Sulpiryd

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

sulpiride

Available from:

TEVA Operations Poland Sp. z o.o

INN (International Name):

sulpiride

Dosage:

50mg

Pharmaceutical form:

capsules

Prescription type:

Prescription

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
SULPIRYD capsules 50 mg and 100 mg
SULPIRYD tablets 200 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 capsule 50 contains 50 mg of _Sulpiridum (Sulpiride). _
1 capsule 100 contains 100 mg of _Sulpiridum (Sulpiride). _
1 tablet 200 contains 200 mg of _Sulpiridum (Sulpiride). _
3. PHARMACEUTICAL FORM
Capsules 50 mg and 100 mg
Tablets 200 mg
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Therapeutic indications for the preparation Sulpiryd include:
-
acute and chronic schizophrenic psychoses in schizophrenia;
_Tablets 200 mg: _
-
treatment of acute and chronic psychoses associated with
schizophrenia.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Schizophrenia_ _
_Adults _
The recommended daily dose ranges from 400 mg to 800 mg; in general,
given in two divided
doses (morning and early evening).
In
patients
with
positive
symptoms
(formal
thought
disorder,
hallucinations,
delusions,
incongruity of affect) higher starting doses are recommended i.e. at
least 400mg twice daily,
which may be increased, if needed.
The usual maximum daily dose is 1200mg. In severe cases (resistant to
treatment) the dose may
be increased to 1600mg daily (in divided doses).
In patients with negative symptoms (flattening of affect, poverty of
speech, anergia, apathy as
well as depression) lower doses are recommended. The starting dose of
400mg twice daily may
be decreased towards 200mg twice daily, which increases alerting
effect of sulpiride.
Patients with mixed positive and negative symptoms (with neither
predominating) will normally
respond to dosage of 400-600mg twice daily.
_Children _
There is no sufficient clinical experience to recommend this medicinal
product in children below
14 years.
_Elderly patients _
In general, normal adult doses are used. The dose should be reduced in
elderly patients with
impaired renal function.
_Patients with impaired renal function _
Doses of sulpiride should be adjusted; according to the degree of
renal impairment the dose
should be