Methylin® methylphenidate HCl oral solution, is a mild central nervous system (CNS) stimulant, available as 10 mg/5 mL and 5 mg/5 mL oral solutions 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.

Each mL of Methylin® Oral Solution 5 mg/5 mL contains 1 mg of Methylphenidate Hydrochloride, USP.

Each mL of Methylin® Oral Solution 10 mg/5 mL contains 2 mg of Methylphenidate Hydrochloride, USP.

In addition, Methylin® Oral Solution also contains the following inactive ingredients: Citric Acid Anhydrous USP, Glycerin USP, N&A Grape Flavor, PEG 1450 NF, and Purified Water USP.

Last updated on RxList: 7/10/2007

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.

Methylin® 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.

Special Diagnostic Considerations

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.

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.

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)

Methylin® 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.

Methylin® 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.

Each Methylin® Chewable Tablet 2.5 mg is available as a white to cream colored, grape flavored rounded square tablet with a convex surface, debossed with a "2.5" and "CHEW" below it on one side, and a debossed on the other side.

Bottles of 100........................NDC 68188-132-01

Each Methylin® Chewable Tablet 5 mg is available as a white to cream colored, grape flavored rounded square tablet with a convex surface, debossed with a "5" and "CHEW" below it on one side, and a debossed on the other side.

Bottles of 100........................NDC 68188-135-01

Each Methylin® Chewable Tablet 10 mg is available as a white to cream colored, grape flavored, scored rounded square tablet with a convex surface, debossed with a "10" and "CHEW" below it on one side, and a debossed on the other side.

Bottles of 100........................NDC 68188-137-01

Protect from moisture. Dispense in tight container with child-resistant closure.

Storage: Store at 20º to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Methylin® is a registered trademark of Mallinckrodt Inc. Ritalin® is a registered trademark of Novartis Pharmaceuticals Corp. Manufactured for: Alliant Pharmaceuticals, Inc. 333 North Point Center East, Suite 250 Alpharetta, Georgia 30022 U.S.A. Manufactured by: Mallinckrodt Inc. St. Louis, MO 63134 U.S.A. Rev 052207. FDA rev date: 06/07/07

Last updated on RxList: 8/11/2008

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 abdominal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; 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.

Methylin® may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.

Human pharmacologic studies have shown that Methylin® may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic drugs (imipramine, clomipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Methylin®.

Serious adverse events have been reported in concomitant use with clonidine, although no causality for the combination has been established. The safety of using methylphenidate in combination with clonidine or other centrally acting alpha-2 agonists has not been systemically evaluated.

Last updated on RxList: 8/11/2008

Serious Cardiovascular Events

Sudden Death and Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems

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.

Hypertension and other Cardiovascular Conditions

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.

Assessing Cardiovascular Status in Patients being Treated with Stimulant Medications

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.

Psychiatric Adverse Events

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.

Long-Term Suppression of Growth

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.

Seizures

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.

Visual Disturbance

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

Use In Children Less Than Six Years Of Age

Methylin® should not be used in children under six years, since safety and efficacy in this age group have not been established.

Drug Abuse And Dependence

General

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 Methylin® 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 Methylin® is usually not indicated.

Long-term effects of Methylin® in children have not been well established.

Information For Patients

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 Methylin® Chewable Tablets. 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.

Physicians are advised to discuss the following issues with patients for whom they prescribe Methylin®:

Choking - Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention.

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.

Phenylketonurics - Phenylalanine is a component of aspartame. Each 2.5 mg Methylin® Chewable Tablet contains 0.42 mg of phenylalanine; each 5.0 mg Methylin® Chewable Tablet contains 0.84 mg of phenylalanine and each 10.0 mg Methylin® Chewable Tablet contains 1.68 mg of phenylalanine.

Carcinogenesis, Mutagenesis, Impairment of Fertility

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 2.5 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 increase in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which approximately 22 times and 4 times the maximum recommended human dose on a mg/kg and mg/m² basis, respectively.

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. The genotoxic potential of methylphenidate has not been evaluated in an in vivo assay.

Usage in Pregnancy

Adequate animal reproduction studies to establish safe use of Methylin® during pregnancy have not been conducted. However, in a recently conducted study, methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 167 times and 78 times the maximum recommended human dose on a mg/kg and a mg/m² basis, respectively. In rats, teratogenic effects were not seen when the drug was given in doses of 75 mg/kg/day, which is approximately 62.5 and 13.5 times the maximum recommended human dose on a mg/kg and a mg/m² basis, respectively. Therefore, until more information is available, methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks.

Last updated on RxList: 8/11/2008

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 methylphenidate overdosage has not been established.

