Methylphenidate Chewable Tablets

• It is used to treat attention deficit problems with hyperactivity.
• It is used to treat narcolepsy.
• It may be given to you for other reasons. Talk with the doctor.

Attention Deficit Disorders, Narcolepsy

Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction.

Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

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.

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 Methylphenidate Hydrochloride Chewable Tablets 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 Methylphenidate Hydrochloride Chewable Tablets are usually not indicated.

Long-term effects of Methylphenidate Hydrochloride Chewable Tablets 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 Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets:

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.

Priapism

Advise patients, caregivers, and family members of the possibility of painful or prolonged penile erections (priapism). Instruct the patient to seek immediate medical attention in the event of priapism.

Circulation Problems in Fingers and Toes [Peripheral Vasculopathy, Including Raynaud’s Phenomenon]

• Instruct patients beginning treatment with Methylphenidate Hydrochloride Chewable Tablets about the risk of peripheral vasculopathy, including Raynaud’s Phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red.
•  Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes.
• Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Methylphenidate Hydrochloride Chewable Tablets.
• Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

Phenylketonurics – Phenylalanine is a component of aspartame. Each 2.5 mg Methylphenidate Hydrochloride Chewable Tablet contains 0.56 mg of phenylalanine; each 5.0 mg Methylphenidate Hydrochloride Chewable Tablet contains 1.12 mg of phenylalanine and each 10.0 mg Methylphenidate Hydrochloride Chewable Tablet contains 2.24 mg of phenylalanine.

Drug Interactions

Methylphenidate Hydrochloride Chewable Tablets may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents.

Human pharmacologic studies have shown that Methylphenidate Hydrochloride Chewable Tablets 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 Methylphenidate Hydrochloride Chewable Tablets.

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 is 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 Methylphenidate Hydrochloride Chewable Tablets 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.

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)

Methylphenidate Hydrochloride Chewable Tablets should be initiated in small doses, with gradual weekly increments. Daily dosage above 60 mg is not recommended.

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

Chewable Tablets: Start with 5 mg twice daily (before breakfast and lunch) with gradual increments of 5 to 10 mg weekly.

If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug.

Methylphenidate Hydrochloride Chewable Tablets should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued.

Drug treatment should not and need not be indefinite and usually may be discontinued after puberty.

Each Methylphenidate Hydrochloride Chewable Tablets 2.5 mg is available as a white to off-white, grape flavored, round-shaped tablets debossed with “C1” on one side.

Bottles of 100 .........NDC 29033-206-01

Each Methylphenidate Hydrochloride Chewable Tablets 5 mg is available as a white to off-white, grape flavored round shaped tablets debossed with “C2” on one side.

Bottles of 100 .........NDC 29033-205-01

Each Methylphenidate Hydrochloride Chewable Tablets 10 mg is available as a white to off-white, grape flavored, round-shaped, scored tablets debossed with “C” and “3” below it on one side.

Bottles of 100 .........NDC 29033-204-01

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

Storage: Store at 20º to 25°C (68° to 77°F): excursions permitted to 15º to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured by:
Nostrum Laboratories Inc.
Kansas City, MO 64120 USA

January 2017

Methylphenidate Hydrochloride Chewable Tablets
(meth” il fen’ i date hye” droe klor’ ide)

2.5 mg, 5 mg, and 10 mg
CII

Read the Medication Guide that comes with Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets.

What Are Methylphenidate Hydrochloride Chewable Tablets?

Methylphenidate Hydrochloride Chewable Tablets are a central nervous system stimulant prescription medicine. Methylphenidate Hydrochloride Chewable Tablets are tablets that are made to be chewed and swallowed. They are used for the treatment of Attention Deficit and Hyperactivity Disorder (ADHD). Methylphenidate Hydrochloride Chewable Tablets may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

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

Methylphenidate Hydrochloride Chewable Tablets are also used in the treatment of a sleep disorder called narcolepsy.

Who should not take Methylphenidate Hydrochloride Chewable Tablets?

Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets. See the end of this Medication Guide for a complete list of ingredients.

Methylphenidate Hydrochloride Chewable Tablets should not be used in children less than 6 years old because they have not been studied in this age group.

Methylphenidate Hydrochloride Chewable Tablets may not be right for you or your child. Before starting Methylphenidate Hydrochloride 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)

• circulation problems in fingers and toes

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

Can Methylphenidate Hydrochloride 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.

Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets.

Your doctor will decide whether Methylphenidate Hydrochloride Chewable Tablets can be taken with other medicines.

Especially tell your doctor if you or your child takes:

• antidepression 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 Chewable Tablets without talking to your doctor first.

How should Methylphenidate Hydrochloride Chewable Tablets be taken?

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

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

What are possible side effects of Methylphenidate Hydrochloride Chewable Tablets?

See “What is the most important information I should know about Methylphenidate Hydrochloride 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

• 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:

• 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.

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 Chewable Tablets?

• Store Methylphenidate Hydrochloride Chewable Tablets in a safe place at room temperature, 20° to 25°C (68° to 77°C): excursion permitted to 15° to 30°C (59° to 86°F). Protect from moisture.
• Keep Methylphenidate Hydrochloride Chewable Tablets and all medicines out of the reach of children.

General information about Methylphenidate Hydrochloride Chewable Tablets

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Methylphenidate Hydrochloride Chewable Tablets for a condition for which it was not prescribed. Do not give Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Methylphenidate Hydrochloride Chewable Tablets that was written for healthcare professionals. For more information, please contact Nostrum Laboratories Inc. at quality@nostrumpharma.com or 1-877-770-1288

What are the ingredients in Methylphenidate Hydrochloride Chewable Tablets?

Active Ingredient: Methylphenidate Hydrochloride USP

Inactive Ingredients: aspartame, croscarmellose sodium, grape flavor Nat & Art, magnesium stearate and mannitol.

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

Manufactured by:
Nostrum Laboratories Inc.
Kansas City, MO 64120

November 2015

NDC 29033-206-01

100 TABLETS

Methylphenidate Hydrochloride Chewable Tablets


CII

2.5 mg Rx only

Each tablet contains: Methylphenidate Hydrochloride USP. . . . . . . 2.5 mg

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED WITH PRODUCT

NOSTRUM LABORATORIES INC.

NDC 29033-205-01

100 TABLETS

Methylphenidate Hydrochloride Chewable Tablets


CII

5 mg Rx only

Each tablet contains:
Methylphenidate Hydrochloride USP. . . . . . . 5 mg

PHARMACIST: PLEASE DISPENSE WITH
MEDICATION GUIDE PROVIDED WITH PRODUCT

NOSTRUM LABORATORIES INC.