Methylphenidate CD Capsules

Pharmacodynamics

Methylphenidate HCl is a central nervous system (CNS) stimulant. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. 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. 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.

Pharmacokinetics

The pharmacokinetics of the methylphenidate capsule (CD) methylphenidate hydrochloride formulation have been studied in healthy adult volunteers and in children with Attention Deficit Hyperactivity Disorder (ADHD).

Absorption and Distribution

Methylphenidate is readily absorbed. Methylphenidate capsules (CD) have a plasma/time concentration profile showing two phases of drug release with a sharp, initial slope similar to a methylphenidate immediate-release tablet, and a second rising portion approximately three hours later, followed by a gradual decline (see FIGURE 1 below).

Comparison of Immediate Release (IR) and Methylphenidate Capsule (CD) Formulations After Repeated Doses of Methylphenidate HCl in Children With ADHD

Methylphenidate capsules (CD) were administered as repeated once-daily doses of 20 mg or 40 mg to children aged 7 to 12 years with ADHD for one week. After a dose of 20 mg, the mean (± SD) early Cmax was 8.6 (± 2.2) ng/mL, the later Cmax was 10.9 (± 3.9)* ng/mL and AUC0-9h was 63.0 (± 16.8) ng•h/mL. The corresponding values after a 40 mg dose were 16.8 (± 5.1) ng/mL, 15.1 (± 5.8)* ng/mL and 120 (± 39.6) ng•h/mL, respectively. The early peak concentrations (median) were reached about 1.5 hours after dose intake, and the second peak concentrations (median) were reached about 4.5 hours after dose intake. The means for Cmax and AUC following a dose of 20 mg were slightly lower than those seen with 10 mg of the immediate-release formulation, dosed at 0 and 4 hours.

* 25 to 30% of the subjects had only one observed peak (Cmax) concentration of methylphenidate.

FIGURE 1: Comparison of Immediate Release (IR) and Methylphenidate Capsule (CD) Formulations After Repeated Doses of Methylphenidate HCl in Children With ADHD

Dose Proportionality

Following single oral doses of 10 to 60 mg methylphenidate free base as a solution given to ten healthy male volunteers, Cmax and AUC increased proportionally with increasing doses. After the 60 mg dose, tmax was reached 1.5 hours post-dose, with a mean Cmax of 31.8 ng/mL (range 24.7 to 40.9 ng/mL).

Following one week of repeated once-daily doses of 20 mg or 40 mg methylphenidate capsules (CD) to children aged 7 to 12 years with ADHD, Cmax and AUC were proportional to the administered dose.

Food Effects

In a study in adult volunteers to investigate the effects of a high-fat meal on the bioavailability of a dose of 40 mg, the presence of food delayed the early peak by approximately 1 hour (range -2 to 5 hours delay). The plasma levels rose rapidly following the food-induced delay in absorption. Overall, a high-fat meal increased the Cmax of methylphenidate capsules (CD) by about 30% and AUC by about 17%, on average (see DOSAGE AND ADMINISTRATION).

After a single dose, the bioavailability (Cmax and AUC) of methylphenidate in 26 healthy adults was unaffected by sprinkling the capsule contents on applesauce as compared to the intact capsule. This finding demonstrates that a 20 mg methylphenidate capsule (CD), when opened and sprinkled on one tablespoon of applesauce, is bioequivalent to the intact capsule.

Metabolism and Excretion

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

In vitro studies showed that methylphenidate was not metabolized by cytochrome P450 isoenzymes, and did not inhibit cytochrome P450 isoenzymes at clinically observed plasma drug concentrations.

The mean terminal half-life (t½) of methylphenidate following administration of methylphenidate capsules (CD) (t½ = 6.8 h) is longer than the mean terminal (t½) following administration of methylphenidate hydrochloride immediate-release tablets (t½ = 2.9 h) and methylphenidate hydrochloride sustained-release tablets (t½ = 3.4 h) in healthy adult volunteers. This suggests that the elimination process observed for methylphenidate capsules (CD) is controlled by the release rate of methylphenidate from the extended-release formulation, and that the drug absorption is the rate-limiting process.

Alcohol Effect

An in vitro study was conducted to explore the effect of alcohol on the release characteristics of methylphenidate from the methylphenidate capsules (CD) 60 mg capsule dosage form. At an alcohol concentration of 40% there was an increase in the release rate of methylphenidate in the first hour, resulting in 84% of the methylphenidate being released. The results with the 60 mg capsule are considered to be representative of the other available capsule strengths. Patients should be advised to avoid alcohol while taking methylphenidate capsules (CD).

