Merck Sharp & Dohme


Zuellig Pharma
Concise Prescribing Info
Schizophrenia. Mono- & adjunct therapy for acute treatment of manic or mixed episodes associated w/ bipolar I disorder.
Dosage/Direction for Use
Adult Schizophrenia 5 mg bd. Maintenance: 5 mg bd, may be increased up to 10 mg bd after 1 wk. Acute treatment of manic & mixed episodes associated w/ bipolar I disorder Monotherapy: 5 mg bd, may be increased to 10 mg bd. Adjunctive therapy: Initially 5 mg bd w/ either lithium or valproate, may be increased to 10 mg bd.
May be taken with or without food: Place tab under the tongue & allow to dissolve completely. Do not chew/crush/swallow. Do not eat or drink for 10 min after administration.
Special Precautions
Hypersensitivity. Not indicated for dementia-related psychosis. Not to be used in patients at risk of aspiration pneumonia. Avoid use in patients w/ history of cardiac arrhythmias & congenital QT interval prolongation. Recent MI or unstable heart disease. Neuroleptic malignant syndrome, tardive dyskinesia, hyperglycemia & DM. CV or cerebrovascular disease or other conditions predisposing to hypotension; falls; leukopenia, neutropenia, agranulocytosis. Hyperprolactinemia, wt gain, history of seizures or conditions lowering seizure threshold; suicide. Conditions contributing to core body temp elevation or dehydration. Monitor complete blood count regularly. Avoid concomitant use w/ drugs prolonging QTc interval. May affect ability to drive or operate machinery. Not recommended in severe hepatic impairment. Pregnancy. Not to be used during lactation. Childn >18 yr. Elderly.
Adverse Reactions
Akathisia, oral hypoesthesia, somnolence; dizziness, extrapyramidal symptoms, increased wt.
Drug Interactions
Enhanced effects of certain antihypertensives. Increased AUC & plasma conc w/ fluvoxamine. Enhanced inhibitory effects of paroxetine. Co-administration w/ other centrally-acting drugs, alcohol, CYP2D6 substrates & inhibitors.
MIMS Class
ATC Classification
N05AH05 - asenapine ; Belongs to the class of diazepines, oxazepines and thiazepines antipsychotics.
Saphris SL tab 10 mg
Saphris SL tab 5 mg
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