Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
FLUPENTIXOL DECANOATE
Lundbeck Limited
200 Mg/Ml
Solution for Injection
1992-02-28
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Depixol 200 mg/ml Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1ml ampoule contains 200mg (20 % w/v) cis(Z)-flupentixol decanoate. For a full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection (injection). Clear yellowish oil, practically free from particles. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The management of schizophrenia or paranoid psychoses. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration Deep intramuscular injection into the upper outer buttock or lateral thigh. Dosage and dosage interval should be adjusted according to the patients' symptoms and response to treatment. Note: As with all oil based injections it is important to ensure, by aspiration before injection, that inadvertent intravascular entry does not occur. Adults The dosage should be adjusted according to the severity of the patients' symptoms. The dosage range of Depixol 200 mg/ml lies between 50mg (0.25ml) every 4 weeks and 300mg (1.5ml) every 2 weeks but some patients may require up to 400mg (2 ml) weekly. Adequate control of severe psychotic symptoms by Depixol 200mg/ml Injection is usually achieved within 4 to 6 months and this may justify a return to lower dose maintenance treatment with Depixol Conc. (100 mg/ml) or standard Depixol (20mg/ml) injection. _Elderly patients_ Elderly patients should receive dosages in the lower end of the dosage range. _Reduced renal function_ Flupentixol decanoate can be given in usual doses to patients with reduced renal function. _Reduced hepatic function_ Dose reduction (relative to the degree of hepatic impairment) should be considered. If possible, where assay facilities exist dosage should be adjusted according to s Read the complete document