Soltus Tablet
Amisulpride
400mg
Intas Pharmaceuticals Ltd.
| Pack size | 400's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 53.84 NPR |
Available as:
Indications
Soltus Tablet is used for:
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.
Adult Dose
Adult
Acute episodes, 400—800mg daily in two divided doses. Adjust according to response; max 1.2g daily.
Mixed positive and negative symptoms, adjust dose to control positive symptoms.
Predominant negative symptoms, 50—300mg once daily.
Elderly: Dose reduction may be required.
Hepatic Failure: Since the drug is weakly metabolised a dosage reduction should not be necessary.
Child Dose
Under 18 years, not recommended.
Renal Dose
Amisulpride is eliminated by the renal route. In renal insufficiency, the dose should be reduced to half in patients with creatinine clearance (CRCL) between 30-60 ml/min and to a third in patients with CRCL between 10-30 ml/min.
As there is no experience in patients with severe renal impairment (CRCL < 10 ml/min) particular care is recommended in these patients
Administration
Contra Indications
Prolactin-dependent tumours, phaeochromocytoma. Lactation.
Precautions
Cardiovascular disease, family history of QT prolongation, hypokalaemia, renal impairment (CrCl <60ml/min), epilepsy, Parkinson's disease, diabetes, risk factors for stroke or VTE, history or family history of breast cancer. Elderly. Withdraw gradually. Pregnancy; ensure contraception in women.
Lactation
It is not known whether amisulpride is excreted in breast milk, breast-feeding is therefore contra-indicated.
Pregnancy-Lactation
Interactions
Other antipsychotics, drugs that prolong QT interval, levodopa, CNS depressants, alcohol, antihypertensives.
Adverse Effects
Side effects of Amisulpride :
Nervous system disorders:
Very common: Extrapyramidal symptoms may occur: tremor, rigidity, hypokinesia, hypersalivation, akathisia, dyskinesia. These symptoms are generally mild at optimal dosages and partially reversible without discontinuation of amisulpride upon administration of antiparkinsonian medication. The incidence of extrapyramidal symptoms which is dose related, remains very low in the treatment of patients with predominantly negative symptoms with doses of 50-300 mg/day.
Common: Acute dystonia (spasm torticollis, oculogyric crisis, trismus) may appear. This is reversible without discontinuation of amisulpride upon treatment with an antiparkinsonian agent. Somnolence.
Uncommon: Tardive dyskinesia characterized by rhythmic, involuntary movements primarily of the tongue and/or face have been reported, usually after long term administration. Antiparkinsonian medication is ineffective or may induce aggravation of the symptoms. Seizures.
Psychiatric disorders:
Common: Insomnia, anxiety, agitation, orgasmic dysfunction
Gastrointestinal disorders:
Common: Constipation, nausea, vomiting, dry mouth
Endocrine disorders:
Common: Amisulpride causes an increase in plasma prolactin levels which is reversible after drug discontinuation. This may result in galactorrhoea, amenorrhoea, gynaecomastia, breast pain, and erectile dysfunction.
Metabolism and nutrition disorders:
Uncommon: Hyperglycaemia
.
Cardiovascular disorders:
Common: Hypotension
Uncommon: Bradycardia
Investigations:
Common: Weight gain
Uncommon: Elevations of hepatic enzymes, mainly transaminases
Immune system disorders:
Uncommon: Allergic reaction
Mechanism of Action
Amisulpride binds selectively with a high affinity to human dopaminergic D2/D3 receptor subtypes whereas it is devoid of affinity for D1, D4 and D5 receptor subtypes.
Note
Soltus 400mg Tablet manufactured by Intas Pharmaceuticals Ltd.. Its generic name is Amisulpride. Soltus is availble in Nepal.
Farmaco Nepal drug index information on Soltus Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.