Concise Prescribing Info
Treatment of acute & chronic schizophrenia characterized by +ve symptoms (eg, delirium, hallucinations, thought disorders) &/or -ve symptoms (eg, blunted emotions, emotional & social w/drawal), including when -ve symptoms predominate.
Dosage/Direction for Use
≤400 mg daily dose, single intake. >400 mg, in 2 divided doses. Predominant -ve episode 50-300 mg/day. Dosage should be adjusted individually. Optimum dosage: 100 mg/day. Mixed episodes w/ +ve & -ve symptoms 400-800 mg/day. Dosage should be adjusted individually according to patients' response, so as to maintain min effective dose. Acute psychotic episodes IM max dose of 400 mg/day w/ follow-on treatment by the oral route. Oral dose: 400-800 mg, max dosage: 1200 mg.
Should be taken on an empty stomach.
Hypersensitivity. Concomitant prolactin-dependent tumors eg, pituitary gland prolactinomas & breast cancer. Pheochromocytoma. Severe renal insufficiency. Childn up to puberty. Lactation.
Special Precautions
Hyperglycemia. May lower seizure threshold. Renal insufficiency. W/drawal symptoms have been described after abrupt cessation. Leukopenia, neutropenia & agranulocytosis. Pituitary imaging in case of very high levels of prolactin or clinical signs of pituitary tumour. May impair ability to drive or operate machinery. Pregnancy. Elderly.
Adverse Reactions
Extrapyramidal symptoms including tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia may occur. Acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. Somnolence. Blurred vision. Insomnia, anxiety, agitation, orgasmic dysfunction. Constipation, nausea, vomiting, dry mouth. Increased plasma prolactin levels which may result in galactorrhea, amenorrhea, gynecomastia, breast pain & erectile dysfunction. Hyperglycemia. Hypotension. Wt gain.
Drug Interactions
Induced torsades de pointes w/ class Ia antiarrhythmics eg, quinidine, disopyramide. Class III antiarrhythmics eg, amiodarone, sotalol. Other medications eg, bepridil, cisapride, sultopride, thioridazine, methadone, erythromycin IV, vincamine IV, halofantrine, pentamidine, sparfloxacin. Reciprocal antagonism w/ levodopa & neuroleptics. Enhance central effects of alcohol. Enhance risk of torsades de pointes or could prolong the QT interval. Bradycardia-inducing medications eg, β-blockers, bradycardia-inducing Ca channel blockers eg, diltiazem & verapamil, clonidine, guanfacine; digitalis. Induce hypokalemia w/ hypokalemic diuretics, stimulant laxatives, amphotericin B IV, glucocorticoids, tetracosactides. Neuroleptics eg, pimozide, haloperidol; imipramine antidepressants; lithium. CNS depressants including narcotics, analgesics, sedative H1 antihistamines, barbiturates, benzodiazepines & other anxiolytics, clonidine & derivatives. Antihypertensives & other hypotensive medications.
MIMS Class
ATC Classification
N05AL05 - amisulpride ; Belongs to the class of benzamides antipsychotics.
Solian tab 200 mg
30's (P219/tab)
Solian tab 400 mg
30's (P352/tab)
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