Clozapine ratiopharm may be available in the countries listed below.
Clozapine is reported as an ingredient of Clozapine ratiopharm in the following countries:
International Drug Name Search
Class: Monoamine Oxidase B Inhibitors
Chemical Name: (R)-2,3-dihydro-N-2-propynyl-1H-inden-1-amine methanesulfonate
Molecular Formula: C12H13N•CH4O3S
CAS Number: 161735-79-1
Brands: Azilect
Irreversible MAO-B inhibitor.1 2 3 4 5
Symptomatic treatment of idiopathic parkinsonian syndrome.1 2
Used as initial monotherapy in patients with early disease1 2 5 or as adjunctive therapy to levodopa in patients with more advanced disease who exhibit a deteriorating response to levodopa/carbidopa.1 2 3 4
Consider reduction of levodopa dosage if adverse dopaminergic effects (e.g., dyskinesia, hallucinations) occur.1 In clinical studies, approximately 9–17% of patients receiving 0.5 or 1 mg rasagiline daily required reduction of levodopa dosage (average reduction: about 9–13%).1
Administer orally once daily without regard to meals.1 2
Available as rasagiline mesylate; dosage expressed in terms of rasagiline.1
1 mg once daily.1
Initially, 0.5 mg once daily.1
If adequate response is not achieved, may increase dosage to 1 mg once daily.1
0.5 mg once daily in patients with mild (Child-Pugh score of 5–6) hepatic impairment.1 2
Use not recommended in patients with moderate or severe (Child-Pugh score ≥7) hepatic impairment.1 2 (See Special Populations under Pharmacokinetics.)
No dosage adjustment required in patients with mild renal impairment.1
No dosage adjustment required.1
Concomitant use with cyclobenzaprine, dextromethorphan, meperidine, mirtazapine, methadone, propoxyphene, tramadol, St. John’s wort (Hypericum perforatum), sympathomimetic amines (e.g., amphetamines, ephedrine, phenylephrine, phenylpropanolamine [no longer commercially available in the US], pseudoephedrine), or other MAO inhibitors.1 (See Interactions.)
Elective surgery that requires general anesthetics, cocaine, or local anesthetics containing sympathomimetic vasoconstrictors.1 Discontinue rasagiline ≥14 days prior to elective surgery; if surgery is needed sooner, may use benzodiazepines, mivacurium, rapacuronium, fentanyl, morphine, or codeine with caution.1 8
Pheochromocytoma.1
Selectivity for MAO-B (and not MAO-A) in humans not sufficiently elucidated to permit rasagiline treatment without restriction of dietary tyramine or sympathomimetic amines.1 Even for relatively selective MAO-B inhibitors, selectivity for MAO-B usually diminishes and ultimately is lost at high dosages, and the drug will inhibit both MAO-B and MAO-A.1
Possibly severe hypertensive reaction or hypertensive crisis (i.e., cheese reaction) following ingestion of foods, beverages, or dietary supplements containing large amounts of tyramine.1 (See Interactions and see also Advice to Patients.)
Severe hypertensive reaction or hypertensive crisis reported following concomitant use of selective (i.e., selegiline) or nonselective (e.g., phenelzine, tranylcypromine) MAO inhibitors with sympathomimetic amines (e.g., ephedrine).1 (See Interactions and see also Advice to Patients.)
Severe, sometimes fatal reactions resembling serotonin syndrome reported following concomitant use of selective or nonselective MAO inhibitors with highly serotonergic drugs (e.g., selective serotonin- and norepinephrine-reuptake inhibitors [SNRIs], SSRIs, tricyclic antidepressants).1 (See Interactions.)
Concomitant use with ciprofloxacin or other CYP1A2 inhibitors shown, or expected, to increase plasma rasagiline concentrations by up to twofold.1 Adjustment of rasagiline dosage recommended.1 8 (See Drugs Affecting Hepatic Microsomal Enzymes under Interactions.)