Marked anxiety, tension, and agitation are contraindications to Methylin®, since the drug may aggravate these symptoms. Methylin® 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.

Methylin® 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).

Last updated on RxList: 8/11/2008

Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer.

Methylphenidate HCl is a central nervous system (CNS) stimulant.

The mode of therapeutic action in humans is not completely understood, but methylphenidate presumably activates the brain stem arousal system and cortex to produce its stimulant effect. Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

There is neither specific evidence which clearly establishes the mechanism whereby Methylin® produces its mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Pharmacokinetics

Absorption

Methylin® Chewable Tablets are readily absorbed. Following oral administration of Methylin® Chewable Tablets, peak plasma methylphenidate concentrations are achieved at about 1 to 2 hours. Methylin® Chewable Tablets have been shown to be bioequivalent to Ritalin® tablet. The mean Cmax following a 20 mg dose is approximately 10 ng/mL.

Food Effect

In a study in adult volunteers investigating the effects of a high-fat meal on the bioavailability of Methylin® Chewable Tablets at a dose of 20 mg, the presence of food delayed the peak concentrations by approximately 1 hour (1.5 hours, fasted and 2.4 hours, fed). Overall, a high-fat meal increased the AUC of Methylin® Chewable Tablets by about 20%, on average. Through a cross-study comparison, the magnitude of food effect is found to be comparable between the Methylin® Chewable Tablets and Ritalin®, the immediate release tablet.

Metabolism and Excretion

In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenyl-piperidine acetic acid (PPA, ritalinic acid). The metabolite has little or no pharmacologic activity.

After oral dosing of radiolabeled methylphenidate in humans, about 90% of the radioactivity was recovered in urine. The main urinary metabolite was PPA, accounting for approximately 80% of the dose.

The pharmacokinetics of the Methylin® Chewable Tablets have been studied in healthy adult volunteers. The mean terminal half-life (t½) of methylphenidate following administration of 20 mg Methylin® Chewable Tablets (t½ = 3 hours) is comparable to the mean terminal t½ following administration of Ritalin® (methylphenidate hydrochloride immediate-release tablets) (t½ = 2.8 hours) in healthy adult volunteers.

Special Populations

Gender - The effect of gender on the pharmacokinetics of methylphenidate after Methylin® Chewable Tablets administration has not been studied.

Race - The influence of race on the pharmacokinetics of methylphenidate after Methylin® Chewable Tablets administration has not been studied.

Age - The pharmacokinetics of methylphenidate after Methylin® Chewable Tablets administration have not been studied in pediatrics.

Renal Insufficiency

There is no experience with the use of Methylin® Chewable Tablets in patients with renal insufficiency. After oral administration of radiolabeled methylphenidate in humans, methylphenidate was extensively metabolized and approximately 80% of the radioactivity was excreted in the urine in the form of ritalinic acid. Since renal clearance is not an important route of methylphenidate clearance, renal insufficiency is expected to have little effect on the pharmacokinetics of Methylin® Chewable Tablets.

Hepatic Insufficiency

There is no experience with the use of Methylin® Chewable Tablets in patients with hepatic insufficiency.

Last updated on RxList: 8/11/2008

MEDICATION GUIDE

METHYLIN® CHEWABLE TABLETS
(methylphenidate HCl chewable tablets) 2.5 mg, 5 mg, and 10 mg

Read the Medication Guide that comes with METHYLIN® CHEWABLE TABLETS 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 METHYLIN® CHEWABLE TABLETS.

What Is METHYLIN® Chewable Tablets?

METHYLIN® Chewable Tablets is a central nervous system stimulant prescription medicine. METHYLIN® Chewable Tablets are tablets that are made to be chewed and swallowed. It is used for the treatment of attention deficit and hyperactivity disorder (ADHD).

METHYLIN® Chewable Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

METHYLIN® Chewable Tablets should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

METHYLIN® Chewable Tablets is also used in the treatment of a sleep disorder called narcolepsy.

Who should not take METHYLIN® Chewable Tablets?

METHYLIN® Chewable Tablets should not be taken if you or your child:

• are very anxious, tense, or agitated
• have an eye problem called glaucoma
• have tics or Tourette's syndrome, or a family history of Tourette's syndrome. Tics are hard to control repeated movements or sounds.
• are taking or have taken within the past 14 days an antidepression medicine called a monoamine oxidase inhibitor or MAOI.
• are allergic to anything in METHYLIN® Chewable Tablets. See the end of this Medication Guide for a complete list of ingredients.

