FLUANXOL DEPOT INJECTION 20 MG/ML [SIN01366P]

Product Info

FLUANXOL DEPOT INJECTION 20 MG/ML

[SIN01366P]

4.1 Therapeutic Indications
Maintenance treatment of schizophrenia and other psychoses, especially with symptoms such as hallucinations, delusions and thought disturbances along with apathy, lack of energy, and withdrawal.

4.2 Posology and method of administration

Posology
Adults:
Dosage and interval between injections should be adjusted for each individual patient so as to achieve a maximum suppression of psychotic symptoms with a minimum of side effects.

Flupentixol decanoate 20mg/ml
In the maintenance treatment the dosage range would normally be 20–40mg (1–2ml) at intervals of 2 to 4 weeks depending on the response. Some patients may need larger doses or need them at shorter intervals.

Flupentixol decanoate 20mg/ml is unsuitable for patients in whom sedation is required. Injection volumes larger than 2ml should be distributed between two injection sites.

If volumes larger than 2–3ml of the 20mg/ml solution are required the more concentrated solution (flupentixol decanotae 100mg/ml or 200mg/ml) should be preferred.

During an exacerbation or acute relapse of the illness single injections of as much as 400mg fortnightly (or in the occasional cases weekly for a short period) may be required.

Adequate control of severe psychotic symptoms by the concentrated injection fluids is usually achieved within 4 to 6 months and may justify gradual return to lower dose maintenance.

When changing the medication from oral flupentixol to maintenance treatment with flupentixol decanoate the following guidelines should be used:

x mg p.o. daily corresponds to 4x mg decanoate every 2 weeks.
x mg p.o. daily corresponds to 8x mg decanoate every 4 weeks

Oral Fluanxol should be continued during the first week after the first injection but in diminishing dosage.

Patients being transferred from other depot preparations should receive a dose in the ratio of 40mg flupentixol decanoate equivalent to 25mg fluphenazine decanoate, to 200mg zuclopenthixol decanoate, or to 50mg haloperidol decanoate.

Subsequent doses of flupentixol decanoate and interval between injections should be adjusted to the patient’s response.

Elderly patients
The pharmacokinetics, safety and efficacy of flupentixol in elderly patients with schizophrenia have not been systematically evaluated in clinical trials. Caution should thus be exercised in dose selection for an elderly patient, recognizing the more frequent hepatic, renal and cardiac dysfunctions in this population.

Reduced renal function
Based on the characteristics for elimination it is reasonable to assume that reduced kidney function is likely not to have much influence on the serum levels of parent drug.

Reduced liver function Flupentixol has not been studied in hepatic impairment. It is extensively metabolized by the liver and particular caution should be used in this situation and serum level monitoring is advised.
Fluanxol should be initiated at low doses orally to check for tolerability before switching to the depot formulation.

Children
Flupentixol decanoate is not recommended for use in children due to lack of clinical experience.

Method of administration
Flupentixol decanoate is administered by intramuscular injection into the upper outer quadrant of the gluteal region.
Injection volumes exceeding 2ml should be distributed between two injection sites. Local tolerability is good.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the exicipients (listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Circulatory collapse, depressed level of consciousness due to any cause (e.g. intoxication with alcohol, barbiturate or opiate); coma.