Asenapt 5 Tablet
Asenapine
5mg
Sun Pharmaceutical Industries Ltd.
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Available as:
Indications
Asenapt 5 Tablet is used for:
Schizophrenia, Acute mixed or manic episodes in bipolar disorder
Adult Dose
Sublingual
Schizophrenia
Adult: Initially, 5 mg bid, may increase to 10 mg bid after 1 wk if tolerated.
Sublingual
Acute mixed or manic episodes in bipolar disorder
Adult: As monotherapy or adjunct to lithium or valproate: Initially, 5 mg bid, may increase to 10 mg bid depending on clinical response and tolerability.
Hepatic impairment
Mild to moderate impairment (Child-Pugh class A or B): Dose adjustment not necessary
Severe impairment (Child-Pugh class C): Contraindicated
Child Dose
Bipolar Disorder
Indicated as monotherapy for acute treatment of manic or mixed episodes associated with bipolar I disorder
<10 years: Safety and efficacy not established
10-17 years: 2.5 SL q12hr initially; may increase to 5 mg SL q12hr after 3 days and to 10 mg SL q12hr after 3 additional days
Renal Dose
Renal impairment
Dose adjustment not necessary
Administration
Sublingual tablet; to allow optimal absorption, place under tongue and allow to dissolve completely (dissolves within seconds)
Do not chew, split, crush, or swallow sublingual tablet
Do not eat or drink for at least 10 minutes after administration
Contra Indications
Hypersensitivity to asenapine. Dementia-related psychosis. Severe (Child-Pugh Class C) hepatic impairment.
Precautions
Patient w/ history of seizure disorder, known CV disease (e.g. heart failure, MI or ischaemia, arrhythmia), cerebrovascular disease, dehydration, bradycardia, hypovolaemia, hypokalaemia, Parkinson’s disease, dementia w/ Lewy Bodies (DLB). Moderate (Child-Pugh Class B) hepatic impairment. Pregnancy and lactation.
Pregnancy-Lactation
Interactions
Increased plasma concentration w/ fluvoxamine. May enhance the effects of certain antihypertensive agents (due to its α1-adrenergic antagonism) and CNS depressants. May increase exposure of paroxetine. May antagonise the effects of levodopa and dopaminergics.
Adverse Effects
Side effects of Asenapine :
Significant: Extrapyramidal symptoms (e.g. pseudoparkinsonism, dystonia, akathisia, tardive dyskinesia) seizure, syncope, orthostatic hypotension, QT prolongation, dysphagia, hyperprolactinaemia, leukopenia, neutropenia.
Nervous: Somnolence, sedation, dizziness, oral hypoaesthesia, paraesthesia, speech disturbance, irritability, anxiety.
CV: Tachycardia.
GI: Constipation, nausea, dry mouth, glossodynia, hypersalivation, taste disturbance, swollen tongue.
Genitourinary: Urinary retention.
Endocrine: Galactorrhoea, gynaecomastia, amenorrhoea, impotence.
Haematologic: Thrombocytopenia.
Ophthalmologic: Blurred vision, mydriasis.
Others: Fatigue.
Potentially Fatal: Neuroleptic malignant syndrome (manifesting as hyperthermia, muscle rigidity, altered mental status, autonomic instability, elevated serum creatine phosphokinase levels, myoglobinuria, acute renal failure), agranulocytosis, hyperglycaemia (associated w/ ketoacidosis or hyperosmolar coma).
Mechanism of Action
Mechanism of action unknown; efficacy thought to be mediated via combined antagonist activity at dopamine D2 and serotonin type 2 (5-HT2) receptors
Note
Asenapt 5 5mg Tablet manufactured by Sun Pharmaceutical Industries Ltd.. Its generic name is Asenapine. Asenapt 5 is availble in Nepal.
Farmaco Nepal drug index information on Asenapt 5 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.