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RITALIN AND RITALIN-SR (METHYLPHENIDATE) TABLETS: PRESCRIBING INFORMATION
Ritalin (Methylphenidate Hydrochloride USP), is a mild central nervous system (CNS) stimulant, available as tablets of 5 mg, 10 mg, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg for oral administration. Methylphenidate Hydrochloride is methyl-alpha-phenyl-2-piperidineacetate hydrochloride.
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.
Ritalin tablets: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10 mg tablets), magnesium stearate, lactose, polyethylene glycol, starch (5 mg and 10 mg tablets), talc, sucrose, tragacanth (20 mg tablets).
Ritalin-SR tablets: cetostearyl alcohol, cellulose compounds, lactose, magnesium stearate, povidone, mineral oil,titanium dioxide, zein.
Ritalin and Ritalin-SR clinical pharmacology
INDICATIONS AND USAGE
Ritalin and Ritalin-SR indications and usage
Marked anxiety, tension, and agitation are contraindications to Ritalin (Methylphenidate HCl), since the drug may aggravate these symptoms. Ritalin is 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.
Ritalin (Methylphenidate HCl) 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).
Ritalin and Ritalin-SR warnings
Ritalin and Ritalin-SR precautions
Ritalin and Ritalin-SR nonclinical toxicology
USE IN SPECIAL POPULATIONS
Ritalin and Ritalin-SR use in special populations
Ritalin and Ritalin-SR adverse reactions
DOSAGE AND ADMINISTRATION
Ritalin and Ritalin-SR dosage and administration
Ritalin and Ritalin-SR overdosage
Ritalin and Ritalin-SR how supplied
Manufactured and distributed by Novartis pharmaceutical company and its divisions.
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