Methylphenidate Hydrochloride (Page 3 of 3)

Nursing Mothers

It is not known whether methylphenidate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if Methylphenidate Hydrochloride Tablets are administered to a nursing woman.

Pediatric Use

Long-term effects of methylphenidate in children have not been well established. Methylphenidate Hydrochloride Tablets should not be used in children under six years of age (see WARNINGS).

In a study conducted in young rats, methylphenidate was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (Postnatal Day 7) and continuing through sexual maturity (Postnatal Week 10). When these animals were tested as adults (Postnatal Weeks 13-14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day (approximately 6 times the maximum recommended human dose [MRHD] on a mg/m2 basis) or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (12 times the MRHD on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day (half the MRHD on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

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. There have been rare reports of Tourette’s syndrome. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: instances of abnormal liver function, ranging from transaminase elevation to hepatic coma; isolated cases of cerebral arteritis and/or occlusion; leukopenia and/or anemia; transient depressed mood; a few instances of scalp hair loss. Very rare reports of neuroleptic malignant syndrome (NMS) have been received, and, in most of these, patients were concurrently receiving therapies associated with NMS. In a single report, a ten year old boy who had been taking methylphenidate for approximately 18 months experienced an NMS-like event within 45 minutes of ingesting his first dose of venlafaxine. It is uncertain whether this case represented a drug-drug interaction, a response to either drug alone, or some other cause.

In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

Postmarketing Experience

In addition to the adverse events listed above, the following have been reported in patients receiving methylphenidate worldwide. The list is alphabetized: abnormal behavior, aggression, anxiety, cardiac arrest, depression, fixed drug eruption, hyperactivity, irritability, sudden death, suicidal behavior (including completed suicide), and thrombocytopenia. Data are insufficient to support an estimation of incidence or establish causation.

DOSAGE AND ADMINISTRATION

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

Adults

Tablets

Administer in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Average dosage is 20 to 30 mg daily. Some patients may require 40 to 60 mg daily. In others, 10 to 15 mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m.

Extended-Release Tablets

Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.

Children (6 years and over)

Methylphenidate hydrochloride 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.

Tablets

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

Extended-Release Tablets

Methylphenidate hydrochloride extended-release tablets have a duration of action of approximately 8 hours. Therefore, the extended-release tablets may be used in place of the immediate-release tablets when the 8-hour dosage of methylphenidate hydrochloride extended-release tablets corresponds to the titrated 8-hour dosage of the immediate-release tablets. Methylphenidate hydrochloride extended-release tablets must be swallowed whole and never crushed or chewed.

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

Methylphenidate 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.

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, and dryness of mucous membranes.

Consult with a Certified Poison Control Center regarding treatment for up-to-date guidance and advice.

Treatment consists of appropriate supportive measures. The patient must be protected against self-injury and against external stimuli that would aggravate overstimulation already present. Gastric contents may be evacuated by gastric lavage. In the presence of severe intoxication, use a carefully titrated dosage of a short-acting barbiturate before performing gastric lavage. Other measures to detoxify the gut include administration of activated charcoal and a cathartic.

Intensive care must be provided to maintain adequate circulation and respiratory exchange; external cooling procedures may be required for hyperpyrexia.

Efficacy of peritoneal dialysis or extracorporeal hemodialysis for methylphenidate overdosage has not been established.

HOW SUPPLIED

Methylphenidate Hydrochloride Tablets, USP are supplied as follows:

5 mg: round, yellow, uncoated, unscored, (debossed 531 and MD).

bottles of 100 NDC 0781-8840-01

10 mg: round, pale blue/green, uncoated, scored, (debossed 530 and MD).

bottles of 100 NDC 0781-8841-01

20 mg: round, orange, uncoated, scored, (debossed 532 and MD).

bottles of 100 NDC 0781-8842-01

Extended-Release, 20 mg: round, white, uncoated, unscored, (debossed 562 and MD).

bottles of 100 NDC 0781-8843-01

NOTE: Extended-release tablets are color-additive free.

Pharmacist

Dispense in a tight container as defined in the USP with a child-resistant closure.

Store at 20° -25°C (68° -77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture.

Manufactured by
UCB Manufacturing, Inc.
Rochester, NY 14623 for
Sandoz Inc.
Broomfield, CO 80020

Rev. 3E 06/2006
4000391

© 2006, UCB, Inc., Smyrna, GA 30080 All rights reserved. Printed in U.S.A.

METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 0781-8840
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methylphenidate hydrochloride (methylphenidate) methylphenidate 5 mg
Inactive Ingredients
Ingredient Name Strength
lactose
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
D & C Yellow No. 10
Product Characteristics
Color YELLOW (YELLOW) Score no score
Shape ROUND (ROUND) Size 6mm
Flavor Imprint Code 531;MD
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-8840-01 100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC None
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 0781-8841
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methylphenidate hydrochloride (methylphenidate) methylphenidate 10 mg
Inactive Ingredients
Ingredient Name Strength
lactose
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
FD & C Green No. 3
Product Characteristics
Color BLUE (pale blue/green) , GREEN (pale blue/green) Score 2 pieces
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 530;MD
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-8841-01 100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC None
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 0781-8842
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methylphenidate hydrochloride (methylphenidate) methylphenidate 20 mg
Inactive Ingredients
Ingredient Name Strength
lactose
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
FD & C Yellow No. 6
Product Characteristics
Color ORANGE (ORANGE) Score 2 pieces
Shape ROUND (ROUND) Size 8mm
Flavor Imprint Code 532;MD
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-8842-01 100 TABLET (100 TABLET) in 1 BOTTLE, PLASTIC None
METHYLPHENIDATE HYDROCHLORIDE
methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) 0781-8843
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
methylphenidate hydrochloride (methylphenidate) methylphenidate 20 mg
Inactive Ingredients
Ingredient Name Strength
cetyl alcohol
ethylcellulose
anhydrous lactose
magnesium stearate
Product Characteristics
Color WHITE (WHITE) Score no score
Shape ROUND (ROUND) Size 7mm
Flavor Imprint Code 562;MD
Contains
Coating false Symbol false
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0781-8843-01 100 TABLET, EXTENDED RELEASE (100 TABLET) in 1 BOTTLE, PLASTIC None
Labeler — UCB Pharma, Inc.

Revised: 09/2006 UCB Pharma, Inc.

Page 3 of 3 1 2 3

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.