ADDERALL XR Extended-release capsule (2022)

Βιβλιογραφική αναφορά

Συγγραφείς

Takeda Pharmaceuticals America, Inc.

Λέξεις κλειδιά

54092-381 54092-385 54092-387 54092-389 54092-391 54092-383

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BOXED WARNING SECTION

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

1. Indications and Usage

1.1 Attention Deficit Hyperactivity Disorder ADDERALL XR is indicated for the treatment of attention deficit hyperactivity disorder (ADHD). The efficacy of ADDERALL XR in the treatment of ADHD was established ...

2. Dosage and Administration

2.1 Important Information Prior to Initiating Treatment Prior to initiating treatment with ADDERALL XR, assess for the presence of cardiac disease (e.g., perform a careful history, family history of sudden ...

3. Dosage Forms and Strengths

ADDERALL XR 5 mg extended release capsules: Clear/blue (imprinted ADDERALL XR 5 mg). ADDERALL XR 10 mg extended release capsules: Blue/blue (imprinted ADDERALL XR 10 mg). ADDERALL XR 15 ...

4. Contraindications

ADDERALL XR administration is contraindicated in patients with the following conditions: Advanced arteriosclerosis Symptomatic cardiovascular disease Moderate to severe hypertension Hyperthyroidism In ...

5. Warnings and Precautions

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

6. Adverse Reactions

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 ...

6.1. Clinical Trials Experience

The premarketing development program for ADDERALL XR included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy ...

7. Drug Interactions

7.1 Clinically Important Interactions with Amphetamines Table 4. Drugs Having Clinically Important Interactions with Amphetamines: Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact ...

8.1. Pregnancy

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADDERALL XR during pregnancy. Healthcare providers are encouraged to register patients ...

8.2. Lactation

Risk Summary Based on limited case reports in published literature, amphetamine (d- or d, l-) is present in human milk, at relative infant doses of 2% to 13.8% of the maternal ...

8.4. Pediatric Use

ADDERALL XR is indicated for use in children 6 years of age and older. The safety and efficacy of ADDERALL XR in children under 6 years of age have not been studied. Long-term effects of amphetamines in ...

8.5. Geriatric Use

ADDERALL XR has not been studied in the geriatric population.

8.6. Renal Impairment

Due to reduced clearance of amphetamines in patients with severe renal impairment (GFR 15 to <30 mL/min/1.73m²), the recommended dose should be reduced. ADDERALL XR is not recommended in patients with ...

9.1. Controlled Substance

ADDERALL XR contains amphetamine, a Schedule II controlled substance.

9.2. Abuse

ADDERALL XR is a CNS stimulant that contains amphetamine, which has a high potential for abuse. Abuse is characterized by impaired control of drug use, compulsive use despite harm, and craving. Signs and ...

9.3. Dependence

Tolerance (a state of adaptation in which exposure to a specific dose of a drug results in a reduction of the drugs desired and/or undesired effects over time, in such a way that a higher dose of the drug ...

10. Overdosage

Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue ...

11. Description

ADDERALL XR extended-release capsules contain mixed salts of a single-entity amphetamine, a CNS stimulant. ADDERALL XR contains equal amounts (by weight) of four salts: dextroamphetamine sulfate, amphetamine ...

12.1. Mechanism of Action

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in ADHD is not known.

12.2. Pharmacodynamics

Amphetamines block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

12.3. Pharmacokinetics

Pharmacokinetic studies of ADDERALL XR have been conducted in healthy adult and pediatric (children aged 6-12 yrs) subjects, and adolescent (13-17 yrs) and children with ADHD. Both ADDERALL (immediate-release) ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to ...

13.2. Animal Toxicology and/or Pharmacology

Acute administration of high doses of amphetamine (d- or d,l-) has been shown to produce long-lasting neurotoxic effects, including irreversible nerve fiber damage, in rodents. The significance of these ...

14. Clinical Studies

Pediatric Patients A double-blind, randomized, placebo-controlled, parallel-group study was conducted in children aged 6-12 (N=584) who met DSM-IV criteria for ADHD (either the combined type or the hyperactive-impulsive ...

16.1. How Supplied

ADDERALL XR 5 mg extended release capsules: Clear/blue (imprinted ADDERALL XR 5 mg), bottles of 100, NDC 54092-381-01 ADDERALL XR 10 mg extended release capsules: Blue/blue (imprinted ADDERALL ...

16.2. Storage and Handling

Dispense in a tight, light-resistant container as defined in the USP. Store at room temperature, 20º C to 25º C (68º F to 77º F). Excursions permitted to 15-30º C (59-86ºF) [see USP CONTROLLED ROOM ...

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Medication Guide). Controlled Substance Status/Potential for Abuse, Misuse, and Dependence Advise patients that ADDERALL XR is a federally ...