Orthostatic hypotension reported in patients receiving rasagiline as monotherapy or as adjunctive therapy with levodopa.1 Occurs most frequently during the first 2 months of therapy and less frequently over time.1
Hallucinations reported in patients receiving rasagiline as monotherapy or as adjunctive therapy with levodopa.1 (See Advice to Patients.)
Risk of melanoma developing4 5 in patients receiving rasagiline appears to be greater than that in the general population but comparable to that in patients with Parkinson’s disease.1
Monitor for melanomas frequently.1 Perform dermatologic examinations periodically;1 frequency of examinations determined by patient’s dermatologist.8
Category C.1
Inhibits prolactin secretion in rats; may inhibit milk secretion in women.1 8 Not known whether rasagiline is distributed into milk; caution if used in nursing women.1
Safety and efficacy not established in pediatric patients <18 years of age.1 8
No overall differences in safety relative to younger adults.1
Dosage adjustment recommended in patients with mild (Child-Pugh score of 5–6) hepatic impairment.1
Use not recommended in patients with moderate or severe (Child-Pugh score ≥7) hepatic impairment.1 2 (See Special Populations under Pharmacokinetics.)
Monotherapy: Flu syndrome,1 arthralgia,1 5 depression,1 dyspepsia,1 fall.1
Adjunctive therapy with levodopa: Dyskinesia,1 3 4 accidental injury,1 weight loss,1 4 orthostatic hypotension,1 3 vomiting,1 3 4 anorexia,1 4 arthralgia,1 abdominal pain,1 nausea,1 3 constipation,1 3 dry mouth,1 3 rash,1 ecchymosis,1 somnolence,1 3 paresthesia.1
Extensively metabolized, principally by CYP1A2; does not inhibit CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, 3A4, or 4A in vitro.1 2
Consider the possibility of interactions such as those reported with nonselective MAO inhibitors.1
Inhibitors of CYP1A2 (e.g., ciprofloxacin): Possibly substantial (up to twofold) increase in plasma rasagiline concentrations.1 2 If used concomitantly, limit rasagiline dosage to 0.5 mg once daily.1 8
Substrates of CYP1A2 (e.g., theophylline): Pharmacokinetic interaction unlikely.1 2
Substrates of 2A6, 2C9, 2C19, 2D6, 2E1, 3A4, or 4A: Pharmacokinetic interaction unlikely.1 2
Drug | Interaction | Comments |
|---|---|---|
Antidepressants, SNRIs (e.g., duloxetine, venlafaxine) | Potential for serious, possibly fatal adverse effects (e.g., hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of vital signs, extreme agitation, delirium, coma)1 | Generally avoid concomitant use1 Allow ≥ 2 weeks to elapse between discontinuance of rasagiline and initiation of an SNRI 1 |
Antidepressants, SSRIs (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline) | Potential for serious, possibly fatal adverse effects (e.g., hyperthermia, rigidity, myoclonus, autonomic instability with rapid fluctuations of vital signs, extreme agitation, delirium, coma) 1 2 | Generally avoid concomitant use1 Allow ≥2 weeks to elapse between discontinuance of rasagiline and initiation of an SSRI1 Allow ≥5 weeks to elapse between discontinuance of fluoxetine and initiation of rasagiline; consider a longer interval in patients who received long-term or high-dosage fluoxetine therapy1 |
Antidepressants, tetracyclics (e.g., mirtazapine) | Concomitant use with mirtazapine is contraindicated1 | |
Antidepressants, tricyclics (e.g., amitriptyline, protriptyline) | Potential for serious, possibly fatal adverse effects (e.g., behavioral and mental status changes, hyperpyrexia, diaphoresis, muscular rigidity, hypertension, syncope) 1 8 | Generally avoid concomitant use1 Allow ≥2 weeks to elapse between discontinuance of rasagiline and initiation of a tricyclic antidepressant1 |
Ciprofloxacin | Substantial (83%) increase in AUC of rasagiline1 | Limit rasagiline dosage to 0.5 mg once daily1 |
Cyclobenzaprine | Concomitant use contraindicated1 | |
Dextromethorphan | Possible brief episodes of psychosis or bizarre behavior1 | Concomitant use contraindicated1 |
