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 asenapine |
| Saphris |
Pharmaceutical
company:
Schering-Plough, Corp.
www.saphris.com |
Pharmacologic classification: dopamine and serotonin antagonist
Therapeutic classification: atypical antipsychotic
Pregnancy risk category: C
AVAILABLE FORMS
Sublingual tablets: 5 mg, 10 mg
INDICATIONS AND DOSAGES
Acute schizophrenia—
Adults: 5 mg sublingually b.i.d.
CONTRAINDICATIONS AND CAUTIONS
Avoid use in elderly patients with dementia-related psychosis and in those at risk for aspiration.
Avoid use in patients with conditions that may increase the risk for torsades de pointes and in those taking other drugs that prolong QT interval.
Use cautiously in elderly or debilitated patients and in those with a history of neuroleptic malignant syndrome, diabetes mellitus, CV disease, cardiac arrhythmias, seizures, cerebrovascular disease, or conditions that predispose patients to hypotension.
INTERACTIONS
Drug-drug.
Alpha-1 blockers (doxazosin, terazosin): May increase risk of hypotension. Use together cautiously.
Dextromethorphan, paroxetine: May increase drug levels. Use together cautiously.
Drugs known to prolong QTc (quinidine, procainamide, amiodarone, sotalol, gatifloxacin, moxifloxacin, levofloxacin): May prolong QTc, leading to lethal arrhythmias such as torsades de pointes. Avoid use together.
Fluvoxamine: May increase asenapine levels. Use together cautiously.
Drug-lifestyle.
Alcohol use: May increase CNS effects. Discourage use together.
ADVERSE REACTIONS
CNS: akathisia, anxiety, depression, dizziness, dysgeusia, extrapyramidal symptoms, fatigue, headache, insomnia, irritability, somnolence.
CV: hypertension.
EENT: dry mouth, oral hypoesthesia, salivary hypersecretion, toothache.
GI: constipation, dyspepsia, increased appetite, stomach discomfort, vomiting.
Metabolic: weight gain.
Musculoskeletal: arthralgia, extremity pain.
Reactions may be common, uncommon, life-threatening,
or COMMON AND LIFE-THREATENING.
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