METHYLPHENIDATE HYDROCHLORIDE tablet, chewable

United States - English - NLM (National Library of Medicine)

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Active ingredient:
METHYLPHENIDATE HYDROCHLORIDE (UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)
Available from:
Novel Laboratories, Inc.
INN (International Name):
METHYLPHENIDATE HYDROCHLORIDE
Composition:
METHYLPHENIDATE HYDROCHLORIDE 2.5 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
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 centra
Product summary:
Each Methylphenidate Hydrochloride Chewable Tablet 2.5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "570" below on the one side and plain on the other side.  Bottles of 100 .........NDC 40032-570-01 Each Methylphenidate Hydrochloride Chewable Tablet 5 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above and "571" below on the one side and plain on the other side. Bottles of 100 .........NDC 40032-571-01 Each Methylphenidate Hydrochloride Chewable Tablet 10 mg is available as a white colored, grape flavored round, flat faced, beveled edge tablet debossed with "NL" above the bisect and "572" below the bisect on one side and plain on the other side. Bottles of 100 .........NDC 40032-572-01 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]. Ritalin is a registered trademark of Novartis Corporation. Manufactured by: Novel Laboratories Inc. 400 Campus Drive Somerset, NJ 08873 USA PI5700000103 Rev. 09/2016
Authorization status:
Abbreviated New Drug Application
Authorization number:
40032-570-01, 40032-571-01, 40032-572-01

Novel Laboratories, Inc.

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MEDICATION GUIDE

Methylphenidate Hydrochloride Chewable Tablets

2.5 mg, 5 mg, and 10 mg

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.

Revised: 12/2019

Document Id: 7620b57a-02e8-4fe6-9cd1-0e07a6152636

34391-3

Set id: 16508cc6-13c7-4088-927a-b7206eb7c633

Version: 5

Effective Time: 20191220

Novel Laboratories, Inc.

METHYLPHENIDATE HYDROCHLORIDE- methylphenidate hydrochloride tablet, chewable

Novel Laboratories, Inc.

----------

Methylphenidate HCl Chewable Tablets CII

DESCRIPTION

Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5

mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-

phenyl-2-piperidineacetate hydrochloride, and its structural formula is

Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It

is soluble in water, alcohol, and chloroform.

Each Methylphenidate Hydrochloride Chewable Tablet, for oral administration, contains 2.5 mg, 5 mg

or 10 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride

Chewable Tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline

cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid.

CLINICAL PHARMACOLOGY

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 Methylphenidate

Hydrochloride Chewable Tablets 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

Abs orption

Methylphenidate Hydrochloride Chewable Tablets are readily absorbed. Following oral administration

of Methylphenidate Hydrochloride Chewable Tablets, peak plasma methylphenidate concentrations are

achieved at about 1 to 2 hours. Methylphenidate Hydrochloride Chewable Tablets have been shown to

be bioequivalent to Ritalin® tablet. The mean Cmax following a 20 mg dose is approximately10 ng/mL.

Food Effect

In a study in adult volunteers investigating the effects of a high-fat meal on the bioavailability of

Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets by about 20%, on

average. Through a cross-study comparison, the magnitude of food effect is found to be comparable

between the Methylphenidate Hydrochloride Chewable Tablets and Ritalin, the immediate release

tablet.

Metabolism and Excretion

In humans, methylphenidate is metabolized primarily via deesterification to alpha-phenylpiperidine

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 Methylphenidate Hydrochloride Chewable Tablets have been studied in

healthy adult volunteers. The mean terminal half-life (t½) of methylphenidate following administration

of 20 mg Methylphenidate Hydrochloride 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 Methylphenidate

Hydrochloride Chewable Tablets administration has not been studied.

Race – The influence of race on the pharmacokinetics of methylphenidate after Methylphenidate

Hydrochloride Chewable Tablets administration has not been studied.

Age – The pharmacokinetics of methylphenidate after Methylphenidate Hydrochloride Chewable

Tablets administration have not been studied in pediatrics.

Renal Insufficiency

There is no experience with the use of Methylphenidate Hydrochloride 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 Methylphenidate Hydrochloride Chewable Tablets.

Hepatic Insufficiency

There is no experience with the use of Methylphenidate Hydrochloride Chewable Tablets in patients

with hepatic insufficiency.