Foods, tyramine-containing | Possible severe hypertensive reaction or hypertensive crisis1 | Avoid foods, beverages, and dietary supplements containing large amounts of tyramine during and for 2 weeks following discontinuance of rasagiline1 (See Advice to Patients) Consult specialized references on food constituents or a dietician for specific information on the tyramine content of foods and beveragesa |
Levodopa | Possible increased adverse dopaminergic effects and increased risk of dyskinesia and orthostatic hypotension1 2 Possible modest increase in plasma rasagiline concentrations1 2 | Reduction of levodopa dosage may be considered; adjustment of rasagiline dosage not necessary1 Combination used to therapeutic advantage1 |
MAO inhibitors (e.g., phenelzine, tranylcypromine) | Possible increased risk of nonselective MAO inhibition, resulting in hypertensive crisis1 | Concomitant use contraindicated1 Allow ≥2 weeks to elapse between discontinuance of rasagiline and initiation of other MAO inhibitors1 |
Opiate agonists (e.g., meperidine, methadone, propoxyphene, tramadol) | Potential for serious, possibly fatal adverse effects (resembling serotonin syndrome) (e.g., coma, severe hypertension or hypotension, severe respiratory depression, seizures, malignant hyperpyrexia, excitation, peripheral vascular collapse)1 2 | Concomitant use with meperidine, methadone, propoxyphene, or tramadol is contraindicated1 2 Allow ≥2 weeks to elapse between discontinuance of rasagiline and initiation of meperidine1 |
St. John's wort (Hypericum perforatum) | Concomitant use contraindicated1 | |
Sympathomimetic amines (e.g., amphetamines, ephedrine, phenylephrine, phenylpropanolamine, pseudoephedrine) | Possible severe hypertensive reaction or hypertensive crisis1 | Concomitant use with amphetamines, ephedrine, phenylephrine, phenylpropanolamine, or pseudoephedrine is contraindicated during and for 2 weeks following discontinuance of rasagiline1 8 |
Theophylline | Pharmacokinetic interaction unlikely1 2 |
Rapidly absorbed following oral administration, with peak plasma concentration attained within approximately 1 hour.1 2
Absolute bioavailability is about 36%.1 2
Inhibition of platelet MAO-B in humans persists ≥1 week after last dose.1
High-fat meals decrease peak plasma concentrations and AUC of rasagiline by approximately 60 and 20%, respectively.1 2 Because of modest effect on AUC, may administer rasagiline without regard to meals.1 2
Following daily administration for 7 days, AUC or peak plasma concentration of rasagiline was increased by 2- or 1.4-fold, respectively, in patients with mild (Child-Pugh score of 5–6) hepatic impairment and by seven- or twofold, respectively, in patients with moderate (Child-Pugh score of 7–9) hepatic impairment.1 (See Hepatic Impairment under Dosage and Administration.)
Conclusive pharmacokinetic data in patients with renal impairment not available.1 8 However, because unconjugated rasagiline is not excreted by the kidneys, no dosage adjustment is necessary in patients with mild renal impairment.1
Readily crosses the blood-brain barrier.2 8
Approximately 88–94% (with 61–63% bound to albumin).1
Undergoes almost complete biotransformation in the liver prior to excretion.1 Metabolized via dealkylation and/or hydroxylation by CYP isoenzymes, principally CYP1A2.1 2
Excreted in urine (62%) and feces (7%) as metabolites over 7 days; <1% excreted as unchanged drug in urine.1 2
Mean steady-state or terminal half-life is 31 or 1.342 hours, respectively.1 2 However, no correlation between pharmacokinetic profile and pharmacologic effects because rasagiline irreversibly inhibits MAO-B, and restoration of normal enzyme activity depends on the rate of de novo enzyme synthesis.1 2
25°C (may be exposed to 15-30°C).1
Irreversible MAO-B inhibitor.1 2 3 4 5
Precise mechanism of activity not fully characterized, but data from ex vivo animal studies indicate rasagiline potently and irreversibly inhibits MAO-B in brain, liver, and intestinal tissues; also potently and irreversibly inhibits MAO-B in platelets.1 6 Selectivity in inhibiting MAO-B (and not MAO-A) in humans not fully elucidated.1 (See Risks Associated with MAO Inhibition under Cautions.)
