.
Less than 60 kg
(132 lb)0.1 mL/kg
(0.01 mg/kg ibutilide fumarate)In a trial comparing ibutilide and sotalol (see CLINICAL PHARMACOLOGY: Clinical Studies), 2 mg ibutilide fumarate administered as a single infusion to patients weighing more than 60 kg was also effective in terminating atrial fibrillation or atrial flutter.
In the post-cardiac surgery study (see CLINICAL PHARMACOLOGY: Clinical Studies), one or two intravenous infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) was effective in terminating atrial fibrillation or atrial flutter.
Patients should be observed with continuous ECG monitoring for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if any arrhythmic activity is noted. Skilled personnel and proper equipment (see WARNINGS, Proarrhythmia), such as a cardioverter/defibrillator, and medication for treatment of sustained ventricular tachycardia, including polymorphic ventricular tachycardia, must be available during administration of ibutilide fumarate injection and subsequent monitoring of the patient.
DilutionIbutilide fumarate injection may be administered undiluted or diluted in 50 mL of diluent. Ibutilide fumarate injection may be added to 0.9% Sodium Chloride injection or 5% Dextrose injection before infusion. The contents of one 10 mL vial (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL ibutilide fumarate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Compatibility and StabilityThe following diluents are compatible with ibutilide fumarate injection (0.1 mg/mL):
5% Dextrose injection 0.9% Sodium Chloride injection.The following intravenous solution containers are compatible with admixtures of ibutilide fumarate injection (0.1 mg/mL):
polyvinyl chloride plastic bags polyolefin bags.Admixtures of the product, with approved diluents, are chemically and physically stable for 24 hours at room temperature (15° to 30°C or 59° to 86°F) and for 48 hours at refrigerated temperatures (2° to 8°C or 36° to 46°F). Strict adherence to the use of aseptic technique during the preparation of the admixture is recommended in order to maintain sterility.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules and other treatment options before deciding to use Indomethacin Extended-Release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-Release Capsules 75 mg are available for oral use. Indomethacin Extended-Release Capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-Release Capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-Release Capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-Release Capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use:Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use:Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to sever ankylosing spondylitis; and moderate to sever osteoarthritis.
The following information is provided as background only and refers to immediate-released Indomethacin capsules (25 mg or 50 mg)
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREAS THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If Indomethacin Extended-Release Capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin Extended-Release Capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance. Indomethacin Extended-release Capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develops as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phrase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-Release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendonitis). Initial dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Pd-rx Pharmaceuticals, Inc.
Indomethacin | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Indomethacin | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Mylan Institutional Inc.
Indomethacin | Mylan Institutional Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Pd-rx Pharmaceuticals, Inc.
Indomethacin | Pd-rx Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Kvk-tech, Inc.
Indomethacin | Kvk-tech, Inc.
Carefully consider the potential benefits and risks of Indomethacin Extended-release Capsules and other treatment options before deciding to use Indomethacin Extended-release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-release Capsules USP 75 mg are available for oral use. Indomethacin Extended-release Capsules USP 75 mg can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-release Capsules USP 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-release Capsules USP 75 mg may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-release Capsules USP 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin Extended-release Capsules USP 75 mg ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic
disesase; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing Indomethacin Extended-release Capsules USP 75 mg.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.The following information refers to Indomethacin Extended-release Capsules USP 75 mg:
If Indomethacin Extended-release Capsules USP 75 mg are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If Indomethacin Extended-release Capsules USP 75 mg are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, Indomethacin Extended-release Capsules USP 75 mg may be prescribed as one capsule twice daily.If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis): Initial Dose: 75 mg to 150mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. -
Camber Pharmaceuticals, Inc.
Indomethacin | Camber Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extended-release capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give indomethacin extended-release capsules 75 mg with food, immediately after meals or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Bryant Ranch Prepack
Indomethacin | Bryant Ranch Prepack
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
American Health Packaging
Indomethacin | Avkare, Inc.
