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Logo THEOPLUS® 200 mg sustained release tablets
THEOPLUS® 300 mg sustained release tablets

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

THEOPLUS® 200 mg sustained release tablets
THEOPLUS® 300 mg sustained release tablets

COMPOSITION:
Each tablet contains:
200 mg
theophylline, anhydrous; or
300 mg theophylline, anhydrous.

PHARMACOLOGICAL CLASSIFICATION:
A 10.2 (Bronchodilators)

PHARMACOLOGICAL ACTION:
Theophylline relaxes the smooth muscle of the bronchial airways.

INDICATIONS:
For the relief or prevention of bronchospasm associated with bronchial asthma, chronic bronchitis and emphysema.

CONTRA-INDICATIONS:
Acute myocardial infarction.
Hypersensitivity to theophylline or other xanthine derivatives.
THEOPLUS
® should not be used during pregnancy as safety has not been established.

WARNINGS:
Patients undergoing routine haemodialysis may require increased doses. Care should be taken in patients with a history of peptic ulceration.
In elderly patients or patients with impaired hepatic or renal function and congestive heart failure, the dosage must be reduced.

DOSAGE AND DIRECTIONS FOR USE:
The daily dose per kilogram should be adjusted according to the bodyweight. (7-14 mg/kg/day for 70 kg bodyweight).
The individual biotransformation of theophylline may vary. Where possible, it is advisable to monitor theophylline therapy with serum levels of theophylline. For optimum therapeutic benefit, the dosage should be titrated to maintain serum levels of theophylline between 10-20 micrograms/mL.
The tablets should be taken every 12 hours. The tablets should not be chewed.

ADULTS:
200 mg tablets
Start treatment with 1 tablet (200 mg) twice a day and after at least 3 days, treatment can be gradually increased by 100 mg twice a day.
300 mg tablets
1 tablet (300 mg) twice a day or two tablets at night.
The maximum maintenance dose without measurement of serum concentration should not exceed 13 mg/kg/day.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
The side-effects commonly encountered are gastro- intestinal irritation and stimulation of the Central Nervous System.
Other side-effects include nausea, vomiting, gastro-intestinal bleeding, insomnia, headache, anxiety, confusion, restlessness, hyperventilation, vertigo, palpitations, diarrhoea, diuresis, anorexia, tremor and reduced exercising ability.
Theophylline should be administered with caution to elderly patients and those suffering from cardiac and liver disease.
The bronchodilation and toxic effects of theophylline may be enhanced by sympathomimetics and by administration of other xanthines.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Treatment is symptomatic.
Gastric lavage may be used, dialysis, haemoperfusion have been used. Fluid and electrolyte balance should be maintained with intravenous fluids and oxygen given if necessary.
Convulsions may be controlled by the intravenous administration of diazepam 5 mg or 10 mg or if necessary, thiopentone sodium.

IDENTIFICATION:
White oblong scored tablets.

PRESENTATION:
Containers of 60 and 500 tablets.

STORAGE INSTRUCTIONS:
Store in a dry place at room temperature (below 30°C).
Protect from light. Keep out of reach of children.

REGISTRATION NUMBER:
V/10.2/96, V/10.2/97

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Byk Madaus (Pty) Ltd
2nd Road (Cnr. 16th Road)
Randjespark, 1685 Midrand

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
6 January 1989.

Under licence from: Pierre Fabre Médicament, France

Postal Address
Byk Madaus (Pty) Ltd
P.O. Box 3435
Halfway House 1685

                SD 70010
                TPI 03/00/08
                Futura Offset
Updated on this site: November 2000

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