Drug Interaction:
Quinidine, disopyramide, procainamide, solatol, amiodarone, bepridil, Cisapride, sultopride,thioridazine,
Intravenous erythromycin, intra veous vincamine, Halofanthine, pentamidine, spafloxacin,
Ditiazem, betablockers, verapramil, clonidine, digoxin, Hypokalemic agents, diuretics, stimulant laxatives,
I V amphotericin, glucocorticoids,
Other antipschyotic CNS depressants ( including alcohol )
Neuroleptics, and other drugs that could induce torsades de points, Levodopa, antihypertensives
Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
93. Amisulpiride 300mg tablets 20-03-08
(Addl.stgth)
Same as approved
232. Amisulphide SR Bilayered tablet 200/400mg 03-11-08
For acute and chronic schizophrenic disorders,
in which positive sypmtoms and or negative symptoms
are prominent, including patients characterized by
predominant negative symptoms
U.S FDA APPROVED DRUGS DURING 2006
87. Amisulpiride (50/100/200mg) 01-08-2006 Schizophrenic disorder
154. Amisulphide 400mg tablet
(addl.stgth.) As approved
Schizophrenia
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Amisulphide 50/100/200mg tablets 01-08-2006
For Scizophrenic disorder
2. Amisulphide 300mg tablets (Addl strength) 20-03-2008
same as approved
3.Amisulphide SR tablets same as approved 27-11-2009
4.Amisulphide SR bilayered tablets 200/400mg 03-11-2008
For acute and chronic schizophrenic disorder in which positive
symptoms and or negative symptoms are quite prominent, including
patients characterized by predominent negative symptoms
Adverse Reaction:
Insomnia, anxiety, agitaion, somnolence GI upse, raised serum prolactin,
Weight gain, dystonia, extrapyrimidal reactions, tardive dyskinea, Amenorrhea, impotence,
Hypotension,bradycardia,
QT prolongation, Torsesades de Pointes
Allergic reactions, Risk of neuroleptic malignant syndrome
Withdraw if hyperthermia occurs
Contra-Indications:
Protein -dependent tumours, phaetocromocytoma
Concomittant Class IA III antiarrhythmics ( eg quinidine, disopyramide, amiodarone, solatol )
Others which increase risk of Torsedes de Pointes including ( eg cisapride, iv erthromycin, pentamide ) levodopa
Special precaution-
Bradycardia, hypokalemia
QT prolongation, renal impairment, epilepsy
Parkinsons disease
Elderly, withdraw gradually
Hepatic impairment
Lactation,
Pregnancy
Contraception must be used
Dosages/ Overdosage Etc:
Date of Approval 2006
Indication-
Schizophrenia
Dosage
Acute episode - initially 400-800mg daily in 2 divided doses
Adjust according to response
Mixed symptoms - adjust dose to control positive symptoms
Predominent negative symptoms- 50 - 300mg daily as a single dose
Not recommended for children
Patient Information:
Preferably taken before meals
Interaction with Food:
Preferably taken before meals
Pregnancy and lactation:
Contraindicated for use during pregnanncy and lactation
Caution should be excercised if required to be used
Manufacturer Details