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SAPHRIS
Mood disorders
Psychosis
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Drug Name:

SAPHRIS Rx

Generic Name and Formulations:
Asenapine 2.5mg, 5mg, 10mg; sublingual (SL) tabs; black-cherry flavored.

Company:
Allergan

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. Maintenance treatment of bipolar I disorder as monotherapy.

Adult:

Do not split, crush, chew, or swallow; do not eat or drink for 10 min after administration. Allow tablet to dissolve on tongue completely. Acute (monotherapy): 5–10mg twice daily; (adjunctive): initially 5mg twice daily; may increase to 10mg twice daily if needed. Maintenance: continue stabilized dose (5–10mg twice daily); may reduce to 5mg twice daily if needed. For all: max 10mg twice daily. Reevaluate periodically.

Children:

<10yrs: not established. 10–17yrs: Acute (monotherapy): initially 2.5mg twice daily; may increase to 5mg twice daily after 3 days, then to 10mg twice daily after 3 more days. Max: 10mg twice daily. Reevaluate periodically.

Contraindications:

Severe hepatic impairment.

Warnings/Precautions:

Elderly (not for dementia-related psychosis; may increase risk of death). Avoid in congenital long QT syndrome, cardiac arrhythmias. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Volume depletion. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for hyperglycemia/diabetes, dyslipidemia, and weight gain prior to or soon after initiation. History of seizures. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Aspiration risk. Suicidal tendencies (monitor). Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:

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

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Akathisia, oral hypoesthesia, somnolence, dizziness, extrapyramidal effects, GI upset, increased appetite, fatigue, increased weight; orthostatic hypotension, syncope, QT prolongation, leukopenia, dysphagia, hypersensitivity reactions, hyperprolactinemia.

How Supplied:

SL tabs—60

Indications for SAPHRIS:

Schizophrenia.

Adult:

Do not split, crush, chew, or swallow; do not eat or drink for 10 min after administration. Allow tablet to dissolve on tongue completely. 5mg twice daily; may increase to 10mg twice daily after 1 week, if tolerated. Max: 10mg twice daily. Reevaluate periodically.

Children:

Not recommended.

Contraindications:

Severe hepatic impairment.

Warnings/Precautions:

Elderly (not for dementia-related psychosis; may increase risk of death). Avoid in congenital long QT syndrome, cardiac arrhythmias. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Volume depletion. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for hyperglycemia/diabetes, dyslipidemia, and weight gain prior to or soon after initiation. History of seizures. Exposure to extreme heat. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Aspiration risk. Suicidal tendencies (monitor). Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:

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

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Akathisia, oral hypoesthesia, somnolence, dizziness, extrapyramidal effects, GI upset, increased appetite, fatigue, increased weight; orthostatic hypotension, syncope, QT prolongation, leukopenia, dysphagia, hypersensitivity reactions, hyperprolactinemia.

How Supplied:

SL tabs—60

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