Description
(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
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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)
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
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).
The following are discussed in more detail in other sections of the labeling:
- Abuse and Dependence
- Known hypersensitivity to methylphenidate or other ingredients of Ritalin and Ritalin-SR
- Hypertensive crisis with Concomitant Use of Monoamine Oxidase Inhibitors
- Serious Cardiovascular Reactions
- Blood Pressure and Heart Rate Increases
- Psychiatric Adverse Reactions
- Priapism
- Peripheral Vasculopathy, including Raynaud’s Phenomenon
- Long-term Suppression of Growth
The following adverse reactions associated with the use of all Ritalin, Ritalin-SR, and other methylphenidate products were identified in clinical trials, spontaneous reports, and literature. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
Common side effects include:
- fast heart beat
- abnormal heartbeat (palpitations)
- headache
- trouble sleeping
- nervousness
- sweating a lot
- decreased appetite
- dry mouth
- nausea
- stomach pain
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