RVP

Drug Catalog - Product Detail

METHYLPHENIDATE HCL TB 20MG 100CT

NDC Mfr Size Str Form
10702-0102-01 KVK TECH 100 20MG TABLET
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Generic Name
METHYLPHENIDATE HYDROCHLORIDE
Substance Name
METHYLPHENIDATE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA206932
Description
11 DESCRIPTION Methylphenidate hydrochloride tablets contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5mg, 10 mg and 20 mg strength for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is: Methylphenidate hydrochloride USP is a white, odorless, fine crystalline powder. Its solutions are acid to litmus. It is freely soluble in water and in methanol, soluble in alcohol, and slightly soluble in chloroform and in acetone. Its molecular weight is 269.77 g/mol. Methylphenidate hydrochloride tablet contains the following inactive ingredients: corn starch, D&C Yellow # 10, lactose monohydrate, magnesium stearate, talc, and FD&C Blue #1 (10mg tablets). Chemical Formula
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate hydrochloride tablets, USP are available as follows: Tablets 5 mg- Yellow, round, flat faced beveled edge tablets, debossed “K” above “100” on one side and plain on other side. Bottles of 100 NDC 10702-100-01 Tablets 10 mg- Pale green colored, round, biconvex tablets debossed “K” above bisect “101” on one side and plain on the other side. Bottles of 100 NDC 10702-101-01 Tablets 20 mg- Light yellow, round, biconvex tablets debossed “K” above bisect “102” on one side and plain on the other side. Bottles of 100 NDC 10702-102-01 Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C and 30°C (59°F and 86°F). [see USP controlled room temperature]. Protect from light. Dispense in tight, light-resistant container (USP).
Indications & Usage
1 INDICATIONS AND USAGE Methylphenidate hydrochloride tablets are indicated for the treatment of: Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults Narcolepsy Methylphenidate hydrochloride tablets is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorders (ADHD) and Narcolepsy (1).
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Pediatric Patients 6 Years and Older: Start with 5 mg twice daily (before breakfast and lunch), titrating the dose weekly in 5- to 10-mg increments. Dosages above 60 mg/day are not recommended (2.2). Adults: Average daily dosage is 20 mg to 30 mg, administered 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg (2.2). 2.1 Pretreatment Screening Prior to treating patients with Methylphenidate hydrochloride tablets, assess: for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)]. the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome before initiating Methylphenidate hydrochloride tablets [see Warnings and Precautions (5.10)] 2.2 General Dosing Information Pediatric Patients 6 years and Older: Start with 5 mg orally twice daily (before breakfast and lunch). Increase dosage gradually, in increments of 5-to 10-mg weekly. Daily Dosage above 60 mg is not recommended. Adults: Average dosage is 20 to 30 mg daily. Administer orally in divided doses 2 or 3 times daily, preferably 30 to 45 minutes before meals. Maximum total daily dosage is 60 mg. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m. 2.3 Dose Reduction and Discontinuation If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Methylphenidate hydrochloride tablets. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.