Lisinopril is an effective treatment of hypertension in once-daily doses of 10 mg to 80 mg, while hydrochlorothiazide is effective in doses of 12.5 mg to 50 mg. In clinical trials of lisinopril and hydrochlorothiazide combination therapy using lisinopril doses of 10 mg to 80 mg and hydrochlorothiazide doses of 6.25 mg to 50 mg, the antihypertensive response rates generally increased with increasing dose of either component.
The side effects (see WARNINGS) of lisinopril are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent phenomena (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of lisinopril and hydrochlorothiazide will be associated with both sets of dose-independent side effects, but addition of lisinopril in clinical trials blunted the hypokalemia normally seen with diuretics.
To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.
Dose Titration Guided by Clinical EffectA patient whose blood pressure is not adequately controlled with either lisinopril or hydrochlorothiazide monotherapy may be switched to lisinopril and hydrochlorothiazide tablet 10 mg/12.5 mg or lisinopril and hydrochlorothiazide tablet 20 mg/12.5 mg. Further increases of either or both components could depend on clinical response. The hydrochlorothiazide dose should generally not be increased until 2 to 3 weeks have elapsed. Patients whose blood pressures are adequately controlled with 25 mg of daily hydrochlorothiazide, but who experience significant potassium loss with this regimen, may achieve similar or greater blood pressure control with less potassium loss if they are switched to lisinopril and hydrochlorothiazide tablet 10 mg/12.5 mg. Dosage higher than lisinopril 80 mg and hydrochlorothiazide 50 mg should not be used.
Replacement TherapyThe combination may be substituted for the titrated individual components.
Use in Renal ImpairmentThe usual regimens of therapy with lisinopril and hydrochlorothiazide tablets need not be adjusted as long as the patient's creatinine clearance is >30 mL/min/1.73 m2 (serum creatinine approximately ≤3 mg/dL or 265 mcmol/L). In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so lisinopril and hydrochlorothiazide tablet is not recommended (see WARNINGS, Anaphylactoid Reactions During Membrane Exposure).
-
Sandoz Inc
Indomethacin | Sandoz Inc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS: Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following 1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). 2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75-150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7-14 days. 3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Rebel Distributors Corp
Indomethacin | Rebel Distributors Corp
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Rebel Distributors Corp
Indomethacin | Rebel Distributors Corp
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Caraco Pharmaceutical Laboratories, Ltd.
Indomethacin | Caraco Pharmaceutical Laboratories, Ltd.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Lake Erie Medical Dba Quality Care Products Llc
Indomethacin | Lake Erie Medical Dba Quality Care Products Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
A-s Medication Solutions Llc
Indomethacin | A-s Medication Solutions Llc
Carefully consider the potential benefits and risks of Indomethacin Extended-release Capsules and other treatment options before deciding to use Indomethacin Extended-release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-release Capsules USP 75 mg are available for oral use. Indomethacin Extended-release Capsules USP 75 mg can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-release Capsules USP 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-release Capsules USP 75 mg may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-release Capsules USP 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin Extended-release Capsules USP 75 mg ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic
disesase; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing Indomethacin Extended-release Capsules USP 75 mg.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.The following information refers to Indomethacin Extended-release Capsules USP 75 mg:
If Indomethacin Extended-release Capsules USP 75 mg are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If Indomethacin Extended-release Capsules USP 75 mg are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, Indomethacin Extended-release Capsules USP 75 mg may be prescribed as one capsule twice daily.If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis): Initial Dose: 75 mg to 150mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. -
Medvantx, Inc.
Indomethacin | Medvantx, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use). Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Fresenius Kabi Usa, Llc
Indomethacin | Fresenius Kabi Usa, Llc
For intravenous administration only.
Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of Indomethacin for Injection given at 12 to 24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin for Injection, do not give additional doses until laboratory studies indicate that renal function has returned to normal [see Warnings and Precautions (5.7)].