INDICATIONS AND USAGE

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.

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.

CONTRAINDICATIONS

Marked anxiety, tension, and agitation are contraindications to Methylphenidate Hydrochloride

Chewable Tablets, since the drug may aggravate these symptoms. Methylphenidate Hydrochloride

Chewable Tablets are 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.

Methylphenidate Hydrochloride Chewable Tablets are 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).

WARNINGS

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 to 4 mmHg) and

average heart rate (about 3 to 6 bpm), and individuals may have larger increases. While the mean

changes alone would not be expected to have short-term consequences, all patients should be monitored

for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose

underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g.,

those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular

arrhythmia.

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.

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.

Priapis m

Prolonged and painful erections, sometimes requiring surgical intervention, have been reported with

methylphenidate products in both pediatric and adult patients. Priapism was not reported with drug

initiation but developed after some time on the drug, often subsequent to an increase in dose. Priapism

has also appeared during a period of drug withdrawal (drug holidays or discontinuation): Patients who

develop abnormally sustained or frequent and painful erections should seek immediate medical attention.

Peripheral Vasculopathy, Including Raynaud's Phenomenon

Stimulants, including Methylphenidate Hydrochloride Chewable Tablets, used to treat ADHD are

associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are

usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue

breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in

post-marketing reports at different times and at therapeutic doses in all age groups throughout the

course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of

drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants.

Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

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.

Visual Disturbance

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

USE IN CHILDREN LESS THAN SIX YEARS OF AGE

Methylphenidate Hydrochloride Chewable Tablets should not be used in children under six years, since

safety and efficacy in this age group have not been established.

DRUG ABUSE AND DEPENDENCE

Methylphenidate Hydrochloride Chewable Tablets should be given cautiously to emotionally

unstable patients, such as those with a history of drug dependence or alcoholism, because such

patients may increase dosage on their own initiative.

Chronically abusive use can lead to marked tolerance and psychic dependence with varying

degrees of abnormal behavior. Frank psychotic episodes can occur, especially with parenteral

abuse. Careful supervision is required during drug withdrawal, since severe depression as well

as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required

because of the patient's basic personality disturbances.

PRECAUTIONS

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 is 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.

Priapis m

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 0.42 mg of phenylalanine; each 5.0 mg Methylphenidate

Hydrochloride Chewable Tablet contains 0.84 mg of phenylalanine and each 10.0 mg Methylphenidate

Hydrochloride Chewable Tablet contains 1.68 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 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.

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.

ADVERSE REACTIONS

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; libido changes; and rhabdomyolysis. 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 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; serotonin syndrome in combination with serotonergic drugs. 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.

OVERDOSAGE

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, dryness of mucous membranes, and

rhabdomyolysis.

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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Each Methylphenidate Hydrochloride Chewable Tablet 2.5 mg is available as a white colored, grape

flavored round, flat faced, beveled edge tablet debossed with "NL" above and "570" below on the one

side and plain on the other side.

Bottles of 100 .........NDC 40032-570-01

Each Methylphenidate Hydrochloride Chewable Tablet 5 mg is available as a white colored, grape

flavored round, flat faced, beveled edge tablet debossed with "NL" above and "571" below on the one

side and plain on the other side.

Bottles of 100 .........NDC 40032-571-01

Each Methylphenidate Hydrochloride Chewable Tablet 10 mg is available as a white colored, grape

flavored round, flat faced, beveled edge tablet debossed with "NL" above the bisect and "572" below

the bisect on one side and plain on the other side.

Bottles of 100 .........NDC 40032-572-01

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].

Ritalin is a registered trademark of Novartis Corporation.

Manufactured by:

Novel Laboratories Inc.

400 Campus Drive

Somerset, NJ 08873

PI5700000103

Rev. 09/2016

MEDICATION GUIDE

Methylphenidate Hydrochloride Chewable Tablets

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 is the most important information I should know about Methylphenidate Hydrochloride Chewable Tablets?

The following have been reported with use of methylphenidate HCl 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 Chewable Tablets.

Your doctor should check you or your child's blood pressure and heart rate regularly during

treatment with Methylphenidate Hydrochloride Chewable Tablets.