Inhibition of MAO-B results in increased extracellular concentrations of dopamine and, therefore, enhanced dopaminergic activity in the striatum.1 2 3
Importance of recognizing tyramine content of foods, beverages, and dietary supplements, and avoiding those containing large amounts of tyramine (e.g., aged/fermented meat or cheese, pickled herring, pods of fava beans, sauerkraut, soy sauce, tofu, concentrated yeast extract, red wine, tap/draft beer) during and for 2 weeks following discontinuance of rasagiline.1
Importance of avoiding OTC preparations containing sympathomimetic amines (e.g., ephedrine, phenylephrine, pseudoephedrine) during and for 2 weeks following discontinuance of rasagiline.1
Importance of recognizing manifestations of a hypertensive crisis (e.g., severe headache, blurred vision or visual disturbances, difficulty thinking, stupor or coma, seizures, chest pain, unexplained nausea or vomiting, manifestations of a stroke) and promptly seeking medical attention if such manifestations occur.1
Importance of informing clinicians promptly if hallucinations occur.1
Risk of increased dyskinesia and orthostatic hypotension when used concomitantly with levodopa.1
Importance of monitoring for melanomas frequently and receiving dermatologic examinations (i.e., performed by dermatologists) periodically.1
Importance of taking as prescribed.1 If a dose is missed, omit dose and administer next dose at the regularly scheduled time on the following day.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, dietary supplements, and/or herbal products (e.g., St. John’s wort), as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 0.5 mg (of rasagiline) | Azilect | Teva Neuroscience |
1 mg (of rasagiline) | Azilect | Teva Neuroscience |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Azilect 0.5MG Tablets (TEVA NEUROSCIENCE): 30/$360 or 90/$979.95
Azilect 1MG Tablets (TEVA NEUROSCIENCE): 30/$346 or 90/$979.95
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions October 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Teva Neuroscience, Inc. Azilect (rasagiline mesylate) tablets prescribing information. Teva Neuroscience, Inc. Kansas City, MO; 2006 May.
2. Chen JJ and Swope DM. Clinical pharmacology of rasagiline: A novel, second-generation propargylamine for the treatment of Parkinson disease. J Clin Pharmacol. 2005; 45:878-94. [PubMed 16027398]
3. Rascol O, Brooks DJ, Melamed E et al for the LARGO study group. Rasagiline as an adjunct to levodopa in patients with Parkinson’s disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): A randomised, double-blind, parallel-group trial. Lancet. 2005; 365:947-54. [PubMed 15766996]
4. Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations: The PRESTO Study. Arch Neurol. 2005; 62:241-8. [PubMed 15710852]
5. Parkinson Study Group. A controlled trial of rasagiline in early Parkinson disease: The TEMPO Study. Arch Neurol. 2002; 59:1937-43. [PubMed 12470183]
6. Youdim MBH, Gross A, and Finberg JPM. Rasagiline [N-propargyl-1R(+)-aminoindan], a selective and potent inhibitor of mitochondrial monoamine oxidase B. Br J Pharmacol. 2001; 132:500-6. [PubMed 11159700]
8. Teva Neuroscience, Inc., Overland Park, KS: Personal communication.
a. AHFS drug information 2007. McEvoy GK, ed. Monoamine Oxidase Inhibitors General Statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2264-9.
