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

Logo PONDERAX PACAPS, capsules (withdrawn)

SCHEDULING STATUS:
S5

PROPRIETARY NAME:

PONDERAX PACAPS, capsules (withdrawn)

COMPOSITION:
Each capsule contains 60 mg
fenfluramine HCl B.P.

PHARMACOLOGICAL CLASSIFICATION:
A 11.3 Anorexigenics

PHARMACOLOGICAL ACTION:
Anorexigenic action:
Fenfluramine's anorexigenic effect is mediated by a central serotoninergic mechanism. By inhibiting the 5-HT uptake and increasing its release, it has the effect of increasing the availability of serotonin at the specific serotonin receptors.
This mode of action distinguishes fenfluramine from amphetamine and its related compounds such as diethylpropion, phenmetrazine, phentermine, etc., as well as from mazindol where the anorexigenic action is mediated by catecholaminergic systems. Studies in animals suggests that fenfluramine increases the activity of the ventro-medial hypothalamic “satiety centre”and may according to certain authors decrease the activity of the lateral hypothalamic “feeding centre”.

Metabolic action: In contrast to those of other anorexigenic compounds: Fenfluramine increases the glucose uptake by skeletal muscles.
Fenfluramine lowers plasma triglycerides and produces a fat mobilizing effect.
Fenfluramine inhibits the synthesis of triglycerides by blocking phosphatidate-phosphohydrolase and impairs the intestinal absorption of triglycerides.

Hypotensive: Fenfluramine has been reported as having a slight hypotensive effect in both animal and man compared to the amphetamine derivatives which have a hypertensive effect.

INDICATIONS:
An aid in the treatment of obesity. Diet must be maintained.

CONTRA-INDICATIONS:
Should not be used concomitantly with mono-amino-oxidase inhibitors and in glaucoma. There should be an interval of three weeks between stopping mono-amino-oxidase inhibitors and starting PONDERAX PACAPS therapy.

Safety in pregnancy and lactation has not been established.

WARNING:
Cases of pulmonary hypertension have been reported with fenfluramine. Symptomatology is indistinguishable from primary pulmonary hypertension.

DOSAGE AND DIRECTIONS FOR USE:
Oral administration.
Adults: one capsule daily before breakfast.
Depending on the degree of obesity, this can be increased to two capsules daily after the first week of treatment, one capsule to be taken before breakfast and one capsule in the evening. The dosage should be reduced to one capsule daily for one week before the end of treatment.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Fenfluramine HCl may often cause nausea, diarrhoea, headache, dizziness and sedation. Other side-effects reported include dry mouth, flatulence, abdominal discomfort, constipation, fatigue, reduction or lightening of sleep, increase of depression, nightmare, palpitations, shivering, fluid retention, urinary infrequency, impotence, skin rash, alopecia and haemolytic anaemia.
Exertional dyspnoea, syncope, chest pain, palpitation and signs of cardiac insufficiency constitute prodromal symptoms of pulmonary hypertension. Patients should be informed that if such symptoms occur they should discontinue treatment immediately and seek medical attention.
Because of fenfluramine's mode of action, some patients may experience a feeling of hunger in consequence to the decreased food intake.

Care should be exercised when giving PONDERAX to depressed patients, those receiving anti-depressant therapy and with epileptic patients.
It is not recommended that PONDERAX be given concomitantly with other appetite suppressants. There should be an interval of two weeks between stopping any other appetite suppressant and starting PONDERAX to allow for any possible withdrawal symptoms to subside. PONDERAX may potentiate the action of antihypertensive, antidiabetic and sedative drugs. The dosage of these drugs should be reassessed when PONDERAX is prescribed.
In those patients who experience sedation with PONDERAX care should be taken when driving, working machinery or taking alcohol. Patients may experience transient depression following abrupt cessation of treatment. Gradual reduction of dosage will usually prevent this.
Dependence has been reported.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
The following symptoms have been reported: dilated pupils, tachycardia, flushing of the face, agitation and fine tremor. This can progress to vomiting, convulsions, unconsciousness and hyperpyrexia. Depression of respiration, cardiac arrhythmias, ventricular fibrillation and death may occur following very high dosage. Action to be taken in the event of an overdosage:
–Continuously monitor pulse, heart rate, blood pressure and ECG.
–Use diazepam to control convulsions.
–Reduce hyperthermia.
–Use anti-arrhythmic drugs to control cardiac tachyarrhythmias.
–Monitor plasma drug levels, if facilities are available.

IDENTIFICATION:
White, rounded subspherical pellets, contained in a hard gelatin No. 3 locking type capsule with a clear body and opaque blue cap, carrying print in black, Px PA 60.

PRESENTATION:
Carton of 30 capsules.

STORAGE INSTRUCTIONS:
Store below 25°C in a dry place.
Keep out of reach of children.

REGISTRATION NUMBER:
F/11.3.2/227

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
SERVIER LABORATORIES (S.A.) (PTY) LTD.
1st Floor, Rivonia Gate,
Cnr. Rivonia Road and 12th Avenue,
Rivonia 2128.

DATE OF PUBLICATION:
January 1992

10/93/820

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