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SOLIAN (AMISULPRIDE): PRESCRIBING INFORMATION
Name of the medication
Solian 50 tablets
Solian 100 tablets
Solian 200 tablets
Solian 400 tablets
Solian Solution 100 mg / ml
Approved International Name
Chemical Name: (R, S)-4-Amino-N-[(1-ethyl-2-pyrrolidinyl)methyl]-5-ethylsulfonyl-2-methoxybenzamide
Molecular Weight: 369.48
Molecular Formula: C17H27N3O4S
Amisulpride is a white to off-white powder, which is practically insoluble in water, sparingly soluble in ethanol, soluble in methanol and freely soluble in dichloromethane.
Solian tablets contain amisulpride (50 mg, 100 mg, 200 mg and 400 mg) and the following excipients:
50, 100 and 200 mg tablets: lactose, sodium starch glycollate type A, microcrystalline cellulose, magnesium stearate, hypromellose.
400 mg tablets: sodium starch glycollate type A, microcrystalline cellulose, lactose, hypromellose, PEG-40 stearate, magnesium stearate, titanium dioxide.
Solian solution contains amisulpride 100 mg / ml and the following excipients: methyl hydroxybenzoate, hydrochloric acid, propyl hydroxybenzoate, potassium sorbate, purified water, and the following proprietary ingredients: Gesweet 2023 and Caramel Flavour E9422058.
Solian clinical pharmacology
Solian clinical trials
INDICATIONS AND USAGE
Solian (Amisulpride) is indicated for the treatment of acute and chronic schizophrenic disorders, in which positive symptoms (such as delusions, hallucinations, thought disorders) and/or negative symptoms (such as blunted affect, emotional and social withdrawal) are prominent, including patients characterised by predominant negative symptoms.
USE IN SPECIFIC POPULATIONS
Solian use in specific populations
Solian drug interactions
Solian adverse reactions
DOSAGE AND ADMINISTRATION
Solian dosage and administration
HOW SUPPLIED / STORAGE CONDITIONS
Solian 50: white to off white, flat-faced breakable tablet, engraved "AMI 50". Packed in blister packs.
Solian 100: white to off white, flat-faced breakable tablet, engraved "AMI 100". Packed in blister packs.
Solian 200: white to off white, flat-faced breakable tablet, engraved "AMI 200". Packed in blister packs.
Solian 400: white, film-coated, breakable, oblong tablet, engraved "AMI 400". Packed in blister packs.
Store Solian (Amisulpride) tablets below 30°C.
Solian Solution 100 mg / ml: a clear, pale yellow coloured liquid, is packed in 60mL brown glass bottles.
Store Amisulpride (Solian) oral solution below 25°C. Once opened, discard after two months.
Manufactured and distributed by Sanofi-Aventis pharmaceutical company and its divisions.
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