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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
liver disease.
taking the blood thinning drug warfarin.
- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
liver disease.
Ask a doctor or pharmacist before use if the user istaking the blood thinning drug warfarin.
Stop use and ask a doctor if- Pain gets worse or lasts more than 10 days in adults and children
- Pain gets worse or lasts more than 5 days in children under 12 years
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Redness or swelling is present
These could be signs of a serious condition.
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 the temporary relief of minor aches and pains due to:
- Headache
- Muscular aches
- Backache
- Minor pain of arthritis
- The common cold
- Toothache
- Premenstrual and menstrual cramps
Temporarily reduces fever.
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Metformin Hydrochloride Er Manufacturers
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Golden State Medical Supply, Inc.
Metformin Hydrochloride Er | Gemini Pharmaceuticals, Inc. Dba Plus Pharma
Do not take more than directed
AGE DOSE Adults and Children 12 years and over Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6 - 11 years Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours Children under 6 years Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.
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Nivagen Pharmaceuticals Inc
Metformin Hydrochloride Er | Nivagen Pharmaceuticals Inc
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride extended release tablets USP or any other pharmacologic agent. Dosage of metformin hydrochloride extended release tablets USP must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily doses. The maximum recommended daily dose of metformin hydrochloride extended release tablets USP in adults is 2000 mg.
Metformin hydrochloride extended release tablets USP should generally be given once daily with the evening meal. Metformin hydrochloride extended release tablets USP should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient.
During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride extended release tablets USP and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride extended release tablets USP, either when used as monotherapy or in combination with sulfonylurea or insulin.
Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of metformin hydrochloride extended release tablets USP may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
Metformin hydrochloride extended release tablets USP must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin hydrochloride extended release tablets USP will be eliminated in the feces as a soft, hydrated mass. (See Patient Information printed below.)
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Northwind Pharmaceuticals
Metformin Hydrochloride Er | Northwind Pharmaceuticals
There is no fixed dosage regimen for the management of hyperglycemia in patients with type 2 diabetes with metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP or any other pharmacologic agent. Dosage of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP must be individualized on the basis of both effectiveness and tolerance, while not exceeding the maximum recommended daily dose. The maximum recommended daily dose of metformin hydrochloride tablets, USP is 2550 mg in adults and 2000 mg in pediatric patients (10-16 years of age); the maximum recommended daily dose of metformin hydrochloride extended-release tablets, USP in adults is 2000 mg.
Metformin hydrochloride tablets, USP should be given in divided doses with meals while metformin hydrochloride extended-release tablets, USP should generally be given once daily with the evening meal. Metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP should be started at a low dose, with gradual dose escalation, both to reduce gastrointestinal side effects and to permit identification of the minimum dose required for adequate glycemic control of the patient. During treatment initiation and dose titration (see Recommended Dosing Schedule), fasting plasma glucose should be used to determine the therapeutic response to metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP and identify the minimum effective dose for the patient. Thereafter, glycosylated hemoglobin should be measured at intervals of approximately three months. The therapeutic goal should be to decrease both fasting plasma glucose and glycosylated hemoglobin levels to normal or near normal by using the lowest effective dose of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP, either when used as monotherapy or in combination with sulfonylurea or insulin.
Monitoring of blood glucose and glycosylated hemoglobin will also permit detection of primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication, and secondary failure, i.e., loss of an adequate blood glucose lowering response after an initial period of effectiveness.
Short-term administration of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP may be sufficient during periods of transient loss of control in patients usually well-controlled on diet alone.
Metformin hydrochloride extended-release tablets, USP must be swallowed whole and never crushed or chewed. Occasionally, the inactive ingredients of metformin hydrochloride extended-release will be eliminated in the feces as a soft, hydrated mass. (See Patient Information printed separately.)
Recommended Dosing Schedule
Adults - In general, clinically significant responses are not seen at doses below 1500 mg per day. However, a lower recommended starting dose and gradually increased dosage is advised to minimize gastrointestinal symptoms.
The usual starting dose of metformin hydrochloride tablets, USP is 500 mg twice a day or 850 mg once a day, given with meals. Dosage increases should be made in increment of 500 mg weekly or 850 mg every 2 weeks, up to a total of 2000 mg per day, given in divided doses. Patients can also be titrated from 500 mg twice a day to 850 mg twice a day after 2 weeks. For those patients requiring additional glycemic control, metformin hydrochloride tablets, USP may be given to a maximum daily dose of 2550 mg per day. Doses above 2000 mg may be better tolerated given three times a day with meals.
