Methylphenidate Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
Children and Adolescents – Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
Adults – Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs.
Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia.
Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation.
Pre-Existing Psychosis – Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
Bipolar Illness – Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
Emergence of New Psychotic or Manic Symptoms – Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
Aggression – Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of or worsening of aggressive behavior or hostility.
There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Priapism
Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism has also appeared during a period of drug withdrawal (drug holidays or discontinuation): Patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
Peripheral Vasculopathy, Including Raynaud’s Phenomenon
Stimulants, including Methylphenidate Hydrochloride Chewable Tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.
Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children over 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e., treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development.
Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
USE IN CHILDREN LESS THAN SIX YEARS OF AGE
Methylphenidate Hydrochloride Chewable Tablets should not be used in children under six years, since safety and efficacy in this age group have not been established.
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
Attention Deficit Disorders, Narcolepsy
Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.
Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics.
Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.
History
There is currently no drug history available for this drug.
Other Information
Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is freely soluble in water, alcohol, and chloroform.
Each Methylphenidate Hydrochloride Chewable Tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Chewable Tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid.
Sources
Methylphenidate Hydrochloride Manufacturers
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Gavis Pharmaceuticals, Llc
![Methylphenidate Hydrochloride Tablet, Chewable [Gavis Pharmaceuticals, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Methylphenidate Hydrochloride | Gavis Pharmaceuticals, Llc
Dosage should be individualized according to the needs and responses of the patient.
Directions – Take this product (child or adult dose) with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning.
AdultsAdminister in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Children (6 years and over)Methylphenidate Hydrochloride Chewable Tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Chewable Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate Hydrochloride Chewable Tablets should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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American Health Packaging
Methylphenidate Hydrochloride | American Health Packaging
Methylphenidate capsules (CD) are administered once daily in the morning, before breakfast.
Methylphenidate capsules (CD) may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g., water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed (see PRECAUTIONS, Information for Patients). Patients should be advised to avoid alcohol while taking methylphenidate capsules (CD).
Dosage should be individualized according to the needs and responses of the patient.
Initial TreatmentThe recommended starting dose of methylphenidate capsules (CD) is 20 mg once daily. Dosage may be adjusted in weekly 10 to 20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended.
Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate capsules (CD). It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use methylphenidate capsules (CD) for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose Reduction and DiscontinuationIf paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
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American Health Packaging
Methylphenidate Hydrochloride | American Health Packaging
Administration of DoseMethylphenidate hydrochloride extended-release capsules (LA) are for oral administration once daily in the morning. Methylphenidate hydrochloride extended-release capsules (LA) may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules (LA) and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Patients should be advised to avoid alcohol while taking methylphenidate hydrochloride extended-release capsules (LA).
Dosing RecommendationsDosage should be individualized according to the needs and responses of the patients.
Initial Treatment
The recommended starting dose of methylphenidate hydrochloride extended-release capsules (LA) is 20 mg once daily. Dosage may be adjusted in weekly 10 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending on tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended. When in the judgement of the clinician a lower initial dose is appropriate, patients may begin treatment with methylphenidate hydrochloride extended-release capsules (LA) 10 mg.Patients Currently Receiving Methylphenidate
Previous Methylphenidate Dose Recommended Methylphenidate Hydrochloride Extended-Release Capsule (LA) Dose
The recommended dose of methylphenidate hydrochloride extended-release capsules (LA) for patients currently taking methylphenidate b.i.d. or sustained release (SR) is provided below.5 mg methylphenidate b.i.d.
10 mg q.d.
10 mg methylphenidate b.i.d.or 20 mg methylphenidate SR
20 mg q.d.
15 mg methylphenidate b.i.d.
30 mg q.d.
20 mg methylphenidate b.i.d.or 40 mg of methylphenidate SR
40 mg q.d.
30 mg methylphenidate b.i.d.or 60 mg methylphenidate SR
60 mg q.d.
For other methylphenidate regimens, clinical judgment should be used when selecting the starting dose. Methylphenidate hydrochloride extended-release capsule (LA) dosage may be adjusted at weekly intervals in 10 mg increments. Daily dosage above 60 mg is not recommended.