Special Populations

Gender

The pharmacokinetics of methylphenidate after a single dose of methylphenidate capsules (CD) were similar between adult men and women.

Race

The influence of race on the pharmacokinetics of methylphenidate after methylphenidate capsules (CD) administration has not been studied.

Age

The pharmacokinetics of methylphenidate after methylphenidate capsules (CD) administration have not been studied in children less than 6 years of age.

Renal Insufficiency

There is no experience with the use of methylphenidate capsules (CD) 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 methylphenidate capsules (CD).

Hepatic Insufficiency

There is no experience with the use of methylphenidate capsules (CD) in patients with hepatic insufficiency.

Attention Deficit Hyperactivity Disorder (ADHD)

Methylphenidate capsules (CD) are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of methylphenidate capsules (CD) in the treatment of ADHD was established in one controlled trial of children aged 6 to 15 who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY).

A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Types requires both inattentive and hyperactive-impulsive criteria to be met.

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. 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 the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

Methylphenidate capsules (CD) are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be 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 other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. 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.

Long-Term Use

The effectiveness of methylphenidate capsules (CD) for long-term use, i.e., for more than 3 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use methylphenidate capsules (CD) for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

The premarketing development program for methylphenidate capsules (CD) included exposures in a total of 228 participants in clinical trials (188 pediatric patients with ADHD, 40 healthy adult subjects). These participants received methylphenidate capsules (CD) 20, 40, and/or 60 mg/day. The 188 patients (ages 6 to 15) were evaluated in one controlled clinical study, one controlled, crossover clinical study, and one uncontrolled clinical study. Safety data on all patients are included in the discussion that follows. Adverse reactions were assessed by collecting adverse events, results of physical examinations, vital signs, weights, laboratory analyses, and ECGs.

Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and listings that follow, COSTART terminology has been used to classify reported adverse events.

The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings in Clinical Trials With Methylphenidate Capsules (CD)

Adverse Events Associated With Discontinuation of Treatment

In the 3 week placebo-controlled, parallel-group trial, two methylphenidate capsule (CD)-treated patients (1%) and no placebo-treated patients discontinued due to an adverse event (rash and pruritus; and headache, abdominal pain, and dizziness, respectively).

Adverse Events Occurring at an Incidence of 5% or More Among Methylphenidate Capsule (CD)-Treated Patients

TABLE 1 enumerates, for a pool of the three studies in pediatric patients with ADHD, at methylphenidate capsule (CD) doses of 20, 40, or 60 mg/day, the incidence of treatment-emergent adverse events. One study was a 3 week placebo-controlled, parallel-group trial, one study was a controlled, crossover trial, and the third study was an open titration trial. The table includes only those events that occurred in 5% or more of patients treated with methylphenidate capsules (CD) where the incidence in patients treated with methylphenidate capsules (CD) was greater than the incidence in placebo-treated patients.

The prescriber should be aware that these figures cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

TABLE 1: Incidence of Treatment-Emergent Events* in a Pool of 3 to 4 Week Clinical Trials of Methylphenidate Capsules (CD)

* Events, regardless of causality, for which the incidence for patients treated with methylphenidate capsules (CD) was at least 5% and greater than the incidence among placebo-treated patients. Incidence has been rounded to the nearest whole number.
Body System	Preferred Term	Methylphenidate Capsules (CD) (n = 188)	Placebo (n = 190)
General	Headache	12%	8%
	Abdominal pain (stomach ache)	7%	4%
Digestive System	Anorexia (loss of appetite)	9%	2%
Nervous System	Insomnia	5%	2%

Adverse Events With Other Marketed Methylphenidate HCl Products

Nervousness and insomnia are the most common adverse reactions reported with other methylphenidate products. 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 and obsessive-compulsive disorder. 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 severe hepatic injury; 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 reported, 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.

Postmarketing Experience

In addition to the adverse events listed above, the following have been reported in patients receiving methylphenidate capsules (CD) worldwide. The list is alphabetized: abnormal behavior, aggression, anxiety, bruxism, cardiac arrest, depression, fixed drug eruption, hyperactivity, irritability, libido changes, migraine, obsessive-compulsive disorder, peripheral coldness, Raynaud’s phenomenon, reversible ischaemic neurological deficit, rhabdomyolysis, serotonin syndrome in combination with serotonergic drugs, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.