The usual starting dose of metformin hydrochloride extended-release tablets, USP is 500 mg once daily with the evening meal. Dosage increases should be made in increments of 500 mg weekly, up to a maximum of 2000 mg once daily with the evening meal. If glycemic control is not achieved on metformin hydrochloride extended-release tablets, USP 2000 mg once daily, a trial of metformin hydrochloride extended-release tablets, USP 1000 mg twice daily should be considered. If higher doses of metformin hydrochloride tablets, USP are required, metformin hydrochloride tablets, USP should be used at total daily doses up to 2550 mg administered in divided daily doses, as described above. (See CLINICAL PHARMACOLOGY, Clinical Studies.)
In a randomized trial, patients currently treated with metformin hydrochloride tablets, USP were switched to metformin hydrochloride extended-release tablets, USP. Results of this trial suggest that patients receiving metformin hydrochloride tablets, USP treatment may be safely switched to metformin hydrochloride extended-release tablets, USP once daily at the same total daily dose, up to 2000 mg once daily. Following a switch from metformin hydrochloride tablets, USP to metformin hydrochloride extended-release tablets, USP glycemic control should be closely monitored and dosage adjustments made accordingly (see CLINICAL PHARMACOLOGY, Clinical Studies).
Pediatrics - The usual starting dose of metformin hydrochloride tablets, USP is 500 mg twice a day, given with meals. Dosage increases should be made in increments of 500 mg weekly up to a maximum of 2000 mg per day, given in divided doses. Safety and effectiveness of metformin hydrochloride extended-release tablets, USP in pediatric patients have not been established.
Transfer from Other Antidiabetic Therapy
When transferring patients from standard oral hypoglycemic agents other than chlorpropamide to metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP no transition period generally is necessary. When transferring patients from chlorpropamide, care should be exercised during the first two weeks because of the prolonged retention of chlorpropamide in the body, leading to overlapping drug effects and possible hypoglycemia.
Concomitant Metformin Hydrochloride Tablets, USP or Metformin Hydrochloride Extended-release Tablets, USP and Oral Sulfonylurea Therapy in Adult Patients
If patients have not responded to four weeks of the maximum dose of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP monotherapy, consideration should be given to gradual addition of an oral sulfonylurea while continuing metformin hydrochloride tablets, USP or metformin hydrochloride extendedrelease tablets, USP at the maximum dose, even if prior primary or secondary failure to a sulfonylurea has occurred. Clinical and pharmacokinetic drug-drug interaction data are currently available only for metformin plus glyburide (glibenclamide).
With concomitant metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP and sulfonylurea therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. In a clinical trial of patients with type 2 diabetes and prior failure on glyburide, patients started on metformin hydrochloride tablets, USP 500 mg and glyburide 20 mg were titrated to 1000/20mg, 1500/20 mg, 2000/20 mg or 2500/20 mg of metformin hydrochloride tablets, USP and glyburide, respectively, to reach the goal of glycemic control as measured by FPG, HbA1c and plasma glucose response (see CLINICAL PHARMACOLOGY: Clinical Studies). However, attempts should be made to identify the minimum effective dose of each drug to achieve this goal. With concomitant metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP and sulfonylurea therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken. (See Package Insert of the respective sulfonylurea.)
If patients have not satisfactorily responded to one to three months of concomitant therapy with the maximum dose of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP and the maximum dose of an oral sulfonylurea, consider therapeutic alternatives including switching to insulin with or without metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP.
Concomitant Metformin Hydrochloride Tablets, USP or Metformin Hydrochloride Extended-release Tablets, USP and Insulin Therapy in Adult Patients
The current insulin dose should be continued upon initiation of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP therapy. Metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP should be initiated at 500 mg once daily in patients on insulin therapy. For patients not responding adequately, the dose of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP should be increased by 500 mg after approximately 1 week and by 500 mg every week thereafter until adequate glycemic control is achieved. The maximum recommended daily dose is 2500 mg for metformin hydrochloride tablets, USP and 2000 mg for metformin hydrochloride extended-release tablets, USP. It is recommended that the insulin dose be decreased by 10% to 25% when fasting plasma glucose concentrations decrease to less than 120 mg/dL in patients receiving concomitant insulin and metformin hydrochloride tablets, USP or metformin hydrochlorideextended-release tablets, USP. Further adjustment should be individualized based on glucose-lowering response.
Specific Patient Populations
Metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP are not recommended for use in pregnancy. Metformin hydrochloride tablets, USP are not recommended in patients below the age of 10 years. Metformin hydrochloride extended-release tablets, USP are not recommended in pediatric patients (below the age of 17 years).
The initial and maintenance dosing of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment should be based on a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of metformin hydrochloride tablets, USP or metformin hydrochloride extended-release tablets, USP.
Monitoring of renal function is necessary to aid in prevention of lactic acidosis, particularly in the elderly. (See WARNINGS.)
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Northwind Pharmaceuticals
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