Maintenance/Extended Treatment
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate hydrochloride extended-release capsules (LA). It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use methylphenidate hydrochloride extended-release capsules (LA) for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.Dose Reduction and Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued. If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued. -
Upstate Pharma, Llc
Methylphenidate Hydrochloride | Upstate Pharma, Llc
Dosage should be individualized according to the needs and responses of the patient.
Adults TabletsAdminister in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Extended-Release TabletsMethylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
Children (6 Years And Over)Methylphenidate hydrochloride tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
TabletsStart with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Extended-Release TabletsMethylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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Qualitest Pharmaceuticals
Methylphenidate Hydrochloride | Glaxosmithkline Llc
Adults and Children 12 Years of Age and Older:The usual dosage is 1 or 2 nasal inhalations (42 to 84 mcg) in each nostril twice a day (total dose, 168 to 336 mcg/day).
Children 6 to 12 Years of Age:Patients should be started with 1 nasal inhalation in each nostril twice daily; patients not adequately responding to 168 mcg or those with more severe symptoms may use 336 mcg (2 inhalations in each nostril). Once adequate control is achieved, the dosage should be decreased to 84 mcg (1 spray in each nostril) twice daily. BECONASE AQ Nasal Spray is not recommended for children below 6 years of age.
The maximum total daily dosage should not exceed 2 sprays in each nostril twice daily (336 mcg/day).
In patients who respond to BECONASE AQ Nasal Spray, an improvement of the symptoms of seasonal or perennial rhinitis usually becomes apparent within a few days after the start of therapy with BECONASE AQ Nasal Spray. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement.
The therapeutic effects of corticosteroids, unlike those of decongestants, are not immediate. This should be explained to the patient in advance in order to ensure cooperation and continuation of treatment with the prescribed dosage regimen.
In the presence of excessive nasal mucous secretion or edema of the nasal mucosa, the drug may fail to reach the site of intended action. In such cases it is advisable to use a nasal vasoconstrictor during the first 2 to 3 days of therapy with BECONASE AQ Nasal Spray.
Directions for Use:Illustrated Patient’s Instructions for Use accompany each package of BECONASE AQ Nasal Spray.
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Physicians Total Care, Inc.
Methylphenidate Hydrochloride | Physicians Total Care, Inc.
Dosage should be individualized according to the needs and responses of the patient.
Adults TabletsAdminister in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Extended-Release TabletsMethylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
Children (6 years and over)Methylphenidate hydrochloride tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
TabletsStart with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Extended-Release TabletsMethylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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Bryant Ranch Prepack
Methylphenidate Hydrochloride | Bryant Ranch Prepack
Dosage should be individualized according to the needs and responses of the patient.
Adults
Tablets: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Extended-Release Tablets: Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
Children (6 years and over)
Methylphenidate hydrochloride tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Extended-Release Tablets: Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty
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Physicians Total Care, Inc.
Methylphenidate Hydrochloride | Physicians Total Care, Inc.
2.1 General Dosing InformationMethylphenidate HCl Extended-Release Tablets should be administered orally once daily in the morning with or without food.
Methylphenidate HCl Extended-Release Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17)].
2.2 Patients New to MethylphenidateThe recommended starting dose of Methylphenidate HCl Extended-Release Tablets for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).
TABLE 1. Methylphenidate HCl Extended-Release Tablets Recommended Starting Doses and Dose Ranges Patient Age Recommended Starting Dose Dose Range Children 6–12 years of age 18 mg/day 18 mg – 54 mg/day Adolescents 13–17 years of age 18 mg/day 18 mg – 72 mg/day
not to exceed 2 mg/kg/day Adults 18–65 years of age 18 or 36 mg/day 18 mg – 72 mg/day 2.3 Patients Currently Using MethylphenidateThe recommended dose of Methylphenidate HCl Extended-Release Tablets for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.
