Amiabel

Amiabel

amisulpride

Manufacturer:

Medichem

Distributor:

United Lab
Concise Prescribing Info
Contents
Amisulpride
Indications/Uses
Psychoses eg, acute & chronic schizophrenic disorders in which +ve symptoms (eg, delusions, hallucinations, thought disorders) &/or -ve symptoms (eg, blunted effect, emotional & social w/drawal) are prominent including patients characterized by predominant -ve symptoms.
Dosage/Direction for Use
Acute psychotic episodes 400-800 mg/day, may be increased up to 1,200 mg/day. Mixed +ve & -ve symptoms Initially 400-800 mg/day. Predominant -ve symptoms 50-300 mg/day.
Administration
Should be taken on an empty stomach.
Contraindications
Hypersensitivity. Concomitant prolactin-dependent tumors eg, pituitary gland prolactinomas & breast cancer. Pheochromocytoma. In combination w/ levodopa & drugs that induce Torsades de pointes including class Ia antiarrhythmic agents (eg, quinidine, procainamide, disopyramide), class III antiarrhythmic agents (eg, amiodarone, sotalol), certain antipsychotic drugs (eg, sertindole) & other drugs eg, bepridil, cisapride, sultopride, thioridazine, erythromycin IV, vincamine IV, halofantrine, pentamidine & sparfloxacin. Women of childbearing potential. Pregnancy & lactation. Childn <15 yr.
Special Precautions
Patients w/ stroke risk factors. Neuroleptic malignant syndrome (hyperthermia, muscle rigidity, autonomic instability, altered consciousness & elevated creatinine phosphokinase). Monitor patients w/ history of epilepsy. Acute dystonia, extrapyramidal symptoms eg, tremor, rigidity, hypokinesia & akathisia. Tardive dyskinesia. Patients w/ DM should be monitored for hyperglycemia. Increased plasma prolactin levels, QT interval prolongation & venous thromboembolism may occur, monitor & assess ECG. Patients w/ risk factors for thromboembolism. Patients w/ Parkinson's disease, severe renal insufficiency, moderate or severe hepatic impairment. Concomitant use w/ other renally-excreted drugs including lithium. Avoid abrupt w/drawal. May affect ability to drive or operate machinery. Elderly especially w/ dementia-related psychosis.
Adverse Reactions
Hypotension, bradycardia, QT interval prolongation, ventricular arrhythmias eg, torsades de pointes, ventricular tachycardia which may result to ventricular fibrillation or cardiac arrest, sudden death, venous thromboembolism eg, cases of pulmonary embolism & DVT. Allergic reaction, angioedema, urticaria. Wt gain, increased plasma prolactin levels which may result in galactorrhea, amenorrhea, gynecomastia, breast pain, orgasmic dysfunction & impotency; hyperglycemia. Constipation, nausea, vomiting, dry mouth. Hepatic enzymes elevations. Insomnia, anxiety, agitation, somnolence, extrapyramidal symptoms (eg, tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia), acute dystonia (eg, spasm torticollis, oculogyric crisis, trismus), tardive dyskinesia (characterized by rhythmic, involuntary movements primarily of the tongue &/or face), NMS, seizures.
Drug Interactions
Reciprocal antagonism of effects between levodopa & antipsychotics. May enhance the effects of alcohol. May enhance the risk of Torsades de pointes w/ bradycardia-inducing drugs eg, β-blockers (eg, bisoprolol, carvedilol, metoprolol), Ca channel blockers (eg, diltiazem & verapamil), guanfacine, clonidine & digitalis; hypokalemic diuretics, stimulant laxatives, amphotericin B IV, glucocorticoids & tetracosactides; antipsychotics. May enhance the effects of CNS depressants, antihypertensives & other hypotensive drugs.
MIMS Class
Antipsychotics
ATC Classification
N05AL05 - amisulpride ; Belongs to the class of benzamides antipsychotics.
Presentation/Packing
Form
Amiabel FC tab 200 mg
Packing/Price
30's (P91.25/film-coated tab, P2,737.5/box)
Form
Amiabel FC tab 400 mg
Packing/Price
30's (P4,387.5/box, P146.25/film-coated tab)
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