Dosage according to age is as follows:
AGE at 1stdose
DOSAGE (mg/kg)
Less than 48 hours
1st
0.2
2nd
0.1
3rd
0.1
2 to 7 days
0.2
0.2
0.2
Over 7 days
0.2
0.25
0.25
If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of Indomethacin for Injection, no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval as described above.
If the neonate remains unresponsive to therapy with Indomethacin for Injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus.
2.1 Directions for Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.
Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.
Further dilution with intravenous infusion solutions is not recommended.
2.1 Directions for Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.
Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.
Further dilution with intravenous infusion solutions is not recommended.
-
Unit Dose Services
Indomethacin | Unit Dose Services
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ). WARNINGS
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see ). WARNINGS
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis. Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see ). PRECAUTIONS:Geriatric Use
Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days
Acute gouty arthritis. Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Stat Rx Usa Llc
Indomethacin | Stat Rx Usa Llc
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Liberty Pharmaceuticals, Inc.
Indomethacin | Liberty Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Actavis Inc.
Indomethacin | Actavis Inc.
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extended-release capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give indomethacin extended-release capsules 75 mg with food, immediately after meals or with antacids to reduce gastric irritation.
Pediatric UseIndomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to extended-release Indomethacin Capsules (75 mg):
If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.
Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules and other treatment options before deciding to use Indomethacin Extended-Release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-Release Capsules 75 mg are available for oral use. Indomethacin Extended-Release Capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-Release Capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-Release Capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-Release Capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to sever ankylosing spondylitis; and moderate to sever osteoarthritis.
The following information is provided as background only and refers to immediate-released Indomethacin capsules (25 mg or 50 mg)
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREAS THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If Indomethacin Extended-Release Capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin Extended-Release Capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance. Indomethacin Extended-release Capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develops as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phrase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-Release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendonitis). Initial dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules and other treatment options before deciding to use Indomethacin Extended-Release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-Release Capsules 75 mg are available for oral use. Indomethacin Extended-Release Capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-Release Capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-Release Capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-Release Capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to sever ankylosing spondylitis; and moderate to sever osteoarthritis.
The following information is provided as background only and refers to immediate-released Indomethacin capsules (25 mg or 50 mg)
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREAS THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If Indomethacin Extended-Release Capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin Extended-Release Capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance. Indomethacin Extended-release Capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develops as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phrase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-Release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendonitis). Initial dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Preferred Pharmaceuticals, Inc.
Indomethacin | Preferred Pharmaceuticals, Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG. In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY. If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued. Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions. As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use). 2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. 3. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Teva Pharmaceuticals Usa Inc
Indomethacin | Bausch & Lomb Incorporated
Apply a small amount (approximately ½ inch ribbon) into the conjunctival sac(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.
-
Fresenius Kabi Usa, Llc
Indomethacin | Fresenius Kabi Usa, Llc
For intravenous administration only.
Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of Indomethacin for Injection given at 12 to 24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin for Injection, do not give additional doses until laboratory studies indicate that renal function has returned to normal [see Warnings and Precautions (5.7)].
Dosage according to age is as follows:
AGE at 1st dose
DOSAGE (mg/kg)
Less than 48 hours
1st
0.2
2nd
0.1
3rd
0.1
2 to 7 days
0.2
0.2
0.2
Over 7 days
0.2
0.25
0.25
If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of Indomethacin for Injection, no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval as described above.
If the neonate remains unresponsive to therapy with Indomethacin for Injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus.
2.1 Directions for Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.
Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.
Further dilution with intravenous infusion solutions is not recommended.
2.1 Directions for Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.
Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.
Further dilution with intravenous infusion solutions is not recommended.
-
Heritage Pharmaceuticals Inc.
Indomethacin | Heritage Pharmaceuticals Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Cardinal Health
Indomethacin | Cardinal Health
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Mylan Pharmaceuticals Inc.