TABLE 2. Recommended Dose Conversion from Methylphenidate Regimens to Methylphenidate HCl Extended-Release Tablets Previous Methylphenidate Daily Dose Recommended Methylphenidate HCl Extended-Release Tablets Starting Dose 5 mg Methylphenidate twice daily or three times daily 18 mg every morning 10 mg Methylphenidate twice daily or three times daily 36 mg every morning 15 mg Methylphenidate twice daily or three times daily 54 mg every morning 20 mg Methylphenidate twice daily or three times daily 72 mg every morningOther methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.
2.4 Dose TitrationDoses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.
A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.
2.5 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Methylphenidate HCl Extended-Release Tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.
The effectiveness of Methylphenidate HCl Extended-Release Tablets for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Methylphenidate HCl Extended-Release Tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.6 Dose Reduction and DiscontinuationIf paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
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Golden State Medical Supply, Inc.
Methylphenidate Hydrochloride | Golden State Medical Supply, Inc.
Dosage should be individualized according to the needs and responses of the patient.
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Teva Pharmaceuticals Usa Inc
Methylphenidate Hydrochloride | Teva Pharmaceuticals Usa Inc
Administration of DoseMethylphenidate hydrochloride extended-release capsules are for oral administration once daily in the morning. Methylphenidate hydrochloride extended-release capsules may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the pellets sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use.
Dosing RecommendationsDosage should be individualized according to the needs and responses of the patients.
Initial TreatmentThe recommended starting dose of methylphenidate hydrochloride extended-release capsules is 20 mg once daily. Dosage may be adjusted in weekly 10 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending on tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended. When in the judgement of the clinician a lower initial dose is appropriate, patients may begin treatment with methylphenidate hydrochloride extended-release capsules 10 mg.
Patients Currently Receiving MethylphenidateThe recommended dose of methylphenidate hydrochloride extended-release capsules for patients currently taking methylphenidate b.i.d. or sustained release (SR) is provided below.
Previous Methylphenidate Dose Recommended Methylphenidate Hydrochloride Extended-Release Capsules Dose 5 mg methylphenidate b.i.d. 10 mg q.d.10 mg methylphenidate b.i.d.
or 20 mg methylphenidate-SR 20 mg q.d. 15 mg methylphenidate b.i.d. 30 mg q.d.20 mg methylphenidate b.i.d.
or 40 mg of methylphenidate-SR 40 mg q.d.30 mg methylphenidate b.i.d.
or 60 mg methylphenidate-SR 60 mg q.d.For other methylphenidate regimens, clinical judgment should be used when selecting the starting dose. Methylphenidate hydrochloride extended-release capsule dosage may be adjusted at weekly intervals in 10 mg increments.
Daily dosage above 60 mg is not recommended.
Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate hydrochloride extended-release capsules. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use methylphenidate hydrochloride extended-release capsules for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Dose Reduction and DiscontinuationIf paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
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Lake Erie Medical Dba Quality Care Products Llc
Methylphenidate Hydrochloride | Lake Erie Medical Dba Quality Care Products Llc
There is currently no dosage information available for this product. We apologize for any inconvenience.
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Bryant Ranch Prepack
Methylphenidate Hydrochloride | Bryant Ranch Prepack
Dosage should be individualized according to the needs and responses of the patient.
AdultsTablets: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Sustained-release Tablets: Methylphenidate hydrochloride sustained-release tablets have a duration of action of approximately 8 hours. Therefore, methylphenidate hydrochloride sustained-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of methylphenidate hydrochloride sustained-release corresponds to the titrated 8-hour dosage of Methylphenidate hydrochloride . Methylphenidate hydrochloride sustained-release tablets must be swallowed whole and never crushed or chewed.
Children (6 years and over)Methylphenidate hydrochloride should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Sustained-release Tablets: Methylphenidate hydrochloride sustained-release tablets have a duration of action of approximately 8 hours. Therefore, methylphenidate hydrochloride sustained-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of methylphenidate hydrochloride sustained-release corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride. Methylphenidate hydrochloride sustained-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate hydrochloride should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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Kremers Urban Pharmaceuticals Inc.
