Country: South Africa
Language: English
Source: South African Health Products Regulatory Authority (SAHPRA)
Sad-otc
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, acut Read the complete document