Indomethacin | Mylan Pharmaceuticals Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult UseDosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS: Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Fresenius Kabi Usa, Llc
Indomethacin | Fresenius Kabi Usa, Llc
For intravenous administration only.
Dosage recommendations for closure of the ductus arteriosus depend on the age of the infant at the time of therapy. A course of therapy is defined as three intravenous doses of Indomethacin for Injection given at 12 to 24 hour intervals, with careful attention to urinary output. If anuria or marked oliguria (urinary output <0.6 mL/kg/hr) is evident at the scheduled time of the second or third dose of Indomethacin for Injection, do not give additional doses until laboratory studies indicate that renal function has returned to normal [see Warnings and Precautions (5.7)].
Dosage according to age is as follows:
AGE at 1st dose
DOSAGE (mg/kg)
Less than 48 hours
1st
0.2
2nd
0.1
3rd
0.1
2 to 7 days
0.2
0.2
0.2
Over 7 days
0.2
0.25
0.25
If the ductus arteriosus closes or is significantly reduced in size after an interval of 48 hours or more from completion of the first course of Indomethacin for Injection, no further doses are necessary. If the ductus arteriosus re-opens, a second course of 1 to 3 doses may be given, each dose separated by a 12 to 24 hour interval as described above.
If the neonate remains unresponsive to therapy with Indomethacin for Injection after 2 courses, surgery may be necessary for closure of the ductus arteriosus.
2.1 Directions for Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.
Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.
Further dilution with intravenous infusion solutions is not recommended.
2.1 Directions for Use
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
The reconstituted solution, pH 6.0 to 7.5, is clear, slightly yellow and essentially free from visible particles.
Prepare the solution with 1 to 2 mL of preservative-free Sterile Sodium Chloride Injection, 0.9 percent or preservative-free Sterile Water for Injection. Benzyl alcohol as a preservative has been associated with toxicity in neonates. Therefore, do not use diluents that contain preservatives. If 1 mL of diluent is used, the concentration of indomethacin in the solution will equal approximately 0.1 mg/0.1 mL; if 2 mL of diluent are used, the concentration of the solution will equal approximately 0.05 mg/0.1 mL. Discard any unused portion of the solution as it does not contain a preservative. Prepare a fresh solution just prior to each administration. Once reconstituted, the indomethacin solution may be injected intravenously. While the optimal rate of injection has not been established, published literature suggests an infusion rate over 20 to 30 minutes.
Further dilution with intravenous infusion solutions is not recommended.
-
Clinical Solutions Wholesale
Indomethacin | Clinical Solutions Wholesale
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use Dosage Recommendations for Active Stages of the Following:1. Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
2. Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
3. Acute gouty arthritis.
Suggested Dosage:
Indomethacin Capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
-
Bryant Ranch Prepack
Indomethacin | Bryant Ranch Prepack
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Bryant Ranch Prepack
Indomethacin | Bryant Ranch Prepack
Carefully consider the potential benefits and risks of Indomethacin Extended-Release Capsules and other treatment options before deciding to use Indomethacin Extended-Release Capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Indomethacin Extended-Release Capsules 75 mg are available for oral use. Indomethacin Extended-Release Capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant difference between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see CLINICAL PHARMACOLOGY). In addition, Indomethacin Extended-Release Capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin Extended-Release Capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give Indomethacin Extended-Release Capsules 75 mg with food, immediately after meals, or with antacids to reduce gastric irritation.
Pediatric Use: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see WARNINGS).
Adult Use: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to sever ankylosing spondylitis; and moderate to sever osteoarthritis.
The following information is provided as background only and refers to immediate-released Indomethacin capsules (25 mg or 50 mg)
Suggested Dosage:
The following recommendations on dosing pertain to immediate-release indomethacin capsules USP, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150-200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREAS THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If Indomethacin Extended-Release Capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin Extended-Release Capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance. Indomethacin Extended-release Capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develops as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phrase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, Indomethacin Extended-Release Capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendonitis). Initial dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
-
Direct Rx
Indomethacin | Direct Rx
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient's needs.