Methylphenidate Hydrochloride | Pernix Therapeutics
2.1 Dosage in AdultsThe recommended dosage for adults is 1 tablet of TREXIMET 85/500 mg. TREXIMET 85/500 mg contains a dose of sumatriptan higher than the lowest effective dose. The choice of the dose of sumatriptan, and of the use of a fixed combination such as in TREXIMET 85/500 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan with the potential for a greater risk of adverse reactions.
The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart.
The safety of treating an average of more than 5 migraine headaches in adults in a 30-day period has not been established.
2.2 Dosage in Pediatric Patients 12 to 17 Years of AgeThe recommended dosage for pediatric patients 12 to 17 years of age is 1 tablet of TREXIMET 10/60 mg.
The maximum recommended dosage in a 24-hour period is 1 tablet of TREXIMET 85/500 mg.
The safety of treating an average of more than 2 migraine headaches in pediatric patients in a 30-day period has not been established.
2.3 Dosing in Patients with Hepatic ImpairmentTREXIMET is contraindicated in patients with severe hepatic impairment [see Contraindications (4), Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
In patients with mild to moderate hepatic impairment, the recommended dosage in a 24-hour period is 1 tablet of TREXIMET 10/60 mg [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
2.4 Administration InformationTREXIMET may be administered with or without food. Tablets should not be split, crushed, or chewed.
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Teva Pharmaceuticals Usa Inc
Methylphenidate Hydrochloride | Better Living Brands, Llc
take with a glass of wateradults and children 12 years and over
take 1 to 3 tablets
in a single daily dose children 6 to under 12 years of age take 1 tablet in a single daily dose children under 6 years of age ask a doctor
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Actavis South Atlantic Llc
Methylphenidate Hydrochloride | Actavis South Atlantic Llc
Administration of DoseMethylphenidate hydrochloride extended-release capsules (LA) are for oral administration once daily in the morning. Methylphenidate hydrochloride extended-release capsules (LA) may be swallowed as whole capsules or alternatively may be administered by sprinkling the capsule contents on a small amount of applesauce (see specific instructions below). Methylphenidate hydrochloride extended-release capsules (LA) and/or their contents should not be crushed, chewed, or divided.
The capsules may be carefully opened and the beads sprinkled over a spoonful of applesauce. The applesauce should not be warm because it could affect the modified release properties of this formulation. The mixture of drug and applesauce should be consumed immediately in its entirety. The drug and applesauce mixture should not be stored for future use. Patients should be advised to avoid alcohol while taking methylphenidate hydrochloride extended-release capsules (LA).
Dosing RecommendationsDosage should be individualized according to the needs and responses of the patients.
Initial Treatment
The recommended starting dose of methylphenidate hydrochloride extended-release capsules (LA) is 20 mg once daily. Dosage may be adjusted in weekly 10 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending on tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended. When in the judgement of the clinician a lower initial dose is appropriate, patients may begin treatment with methylphenidate hydrochloride extended-release capsules (LA) 10 mg.Patients Currently Receiving Methylphenidate
Previous Methylphenidate Dose Recommended Methylphenidate Hydrochloride Extended-Release Capsule (LA) Dose 5 mg methylphenidate b.i.d. 10 mg q.d. 10 mg methylphenidate b.i.d.or 20 mg methylphenidate SR 20 mg q.d. 15 mg methylphenidate b.i.d. 30 mg q.d. 20 mg methylphenidate b.i.d.or 40 mg of methylphenidate SR 40 mg q.d. 30 mg methylphenidate b.i.d.or 60 mg methylphenidate SR 60 mg q.d.
The recommended dose of methylphenidate hydrochloride extended-release capsules (LA) for patients currently taking methylphenidate b.i.d. or sustained release (SR) is provided below.For other methylphenidate regimens, clinical judgment should be used when selecting the starting dose. Methylphenidate hydrochloride extended-release capsule (LA) dosage may be adjusted at weekly intervals in 10 mg increments. Daily dosage above 60 mg is not recommended.
Maintenance/Extended Treatment
There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate hydrochloride extended-release capsules (LA). It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use methylphenidate hydrochloride extended-release capsules (LA) for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.Dose Reduction and Discontinuation
If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued. If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued. -
Corepharma, Llc
Methylphenidate Hydrochloride | Mylan Pharmaceuticals Inc.
Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibrate capsules and should continue this diet during treatment with fenofibrate capsules. Fenofibrate capsules should be given with meals, thereby optimizing the bioavailability of the medication.
For the treatment of adult patients with primary hypercholesterolemia or mixed hyperlipidemia, the initial dose of fenofibrate capsules is 200 mg per day.
For adult patients with hypertriglyceridemia, the initial dose is 67 to 200 mg per day.
Dosage should be individualized according to patient response and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals. The maximum dose is 200 mg per day.
Treatment with fenofibrate capsules should be initiated at a dose of 67 mg/day in patients having impaired renal function and increased only after evaluation of the effects on renal function and lipid levels at this dose. In the elderly, the initial dose should likewise be limited to 67 mg/day.
Lipid levels should be monitored periodically and consideration should be given to reducing the dosage of fenofibrate capsules if lipid levels fall significantly below the targeted range.
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Unither Manufacturing, Llc
Methylphenidate Hydrochloride | Unither Manufacturing, Llc
Dosage should be individualized according to the needs and responses of the patient.
Adults TabletsAdminister in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Extended-Release TabletsMethylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
Children (6 Years And Over)Methylphenidate hydrochloride tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
TabletsStart with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Extended-Release TabletsMethylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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Sandoz Inc
Methylphenidate Hydrochloride | Sandoz Inc
Dosage should be individualized according to the needs and responses of the patient.
AdultsTablets: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Sustained-Release Tablets: Methylphenidate hydrochloride sustained-release tablets have a duration of action of approximately 8 hours. Therefore, methylphenidate hydrochloride sustained-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of methylphenidate hydrochloride sustained-release corresponds to the titrated 8-hour dosage of Methylphenidate hydrochloride . Methylphenidate hydrochloride sustained-release tablets must be swallowed whole and never crushed or chewed.
Children (6 years and over)Methylphenidate hydrochloride should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.
Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Sustained-Release Tablets: Methylphenidate hydrochloride sustained-release tablets have a duration of action of approximately 8 hours. Therefore, methylphenidate hydrochloride sustained-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of methylphenidate hydrochloride sustained-release corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride. Methylphenidate hydrochloride sustained-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate hydrochloride should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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Mallinckrodt, Inc.
Methylphenidate Hydrochloride | Mallinckrodt, Inc.
Dosage should be individualized according to the needs and responses of the patient.
Tablets: Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to
60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.Extended-Release Tablets: Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, methylphenidate hydrochloride extended-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
Extended-Release Tablets: Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, methylphenidate hydrochloride extended-release tablets may be used in place of methylphenidate hydrochloride tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of methylphenidate hydrochloride tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate hydrochloride tablets and methylphenidate hydrochloride extended-release tablets should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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Actavis Pharma, Inc.
Methylphenidate Hydrochloride | Actavis Pharma, Inc.
2.1 General Dosing InformationMethylphenidate HCl Extended-Release Tablets should be administered orally once daily in the morning with or without food.
Methylphenidate HCl Extended-Release Tablets must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed [see Patient Counseling Information (17)].
2.2 Patients New to MethylphenidateThe recommended starting dose of Methylphenidate HCl Extended-Release Tablets for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults (see Table 1).
Table 1. Methylphenidate HCl Extended-Release Tablets Recommended Starting Doses and Dose Ranges Patient Age Recommended Starting Dose Dose Range Children 6–12 years of age 18 mg/day 18 mg – 54 mg/day Adolescents 13–17 years of age 18 mg/day 18 mg – 72 mg/day
not to exceed 2 mg/kg/day Adults 18–65 years of age 18 or 36 mg/day 18 mg – 72 mg/day 2.3 Patients Currently Using MethylphenidateThe recommended dose of Methylphenidate HCl Extended-Release Tablets for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.