METHYLIN® Chewable Tablets should not be used in children less than 6 years old because it has not been studied in this age group. METHYLIN® Chewable Tablets may not be right for you or your child. Before starting METHYLIN® Chewable Tablets tell your or your child's doctor about all health conditions (or a family history of) including:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette's syndrome
• seizures or have had an abnormal brain wave test (EEG)

Tell your doctor if you or your child is pregnant, planning to become pregnant, or breastfeeding.

Can METHYLIN® Chewable Tablets 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.

METHYLIN® Chewable Tablets 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 METHYLIN® Chewable Tablets.

Your doctor will decide whether METHYLIN® Chewable Tablets can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• anti-depression medicines including MAOIs
• seizure medicines
• blood thinner medicines
• blood pressure medicines cold or allergy medicines that contain decongestants

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 METHYLIN® Chewable Tablets without talking to your doctor first.

How should METHYLIN® Chewable Tablets be taken?

• Take METHYLIN® Chewable Tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• METHYLIN® Chewable Tablets are usually taken 2 to 3 times a day.
• Take METHYLIN® Chewable Tablets 30 to 45 minutes before a meal.

• From time to time, your doctor may stop METHYLIN® Chewable Tablets treatment for awhile to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking METHYLIN® Chewable Tablets. Children should have their height and weight checked often while taking METHYLIN® Chewable Tablets. METHYLIN® Chewable Tablets treatment may be stopped if a problem is found during these check-ups.
• If you or your child takes too much METHYLIN® Chewable Tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of METHYLIN® Chewable Tablets?

See "What is the most important information I should know about METHYLIN® Chewable Tablets?" for information on reported heart and mental problems.

Other serious side effects include:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

Common side effects include:

• nervousness
• trouble sleeping
• headache
• stomach ache
• fast heart beat
• nausea
• decreased appetite
• dizziness
• weight loss

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 METHYLIN® Chewable Tablets?

• Store METHYLIN® Chewable Tablets in a safe place at room temperature, 68° to 77°F (20° to 25°C). Protect from moisture.
• Keep METHYLIN® Chewable Tablets and all medicines out of the reach of children. General information about METHYLIN® Chewable Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use METHYLIN® Chewable Tablets for a condition for which it was not prescribed. Do not give METHYLIN® Chewable Tablets 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 METHYLIN® Chewable Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about METHYLIN® Chewable Tablets that was written for healthcare professionals. For more information, please contact Alliant Pharmaceuticals at 1-770-817-4500 or visit the website at www.methylin4kids.com.

What are the ingredients in METHYLIN® Chewable Tablets?

Active Ingredient: methylphenidate HCl

Inactive Ingredients: aspartame NF, maltose, microcrystalline cellulose NF, guar gum NF, grape flavor, pregelatinized starch, NF, and stearic acid NF.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Last updated on RxList: 8/11/2008

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

METHYLPHENIDATE SOLUTION - ORAL

(meth-ill-FEN-eh-date)

COMMON BRAND NAME(S): Methylin

WARNING: Misuse or abuse of methylphenidate may result in serious (possibly fatal) heart and blood pressure problems.

Methylphenidate should be given cautiously to emotionally unstable patients, especially if there is a history of alcohol or drug abuse. These patients may be more likely to unnecessarily increase their doses or take this medication too often. Long-term overuse of this medication may lead to reduced drug effect, drug dependence, and abnormal behavior.

Take this medication only by mouth. Serious mental/mood changes (e.g., psychosis) may occur, especially if this drug is abused.

If methylphenidate must be stopped, it should be stopped gradually over time. Follow your doctor's instructions on how to gradually lower the dose. In some patients, long-term monitoring may be required after the medication is stopped.

USES: Methylphenidate is used to treat attention disorders (attention deficit hyperactivity disorder, or ADHD) as part of a total treatment plan including psychological, educational and social measures. This medication is also used to treat patients with narcolepsy (a disorder of sleep regulation). When used to treat ADHD, patients may find they have increased attention, decreased impulsiveness, and decreased hyperactivity (see also Notes section). This medication is a mild stimulant that works by affecting the levels of chemicals (neurotransmitters) in the nervous system.

This medication should not be used to treat simple fatigue symptoms.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used for treating depression in certain cases.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using methylphenidate and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Measure each dose out carefully and take by mouth. This medication is best taken 30 to 45 minutes before a meal, or as directed by your doctor.

If loss of appetite occurs or if you experience stomach upset, it may be taken with or after meals or a snack. If you have trouble sleeping, try to take your last dose of the day before 6 PM.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. It may take up to two weeks to notice an improvement while on this drug.

Use this medication exactly as prescribed. Dosage is based on your medical condition and response to therapy. Your doctor may instruct you to gradually increase or decrease your dose. Do not increase your dose, use it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for a long period of time, do not suddenly stop using this without first consulting your doctor.

