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Asenapine Dosage

Applies to the following strength(s): 5 mg ; 10 mg ; 2.5 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Schizophrenia

Acute treatment:
Starting dose: 5 mg sublingually twice a day
Recommended dose: 5 mg sublingually twice a day, if tolerated may increase to 10 mg sublingually twice a day after 1 week if necessary
Maximum dose: 10 mg sublingually twice a 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 10 mg twice daily has not been evaluated in clinical studies.

Maintenance Treatment:
Recommended dose: 5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day

Comments: There is no available evidence to answer the question of how long the schizophrenic patient should remain on therapy; it is generally recommended that responding patients be continued beyond the acute response.

Use: Treatment of schizophrenia.

Usual Adult Dose for Bipolar Disorder

Monotherapy:
Starting dose: 10 mg sublingually twice a day
Recommended dose: 5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day

Comment: In controlled trials, the starting dose was 10 mg twice daily. On the second and subsequent days, the dose could be lowered to 5 mg twice daily, however less than 10% of patients had their dose reduced.

Adjunctive Therapy:
Starting dose: 5 mg sublingually twice a day
Maintenance dose: 5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day

Comments:
-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; it is generally recommended that responding patients be continued beyond the acute response.

Uses: For the acute treatment of manic or mixed episodes associated with bipolar 1 disorder either as monotherapy or as adjunctive therapy with either lithium or valproate.

Usual Pediatric Dose for Bipolar Disorder

Age: 10 years or older
Starting dose: 2.5 mg sublingually twice a day
Dose titration: After 3 days, may increase to 5 mg sublingually twice daily, and after an additional 3 days to 10 mg twice a day, as needed and as tolerated
Recommended dose: 2.5 to 10 mg sublingually twice a day
Maximum dose: 10 mg sublingually twice a day

Comment: Pediatric patients appear to be more sensitive to dystonia with initial dosing and therefore gradual dose escalation is recommended. The safety of doses above 10 mg twice a day has not been studied.

Use: As monotherapy for the acute treatment of manic or mixed episodes associated with bipolar 1 disorder.

Renal Dose Adjustments

CrCl 15 to 90 mL/min: No adjustment recommended
CrCl less than 15 mL/min: No data available

Liver Dose Adjustments

Severe hepatic impairment (Child-Pugh C): Use is contraindicated
Mild to moderate hepatic impairment (Child-Pugh A or B): No adjustment recommended

Dose Adjustments

Doses should be titrated from 5 mg to 10 mg based on clinical response and tolerability. Doses greater than 10 mg sublingually twice a day have not been studied.

Precautions

US BOXED WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:
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.

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; do not push the tablet through the tablet pack, rather using dry hands pull out tablet pack and peel back colored tab gently removing the tablet
-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.

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.

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:
-Inform patients that application site reactions including oral ulcers, blisters, peeling/sloughing and inflammation may occur and they should contact their healthcare provider if this occurs.
-Inform patient that this drug may cause dizziness upon arising; it is best to get up slowly form a seated or lying position.
-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should avoid overheating and dehydration.

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