Indomethacin is available as 25 mg and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric Use
Indomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see WARNINGS).
Adult Use
Dosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage: Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 mg to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS:Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose: 75 mg to 150 mg daily in 3 or 4 divided doses. The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days Acute gouty arthritis.
Suggested Dosage: Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Avpak
Indomethacin | Nash-finch Company
adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours
-
Directrx
Indomethacin | Directrx
Carefully consider the potential benefits and risks of indomethacin and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Indomethacin is available as 25 and 50 mg capsules.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Pediatric UseIndomethacin ordinarily should not be prescribed for pediatric patients 14 years of age and under (see PRECAUTIONS, Pediatric Use).
Adult UseDosage Recommendations for Active Stages of the Following:
Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
Suggested Dosage:
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 - 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin should be used with greater care in the elderly (see PRECAUTIONS, Geriatric Use).
Acute painful shoulder (bursitis and/or tendinitis).
Initial Dose:
75 mg to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. Acute gouty arthritis.
Suggested Dose:
Indomethacin capsules 50 mg t.i.d. until pain is tolerable. The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days. -
Remedyrepack Inc.
Indomethacin | Remedyrepack Inc.
Carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see
WARNINGS
). Indomethacin extended-release capsules 75 mg are available for oral use. Indomethacin extended-release capsules can be administered once a day and can be substituted for indomethacin 25 mg capsules t.i.d. However, there will be significant differences between the two dosage regimens in indomethacin blood levels, especially after 12 hours (see
CLINICAL PHARMACOLOGY
). In addition, indomethacin extended-release capsules 75 mg b.i.d. can be substituted for indomethacin 50 mg capsules t.i.d. Indomethacin extended-release capsules may be substituted for all the indications of indomethacin capsules except acute gouty arthritis.
Adverse reactions appear to correlate with the size of the dose of indomethacin in most patients, but not all. Therefore, every effort should be made to determine the smallest effective dosage for the individual patient.
Always give indomethacin extended-release capsules 75 mg with food, immediately after meals or with antacids to reduce gastric irritation.
Pediatric Use
: Indomethacin ordinarily should not be prescribed for children 14 years of age and under (see
WARNINGS
).
Adult Use
: Dosage Recommendations for Active Stages of the Following:
1. Moderate to severe rheumatoid arthritis, including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis.
The following information is provided as background only and refers to immediate-release indomethacin capsules (25 mg or 50 mg):
Suggested Dosage
:
The following recommendations on dosing pertain to immediate-release indomethacin capsules, and provide important information regarding the dosage and administration of indomethacin. The prescriber should be aware of this information when considering and prescribing extended-release indomethacin.
Indomethacin capsules 25 mg b.i.d. or t.i.d. If this is well tolerated, increase the daily dosage by 25 or 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. DOSES ABOVE THIS AMOUNT GENERALLY DO NOT INCREASE THE EFFECTIVENESS OF THE DRUG.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime, either orally or by rectal suppositories, may be helpful in affording relief. The total daily dose should not exceed 200 mg. In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily.
The following information refers to Extended-release Indomethacin Capsules (75 mg):
If indomethacin extended-release capsules are used for initiating indomethacin treatment, one capsule daily should be the usual starting dose in order to observe patient tolerance since 75 mg per day is the maximum recommended starting dose for indomethacin (see above). If indomethacin extended-release capsules are used to increase the daily dose, patients should be observed for possible signs and symptoms of intolerance since the daily increment will exceed the daily increment recommended for other dosage forms. For patients who require 150 mg of indomethacin per day and have demonstrated acceptable tolerance, indomethacin extended-release capsules 75 mg may be prescribed as one capsule twice daily.
If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and OBSERVE THE PATIENT CLOSELY.
If severe adverse reactions occur, STOP THE DRUG. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions.
As advancing years appear to increase the possibility of adverse reactions, indomethacin extended-release capsules should be used with greater care in the aged.
