FOCALIN Tablet (2020)

Βιβλιογραφική αναφορά

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Novartis Pharmaceuticals Corporation

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BOXED WARNING SECTION

WARNING: ABUSE AND DEPENDENCE CNS stimulants, including Focalin, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence. Assess the risk of ...

1. Indications and Usage

Focalin is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) [see Clinical Studies (14)].

2. Dosage and Administration

2.1 Pretreatment Screening Prior to treating pediatric patients and adults with central nervous system (CNS) stimulants, including Focalin, assess for the presence of cardiac disease (i.e., perform a careful ...

3. Dosage Forms and Strengths

Focalin (dexmethylphenidate hydrochloride) tablets are D-shaped, embossed D on upper convex face and dosage strength on lower convex face in the following colors: 2.5 mg tablets – blue 5 mg tablets – yellow ...

4. Contraindications

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

5. Warnings and Precautions

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

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following additional adverse reactions have been identified during post approval use of dexmethylphenidate. Because these reactions are reported voluntarily from a population of uncertain size, it ...

7. Drug Interactions

7.1 Clinically Important Interactions with Focalin Table 2 presents clinically important drug interactions with Focalin. Table 2. Clinically Important Drug Interactions with Focalin: Monoamine Oxidase ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including Focalin, during pregnancy. Healthcare providers are encouraged ...

8.2. Lactation

Risk Summary Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Limited published literature, based on milk sampling from seven mothers reports that methylphenidate is present ...

8.4. Pediatric Use

The safety and effectiveness of Focalin have been established in pediatric patients ages 6 to 17 years in two adequate and well-controlled clinical trials [see Clinical Studies (14)]. The safety ...

8.5. Geriatric Use

Focalin has not been studied in the geriatric population.

9.1. Controlled Substance

Focalin contains dexmethylphenidate hydrochloride, a Schedule II controlled substance.

9.2. Abuse

CNS stimulants, including Focalin, other methylphenidate-containing products, and amphetamines have a high potential for abuse. Abuse is characterized by impaired control over drug use despite harm, and ...

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 methylphenidate overdosage, resulting principally from overstimulation of the CNS and from excessive sympathomimetic effects, may include the following: vomiting, ...

11. Description

Focalin contains dexmethylphenidate hydrochloride, a CNS stimulant. Dexmethylphenidate hydrochloride is the d-threo enantiomer of racemic methylphenidate hydrochloride. Focalin is available as ...

12.1. Mechanism of Action

Dexmethylphenidate hydrochloride is a CNS stimulant. The mode of therapeutic action in ADHD is not known.

12.2. Pharmacodynamics

Dexmethylphenidate is the more pharmacologically active d-enantiomer of racemic methylphenidate. Methylphenidate blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron ...

12.3. Pharmacokinetics

Absorption Dexmethylphenidate hydrochloride is readily absorbed following oral administration of Focalin. In patients with ADHD, plasma dexmethylphenidate concentrations increase rapidly, reaching a maximum ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Lifetime carcinogenicity studies have not been carried out with dexmethylphenidate. In a lifetime carcinogenicity study carried out in B6C3F1 mice, racemic methylphenidate caused an increase ...

14. Clinical Studies

The efficacy of Focalin for the treatment of ADHD was established in two double-blind, parallel-group, placebo-controlled trials in untreated or previously treated patients (ages 6 to 17 years old) who ...

16.1. How Supplied

Focalin (dexmethylphenidate hydrochloride) tablets (D-shaped, embossed D on upper convex face and dosage strength on lower convex face) are available as follows: 2.5 mg tablets (NDC 0078-0380-05) blue, ...

16.2. Storage and Handling

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container (USP). Disposal ...

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 Focalin is a controlled substance, ...