Medicinal Products

AMISULPRIDE CRISTERS 200 mg

Generic Drug Therapeutic Class: Neurology-Psychiatry
active ingredients: Amisulpride
laboratory: Cristers

Tablet breackable
Box of 60
All forms

Indication

AMISULPRIDE CRISTERS is indicated for the treatment of schizophrenia.

Dosage AMISULPRIDE CRISTERS 200 mg Breakable tablet Box of 60

Oral way.

Generally, AMISULPRIDE CRISTERS can be administered once a day at a dosage of ≤400 mg and twice daily at doses above 400 mg.

In productive - positive forms, oral doses of 400 mg / day to 800 mg / day are recommended. In individual cases, the maximum daily dose should not exceed 1200 mg, as the safety of use in dosages greater than 1200 mg / day has not been fully evaluated.

For patients with mixed episodes with positive and negative symptoms, doses should be adjusted to achieve optimal control of positive symptoms.

The maintenance treatment must be set up individually with the minimum effective dose.

In patients with predominant negative episodes, oral doses of 50 mg / day to 300 mg / day are recommended. Dosages should be adjusted individually. The optimal dose is about 100 mg / day.

Patients with mixed episodes with positive and negative symptoms

At the start of treatment, oral doses (allowing positive symptom control) between 400 mg / day and 800 mg / day of amisulpride are recommended. Thereafter, the dosage will be adjusted individually according to the response of the patient to reach the minimum effective dose.

Children and adolescents under 15 years

AMISULPRIDE CRISTERS is contraindicated in children and adolescents under 15 years of age (see section 4.3 ).

Elderly patients

AMISULPRIDE CRISTERS should be used with special caution because of possible risk of hypotension or sedation (see Warnings and Precautions ) section.

Renal failure

Amisulpride is eliminated by the kidneys. In patients with renal impairment, the dose should be halved in patients with a creatinine clearance (CRCI) of 30 to 60 ml / min, and two-thirds in patients with a CRCl of 10 to 60 ml / min. and 30 ml / min. In the absence of clinical experience in patients with severe renal impairment (CRCI <10 ml / min), amisulpride is contraindicated in these patients (see section 4.3 ).

Hepatic insufficiency

Since the drug is weakly metabolized by the liver, a dose reduction is not necessary.

Duration of treatment

Adequate experience from controlled studies is available for a one-year treatment period. Treatment can be continued as long as the patient derives therapeutic benefit.

Against indications

· Hypersensitivity to the active substance or to any of the excipients.

Serious hypertensive events have been reported in patients with pheochromocytoma treated with anti-dopaminergic drugs, including some benzamides. Therefore, the use of AMISULPRIDE CRISTERS is contraindicated in the diagnosis or suspicion of pheochromocytoma.

· Diagnosis or suspicion of prolactin-dependent tumor (eg prolactin-induced pituitary adenoma and breast cancer).

· Children and adolescents under 15 years old.

· Breastfeeding (see section on Pregnancy and breastfeeding ).

· Severe renal insufficiency (CRCl <10 ml / min).

· Association with the following drugs:

o Dopaminergic agonists, excluding patients treated for Parkinson's disease (see section Interactions with other medicinal products and other forms of interaction ).

Side effects Amisulpride Cristers

The most frequently reported adverse reactions were psychiatric symptoms and extrapyramidal disorders, the latter increasing proportionally with dosages of amisulpride.

The evaluation of adverse events is based on the following frequencies:

Very common (≥ 1/10)

Frequent (≥ 1/100 to <1/10)

Uncommon (≥ 1/1000 to <1/100)

Rare (≥ 1/10 000 to <1/1000)

Very rare (<1 / 10, 000), not known (can not be estimated from available data)

investigations

Uncommon: Increased liver enzymes and transaminases.

Endocrine disorders

Common: Increased prolactin levels (reversible after discontinuation of this drug may result in: galactorrhea, amenorrhea, gynecomastia, mastodynia, orgasmic dysfunction, and impotence).

Metabolism and nutrition disorders

Frequent: weight gain

Uncommon: hyperglycaemia (see Warnings and Precautions ) section.

Heart conditions

Common: hypotension

Uncommon: bradycardia.

Nervous system disorders

Very common: extrapyramidal symptoms (tremors, hypertension, hypokinesia, hypersalivation, akathisia). These symptoms are usually mild at optimal dosages, and partially reversible without interruption of amisulpride with the administration of an antiparkinsonian drug. The incidence of extrapyramidal symptoms, which is dose-dependent, remains very low in patients with predominantly negative symptoms at doses between 50 and 300 mg / day. In clinical studies, patients treated with amisulpride experienced a lower incidence of extrapyramidal symptoms compared with those receiving haloperidol.

Common: Acute dystonia (spasmodic torticollis, oculogyric seizures, trismus) may occur. This symptom is reversible without interruption of amisulpride with antiparkinsonian treatment.

Daytime sleepiness.

Uncommon: Cases of tardive dyskinesia, characterized by involuntary rhythmic movements, mainly of the tongue and / or face, have been observed, usually after long-term administration. Antiparkinsonian treatment is ineffective and may induce a worsening of symptoms.

Cases of convulsions have been reported.

Gastrointestinal disorders

Common: Constipation, nausea, vomiting, dry mouth.

Immune system disorders

Uncommon: allergic reactions

Psychiatric disorders

Frequent: insomnia, anxiety, agitation, frigidity.

pharmacovigilance

The following side effects have been reported spontaneously:

Nervous system disorders

Neuroleptic malignant syndrome (see section Warnings and precautions for use )

Heart conditions

Lengthening of the QT interval.

Ventricular arrhythmias, including torsades de pointes, ventricular tachycardia, which can lead to ventricular fibrillation or cardiac arrest.

Sudden death (see section Warnings and precautions for use ).

Vascular disorders

Venous thromboembolic events, including cases of pulmonary embolism and deep vein thrombosis have been reported with antipsychotics - indeterminate frequency.

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