2. Acute painful shoulder (bursitis and/or tendinitis). Initial Dose: 75 mg to 150 mg daily. When 150 mg is prescribed, give as one capsule twice daily.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days.
![Indomethacin Capsule [Avpak]](http://www.recallguide.org/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Indomethacin Capsule [Proficient Rx Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=86157467-356b-4cb7-abb0-14cdee045f9c&name=Bottle.jpg)
![Indomethacin Capsule [Blenheim Pharmacal, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=119174f1-af2f-355d-e054-00144ff8d46c&name=LABEL_INDOMETHACINCAPS50MG_BPI(10544-216-21)_MYLAN(0378-0147-050)_REV0.jpg)
![Indomethacin Capsule [Direct Rx]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7e7175d7-5e43-4151-9702-88ac2cd44ef6&name=label2.jpg)
![Indomethacin Capsule [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d2997707-1541-4f5d-8c8d-70b0a13be8b2&name=50090-0050-0.jpg)
![Indomethacin Capsule [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7755391e-ede3-4a32-854c-736dc6dd2ee3&name=50090-0054-1.jpg)
![Indomethacin Capsule [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5b05b8bc-4df0-4175-bf53-72129fb21b50&name=50090-0051-0.jpg)
![Indomethacin Capsule [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=175a2d81-0d0f-46a3-aaaa-1732982d85fd&name=50090-0055-0.jpg)
![Indomethacin Capsule [Proficient Rx Lp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6c737ff7-3e1e-429b-9752-6ed617366d59&name=btl-lbl-10mg-12-5mg-100s.jpg)
![Indomethacin Capsule [Contract Pharmacy Services-pa]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3d5df05a-f4af-48d8-b880-97dfb92e900c&name=3d5df05a-f4af-48d8-b880-97dfb92e900c-02.jpg)
![Indomethacin Capsule [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b9e8ab78-ae95-4036-b756-84b0d6ef2fac&name=INDOMETHACIN25MGLABEL129.jpg)
![Indomethacin Capsule [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5e211b18-8cdc-42ab-8756-4ce2dd94925c&name=75mgpackagelabel.jpg)
![Indomethacin Capsule [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4755e174-f5d7-451a-9649-46222a6dfced&name=4755e174-f5d7-451a-9649-46222a6dfced-02.jpg)
![Indomethacin Capsule, Extended Release [Amneal Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e015506e-057d-471c-8f04-eb7b5d637a29&name=43063606.jpg)
![Indomethacin Capsule [Hetero Drugs Ltd.,]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=110aada7-dfe8-4ecf-80c7-4dac8907ad29&name=25mg30scount.jpg)
![Indomethacin (Indomethacin) Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=197c0496-3910-44ed-b8fb-df01b0f925a8&name=MM2.jpg)
![Indomethacin Capsule [Redpharm Drug Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=50df5188-358e-4e59-b7d0-1dcec98c2ab0&name=67296-0527-1.jpg)
![Indomethacin Capsule [Redpharm Drug Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4077592a-8790-4d45-8cb6-2c95a0a929de&name=67296-0560-1.jpg)
![Indomethacin Capsule [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=58ae8e0c-5555-4702-a61f-dde7d396a6db&name=25mgpackagelabel.jpg)
![Indomethacin (Indomethacin) Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dfd184f0-2e52-454c-8ef2-3153be7dd4c9&name=MM2.jpg)
![Indomethacin (Indomethacin) Suppository [G & W Laboratories, Inc.]](http://recallguide.cwdevelopsp.com/wp-content/themes/recallguide/assets/img/drug-image-placeholder.jpg)
![Indomethacin Capsule, Extended Release [Eon Labs, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2ec547bc-355c-42d4-a197-72e652c212de&name=hepatamine-in-glass-4.jpg)
![Indomethacin Capsule, Extended Release [Dispensing Solutions, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=29a6b41c-accb-4b12-92d1-cda19c2148a5&name=NDC66336-0687-XX------AMNEAL.jpg)
