Generic drug from Solian
Therapeutic Class: Neurology-Psychiatry
active ingredients: Amisulpride
Divisible coated tablet
Box of 30
Treatment of psychoses, in particular acute or chronic schizophrenic disorders, characterized by positive symptoms (eg delirium, hallucinations, thought disorders) and / or negative symptoms (eg, emotional blurring, emotional and social withdrawal), including when negative symptoms are predominant.
Dosage AMISULPRIDE IVAX 400 mg Film-coated tablet scored box of 30
In general, if the daily dose is <= 400 mg the administration will be in one dose, above 400 mg, the administration will be done twice daily.
- predominant negative episodes:
The recommended dosage is 50 to 300 mg / day. Dosages will be adapted individually. The optimal dosage is around 100 mg per day.
- Mixed episodes with positive and negative symptoms:
At the beginning of the treatment, the dosage will be the one to control the positive symptoms, ie 400 to 800 mg per day. Then the dosage will be individually adapted according to the patient's response, in order to obtain the minimum effective dose.
- Acute psychotic episodes:
At the beginning of treatment,
. it is possible to start by IM for a few days at a maximum dose of 400 mg / day and relay by the oral route,
. the recommended oral dose is 400 to 800 mg, the maximum dosage should not exceed 1200 mg.
the dosage is maintained or adapted according to the response of the patient.
In all cases, the dosage of the maintenance treatment will be established individually with the minimum effective dose.
- Renal failure :
. Due to the renal elimination of amisulpride, the dosage in patients with renal insufficiency should be halved in patients with a creatinine clearance (Clcr) of 30 to 60 ml / min and a third in patients whose creatinine clearance is between 10 and 30 ml / min.
. In the absence of data in patients with severe renal impairment (CrCl <10 ml / min), amisulpride is contraindicated (see contraindications).
- Hepatic insufficiency :
Since amisulpride is weakly metabolized, dosage reduction is not necessary in patients with hepatic impairment.
This medicine MUST NOT BE USED in the following cases:
- Known hypersensitivity to amisulpride or any other constituent of the product.
Serious hypertensive events have been reported in patients with pheochromocytoma with anti-dopaminergic drugs including some benzamides. It is therefore prudent to refrain from prescribing this product in known or suspected carriers of pheochromocytoma.
- Children under 15, in the absence of clinical data for this age group.
Prolactin-dependent tumor known or suspected, for example prolactin-induced pituitary adenoma and breast cancer.
- Severe renal insufficiency (Clcr <10 ml / min).
- Breast-feeding: In the absence of data on passage into breast milk, breastfeeding is contraindicated.
- In association with:
. dopamine agonists except levodopa (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline) except for the patient with Parkinson's disease.
- Due to the presence of lactose, this drug is contraindicated in case of congenital galactosemia, glucose-galactose malabsorption syndrome or lactase deficiency.
NOT RECOMMENDED :
Associations advised against : drugs that may give torsades de pointes: anti-arrhythmics of class la (quinidine, hydroquinidine, disopyramide), and class III (amiodarone, sotalol, dofetilide, ibutilide), certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, tiapride, pimozide, haloperidol, droperidol), others: erythromycin IV, spiramycin IV, halofantrine, pentamidine, sparfloxacin, moxifloxacin, gatifloxacin, bepridil, cisapride, diphemanil, mizolastine, vincamine IV; alcohol; levodopa; dopamine agonists except levodopa (amantadine, apomorphine, bromocriptine, cabergoline, entacapone, lisuride, pergolide, piribedil, pramipexole, quinagolide, ropinirole, selegiline) in patients with Parkinson's disease.
Adverse effects Amisulpride Ivax
CENTRAL NERVOUS SYSTEM DISORDERS:
. Insomnia, anxiety, agitation.
. Extrapyramidal symptoms (tremor, hypertonia, hypersalivation, akathisia, hypokinesia) may occur. These symptoms are generally mild at maintenance and partially reversible dosages, without discontinuation of AMISULPRIDE IVAX, with antiparkinsonian anti-cholinergic therapy.
The frequency of extrapyramidal symptoms that are dose-dependent, is very low in patients receiving doses between 50 and 300 mg / d in the treatment of predominant deficit symptoms.
In the studies, patients treated with amisulpride had a lower incidence of extrapyramidal symptoms than patients treated with haloperidol.
- Very rarely :
. Acute dystonia (spasmodic torticollis, oculogyric crises, trismus ...) may appear. It is reversible without stopping treatment under the effect of antiparkinsonian anticholinergic.
. Late dyskinesias characterized by involuntary movements of the tongue and / or face have been reported, especially after prolonged administration.
. Antiparkinsonian anti-cholinergic drugs have no action or can cause aggravation.
. Cases of seizures.
. Cases of malignant syndrome (see warnings and precautions for use: hyperthermia, muscle rigidity, neurovegetative disorders, impaired consciousness, increased CPK).
ENDOCRINE AND METABOLIC DISORDERS:
- Increased prolactinemia reversible at the end of treatment, which can lead to clinical: galactorrhea, amenorrhea, gynecomastia, breast tension, impotence, frigidity.
- Weight gain.
constipation, nausea, vomiting, dryness of the mouth.
Very rarely :
- Cases of hypotension and bradycardia.
- Cases of prolongation of the QT interval, and very rare cases of torsades de pointes have been reported (see warnings).
Very rarely :
Elevations of liver enzymes and mainly transaminases have been reported.
Very rarely :