Mitoxantron-Gry may be available in the countries listed below.
Mitoxantrone dihydrochloride (a derivative of Mitoxantrone) is reported as an ingredient of Mitoxantron-Gry in the following countries:
International Drug Name Search
Generic Name: bioflavonoids (BYE oh FLAV oh noids)
Brand Names: Amino-Opti-C, Limbrel, P-1000, Pan C 500, Peridin-C, Rutin, Span C
Bioflavonoids are found in the rind of green citrus fruits and in rose hips and black currants.
Bioflavonoids have been used in alternative medicine as an aid to enhance the action of vitamin C, to support blood circulation, as an antioxidant, and to treat allergies, viruses, or arthritis and other inflammatory conditions.
Bioflavonoids is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Bioflavonoids may also be used for other purposes not listed in this product guide.
Bioflavonoids is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.
Use bioflavonoids as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.
Before using bioflavonoids, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use bioflavonoids if you have certain medical conditions.
When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.
If you choose to take bioflavonoids, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.
Do not use different formulations of bioflavonoids at the same time without first talking to your doctor. Using different formulations together increases the risk of an bioflavonoids overdose.
If your condition does not improve, or if it appears to get worse, contact your doctor.
Consult your doctor, pharmacist, herbalist, or other healthcare provider for instructions if you miss a dose.
There are no known restrictions on food, beverages, or activities while you are taking bioflavonoids unless otherwise directed by your health care provider.
Less serious side effects are more likely to occur, and you may have none at all.
Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
There may be other drugs that can interact with bioflavonoids. Tell your healthcare provider about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your healthcare provider.
Xidan EDO may be available in the countries listed below.
Hyaluronic Acid sodium salt (a derivative of Hyaluronic Acid) is reported as an ingredient of Xidan EDO in the following countries:
International Drug Name Search
Lamotrigina Arrowblue may be available in the countries listed below.
Lamotrigine is reported as an ingredient of Lamotrigina Arrowblue in the following countries:
International Drug Name Search
| Ritalin® hydrochloride methylphenidate hydrochloride tablets USP | |
| Ritalin-SR® methylphenidate hydrochloride USP sustained-release tablets |
Rx only
Prescribing Information
Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is
Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77.
Inactive Ingredients. Ritalin tablets: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).
Ritalin-SR tablets: Cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.
Pharmacodynamics
Ritalin is a mild central nervous system stimulant.
The mode of action in man is not completely understood, but Ritalin presumably activates the brain stem arousal system and cortex to produce its stimulant effect.
There is neither specific evidence which clearly establishes the mechanism whereby Ritalin produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Effects on QT Interval
The effect of Focalin® XR (dexmethylphenidate, the pharmacologically active d-enantiomer of Ritalin) on the QT interval was evaluated in a double-blind, placebo- and open label active (moxifloxacin)-controlled study following single doses of Focalin® XR 40mg in 75 healthy volunteers. ECGs were collected up to 12 h post-dose. Frederica’s method for heart rate correction was employed to derive the corrected QT interval (QTcF). The maximum mean prolongation of QTcF intervals was <5 ms, and the upper limit of the 90% confidence interval was below 10 ms for all time matched comparisons versus placebo. This was below the threshold of clinical concern and there was no evident-exposure response relationship.
Pharmacokinetics
Ritalin in the SR tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the SR tablet compared to the Ritalin tablet, measured by the urinary excretion of Ritalin major metabolite (α-phenyl-2-piperidine acetic acid) was 105% (49%-168%) in children and 101% (85%-152%) in adults. The time to peak rate in children was 4.7 hours (1.3-8.2 hours) for the SR tablets and 1.9 hours (0.3-4.4 hours) for the tablets. An average of 67% of SR tablet dose was excreted in children as compared to 86% in adults.
