INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FLUDECATE 12,5 INJECTION
FLUDECATE 25 INJECTION
FLUDECATE MULTIDOSE INJECTION

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

FLUDECATE 12,5 INJECTION
FLUDECATE 25 INJECTION
FLUDECATE MULTIDOSE INJECTION

COMPOSITION:
Fludecate 12,5, Fludecate 25 and Fludecate Multidose injections each contain:
fluphenazine decanoate 25 mg per mL and 1,2% m/v benzyl alcohol as preservative.

PHARMACOLOGICAL CLASSIFICATION:
A 2.6.1. Phenothiazines and their derivatives.

PHARMACOLOGICAL ACTION:
Fluphenazine decanoate is a phenothiazine derivative of the piperazine type. It is absorbed slowly from the site of injection and hydrolysed in the plasma to the active agent, fluphenazine which is lipophilic and long-acting.

The onset of action is usually 1 to 3 days after injection. Phenothiazines do not produce dependence.

INDICATIONS:
Fluphenazine decanoate is used for the treatment of psychotic disorders such as schizophrenia and mania, and is useful in both the acute and chronic types. It is suitable for the management of problems relating to compliance, absorption and erratic plasma levels particularly in patients on long-term therapy.

CONTRA-INDICATIONS
Fluphenazine is contra-indicated in comatose patients, particularly those under the influence of alcohol, barbiturates, narcotics or other central nervous system depressants, and in patients with bone-marrow depression.
Where possible fluphenazine should not be given in conjunction with drugs that might cause leucopenia such as phenylbutazone and the thiouracil derivatives.

Caution is also advised in patients with liver disease. Interaction with other drugs is of minor significance.

DOSAGE AND DIRECTIONS FOR USE:
Fludecate should be given by subcutaneous or deep intra-muscular injection. The onset of action is usually within 1 to 3 days of injection and significant effects on psychosis are usually evident within 2 to 4 days. The initial dose of fluphenazine decanoate is 12,5 mg given intramuscularly to patients in hospital to assess the extrapyramidal effects. A dose of 25 mg is then given every 2 weeks with subsequent adjustments in the amounts and the dosage interval according to the patient's response. Although the usual dose is 25 mg every two weeks, the amounts required may range from 12,5 to 100 mg and the intervals required may range from 1 to 6 weeks. If doses greater than 50 mg are considered necessary cautious increments, in steps of 12,5 mg should be made.

Fludecate should be given in reduced dosages to elderly patients. Children and young adults are susceptible to extrapyramidal side-effects and for this reason fluphenazine should be avoided in these patients.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects of fluphenazine include drowsiness, dryness of the mouth, nasal congestion, postural hypotension, lowering of body temperature (occasionally pyrexia), tachycardia, arrhythmias, agitation, insomnia, depression, miosis and mydriasis, convulsions, photosensitivity, skin rashes, and inhibition of ejaculation.
Extrapyramidal dysfunction occurs in patients receiving Fludecate and is largely reversible by lowering the dose, or discontinuing therapy. Extrapyramidal symptoms may also be reversed in emergencies by anti-parkinsonian agents, but these do not alleviate or prevent the emergence of tardive dyskinesia on long-term administration, and may mask early symptoms, with eventual exacerbation of the syndrome.

Fludecate alters endocrine function. Patients may experience amenorrhoea, galactorrhoea, gynaecomastia, and weight gain and there have been reports of hyperglycaemia and diabetes mellitus. There have also been reports of raised serum cholesterol concentrations

Fludecate should be used with caution in patients with cardiovascular or respiratory disease, phaeochromocytoma or other conditions in which a sudden drop in blood pressure would be undesirable; if it is used in conjunction with other drugs likely to cause postural hypotension an adjustment of dosage may be necessary.

Fludecate should be used with caution in patients with existing tachycardia or cardiac insufficiency and in patients with liver dysfunction or a history of jaundice. Phenothiazines should be used with care in patients with parkinsonism; the anti-parkinsonian actions of agents such as levodopa may be diminished by concurrent administration of phenothiazines.

Fludecate should be given with caution to patients suffering from extremes of temperature owing to its impairment of the body's temperature-regulating mechanism.

Withdrawal symptoms including nausea, vomiting, gastritis, and tremors, may occur following the abrupt discontinuation of large doses.

Fludecate enhances the activity of central nervous system depressants including alcohol, anaesthetics, hypnotics, and narcotic analgesics and doses of these agents may need to be reduced. However, the anticonvulsant properties of diazepam, phenobarbitone, phenytoin or other anticonvulsants, are not enhanced by phenothiazines which may, conversely, lower the convulsive threshold. The phenothiazines possess an anticholinergic activity and so enhance the anticholinergic properties of drugs such as atropine and tricyclic antidepressants. The antihypertensive action of adrenergic neurone blocking agents such as guanethidine is reduced by phenothiazines. Phenothiazines may raise blood-sugar concentrations which could affect diabetic control.

Patients should be examined periodically for abnormal skin pigmentation or eye-changes, and phenothiazines withheld if necessary. Fludecate should be used with care in the elderly and debilitated. Drowsiness is often experienced at the start of treatment with phenothiazines and patients should be advised not to take charge of vehicles or other machinery during this period.

Pain can occur at the site of injection.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Known symptoms of overdosage: See side-effects and special precautions.
Treatment: Symptomatic and supportive.

IDENTIFICATION:
Fludecate 12,5 and 25: Straw-coloured viscous liquid in amber ampoules.
Fludecate Multidose: Straw-coloured viscous liquid in amber vials with rubber closures.

PRESENTATION:
Fludecate 12,5 is available as a single 0,5 mL ampoule.
Fludecate 25 is available as a single 1 mL ampoule.
Fludecate Multidose is available in a single pack containing one 10 mL multidose vial.

STORAGE INSTRUCTIONS:
Store at room temperature (below 25°C).
Protect from light.
Protect from freezing.
If the product has been frozen and particles have separated out these may be removed by warming gently to 37°C.
Keep out of reach of children.

REGISTRATION NUMBER:
(12,5) V/2.6.1/130
(25) V/2.6.1/131
(Multidose) V/2.6.1/132

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
INTRAMED (PTY) LTD
6 Gibaud Road
Port Elizabeth 6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
9 SEPTEMBER 1988 12-118/4-93
  Tradepak P.E.

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