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SAPHRIS
Mood disorders
Psychosis
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Drug Name:

SAPHRIS Rx

Generic Name and Formulations:
Asenapine 5mg, 10mg; sublingual (SL) tabs.

Company:
Merck & Co., Inc.

e-Prescribe this drug via Surescripts


Therapeutic Use:

Indications for SAPHRIS:

Acute treatment of manic or mixed episodes associated with bipolar I disorder, as monotherapy or adjunctive therapy with lithium or valproate.

Adult Dose for SAPHRIS:

Do not crush, chew, or swallow; do not eat or drink for 10 min after administration. Allow tablet to dissolve on tongue completely. Monotherapy: 10mg twice daily; if adverse effects occur, may reduce to 5mg twice daily. Adjunctive therapy: 5mg twice daily, may increase to 10mg twice daily if needed. Max dose: 10mg twice daily. Reevaluate periodically.

Children's Dose for SAPHRIS:

Not recommended.

Pharmacological Class:

Atypical antipsychotic (dibenzo-oxepino pyrrole).

Warnings/Precautions:

Avoid in congenital long QT syndrome, cardiac arrhythmias. Severe hepatic impairment: not recommended. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. History of seizures. Exposure to extreme heat. Dysphagia. Write ℞ for smallest practical amount. Elderly (not for dementia-related psychosis). Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid drugs that can prolong QT interval (eg, Class 1A or Class III antiarrhythmics, ziprasidone, chlorpromazine, thioridazine, moxifloxacin, alcohol). Potentiates antihypertensives. Potentiated by fluvoxamine. Caution with other CNS drugs, drugs that are CYP2D6 substrates /inhibitors, drugs that cause orthostatic hypotension, and drugs with anticholinergic activity.

Adverse Reactions:

Akathisia, oral hypoesthesia, somnolence, dizziness, extrapyramidal effects, GI upset; orthostatic hypotension, syncope, QT prolongation, hyperglycemia, weight gain, hypersensitivity reactions, hyperprolactinemia.

How Supplied:

SL tabs—60
SL tabs (black cherry flavor)—60

Indications for SAPHRIS:

Schizophrenia.

Adult Dose for SAPHRIS:

Do not crush, chew, or swallow; do not eat or drink for 10 min after administration. Allow tablet to dissolve on tongue completely. Acute treatment: 5mg twice daily. Maintenance: 5mg twice daily for 1 week, then increase to 10mg twice daily. Max dose: 10mg twice daily. Reevaluate periodically.

Children's Dose for SAPHRIS:

Not recommended.

Pharmacological Class:

Atypical antipsychotic (dibenzo-oxepino pyrrole).

Warnings/Precautions:

Avoid in congenital long QT syndrome, cardiac arrhythmias. Severe hepatic impairment: not recommended. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia. History of seizures. Exposure to extreme heat. Dysphagia. Write ℞ for smallest practical amount. Elderly (not for dementia-related psychosis). Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

Avoid drugs that can prolong QT interval (eg, Class 1A or Class III antiarrhythmics, ziprasidone, chlorpromazine, thioridazine, moxifloxacin, alcohol). Potentiates antihypertensives. Potentiated by fluvoxamine. Caution with other CNS drugs, drugs that are CYP2D6 substrates /inhibitors, drugs that cause orthostatic hypotension, and drugs with anticholinergic activity.

Adverse Reactions:

Akathisia, oral hypoesthesia, somnolence, dizziness, extrapyramidal effects, GI upset; orthostatic hypotension, syncope, QT prolongation, hyperglycemia, weight gain, hypersensitivity reactions, hyperprolactinemia.

How Supplied:

SL tabs—60
SL tabs (black cherry flavor)—60