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Asenapine Dosage

Medically reviewed on March 2, 2017.

Applies to the following strengths: 5 mg; 10 mg; 2.5 mg

Usual Adult Dose for Schizophrenia

Initial dose: 5 mg sublingually 2 times a day
Maintenance dose: 5 mg sublingually 2 times a day, if tolerated may increase to 10 mg sublingually 2 times a day after 1 week if necessary
Maximum dose: 20 mg/day

Comments:
-Controlled trials revealed no added benefit with the higher dose, but a clear increase in certain adverse reactions.
-The safety of doses above 20 mg/day has not been evaluated in clinical studies.

Use: Treatment of schizophrenia

Usual Adult Dose for Bipolar Disorder

Monotherapy:
-Initial dose: 10 mg sublingually 2 times a day
-Maintenance dose: 5 to 10 mg sublingually 2 times a day
-Maximum dose: 20 mg/day

Adjunctive Therapy:
-Initial dose: 5 mg sublingually 2 times a day
-Maintenance dose: 5 to 10 mg sublingually 2 times a day
-Maximum dose: 20 mg/day

Comments:
-The safety of doses above 20 mg/day has not been evaluated in clinical studies.
-In controlled trials, the starting dose in monotherapy was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, though approximately 90% of patients remained on the initial dose.
-The dose should be titrated based on clinical response and tolerability.
-There is no available evidence to answer the question of how long the patient should remain on therapy; however, it is generally recommended that responding patients be continued beyond the acute response.

Uses:
-Acute monotherapy of manic or mixed episodes of bipolar I disorder
-Adjunctive treatment to lithium or valproate in bipolar I disorder
-Maintenance monotherapy treatment of bipolar I disorder

Usual Pediatric Dose for Bipolar Disorder

10 years and older
-Initial dose: 2.5 mg sublingually 2 times a day
-Titration regimen: After 3 days, may increase to 5 mg sublingually 2 times a day, and after an additional 3 days to 10 mg sublingually 2 times a day, as needed and as tolerated
-Maintenance dose: 2.5 to 10 mg sublingually 2 times a day
-Maximum dose: 20 mg/day

Comments:
-Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended.
-The safety of doses above 20 mg/day has not been studied.

Use: Acute monotherapy of manic or mixed episodes of bipolar I disorder

Renal Dose Adjustments

Mild to severe renal dysfunction (Glomerular filtration rate [GFR] 15 to 90 mL/min): No adjustment recommended.
GFR less than 15 mL/min: Data not available

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A and B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Contraindicated

Dose Adjustments

Doses should be titrated from 5 mg to 10 mg 2 times a day based on clinical response and tolerability.

Precautions

US BOXED WARNINGS:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:
-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
-This drug is not approved for the treatment of patients with dementia-related psychosis.

CONTRAINDICATIONS:
-Hypersensitivity to the active component or any of the ingredients or a history of hypersensitivity reactions to this drug
-Severe liver dysfunction (Child-Pugh C)

Safety and efficacy have not been established in patients younger than 10 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration Advice:
-Do not remove tablet from package until ready to administer.
-The tablet should not be pushed through the tablet pack.
-Patients should handle tablets with dry hands.
-Place whole tablet under tongue and allow to dissolve completely; do not split, crush, chew, or swallow the tablet
-Do not eat or drink for 10 minutes after administration.
-When taken in combination with other medications, this drug should be taken last.

Storage requirements:
-Tablets should be kept in the tablet pack until ready to be used.

General:
-Controlled clinical trials assessing long-term use are not available; the physician who prescribes this drug should periodically re-evaluate the long-term risks and benefits for the individual patient.
-No specific recommendations are available regarding switching from other antipsychotics or for the use of concomitant antipsychotics.
-Patients should be reassessed periodically to determine continued need for treatment, and to determine the appropriate dosage for treatment.

Monitoring:
-Cardiovascular: Orthostatic vital signs in at-risk patients
-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia.
-Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient Advice:
-Patients, families, and caregivers should be educated on the risks of suicidal thoughts and behaviors, as well as the risk of mania and hypomania; what to watch for and when to seek medical advice.
-This drug may impair judgment, thinking, or motor skills; patients should be told to avoid driving or operating machinery until adverse effects are determined.
-Advise patients to speak to physician or health care professional if they are pregnant, intend to become pregnant, or are breastfeeding.
-Advise patients that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should be instructed to avoid overheating and dehydration.
-Patients should speak with their healthcare provider if they are taking, or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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