In a clinical study involving adult subjects who received SR tablets, plasma concentrations of Ritalin’s major metabolite appeared to be greater in females than in males. No gender differences were observed for Ritalin plasma concentration in the same subjects.
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.
Ritalin is 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.
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources.
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.
Marked anxiety, tension, and agitation are contraindications to Ritalin, since the drug may aggravate these symptoms. Ritalin is contraindicated also in patients known to be hypersensitive to the drug, in patients with glaucoma, and in patients with motor tics or with a family history or diagnosis of Tourette’s syndrome.
Ritalin is contraindicated during treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoamine oxidase inhibitor (hypertensive crises may result).
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.
Sudden death, 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 2-4 mmHg) and average heart rate (about 3-6 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.
Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.
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.
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 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.
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.
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.
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.
Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
Ritalin should not be used in children under 6 years, since safety and efficacy in this age group have not been established.
Ritalin should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use, since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.
Patients with an element of agitation may react adversely; discontinue therapy if necessary.
Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Ritalin should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics.
When these symptoms are associated with acute stress reactions, treatment with Ritalin is usually not indicated.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with methylphenidate and should counsel them in its appropriate use. A patient Medication Guide is available for Ritalin and Ritalin-SR. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Ritalin should not be used in patients being treated (currently or within the proceeding two weeks) with MAO Inhibitors (see CONTRAINDICATIONS, Monoamine Oxidase Inhibitors). Because of possible effects on blood pressure, Ritalin should be used cautiously with pressor agents.
Methylphenidate may decrease the effectiveness of drugs used to treat hypertension. Methylphenidate is metabolized primarily to Ritalinic acid by de-esterification and not through oxidative pathways.
Human pharmacologic studies have shown that racemic methylphenidate may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone), and tricyclic drugs (e.g., imipramine, clomipramine, desipramine). Downward dose adjustments of these drugs may be required when given concomitantly with methylphenidate. It may be necessary to adjust the dosage and monitor plasma drug concentration (or, in case of coumarin, coagulation times), when initiating or discontinuing methylphenidate.
In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 4 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown.
Methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 5 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively.
In a 24-week carcinogenicity study in the transgenic mouse strain p53+/-, which is sensitive to genotoxic carcinogens, there was no evidence of carcinogenicity. Male and female mice were fed diets containing the same concentration of methylphenidate as in the lifetime carcinogenicity study; the high-dose groups were exposed to 60-74 mg/kg/day of methylphenidate.
Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. Methylphenidate was negative in vivo in males and females in the mouse bone marrow micronucleus assay.
Methlyphenidate did not impair fertility in male or female mice that were fed diets containing the drug in an 18-week Continuous Breeding study. The study was conducted at doses up to 160 mg/kg/day, approximately 80-fold and 8-fold the highest recommended dose on a mg/kg and mg/m2 basis, respectively.
In studies conducted in rats and rabbits, methylphenidate was administered orally at doses of up to 75 and 200 mg/kg/day, respectively, during the period of organogenesis. Teratogenic effects (increased incidence of fetal spina bifida) were observed in rabbits at the highest dose, which is approximately 40 times the maximum recommended human dose (MRHD) on a mg/m2 basis. The no effect level for embryo-fetal development in rabbits was 60 mg/kg/day (11 times the MRHD on a mg/m2 basis). There was no evidence of specific teratogenic activity in rats, although increased incidences of fetal skeletal variations were seen at the highest dose level (7 times the MRHD on a mg/m2 basis), which was also maternally toxic. The no effect level for embryo-fetal development in rats was 25 mg/kg/day (2 times the MRHD on a mg/m2 basis). When methylphenidate was administered to rats throughout pregnancy and lactation at doses of up to 45 mg/kg/day, offspring body weight gain was decreased at the highest dose (4 times the MRHD on a mg/m2 basis), but no other effects on postnatal development were observed. The no effect level for pre- and postnatal development in rats was 15 mg/kg/day (equal to the MRHD on a mg/m2 basis).
