Pays: Royaume-Uni
Langue: anglais
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Flupentixol decanoate
Viatris UK Healthcare Ltd
N05AF01
Flupentixol decanoate
200mg/1ml
Solution for injection
Intramuscular
No Controlled Drug Status
Valid as a prescribable product
BNF: 04020200; GTIN: 5016695320274
PSYTIXOL 20 MG/ML, 100 MG/ML & 200 MG/ML INJECTION (flupentixol decanoate) INFORMATION FOR THE HEALTHCARE PROFESSIONAL CONSULT THE SUMMARY OF PRODUCT CHARACTERISTICS FOR FULL INFORMATION ON THIS PRODUCT PHARMACEUTICAL FORM Solution for injection. A clear, colourless to pale yellow, oily solution for deep intramuscular use. THERAPEUTIC INDICATIONS Psytixol is indicated for the treatment of schizophrenia and other psychoses. Use of flupentixol should be restricted to those stabilised on oral therapy. POSOLOGY AND METHOD OF ADMINISTRATION ADULTS - The usual dosage of Psytixol is between 50 mg every 4 weeks and 300 mg every 2 weeks. However, some patients may require up to 400 mg weekly. The maximum single dose at any one time is 400 mg. For example, 800 mg every 2 weeks should not be given. Other patients may be adequately maintained on dosages of 20-40 mg Psytixol every 2-4 weeks. For patients who have not previously received depot antipsychotic, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability. An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patient’s condition. Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilized, lower maintenance doses may be considered, but must be sufficient to prevent relapse. The appropriate presentation of Psytixol should be selected to achieve an injection volume which does not exceed 2 ml. Volumes greater than 2 ml should be distributed between two injection sites. When transferring patients from oral to depot neuroleptic treatment, the oral medication should not be discontinued immediately, but gradually withdrawn over a period of several days after administering the first injection. ELDERLY - In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older people. PAEDIATRIC POPULATION - Psytixol is not indicated for children due to lac Lire le document complet
OBJECT 1 PSYTIXOL 200 MG/ML INJECTION Summary of Product Characteristics Updated 25-Sep-2017 | Generics UK T/A Mylan 1. Name of the medicinal product Psytixol 200 mg/ml injection 2. Qualitative and quantitative composition Each 1 ml ampoule contains 200 mg flupentixol decanoate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Solution for injection. A clear, colourless to pale yellow, oily solution for deep intramuscular use. 4. Clinical particulars 4.1 Therapeutic indications Psytixol is indicated in the treatment of schizophrenia and other psychoses. Use of flupentixol should be restricted to those stabilised on oral therapy. 4.2 Posology and method of administration _Posology _ _Adults:_ The usual dosage of Psytixol is between 50 mg every 4 weeks and 300 mg every 2 weeks. However, some patients may require up to 400 mg weekly. The maximum single dose at any one time is 400 mg. For example, 800 mg ever 2 weeks should not be given. Other patients may be adequately maintained on dosages of 20-40 mg Psytixol every 2-4 weeks. For patients who have not previously received depot neuroleptics, treatment is usually started with a small dose (e.g. 20 mg) to assess tolerability. An interval of at least one week should be allowed before the second injection is given at a dose consistent with the patients' condition. Adequate control of severe psychotic symptoms may take up to 4 to 6 months at high enough dosage. Once stabilised lower maintenance doses may be considered, but must be sufficient to prevent relapse. The appropriate presentation of Psytixol should be selected to achieve an injection volume which does not exceed 2 ml. Volumes greater than 2 ml should be distributed between two injection sites. _Elderly:_ In accordance with standard medical practice, initial dosage may need to be reduced to a quarter or half the normal starting dose in the frail or older people. _Paediatric population:_ Psytixol is not indicated for children. _Renal impairment_ Flupentixol has not been studied in renal i Lire le document complet