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Saphris Generic Name & Formulations
Legal Class
Rx
General Description
Asenapine 2.5mg, 5mg, 10mg; sublingual (SL) tabs; black-cherry flavored.
Pharmacological Class
Atypical antipsychotic.
How Supplied
SL tabs—60
Manufacturer
Saphris Indications
Indications
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.
Saphris Dosage and Administration
Adult
Do not split, crush, chew, or swallow; do not eat or drink for 10mins 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.
Saphris Contraindications
Contraindications
Severe hepatic impairment.
Saphris Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Saphris Warnings/Precautions
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 WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBC declines. Monitor for hyperglycemia/diabetes, dyslipidemia, and weight gain prior to or soon after initiation. Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures. Strenuous exercise. Exposure to extreme heat. Dehydration. Aspiration risk. Suicidal tendencies (monitor). Write ℞ for smallest practical amount. Neonates: may cause extrapyramidal and/or withdrawal symptoms (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.
Saphris Pharmacokinetics
Elimination
Renal (50%), fecal (40%). Half-life: ~24 hours.
Saphris Interactions
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.
Saphris Adverse Reactions
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.
Saphris Clinical Trials
See Literature
Saphris Note
Not Applicable
Saphris Patient Counseling
See Literature
Saphris Generic Name & Formulations
Legal Class
Rx
General Description
Asenapine 2.5mg, 5mg, 10mg; sublingual (SL) tabs; black-cherry flavored.
Pharmacological Class
Atypical antipsychotic.
How Supplied
SL tabs—60
Manufacturer
Saphris Indications
Indications
Schizophrenia.
Saphris Dosage and Administration
Adult
Do not split, crush, chew, or swallow; do not eat or drink for 10mins 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.
Saphris Contraindications
Contraindications
Severe hepatic impairment.
Saphris Boxed Warnings
Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis.
Saphris Warnings/Precautions
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 WBC/ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBC declines. Monitor for hyperglycemia/diabetes, dyslipidemia, and weight gain prior to or soon after initiation. Perform fall risk assessments when initiating and recurrently on long-term therapy. History of seizures. Strenuous exercise. Exposure to extreme heat. Dehydration. Aspiration risk. Suicidal tendencies (monitor). Write ℞ for smallest practical amount. Neonates: may cause extrapyramidal and/or withdrawal symptoms (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.
Saphris Pharmacokinetics
Elimination
Renal (50%), fecal (40%). Half-life: ~24 hours.
Saphris Interactions
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.
Saphris Adverse Reactions
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.
Saphris Clinical Trials
See Literature
Saphris Note
Not Applicable
Saphris Patient Counseling
See Literature
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