Adequate and well-controlled studies in pregnant women have not been conducted. Ritalin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Ritalin is administered to a nursing woman.
Ritalin should not be used in children under six years of age (see WARNINGS).
In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.
Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; aggressive behavior; a few instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten-year-old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.
In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.
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.
SR Tablets: Ritalin-SR tablets have a duration of action of approximately 8 hours. Therefore, Ritalin-SR tablets may be used in place of Ritalin tablets when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin. Ritalin-SR tablets must be swallowed whole and never crushed or chewed.
Ritalin 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.
SR Tablets: Ritalin-SR tablets have a duration of action of approximately 8 hours. Therefore, Ritalin-SR tablets may be used in place of Ritalin tablets when the 8-hour dosage of Ritalin-SR corresponds to the titrated 8-hour dosage of Ritalin. Ritalin-SR 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.
Ritalin 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.
Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: vomiting, agitation, tremors, hyperreflexia, muscle twitching, convulsions (may be followed by coma), euphoria, confusion, hallucinations, delirium, sweating, flushing, headache, hyperpyrexia, tachycardia, palpitations, cardiac arrhythmias, hypertension, mydriasis, and dryness of mucous membranes.
Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.
Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a short-acting barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.
Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.
Efficacy of peritoneal dialysis or extracorporeal hemodialysis for Ritalin overdosage has not been established.
Tablets 5 mg - round, yellow (imprinted CIBA 7)
Bottles of 100 ……………………………......NDC 0078-0439-05
Tablets 10 mg - round, pale green, scored (imprinted CIBA 3)
Bottles of 100 NDC 0078-0440-05
Tablets 20 mg - round, pale yellow, scored (imprinted CIBA 34)
Bottles of 100 ………………………………………………………......NDC 0078-0441-05
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light.
Dispense in tight, light-resistant container (USP).
SR Tablets 20 mg - round, white, coated (imprinted CIBA 16)
Bottles of 100……………………………………………………………...NDC 0078-0442-05
Note: SR Tablets are color-additive free.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from moisture.
Dispense in tight, light-resistant container (USP).
Ritalin®
(methylphenidate hydrochloride tablets, USP) CII
Read the Medication Guide that comes with Ritalin® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with Ritalin®.
| What is the most important information I should know about Ritalin®? The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines. 1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Ritalin®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Ritalin®. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Ritalin®. 2. Mental (Psychiatric) problems: All Patients
Children and Teenagers
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Ritalin®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
What Is Ritalin®?
Ritalin® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Ritalin® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Ritalin® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Ritalin® is also used in the treatment of a sleep disorder called narcolepsy.
| Ritalin® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Ritalin® in a safe place to prevent misuse and abuse. Selling or giving away Ritalin® may harm others, and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. |
Who should not take Ritalin®?
Ritalin® should not be taken if you or your child:
Ritalin® should not be used in children less than 6 years old because it has not been studied in this age group.
Ritalin® may not be right for you or your child. Before starting Ritalin® tell your or your child’s doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.
Can Ritalin® be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Ritalin® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Ritalin®.
Your doctor will decide whether Ritalin® can be taken with other medicines.
Especially tell your doctor if you or your child takes:
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Ritalin® without talking to your doctor first.
How should Ritalin® be taken?
What are possible side effects of Ritalin®?
See “What is the most important information I should know about Ritalin®?” for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
How should I store Ritalin®?
General information about Ritalin®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ritalin® for a condition for which it was not prescribed. Do not give Ritalin® to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about Ritalin®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ritalin® that was written for healthcare professionals. For more information about Ritalin® call 1-888-669-6682.
What are the ingredients in Ritalin®?