Controlled Substance Class

Methylphenidate capsules (CD), like other methylphenidate products, are classified as a Schedule II controlled substance by federal regulation.

Abuse, Dependence, and Tolerance

See WARNINGS for boxed warning containing drug abuse and dependence information.

Methylphenidate capsules (CD) are administered once daily in the morning, before breakfast.

Methylphenidate capsules (CD) may be swallowed whole with the aid of liquids, or alternatively, the capsule may be opened and the capsule contents sprinkled onto a small amount (tablespoon) of applesauce and given immediately, and not stored for future use. Drinking some fluids, e.g., water, should follow the intake of the sprinkles with applesauce. The capsules and the capsule contents must not be crushed or chewed (see PRECAUTIONS, Information for Patients). Patients should be advised to avoid alcohol while taking methylphenidate capsules (CD).

Dosage should be individualized according to the needs and responses of the patient.

Initial Treatment

The recommended starting dose of methylphenidate capsules (CD) is 20 mg once daily. Dosage may be adjusted in weekly 10 to 20 mg increments to a maximum of 60 mg/day taken once daily in the morning, depending upon tolerability and degree of efficacy observed. Daily dosage above 60 mg is not recommended.

Maintenance/Extended Treatment

There is no body of evidence available from controlled trials to indicate how long the patient with ADHD should be treated with methylphenidate capsules (CD). It is generally agreed, however, that pharmacological treatment of ADHD may be needed for extended periods. Nevertheless, the physician who elects to use methylphenidate capsules (CD) for extended periods in patients with ADHD should periodically re-evaluate the long-term usefulness of the drug for the individual patient with trials off medication to assess the patient’s functioning without pharmacotherapy. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse events occur, the dosage should be reduced, or, if necessary, the drug should be discontinued.

If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

Methylphenidate (METH-il-FEN-i-date) Hydrochloride Extended-Release Capsules (CD) CII

Rx only

Read the Medication Guide that comes with methylphenidate hydrochloride extended-release capsules (CD) before you or your child starts taking them 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 methylphenidate hydrochloride extended-release capsules (CD).

What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (CD)? The following have been reported with use of methylphenidate HCl, USP and other stimulant medicines. 1. Heart-related problems: • sudden death in patients who have heart problems or heart defects • stroke and heart attack in adults • increased blood pressure and heart rate 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 methylphenidate hydrochloride extended-release capsules (CD). Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment with methylphenidate hydrochloride extended-release capsules (CD). 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 methylphenidate hydrochloride extended-release capsules (CD). 2. Mental (Psychiatric) problems: All Patients • new or worse behavior and thought problems • new or worse bipolar illness • new or worse aggressive behavior or hostility Children and Teenagers • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms 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 methylphenidate hydrochloride extended-release capsules (CD), especially seeing or hearing things that are not real, believing things that are not real, or are suspicious. 3. Circulation Problems in fingers and toes (Peripheral vasculopathy, including Raynaud’s phenomenon): fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red • Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes. • Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking methylphenidate hydrochloride extended-release capsules (CD).

What are methylphenidate hydrochloride extended-release capsules (CD)?

Methylphenidate hydrochloride extended-release capsules (CD) are a central nervous system stimulant prescription medicine. They are used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).

Methylphenidate hydrochloride extended-release capsules (CD) may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

Methylphenidate hydrochloride extended-release capsules (CD) should be used as a part of a total treatment program for ADHD that may include counseling or other therapies.

Methylphenidate hydrochloride extended-release capsules (CD) are a federally controlled substance (CII) because they can be abused or lead to dependence. Keep methylphenidate hydrochloride extended-release capsules (CD) in a safe place to prevent misuse and abuse. Selling or giving away methylphenidate hydrochloride extended-release capsules (CD) 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 methylphenidate hydrochloride extended-release capsules (CD)?

Methylphenidate hydrochloride extended-release capsules (CD) 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. • have severe high blood pressure or a heart problem • have hyperthyroidism • 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 methylphenidate hydrochloride extended-release capsules (CD). See the end of this Medication Guide for a complete list of ingredients.

Methylphenidate hydrochloride extended-release capsules (CD) should not be used in children less than 6 years old because they have not been studied in this age group.