Table 2. Recommended Dose Conversion from Methylphenidate Regimens to Methylphenidate HCl Extended-Release Tablets Previous Methylphenidate Daily Dose Recommended Methylphenidate HCl Extended-Release Tablets Starting Dose 5 mg Methylphenidate twice daily or three times daily 18 mg every morning 10 mg Methylphenidate twice daily or three times daily 36 mg every morning 15 mg Methylphenidate twice daily or three times daily 54 mg every morning 20 mg Methylphenidate twice daily or three times daily 72 mg every morningOther methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.
2.4 Dose TitrationDoses may be increased in 18 mg increments at weekly intervals for patients who have not achieved an optimal response at a lower dose. Daily dosages above 54 mg in children and 72 mg in adolescents have not been studied and are not recommended. Daily dosages above 72 mg in adults are not recommended.
A 27 mg dosage strength is available for physicians who wish to prescribe between the 18 mg and 36 mg dosages.
2.5 Maintenance/Extended TreatmentThere is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with Methylphenidate HCl Extended-Release Tablets. It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods.
The effectiveness of Methylphenidate HCl Extended-Release Tablets for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. The physician who elects to use Methylphenidate HCl Extended-Release Tablets for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient's functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
2.6 Dose Reduction and DiscontinuationIf paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
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American Health Packaging
Methylphenidate Hydrochloride | American Health Packaging
2.1 General Dosing InformationThe recommended adult dosage for ursodiol in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient’s need at the discretion of the physician.
2.2 Liver Function TestsLiver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after start of therapy, and every six months thereafter [see Warnings and Precautions (5.1)].
2.3 Scoring the Ursodiol Tablet USP, 500 mgThe ursodiol 500 mg scored tablet can be broken in halves to provide recommended dosage.
To break ursodiol scored tablet easily, place the tablet on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the scored part of the tablet (groove). Then apply gentle pressure and snap the tablet segments apart (segments breaking incorrectly should not be used). The segments should be washed down unchewed, with water, keeping the segments in the mouth can reveal a bitter taste. Due to the bitter taste, segments should be stored separately from whole tablets. [see How Supplied/Storage and Handling (16.2)].
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Sun Pharmaceutical Industries, Inc.
Methylphenidate Hydrochloride | Sun Pharmaceutical Industries, Inc.
Dosage should be individualized according to the needs and responses of the patient.
AdultsAdminister methylphenidate hydrochloride tablets in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Children (6 years and over)Methylphenidate hydrochloride tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.
Start methylphenidate hydrochloride tablets with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate hydrochloride tablets should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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American Health Packaging
Methylphenidate Hydrochloride | Mylan Pharmaceuticals Inc.
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide extended-release tablets or any other hypoglycemic agent. Glycemic control should be monitored with hemoglobin A1C and/or blood-glucose levels to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Home blood-glucose monitoring may also provide useful information to the patient and physician. Short-term administration of glipizide extended-release tablets may be sufficient during periods of transient loss of control in patients usually controlled on diet.
In general, glipizide extended-release tablets should be given with breakfast.
Recommended DosingThe usual starting dose of glipizide extended-release tablets as initial therapy is 5 mg per day, given with breakfast. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose.
Dosage adjustment should be based on laboratory measures of glycemic control. While fasting blood-glucose levels generally reach steady-state following initiation or change in glipizide extended-release tablets dosage, a single fasting glucose determination may not accurately reflect the response to therapy. In most cases, hemoglobin A1C level measured at 3 month intervals is the preferred means of monitoring response to therapy.
Hemoglobin A1C should be measured as glipizide extended-release tablet therapy is initiated and repeated approximately 3 months later. If the result of this test suggests that glycemic control over the preceding 3 months was inadequate, the glipizide extended-release tablet dose may be increased. Subsequent dosage adjustments should be made on the basis of hemoglobin A1C levels measured at 3 month intervals. If no improvement is seen after 3 months of therapy with a higher dose, the previous dose should be resumed. Decisions which utilize fasting blood glucose to adjust glipizide extended-release tablet therapy should be based on at least two or more similar, consecutive values obtained 7 days or more after the previous dose adjustment.