This medication may cause dependence, especially if it has been used regularly for an extended period of time, or if it has been used in high doses. In such cases, if you suddenly stop this drug, withdrawal reactions may occur. Such reactions can include severe depression and chronic overactivity. Report to your doctor immediately any such reactions. When stopping extended, regular treatment with this drug, gradually reducing the dosage as directed will help prevent withdrawal reactions. Consult your doctor or pharmacist for more details.

Though it is very unlikely to occur, this medication can also result in abnormal drug-seeking behavior (addiction/habit-forming). Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed. Properly stop the medication when so directed. This will lessen the chances of becoming addicted.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Headache, stomach pain, loss of appetite, trouble sleeping, dizziness, nausea, vomiting, lightheadedness, irritability, nervousness, blurred vision, dry mouth, constipation or (rarely) drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: uncontrolled movements (motor tics or tremor), verbal tics (e.g., Tourette's syndrome), weight loss, fast/pounding/irregular heartbeat, mental/mood/behavior changes (e.g., agitation, aggression, mood swings, depression, abnormal thoughts), difficulty urinating.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding.

Seek immediate medical attention if any of these rare but very serious side effects occur: shortness of breath, chest pain, jaw/left arm pain, fainting, seizures, vision changes, weakness on one side of the body, slurred speech, confusion.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking methylphenidate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain mental/mood conditions (e.g., agitation, psychosis), heart/blood vessel disease (e.g., irregular heartbeat/rhythm, coronary artery disease, angina, heart failure, cardiomyopathy), problems with heart structure (e.g., valve problems), history of heart attack or stroke, severe anxiety/tension, glaucoma, motor tics.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: family history of sudden death, family/personal history of mental/mood disorders (e.g., bipolar disorder, depression, psychotic disorder, suicidal thoughts), high blood pressure (hypertension), heart disease (e.g., heart failure, recent heart attack, abnormal heart rhythm), overactive thyroid (hyperthyroidism), seizures, verbal tics (diagnosis or family history of Tourette's syndrome).

This drug may make you dizzy, lightheaded, (rarely) drowsy or cause blurred vision; use caution engaging in activities requiring alertness or clear vision such as driving or using machinery. Limit alcoholic beverages.

Though uncommon, depression itself can lead to thoughts or attempts of suicide. If you are being treated for depression, tell your doctor immediately if you have any suicidal thoughts or other mental/mood changes. Keep all medical appointments so your doctor can monitor your progress closely.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Children younger than 6 years may be at greater risk for the side effects of this medication.

This drug may affect your child's growth rate, weight, and final adult height, especially in children younger than 6 years. To reduce the risk, the doctor may recommend temporarily stopping the medication from time to time. Check your child's weight and height, and consult your doctor or pharmacist for more details.

Methylphenidate should be used during pregnancy only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if methylphenidate passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine) within 2 weeks before or after treatment with this medication. In some cases, a serious, possibly fatal, drug interaction may occur. If you are currently using any of these medications, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), guanethidine, phenylbutazone, drugs that can increase blood pressure (e.g., phenylephrine), anti-seizure drugs (e.g., phenobarbital, phenytoin, primidone), tricyclic antidepressants (e.g., imipramine, desipramine), SSRI antidepressants (e.g., fluoxetine, sertraline).

Also report the use of drugs which might increase seizure risk when combined with this medication such as isoniazid (INH), phenothiazines (e.g., thioridazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline), among others. Consult your doctor or pharmacist for details.

Check the labels on all your medicines/herbal products (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate or blood pressure (e.g., pseudoephedrine, phenylephrine, ephedra/ma huang). Ask your pharmacist about the safe use of these products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: confusion, agitation, sweating, flushing, wide pupils, persistent tremor, muscle twitching, hallucinations, severe headache, severe vomiting, seizures, loss of consciousness.

NOTES: Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (e.g., blood pressure, growth monitoring in children requiring long-term therapy) should be performed periodically to monitor your progress or check for side effects. Other laboratory tests (blood counts, platelets) may also be performed to check for side effects. Consult your doctor for more details.

Methylphenidate may help lessen inattention and hyperactivity ADHD symptoms such as not paying attention, making careless mistakes, not listening, being easily distracted, fidgeting, talking excessively, or interrupting others.

There are different brands and forms of this medication available. Not all have identical effects. Do not change brands or forms without consulting your doctor or pharmacist.

MISSED DOSE: If you miss a dose, take it as soon as you remember and take any remaining doses at evenly spaced times. If it is near bedtime or near time for the next dose, skip that dose and resume your regular dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised September 2008 Copyright(c) 2008 First DataBank, Inc.