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

Logo OBESAN X TABLETS

SCHEDULING STATUS:
Schedule 6.

PROPRIETARY NAME
(and dosage form):

OBESAN X TABLETS

COMPOSITION:
Each tablet contains:
Phendimetrazine tartrate         35.0 mg

PHARMACOLOGICAL CLASSIFICATION:
A 11.3 Anorexigenics

PHARMACOLOGICAL ACTION:
Obesan X is a sympathomimetic agent which is used as an anorectic in the short term treatment of moderate to severe obesity. Obesan X is used to suppress appetite and to make accompanying stringent dietary regimen.
The central effects of anorexia and wakefulness have proven inseperable.
The use of OBESAN X by obese individuals who are well motivated to reduce their food intake may ease the discomfort of adherence to a restricted diet, and may be of help in the earlier part of a regimen while new dietary patterns are being established.

INDICATIONS:
Anorexigenic for the treatment of obesity.

CONTRA-INDICATIONS:
Patients hypersensitive to this or any other sympathomimetic agent may develop a hypersensitive reaction. The sympathomimetic agent is liable to produce dependency and abuse. It should therefore be used with caution in patients with a history of drug or alcohol abuse and in patients with personality disorders or a history of psychiatric illness.
Obesan X should be given with caution to patients suffering from anorexia, insomnia, impaired kidney function, cardiovascular disease (especially coronary insufficiency), hypertension, arteriosclerosis, thyrotoxicosis, prostatism, extrapyrimidal disorders and narrow angle glaucoma.
This drug should be avoided in children because of the possibility of growth suppression.
The use of Obesan X should be avoided during pregnancy and breastfeeding.
Obesan X is contra-indicated in patients being treated with monoamine oxidase inhibitors, Beta-blockers, ephedrine and other sympathomimetic agents, as a hypertensive response may result. Caution should be exercised in administering Obesan X within 14 days of discontinuing other agents with a similar mechanism of action.
Concurrent use of alcohol is not recommended, since this may increase the potential for Central Nervous System effects, such as dizziness and confusion.
The hypersensitive effect of antihypersensitive medication may be decreased by concurrent use with Obesan X.

WARNINGS:
The use of Obesan X should be restricted to short periods only (not in excess of six weeks). There is a lack of evidence for efficacy of these agents in the long term management of obesity.

DOSAGE AND DIRECTIONS FOR USE:
Adults only:
One or two tablets twice daily, one hour before breakfast and the midday meal. If taken after 4p.m. Obesan X may interfere with sleep at night.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Obesan X may produce symptoms of overstimulation of the central nervous system such as, psychotic reactions, insomnia, night terrors, nervousness, irratibility, euphoria, anxiety, agitation, excitability and restlessness, that may be followed by fatigue and depression.
Other side effects include dryness of mouth, nausea, vomiting, difficulty in micturition, sweating, altered libido, impotence and tremor. Side effects which are relatively common include headache, anorexia and dizziness. Constipation or diarrhea with abdominal cramps may occur. Skin rashes have been reported, as well as muscle damage with associated thabdomyolysis and renal complications. Aplastic aneamia and pancytopenia have occasionally occurred after prolonged use. Systolic and diastolic blood pressure may be increased, or sometimes decreased, especially with high doses, and tachycardia, palpitations, anginal pain or cardiac arrhythmias may occur. The risk of cardiovascular effects, including arrhythmias may be increased by concurrent use of amphetamines and tricyclic antidepressants. Rarely, cardiomyopathy has occurred with chronic use. Diabetic control should be monitored.
Urinary excretion of amphetamines is reduced by urinary alkalinizers which may enhance or prolong their effects. Excretion is increased by urinary acidifiers. Prolonged high doses may need gradual withdrawal as abrupt cessation may produce fatigue and mental depression.
Sympathomimetics have dependence producing properties. Tolerance develops rapidly.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Large doses may give rise to nausea, vomiting, abdominal cramps, fatigue, mental depression, talkativeness, restlessness, rapid breathing, tremor, arrhythmia, impotence, changes in libido, fever or chilliness, hypotension or hypertension, respiratory failure, disorientation, severe panic state, aggressive behaviour, hallucinations, convulsions and coma.
Symptoms of gross overdosage may be treated by emptying the stomach by lavage and aspiration, if the drug has been ingested within the preceding 3 to 4 hours.
Keep the patient quiet and warm.
If respiration is irregular or cyanosis is present give assisted respiration or inhalation of oxygen. If hypertension is marked, phentolamine mesylate 5 to 10 mg, or phenoxybenzamine hydrochloride 10 to 20 mg may be given intravenously and may be followed by propanolol hydrochloride 2.5 to 5 mg.
For marked excitement, chlorpromazine 1 to 1.5 mg per kg body mass may be given intramuscularly or intravenously. Diazepam 5 to 10 mg intravenously may also be of value. Alternatively an intermediate acting barbiturate, such as quinalbarbitone sodium or cyclobarbitone calcium may be given by mouth, or, if necessary, thiopentone sodium may be administered by intravenous injection.
Provided renal function is adequate, elimination may be assisted by acidification of the urine with ammonium chloride in conjunction with adequate fluid intake. Dialysis may be of value if renal function is impaired.

IDENTIFICATION:
White flat round tablet with beveled edges and scored on one side.

PRESENTATION:
White plastic containers of 30, 60 and 90 tablets.

STORAGE INSTRUCTIONS:
Store well closed at room temperature (25°C)
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
C877 (Act/Wet 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
TECHNIKON LABORATORIES (PTY) LTD
1073 Anvil Road, Robertville, Florida. Tel: (011) 674-1091

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
July 1984

New addition to this site: February 2007
Source: Pharmaceutical Industry

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