Medicinal Products

AMISULPRIDE RATIOPHARM 100 mg

Generic drug from Solian
Therapeutic Class: Neurology-Psychiatry
active ingredients: Amisulpride
laboratory: Ratiopharm Gmbh

Tablet breackable
Box of 30
All forms

Indication

Treatment of schizophrenia.

Dosage AMISULPRIDE RATIOPHARM 100 mg scored tablet Box of 30

Generally:

· If the daily dose is ≤ 400 mg, administration will be one dose;

· Above 400 mg administration will be twice daily.

Acute psychotic episodes

It is possible to start with the IM route for a few days at a maximum dose of 400 mg / day and then relay by the oral route.

The recommended oral dosage is 400 to 800 mg / day, the maximum dosage should not exceed 1200 mg / day. The tolerance of doses greater than 1200 mg / day has not been widely evaluated. Therefore, these doses should not be used.

The dosage will then be maintained or adapted according to the individual response of the patient.

In all cases, the maintenance treatment will be established individually with the minimum effective dose.

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.

Child and teenager

The efficacy and safety of amisulpride from puberty at age 18 has not been established: available data on the use of amisulpride in adolescent schizophrenia is limited. Therefore, the use of amisulpride is not recommended from puberty until the age of 18 years. In children under 15 years of age, amisulpride is contraindicated (see section 4.3 ).

Old person

Amisulpride should be used with special caution in this population because of the risk of hypotension and sedation (see Warnings and Precautions ).

Renal failure

Due to the renal elimination of amisulpride, the dosage in patients with renal insufficiency should be halved in patients with creatinine clearance (ICCr) of 30 to 60 ml / min and in patients whose creatinine clearance is between 10 and 30 ml / min.

In the absence of data in patients with severe renal impairment (CICr <10ml / min), special monitoring is recommended in these patients (see Warnings and Precautions ).

Hepatic insufficiency

Since amisulpride is weakly metabolized, dosage reduction is not necessary in patients with hepatic impairment.

Against indications

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 certain 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;

· Breastfeeding

Prolactin-dependent tumor known or suspected for example pituitary adenoma prolactin and breast cancer;

· In combination with levodopa (see section Interactions with other medicinal products and other forms of interaction ).

Side effects Amisulpride Ratiopharm

Adverse events were ranked in order of frequency using the following convention: very common ≥1 / 10; frequent ≥1 / 100, <1/10; uncommon ≥1 / 1000, <1/100; rare ≥1 / 10000, <1/1000; very rare <1 / 10, 000, not known (can not be estimated with available data).

Data from clinical studies: The following adverse reactions have been observed in controlled clinical studies. Sometimes it can be difficult to differentiate between adverse events and symptoms of the sub-adjacent disease.

Nervous system disorders

Very common

Extrapyramidal symptoms (tremor, hypertonia, hypersalivation, akathisia, hypokinesia, dyskinesia) may occur. These symptoms are usually moderate at optimal and partially reversible dosages, without discontinuation of AMISULPRIDE RATIOPHARM, with anticholinergic antiparkinsonian 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.

Frequent

Acute dystonia (spasmodic torticollis, oculogyric crises, trismus ...) may appear. It is reversible without stopping treatment under the effect of anticholinergic antiparkinsonian.

Drowsiness.

Rare

Late dyskinesias characterized by involuntary movements of the tongue and / or face have been reported, especially after prolonged administration.

Anti-Parkinson's anticholinergic drugs are ineffective or may cause worsening.

Cases of seizures.

Psychiatric disorders

Frequent

Insomnia, anxiety, agitation, frigidity.

Gastrointestinal disorders

Frequent

Constipation, nausea, vomiting, dryness of the mouth.

Endocrine disorders

Frequent

Increased prolactinemia reversible at the end of treatment, which can lead to clinical: galactorrhea, amenorrhea, gynecomastia, breast tension, erectile dysfunction.

Metabolism and nutrition disorders

Rare

Hyperglycemia (see section Warnings and precautions for use ).

Heart conditions

Frequent

Hypotension.

Rare

Bradycardia.

investigations

Frequent

Weight gain.

Rare

Elevations of liver enzymes, mainly transaminases.

Immune system disorders

Rare

Allergic reactions.

Experience since the placing on the market

The following side effects have been spontaneously reported:

Nervous system disorders

Not known frequency

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

Heart conditions

Not known frequency

QT prolongation, ventricular arrhythmias such as torsades de pointes, ventricular tachycardia, which may lead to ventricular fibrillation or cardiac arrest, sudden death (see Warnings and Precautions section ).

Vascular affection

Not known frequency

Cases of venous thromboembolism, including cases of pulmonary embolism, sometimes fatal, as well as deep vein thrombosis have been reported with antipsychotics (see Warnings and Precautions section ).

Skin and subcutaneous tissue disorders

Not known frequency

Angioedema, urticaria.

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