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

Chewable Tablets.

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 Chewable Tablets,

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

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.

Methylphenidate Hydrochloride Chewable Tablets are a federally controlled substance (CII) because it can be abused or lead to dependence. Keep Methylphenidate

Hydrochloride Chewable

Tablets in a safe place to prevent misuse and abuse. Selling or giving away Methylphenidate Hydrochloride Chewable Tablets 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 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 it has 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:

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 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.

Chew Methylphenidate Hydrochloride Chewable Tablets well and swallow with at least 8

ounces (a full glass) of water or other liquid. Methylphenidate Hydrochloride Chewable

Tablets can swell and cause choking if enough liquid is not taken with them. Get

emergency medical care if you have chest pain, vomiting, or trouble swallowing, or

breathing after taking a Methylphenidate Hydrochloride Chewable Tablet.

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 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?

"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, 68° to

77°F (20° to 25°C). 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.

What are the ingredients in Methylphenidate Hydrochloride Chewable Tablets?

CAUTION PHENYLKETONURICS: Methylphenidate Hydrochloride Chewable Tablets contain phenylalanine.

Active Ingredient: methylphenidate hydrochloride USP

Inactive Ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized

starch, phosphoric acid, and stearic acid.

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

Manufactured by:

Novel Laboratories Inc.

400 Campus Drive

Somerset, NJ 08873

PI5700000103

Rev. 09/2016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg

100 Tablets

NDC 40032-570-01

Methylphenidate Hydrochloride Chewable Tablets, 5 mg

100 Tablets

100 Tablets

NDC 40032-571-01

Methylphenidate Hydrochloride Chewable Tablets, 10 mg

100 Tablets

NDC 40032-572-01

METHYLPHENIDATE HYDROCHLORIDE

methylphenidate hydrochloride tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:40 0 32-570

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYLPHENIDATE HYDRO CHLO RIDE (UNII: 4B3SC438 HI) (METHYLPHENIDATE -

UNII:20 7ZZ9 QZ49 )

METHYLPHENIDATE

HYDROCHLORIDE

2.5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

MALTO SE (UNII: XJ6 S9 RV0 6 F)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

Flavor

GRAPE

Imprint Code

NL;570

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:40 0 32-570 -0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/25/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 4115

0 2/25/20 15

METHYLPHENIDATE HYDROCHLORIDE

methylphenidate hydrochloride tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:40 0 32-571

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYLPHENIDATE HYDRO CHLO RIDE (UNII: 4B3SC438 HI) (METHYLPHENIDATE -

UNII:20 7ZZ9 QZ49 )

METHYLPHENIDATE

HYDROCHLORIDE

5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

MALTO SE (UNII: XJ6 S9 RV0 6 F)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

10 mm

Flavor

GRAPE

Imprint Code

NL;571

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:40 0 32-571-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/25/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 4115

0 2/25/20 15

METHYLPHENIDATE HYDROCHLORIDE

methylphenidate hydrochloride tablet, chewable

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:40 0 32-572

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

METHYLPHENIDATE HYDRO CHLO RIDE (UNII: 4B3SC438 HI) (METHYLPHENIDATE -

UNII:20 7ZZ9 QZ49 )

METHYLPHENIDATE

HYDROCHLORIDE

10 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ASPARTAME (UNII: Z0 H242BBR1)

MALTO SE (UNII: XJ6 S9 RV0 6 F)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

PHO SPHO RIC ACID (UNII: E4GA8 8 8 4NN)

STARCH, CO RN (UNII: O8 232NY3SJ)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

Product Characteristics

Color

WHITE

S core

no sco re

S hap e

ROUND

S iz e

13mm

Flavor

GRAPE

Imprint Code

NL;572

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:40 0 32-572-0 1

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 2/25/20 15

Novel Laboratories, Inc.

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA20 4115

0 2/25/20 15

Labeler -

Novel Laboratories, Inc. (793518643)

Registrant -

Novel Laboratories, Inc. (793518643)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

No vel Labo rato ries,

Inc .

79 3518 6 43

ANALYSIS(40 0 32-570 , 40 0 32-571, 40 0 32-572) , MANUFACTURE(40 0 32-570 , 40 0 32-571,

40 0 32-572)

Revised: 12/2019

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