Most patients will be controlled with 5 mg to 10 mg taken once daily. However, some patients may require up to the maximum recommended daily dose of 20 mg. While the glycemic control of selected patients may improve with doses which exceed 10 mg, clinical studies conducted to date have not demonstrated an additional group average reduction of hemoglobin A1C beyond what was achieved with the 10 mg dose.
Based on the results of a randomized crossover study, patients receiving immediate-release glipizide may be switched safely to glipizide extended-release tablets once-a-day at the nearest equivalent total daily dose. Patients receiving immediate-release glipizide also may be titrated to the appropriate dose of glipizide extended-release tablets starting with 5 mg once daily. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment.
In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions (see PRECAUTIONS section).
Combination UseWhen adding other blood-glucose-lowering agents to glipizide extended-release tablets for combination therapy, the agent should be initiated at the lowest recommended dose, and patients should be observed carefully for hypoglycemia. Refer to the product information supplied with the oral agent for additional information.
When adding glipizide extended-release tablets to other blood-glucose-lowering agents, glipizide extended-release tablets can be initiated at 5 mg. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose. Titration should be based on clinical judgment.
When colesevelam is coadministered with glipizide extended-release tablets, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide extended-release tablets should be administered at least 4 hours prior to colesevelam.
Patients Receiving InsulinAs with other sulfonylurea-class hypoglycemics, many patients with stable type 2 diabetes receiving insulin may be transferred safely to treatment with glipizide extended-release tablets. When transferring patients from insulin to glipizide extended-release tablets, the following general guidelines should be considered:
For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide extended-release tablets therapy may begin at usual dosages. Several days should elapse between titration steps.
For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and glipizide extended-release tablets therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between titration steps.
During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least 3 times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when the patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.
Patients Receiving Other Oral Hypoglycemic AgentsAs with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to glipizide extended-release tablets. Patients should be observed carefully (1 to 2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glipizide extended-release tablets due to potential overlapping of drug effect.
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Avkare, Inc.
Methylphenidate Hydrochloride | Remedyrepack Inc.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally to adults as described in the Dosage Guidelines table.
The determination of dosage for any particular patient must take into consideration the severity and nature of the infection, the susceptibility of the causative organism, the integrity of the patient’s host-defense mechanisms, and the status of renal function and hepatic function.
The duration of treatment depends upon the severity of infection. The usual duration is 7 to 14 days; however, for severe and complicated infections more prolonged therapy may be required. Ciprofloxacin should be administered at least 2 hours before or 6 hours after magnesium/aluminum antacids, or sucralfate, Videx® (didanosine) chewable/buffered tablets or pediatric powder for oral solution, other highly buffered drugs, or other products containing calcium, iron or zinc.
ADULT DOSAGE GUIDELINES Infection Severity Dose Frequency Usual Durations† Urinary Tract
Acute Uncomplicated
250 mg
q 12 h
3 Days
Mild/Moderate
250 mg
q 12 h
7 to 14 Days
Severe/Complicated
500 mg
q 12 h
7 to 14 Days
Chronic Bacterial Prostatits
Mild/Moderate
500 mg
q 12 h
28 Days
Lower Respiratory Tract
Mild/Moderate
500 mg
q 12 h
7 to 14 days
Severe/Complicated
750 mg
q 12 h
7 to 14 days
Acute Sinusitis
Mild/Moderate
500 mg
q 12 h
10 days
Skin and Skin Structure
Mild/Moderate
500 mg
q 12 h
7 to 14 Days
Severe/Complicated
750 mg
q 12 h
7 to 14 Days
Bone and Joint
Mild/Moderate
500 mg
q 12 h
≥4 to 6 weeks
Severe/Complicated
750 mg
q 12 h
≥4 to 6 weeks
Intra-Abdominal*
Complicated
500 mg
q 12 h
7 to 14 Days
Infectious Diarrhea
Mild/Moderate/Severe
500 mg
q 12 h
5 to 7 Days
Typhoid Fever
Mild/Moderate
500 mg
q 12 h
10 Days
Urethral and Cervical
Gonococcal Infections
Uncomplicated
250 mg
single dose
single dose
Inhalational anthrax (post-exposure)**
500 mg
q 12 h
60 Days
Conversion of I.V. to Oral Dosing in Adults:
Patients whose therapy is started with CIPRO I.V. may be switched to Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg when clinically indicated at the discretion of the physician (See
CLINICAL PHARMACOLOGY
and table below for the equivalent dosing regimens).