Methylphenidate hydrochloride extended-release capsules (CD) may not be right for you or your child. Before starting methylphenidate hydrochloride extended-release capsules (CD) 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) • circulation problem in fingers and toes

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

Can methylphenidate hydrochloride extended-release capsules (CD) 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. Methylphenidate hydrochloride extended-release capsules (CD) 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 methylphenidate hydrochloride extended-release capsules (CD).

Your doctor will decide whether methylphenidate hydrochloride extended-release capsules (CD) 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 methylphenidate hydrochloride extended-release capsules (CD) without talking to your doctor first.

How should methylphenidate hydrochloride extended-release capsules (CD) be taken?

• Take methylphenidate hydrochloride extended-release capsules (CD) exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child. • Take a methylphenidate hydrochloride extended-release capsule (CD) once each day in the morning before breakfast. Methylphenidate hydrochloride extended-release capsules (CD) are extended release capsules. They release medicine into your body throughout the day. • Methylphenidate hydrochloride extended-release capsules (CD) can be taken with or without food. • Swallow methylphenidate hydrochloride extended-release capsules (CD) whole with water or other liquids. If you cannot swallow the capsule, open it and sprinkle the medicine over a spoonful of applesauce. Swallow the applesauce and medicine mixture without chewing. Follow with a drink of water or other liquid. Never chew or crush the capsule or the medicine inside the capsule. • Methylphenidate hydrochloride extended-release capsules (CD) should not be taken with alcohol. This may result in a more rapid release of the dose of methylphenidate hydrochloride extended-release capsules (CD). • From time to time, your doctor may stop methylphenidate hydrochloride extended-release capsules (CD) treatment for a while to check ADHD symptoms. • Your doctor may do regular checks of the blood, heart, and blood pressure while taking methylphenidate hydrochloride extended-release capsules (CD). Children should have their height and weight checked often while taking methylphenidate hydrochloride extended-release capsules (CD). Methylphenidate hydrochloride extended-release capsules (CD) treatment may be stopped if a problem is found during these check-ups. • If you or your child takes too many methylphenidate hydrochloride extended-release capsules (CD) or overdoses, call your doctor or poison control center right away, or get emergency treatment.

What are possible side effects of methylphenidate hydrochloride extended-release capsules (CD)?

See “What is the most important information I should know about methylphenidate hydrochloride extended-release capsules (CD)?” 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 • Painful and prolonged erections (priapism) have occurred with methylphenidate. If you or your child develop priapism, seek medical help right away. Because of the potential for lasting damage, priapism should be evaluated by a doctor immediately.

Common side effects include:

• headache • decreased appetite • stomach ache • nervousness • trouble sleeping • dizziness

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store methylphenidate hydrochloride extended-release capsules (CD)?

• Store methylphenidate hydrochloride extended-release capsules (CD) in a safe place at room temperature, 68° to 77°F (20° to 25°C). Protect from moisture. • Keep methylphenidate hydrochloride extended-release capsules (CD) and all medicines out of the reach of children.

General information about methylphenidate hydrochloride extended-release capsules (CD)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use methylphenidate hydrochloride extended-release capsules (CD) for a condition for which they were not prescribed. Do not give methylphenidate hydrochloride extended-release capsules (CD) to other people, even if they have the same condition. They may harm them and it is against the law.

This Medication Guide summarizes the most important information about methylphenidate hydrochloride extended-release capsules (CD). If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about methylphenidate hydrochloride extended-release capsules (CD) that was written for healthcare professionals. For more information about methylphenidate hydrochloride extended-release capsules (CD) call 1-888-838-2872.

What are the ingredients in methylphenidate hydrochloride extended-release capsules (CD)?

Active Ingredient: methylphenidate HCl, USP

Inactive Ingredients: cetyl alcohol, corn starch, D&C Yellow #10 aluminum lake, dibutyl sebacate, ethylcellulose, FD&C Blue #1 aluminum lake, FD&C Blue #2 aluminum lake, FD&C Red #40 aluminum lake, gelatin, hypromellose, iron oxide black, propylene glycol, shellac glaze, sodium lauryl sulfate, sucrose, and titanium dioxide. Additionally, the 10 mg capsules contain D&C Yellow #10 and FD&C Green #3; the 20 mg capsules contain FD&C Blue #1; the 30 mg capsules contain iron oxide red and iron oxide yellow; the 40 mg capsules contain iron oxide red, and iron oxide yellow; the 50 mg capsules contain FD&C Blue #1.

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

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. H 2/2017