Asenapine

ASENAPINE

Manufacturer: Alembic Pharmaceuticals Limited

Score: 144.0

Quick Summary

Asenapine is an atypical antipsychotic used for the treatment of bipolar I disorder, including acute monotherapy of manic or mixed episodes in pediatric patients 10 to 17 years of age, and as adjunctive therapy to lithium or valproate in adults. The mechanism of action is unknown, but it exhibits high affinity for serotonin and dopamine receptors. Important safety information includes a boxed warning for increased mortality in elderly patients with dementia-related psychosis, and contraindications include severe hepatic impairment and hypersensitivity reactions. Common adverse reactions include somnolence, oral hypoesthesia, and fatigue. The recommended dosing is 2.5 mg to 10 mg twice daily for pediatric patients and 5 mg to 10 mg twice daily for adults, with dose adjustments based on individual response and tolerability. Special population considerations include use during pregnancy, pediatric use, and geriatric use, with careful monitoring recommended due to increased risk of adverse reactions.

Key Clinical Findings and Indications

Bipolar I disorder
Acute monotherapy of manic or mixed episodes in pediatric patients 10 to 17 years of age
Adjunctive therapy to lithium or valproate in adults

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

Severe hepatic impairment
Hypersensitivity reactions

Adverse Reactions

Somnolence
Oral hypoesthesia
Fatigue
Dizziness
Dysgeusia
Nausea
Increased appetite
Increased weight

Dosing Recommendations

General Guidance

Dose adjustments based on individual response and tolerability

Bipolar I disorder

Adult Dose

5 mg to 10 mg twice daily

Pediatric Dose

2.5 mg to 10 mg twice daily

Special Population Considerations

Pregnancy

Use during pregnancy is not recommended due to increased risk of adverse reactions

Nursing Mothers

Use during nursing is not recommended due to potential for adverse reactions in the infant

Pediatric Use

Safety and efficacy in pediatric patients under 10 years of age have not been established

Geriatric Use

Elderly patients may be more sensitive to the effects of asenapine, with increased risk of adverse reactions

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