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(methylphenidate hydrochloride) USP Tablets

RITALIN-SR® FOR SALE ONLINE
(methylphenidate hydrochloride) USP Sustained-Release Tablets

DESCRIPTION

Ritalin hydrochloride, methylphenidate hydrochloride USP, is a mild central nervous system (CNS) stimulant, available as tablets of 5, 10, and 20 mg for oral administration; Ritalin-SR is available as sustained-release tablets of 20 mg 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.Inactive Ingredients. Ritalin tablets: D&C Yellow No. 10 (5-mg and 20-mg tablets), FD&C Green No. 3 (10-mg tablets), lactose, magnesium stearate, polyethylene glycol, starch (5-mg and 10-mg tablets), sucrose, talc, and tragacanth (20-mg tablets).

Ritalin-SR tablets: Cellulose compounds, cetostearyl alcohol, lactose, magnesium stearate, mineral oil, povidone, titanium dioxide, and zein.

INDICATIONS

Ritalin and Ritalin-SR are indicated for the treatment of:

• Attention Deficit Hyperactivity Disorders (ADHD) in pediatric patients 6 years and older and adults
• Narcolepsy

RITALIN DOSAGE AND ADMINISTRATION

Pretreatment Screening

Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including Ritalin or Ritalin- SR, assess for the presence of cardiac disease (i.e., perform a careful history including family history of sudden death or ventricular arrhythmia, and physical examination) [see WARNINGS AND PRECAUTIONS].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate the need for Ritalin or Ritalin-SR use [see BOX WARNING, WARNINGS AND PRECAUTIONS , Drug Abuse And Dependence].

General Dosing Information

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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.

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

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re-evaluate the long-term use of Ritalin and Ritalin-SR, and adjust dosage as needed.

Dose Reduction And Discontinuation

If paradoxical worsening of symptoms or other adverse reactions occur, reduce the dosage, or, if necessary, discontinue Ritalin or Ritalin-SR. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.

HOW SUPPLIED

Dosage Forms And Strengths

Tablets

• 5 mg, round, yellow, flat with CIBA monograpm on one side and NDC# 7 on the reverse side
• 10 mg, round, pale green, biconvex with CIBA monograpm on one side and NDC# 3 and a partial bisection on the reverse side
• 20 mg, round, pale yellow, biconvex with CIBA monograpm on one side and NDC# 34 and a partial bisection on the reverse side

Extended-Release Tablets

• 20 mg extended-release tablets, white to off-white, round, bicinvex, film coated with the ‘CIBA’ monograpm and ‘16’ on one side printed in black ink

Storage And Handling

Ritalin Tablets For Sale 

5 mg tablets (NDC 0078-0439-05) round, yellow, (imprinted CIBA 7) supplied in bottles of 100

10 mg tablets (NDC 0078-0440-05) round, pale green, scored, (imprinted CIBA 3) supplied in bottles of 100

20 mg tablets (NDC 0078-0441-05) round, pale yellow, scored, (imprinted CIBA 34) supplied in bottles of 100

Store at 25°C (77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature] Protect from light.

Dispense in tight, light-resistant container (USP).

Ritalin-SR Extended-Release Tablets

20 mg SR extended-release tablets (NDC 0078-0442-05), round, white, coated, (imprinted CIBA 16) supplied in bottles of 100

Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature]

Protect from moisture.

Dispense in tight, light-resistant container (USP).

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