Active Ingredient: methylphenidate HCL
Inactive Ingredients: D&C Yellow No.10 (5-mg and 20-mg tablets), FD&C Green No.3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Ritalin-SR®
(methylphenidate hydrochloride, USP) sustained-release tablets CII
Read the Medication Guide that comes with Ritalin-SR® before you or your child starts taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your or your child’s treatment with Ritalin-SR®.
| What is the most important information I should know about Ritalin-SR®? The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines. 1. Heart-related problems:
Tell your doctor if you or your child have any heart problems, heart defects, high blood pressure, or a family history of these problems. Your doctor should check you or your child carefully for heart problems before starting Ritalin-SR®. Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with Ritalin-SR®. Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Ritalin-SR®. 2. Mental (Psychiatric) problems: All Patients
Children and Teenagers
Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking Ritalin-SR®, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. |
What Is Ritalin-SR®?
Ritalin-SR® is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Ritalin-SR® may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.
Ritalin-SR® should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.
Ritalin-SR® is also used in the treatment of a sleep disorder called narcolepsy.
| Ritalin-SR® is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Ritalin-SR® in a safe place to prevent misuse and abuse. Selling or giving away Ritalin-SR® may harm others, and is against the law. Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs. |
Who should not take Ritalin-SR®?
Ritalin-SR® should not be taken if you or your child:
Ritalin-SR® should not be used in children less than 6 years old because it has not been studied in this age group.
Ritalin-SR® may not be right for you or your child. Before starting Ritalin-SR® tell your or your child’s doctor about all health conditions (or a family history of) including:
Tell your doctor if you or your child is pregnant, planning to become pregnant, or breast-feeding.
Can Ritalin-SR® be taken with other medicines?
Tell your doctor about all of the medicines that you or your child take including prescription and nonprescription medicines, vitamins, and herbal supplements. Ritalin-SR® and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Ritalin-SR®.
Your doctor will decide whether Ritalin-SR® can be taken with other medicines.
Especially tell your doctor if you or your child takes:
Know the medicines that you or your child takes. Keep a list of your medicines with you to show your doctor and pharmacist.
Do not start any new medicine while taking Ritalin-SR® without talking to your doctor first.
How should Ritalin-SR® be taken?
What are possible side effects of Ritalin-SR®?
See “What is the most important information I should know about Ritalin-SR®?” for information on reported heart and mental problems.
Other serious side effects include:
Common side effects include:
Talk to your doctor if you or your child has side effects that are bothersome or do not go away.
This is not a complete list of possible side effects. Ask your doctor or pharmacist for more information.
How should I store Ritalin-SR®?
General information about Ritalin-SR®
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Ritalin-SR® for a condition for which it was not prescribed. Do not give Ritalin-SR® to other people, even if they have the same condition. It may harm them and it is against the law.
This Medication Guide summarizes the most important information about Ritalin-SR®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ritalin-SR® that was written for healthcare professionals. For more information about Ritalin-SR call 1-888-669-6682.
What are the ingredients in Ritalin-SR®?
Active Ingredient: methylphenidate HCL, USP
Inactive Ingredients: cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
REV: DECEMBER 2010 T2010-119/T2009-57/T2009-58
Novartis Pharmaceuticals Corporation
East Hanover, New Jersey 07936
© Novartis
Package Label – 5 mg
Rx Only NDC 0078-0439-05
Ritalin® HCL
Methylphenidate HCL USP
5 mg
100 Tablets
Dispense with Medication Guide attached or provided separately.
Package Label – 10 mg
Rx Only NDC 0078-0440-05
Ritalin® HCL
Methylphenidate HCL USP
10 mg
100 Tablets
Dispense with Medication Guide attached or provided separately.
Package Label – 20 mg
Rx Only NDC 0078-0441-05
Ritalin® HCL
Methylphenidate HCL USP
20 mg
100 Tablets
Dispense with Medication Guide attached or provided separately.
PACKAGE LABEL – 20 MG SUSTAINED-RELEASE
Rx Only NDC 0078-0442-05
Ritalin-SR®
Methylphenidate HCL USP
sustained-release tablets
20 mg
100 Tablets
Dispense with Medication Guide attached or provided separately.
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