THEOPHEN ELIXIR
SCHEDULING STATUS:
S1
PROPRIETARY NAME
(and dosage form):
THEOPHEN ELIXIR
COMPOSITION:
Each 15 mL (three medicine measures) contains:
Theophylline 80,00 mg
b-Hydroxyethyl Theophylline 10,00 mg
Alcohol 96 % 20,00 % v/v
Preservative:
Nipasept 0,04 % m/v
PHARMACOLOGICAL CLASSIFICATION:
A 10.2 Bronchodilators.
PHARMACOLOGICAL ACTION:
Theophen Elixir relaxes smooth muscle and relieves bronchial spasm, stimulates the myocardium and produces a diminution of venous pressure in congestive heart failure leading to an increase in cardiac output. It has a stimulant effect on respiration.
INDICATIONS:
Bronchial asthma, reversible bronchospasm associated with emphysema.
CONTRA-INDICATIONS:
Hypersensitivity. See "Side-effects and Special Precautions" below.
DOSAGE AND DIRECTIONS FOR USE:
Adults:
9 - 12 medicine measuresful (45 - 60 mL) immediately.
Prophylactic:
3 - 6 medicine measuresful (15 - 30 mL) three times daily after meals.
Children:
1 - 3 medicine measuresful (5 - 15 mL) not more frequently than every 8 hours.
Above recommendations are averages. Dosage should be individualised.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Theophylline may cause nausea, vomiting, abdominal pain, gastro-intestinal bleeding, visual disorders, insomnia, headache, anxiety, confusion, restlessness, hyperventilation, vertigo and palpitations.
Theophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias, or other cardiovascular disease, as these conditions may be exacerbated. Theophylline should also be given with caution to patients with congestive heart failure, hepatic dysfunction or chronic alcoholism, acute febrile illness, severe hypoxia, cor pulmonale, acute pulmonary oedema, or other chronic lung disease, and to neonates and the elderly, since in all of these circumstances Theophylline clearance may be decreased, resulting in increases in serum-theophylline concentrations and serum half-life.
The bronchodilator and toxic effects of Theophylline and sympathomimetics or other xanthines are additive. Concomitant use with other xanthine medications should be avoided.
Interaction with allopurinol, cimetidine, influenza vaccine, propranolol, erythromycin, and some other macrolides may result in decreased hepatic Theophylline clearance and increased serum half-life, necessitating dosage reduction. Phenytoin and some other anticonvulsants, and cigarette smoking may increase Theophylline clearance, necessitating an increase in dose or dosing frequency.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Severe overdosage or idiosyncrasy may lead to maniacal behaviour, diuresis and repeated vomiting with extreme thirst, tremor, delirium, hyperthermia, tachycardia, tachypnoea, electrolyte disturbances, convulsions, and death. Convulsions may not be preceded by milder symptoms of toxicity.
After overdosage by mouth the stomach should be emptied by emesis, or gastric aspiration and lavage.
Treatment is symptomatic and supportive.
IDENTIFICATION:
A clear red, syrupy liquid with an apricot taste and odour.
PRESENTATION:
Bottles of 100 mL and 200 mL.
STORAGE INSTRUCTIONS:
Store below 25 °C.
Keep tightly closed and protect from light.
KEEP OUT OF REACH OF CHILDREN.
REGISTRATION NUMBER:
M/10.2/533
NAME AND BUSINESS ADDRESS OF APPLICANT:
S.A.D. SELF MEDICATION [PTY] LIMITED
Co. Reg. No. 92/04769/07
Robbie de Lange Road, Wilsonia, EAST LONDON, 5201
P O Box 422, EAST LONDON, 5200
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
February 1983 |
