Sulpride 100 Tablet
Amisulpride
100 mg
Everest Pharmaceuticals Ltd.
| Pack size | 20's Pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 30.00 AED |
Available as:
Indications
Sulpride 100 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
Oral
Acute psychosis
Acute episodes, 400—800 mg 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—300 mg once daily.
Child Dose
Under 18 years, not recommended.
Renal Dose
Renal Impairment
CrCl (mL/min) Dosage
10-30 One-third of the usual dose.
31-60 Half the usual dose.
Administration
Should be taken on an empty stomach. Preferably taken before meals.
Contra Indications
Phaeochromocytoma, concomitant prolactin-dependent tumours (e.g. pituitary gland prolactinomas or breast cancer). Pre-pubertal childn. Combination w/ levodopa.
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.
Monitoring Parameters
Amisulpride does not affect blood pressure to the same extent as other antipsychotic drugs and so blood pressure monitoring is not mandatory for this drug.
Pregnancy-Lactation
Pregnancy
There are only limited data available from the use of amisulpride in pregnant women. The safety of amisulpride during human pregnancy has not been established.
Amisulpride crosses the placenta.
Studies in animals have shown reproductive toxicity (see section 5.3).
The use of amisulpride is not recommended during pregnancy and in women of childbearing potential not using effective contraception, unless the benefits justify the potential risks.
Neonates exposed to antipsychotics (including Amisulpride) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery (see section 4.8). There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully.
Breast-feeding
Amisulpride is excreted into breastmilk in rather large amounts above the accepted value of 10% of the maternal weight-adjusted dosage in some cases, but blood concentrations in breastfed infants have not been evaluated. There is insufficient information on the effects of amisulpride in newborns/infants. A decision must be made whether to discontinue breast-feeding or to abstain from amisulpride therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.
Fertility
A decrease in fertility linked to the pharmacological effects of the drug (prolactin-mediated effect) was observed in treated animals.
Interactions
Increased risk of arrhythmias w/ cisapride, thioridazine, halofantrine, erythromycin, some antiarrhythmics, pimozide, haloperidol, TCAs, β-blockers, some Ca channel blockers, clonidine, guanfacine, digoxin, K-depleting diuretics, lithium, antimalarials.
May enhance effects of antihypertensives and CNS depressants (e.g. sedative H1-antihistamines, narcotics, anesthetics, analgesics, barbiturates, benzodiazepines, other anxiolytics, clonidine and derivatives).
Amisulpride inhibits MATE1 and MATE2-K transporters
Amisulpride is a substrate for P-gp, BCRP, OCT1, MATE1, and MATE2-K
Dopamine agonists
Reciprocal antagonism of effects occurs between dopamine agonists (eg, levodopa)
Avoid use
Drugs prolonging the QT interval
Amisulpride causes dose- and concentration-dependent QT prolongation
Avoid use with droperidol
ECG monitoring is recommended if coadministered with other drugs known to prolong QT interval (eg, ondansetron)
Adverse Effects
Side effects of Amisulpride :
Common or very common
Anxiety. breast pain. hypersalivation. muscle rigidity. nausea. oculogyric crisis. orgasm abnormal. trismus
Uncommon
Hyperglycaemia
Frequency not known
Angioedema. bone disorders. cardiac arrest. dyslipidemia. hyponatremia. nasal congestion . neoplasms. SIADH. urticaria. vision blurred
Potentially Fatal: Neuroleptic malignant syndrome.
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
Sulpride 100 100 mg Tablet manufactured by Everest Pharmaceuticals Ltd.. Its generic name is Amisulpride. Sulpride 100 is availble in Bangladesh.
Farmaco BD drug index information on Sulpride 100 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.