![Indomethacin Capsule [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1f60d27b-fa95-40dd-969f-51f977142032&name=622ac159-4d19-4c4a-95e2-c3757abf5102-04.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c149ba5c-4c25-426a-a172-6ac3b899cbe3&name=MM2.jpg)
![Indomethacin Capsule [Camber Pharmaceuticals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1ce9c3c5-0cf7-4760-988d-2559adcfb200&name=8c496175-figure-01.jpg)
![Indomethacin Capsule [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=549dba03-10c5-4da8-b893-336a6f4ded20&name=55289147.jpg)
![Indomethacin Capsule, Extended Release [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=570faaad-3e3e-4b89-9f9a-37c90c20a5d9&name=indomethaciner75mgamneal.jpg)
![Indomethacin Capsule [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=564a6f8a-1f80-41e5-90f2-c2f07172130c&name=indomethacin50mg30emcure.jpg)
![Indomethacin Capsule, Extended Release [Paddock Laboratories, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3ea8f628-53f5-41f7-aad3-10ab7d11fd3a&name=948b423d-0f5d-4bfc-bbda-4aab8c91f78d-02.jpg)
![Indomethacin Capsule [Glenmark Generics Inc., Usa]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c25d21e7-6136-4a7a-b139-12f53116fc3d&name=image-01.jpg)
![Indomethacin Capsule, Extended Release [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=41f58ecc-abce-46cc-b18d-1acea74cfa39&name=MM2.jpg)
![Indomethacin Capsule [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b4cf01d1-0d71-4f0f-97a5-07a59744149f&name=43063368.jpg)
![Indomethacin Capsule [Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b5e53529-e370-4916-a23c-8c9d945f971c&name=Indomethacin50mgGlenmark.jpg)
![Indomethacin Capsule [Mylan Institutional Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5647b6ca-5620-4ec4-b364-ce3b8f1e634b&name=image-01.jpg)
![Indomethacin Capsule [Pd-rx Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=b463cd5f-299a-45f8-a1b3-c9e7fe271955&name=55289663.jpg)
![Indomethacin Capsule, Extended Release [Kvk-tech, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dc80228c-acae-44dc-9762-19bd1669bf45&name=12229472-figure-01.jpg)
![Indomethacin (Indomethacin ) Capsule, Extended Release [Camber Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=12f62bae-5fc0-4f8d-a8b4-446524bd53d1&name=75mg30s.jpg)
![Indomethacin Capsule [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=97742638-f888-0020-f9a0-088b42a625a0&name=label1datamaxfda425.jpg)
![Indomethacin Capsule [Sandoz Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=57c11bb8-d133-43e2-a74f-838c31296eb5&name=4a6cd6dc-d3bd-458a-a02e-19ac3dbccf75-02.jpg)
![Indomethacin Capsule [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9f082d89-d218-49e0-8fcb-0000b5eb04a5&name=4f5f9977-2a78-4bf1-8e14-20dd24a119b4-04.jpg)
![Indomethacin Capsule [Rebel Distributors Corp]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4b8dbfb7-5f20-4398-937a-72ed536c57c4&name=4b8dbfb7-5f20-4398-937a-72ed536c57c4-02.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=74914fe0-6fe1-433b-80f2-b64fb8bb52e9&name=MM2.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=73912f56-94a3-443b-a31a-8a246c411a08&name=MM2.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=417d7843-a3ab-4dcd-8b0e-11fae266b41b&name=MM5.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=71e67d09-0669-473c-8a33-c895803ee510&name=MM2.jpg)
![Indomethacin Capsule [Caraco Pharmaceutical Laboratories, Ltd.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c70b5045-706e-443a-9be1-d0bc3c598130&name=indomethacin25mg.jpg)
![Indomethacin Capsule [Lake Erie Medical Dba Quality Care Products Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ad71bdc6-b47f-441c-9d05-279b3d81b975&name=Indomethacin25mgEmcure.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8280103a-b1c0-4a3c-bc7b-ddd0a1088924&name=MM2.jpg)
