RITALIN Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Novartis Pharmaceuticals Corporation

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BOXED WARNING SECTION

WARNING: ABUSE AND DEPENDENCE CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abus e and dependence. Ass ...

1. Indications and Usage

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

2. Dosage and Administration

2.1 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., ...

3. 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 ...

4. Contraindications

Hypersensitivity to methylphenidate or other components of Ritalin or Ritalin-SR. Hypersensitivity reactions, such as angioedema and anaphylactic reactions, have been reported in patients treated with ...

5. Warnings and Precautions

5.1 Potential for Abuse and Dependence CNS stimulants, including Ritalin and Ritalin-SR, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess ...

6. Adverse Reactions

The following are discussed in more detail in other sections of the labeling: Abuse and Dependence [see Boxed Warning, Warnings and Precautions (5.1), Drug Abuse and Dependence (9.2, 9.3)] Known ...

7. Drug Interactions

7.1 Clinically Important Interactions with Ritalin and Ritalin-SR Table 1 presents clinically important drug interactions with Ritalin and Ritalin-SR. Table 1. Clinically Important Drug Interactions with ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Ritalin and Ritalin-SR, during pregnancy. Healthcare ...

8.2. Lactation

Risk Summary Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present in human milk, which resulted in infant doses of 0.16% to 0.7% of the maternal ...

8.4. Pediatric Use

The safety and effectiveness of Ritalin and Ritalin-SR for the treatment of ADHD have been established in pediatric patients 6 to 17 years. The safety and effectiveness of Ritalin and Ritalin-SR in pediatric ...

8.5. Geriatric Use

Ritalin has not been studied in the geriatric population.

9.1. Controlled Substance

Ritalin and Ritalin-SR contain methylphenidate hydrochloride, a Schedule II controlled substance.

9.2. Abuse

CNS stimulants, including Ritalin and Ritalin-SR, have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and craving. Signs and symptoms of CNS stimulant ...

9.3. Dependence

Tolerance Tolerance (a state of adaptation in which exposure to a drug results in a reduction of the drugs desired and/or undesired effects over time) can occur during chronic therapy with CNS stimulants, ...

10. Overdosage

Human Experience Signs and symptoms of acute overdosage, resulting principally from overstimulation of the central nervous system and from excessive sympathomimetic effects, may include the following: ...

11. Description

Ritalin contains methylphenidate hydrochloride, a CNS stimulant. It is available as tablets of 5 mg, 10 mg, and 20 mg strength for oral administration. Ritalin-SR contains methylphenidate hydrochloride, ...

12.1. Mechanism of Action

Methylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD and narcolepsy is not known.

12.2. Pharmacodynamics

Methylphenidate is a racemic mixture comprised of the d- and l-threo enantiomers. The d-threo enantiomer is more pharmacologically active than the l-threo enantiomer. Methylphenidate ...

12.3. Pharmacokinetics

Absorption Ritalin in the SR tablets is more slowly but as extensively absorbed as in the regular tablets. Relative bioavailability of the SR tablet compared to the Ritalin tablet, measured by the urinary ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis In a lifetime carcinogenicity study carried out in B6C3F1 mice, methylphenidate caused an increase in hepatocellular adenomas, and in males only, an increase in hepatoblastomas at a daily ...

16.1. How Supplied

Ritalin Tablets 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 ...

16.2. Storage and Handling

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].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/High Potential for Abuse and Dependence Advise patients that Ritalin and Ritalin-SR are controlled ...