Equivalent AUC Dosing Regimens Cipro Oral Dosage Equivalent Cipro I.V. Dosage 250 mg Tablet q 12 h
200 mg I.V. q 12 h
500 mg Tablet q 12 h
400 mg I.V. q 12 h
750 mg Tablet q 12 h
400 mg I.V. q 8 h
Adults with Impaired Renal Function:
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through the intestine. These alternative pathways of drug elimination appear to compensate for the reduced renal excretion in patients with renal impairment. Nonetheless, some modification of dosage is recommended, particularly for patients with severe renal dysfunction. The following table provides dosage guidelines for use in patients with renal impairment:
RECOMMENDED STARTING AND MAINTENANCE DOSES FOR PATIENTS WITH IMPAIRED RENAL FUNCTION Creatinine Clearance (mL/min) Dose > 50
See Usual Dosage.
30-50
250-500 mg q 12 h
5-29
250-500 mg q 18 h
Patients on hemodialysis
or Peritoneal dialysis
250-500 mg q 24 h
(after dialysis)When only the serum creatinine concentration is known, the following formula may be used to estimate creatinine clearance.
Weight (kg) x (140 - age)
Men: Creatinine clearance (mL/min) = 72 x serum creatinine (mg/dL)
Women: 0.85 x the value calculated for men.
The serum creatinine should represent a steady state of renal function.
In patients with severe infections and severe renal impairment, a unit dose of 750 mg may be administered at the intervals noted above. Patients should be carefully monitored.
Ciprofloxacin Tablets USP 250 mg, 500 mg and 750 mg should be administered orally as described in the Dosage Guidelines table. An increased incidence of adverse events compared to controls, including events related to joints and/or surrounding tissues, has been observed. (See
ADVERSE REACTIONS
and
CLINICAL STUDIES
.)
Dosing and initial route of therapy (i.e., I.V. or oral) for complicated urinary tract infection or pyelonephritis should be determined by the severity of the infection. In the clinical trial, pediatric patients with moderate to severe infection were initiated on 6 to 10 mg/kg I.V. every 8 hours and allowed to switch to oral therapy (10 to 20 mg/kg every 12 hours), at the discretion of the physician.
PEDIATRIC DOSAGE GUIDELINES Infection Route of
Administration Dose
(mg/kg) Frequency Total
Duration Complicated
Urinary Tract or
Pyelonephritis
Intravenous
6 to 10 mg/kg
(maximum 400 mg
per dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 8 hours
10-21 days*
(patients from
1 to 17 years of
age)
Oral
10 mg/kg to 20 mg/kg
(maximum 750 mg per
dose; not to be exceeded
even in patients weighing
> 51 kg)
Every 12 hours
Inhalational
Anthrax
(Post-Exposure)**
Intravenous
10 mg/kg
(maximum 400 mg per
dose)
Every 12 hours
60 days
Oral
15 mg/kg
(maximum 500 mg per dose)
Every 12 hours
Pediatric patients with moderate to severe renal insufficiency were excluded from the clinical trial of complicated urinary tract infection and pyelonephritis. No information is available on dosing adjustments necessary for pediatric patients with moderate to severe renal insufficiency (i.e., creatinine clearance of < 50 mL/min/1.73m
2
).
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Camber Pharmaceuticals Inc.
Methylphenidate Hydrochloride | Camber Pharmaceuticals Inc.
Dosage should be individualized according to the needs and responses of the patient.
Adults
Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.
Children (6 years and over)
Methylphenidate hydrochloride tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.
If improvement is not observed after appropriate dosage adjustment over a 1-month period, the drug should be discontinued.
Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.
If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.
Methylphenidate hydrochloride should be periodically discontinued to assess the child’s condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.
Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.
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