![Indomethacin Capsule, Extended Release [A-s Medication Solutions Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=8df87c64-32fd-4764-9596-4ec406db7f6d&name=12229472-figure-01.jpg)
![Indomethacin Capsule [Medvantx, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=877417ef-7706-44cf-a8a7-1fec3e7a0266&name=877417ef-7706-44cf-a8a7-1fec3e7a0266-05.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2768df38-aadd-4151-aae8-b7f221a45071&name=MM4.jpg)
![Indomethacin Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dd5caa3f-3c09-4034-bf43-2df80c61c07b&name=indomethacin-for-injection-figure-3-prx605903-vial.jpg)
![Indomethacin Capsule [Unit Dose Services]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cc215f27-8fd5-4625-93ff-8a852d4a652b&name=50436-0875.jpg)
![Indomethacin Capsule [Stat Rx Usa Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d3c9e8ef-422a-4657-a4f9-2a668905515f&name=INDONEMTHACIN50MGLABEL130.jpg)
![Indomethacin Capsule [Liberty Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=e3f4420e-0052-4dbd-bb4b-7e7b76dc71ea&name=indomethacin-25-mg-30-caps-for-mylan-2.jpg)
![Indomethacin Capsule, Extended Release [Actavis Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d470bb9f-960c-4782-a96b-e7eff6b14670&name=indomethacin-3.jpg)
![Indomethacin Capsule, Extended Release [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a7789269-28a0-4058-848d-9f014db12c6d&name=MM2.jpg)
![Indomethacin Capsule, Extended Release [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ca36d1da-661a-49b8-87bd-31be1b965929&name=MM2.jpg)
![Indomethacin Capsule [Preferred Pharmaceuticals, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d3f12dab-1802-4d6a-9f90-6359e6b24565&name=image-01.jpg)
![Indomethacin Capsule [Teva Pharmaceuticals Usa Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=902a3c6b-2625-44ec-a077-926e012b3176&name=f2d3e3bb-ed96-4ff6-a862-ed72973e4d0b-02.jpg)
![Indomethacin Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=30e38747-c553-4e2d-bc23-634e1dd90b8d&name=indomethacin-for-injection-figure-3-np605903-vial.jpg)
![Indomethacin Capsule [Heritage Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4babe1c2-15f2-40af-b326-b256507a921c&name=c0ed1c71-figure-01.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cd17444b-88cc-4c7c-9d8b-d90482f73824&name=MM2.jpg)
![Indomethacin Capsule [Cardinal Health]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=3721e946-6f15-43bc-a4ca-aeb3788dac30&name=image-02.jpg)
![Indomethacin Capsule [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=603bc652-31c6-4d50-bb80-e6da5289a3c7&name=88c2182e-7810-4f44-be62-d702e30ad6c3-02.jpg)
![Indomethacin Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ec482425-358c-4500-8f5d-79c1379c1fa8&name=indomethacin-for-injection-figure-3-605903-vial.jpg)
![Indomethacin Capsule [Clinical Solutions Wholesale]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=319c7e12-bcbf-447b-9861-92d367a20182&name=319c7e12-bcbf-447b-9861-92d367a20182-05.jpg)
![Indomethacin Capsule [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1db9d6d7-c53f-5675-5f81-056800ed3875&name=label1datamaxfda378.jpg)
![Indomethacin Capsule [Remedyrepack Inc. ]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=2f82e669-8c91-4b07-adc4-7d64f0ec657a&name=MM2.jpg)
![Indomethacin Capsule, Extended Release [Bryant Ranch Prepack]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=c7eb8830-21c0-6e63-3e3a-c13de600faee&name=label1datamaxfda396.jpg)
![Indomethacin Capsule [Direct Rx]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=aa443877-b407-4ace-b162-9b2a3c89dc93&name=label25MG.jpg)
![Indomethacin Capsule, Extended Release [Avpak]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
Login To Your Free Account