Sentipec 50

POSOLOGY AND METHOD OF ADMINISTRATION

Posology

Adult: Short-term symptomatic treatment of anxiety in adults when the usual therapeutic measures have failed: 50 – 150 mg daily for a maximum period of 4 weeks.

Pediatric population: Serious behavioral disorders in children

Children over 14 years old: the daily dosage is 3 – 5 mg/kg.

Children under 14 years old: not indicate.

Elderly: Lower initial doses of 50 – 100 mg each time, twice daily, subsequently adjusted as required.

Patients with renal impairment: The dosage should be reduced or the dosage interval can be prolonged depending on creatinine clearance.

Patients with creatinine clearance from 30 to 60 ml/min: 2/3 of the normal dose.

Patients with creatinine clearance from 10 to 30 ml/min: ½ of the normal dose.

Patients with creatinine clearance  < 10 ml/min: 1/3 of the normal dose.

Or dosage interval can be prolonged by a factor of 1,5; 2 and 3; respectively.

The drug should not be used for patients with moderate and severe renal impairment if possible.  

Method of administration: Oral route.

CONTRAINDICATIONS

Hypersensitivity to sulpiride or any ingredient of drug.

Pheochromocytoma.

Acute porphyria.

CNS depression states, coma, alcoholic poisoning, and CNS depressants.

WARNINGS AND PRECAUTIONS

In the event of renal impairment, reduce the dosage and increase patient monitoring. In the event of severe renal impairment, prescription of intermittent treatment courses is recommended.

Treatment monitoring must be increased in the following cases:

Epileptic patients, since seizure threshold may be lower.

Elderly patients are more susceptible to postural hypotension, sedation and extrapyramidal effects.

People drink alcohol or use medicinal products containing alcohol during treatment, beceause of enhancement of the sedative effect.

In the event of unexplained hyperthermia, sulpiride must be discontinued to eliminate neuroleptic malignant syndrome.

Hypomanic patients as the low dose of sulpiride can make symptoms worsening.

SHELF-LIFE

36 months from the manufacturing date. Do not use after the expiry date

Box of 5 blisters x 10 hard capsules.