PHARMACOLOGICAL ACTION; Aminophylline relaxes bronchial smooth muscle thereby relieving bronchial spasm. Ephedrine hydrochloride is a sympathomimetic agent which is valuable in treating the bronchospasm of asthma.
INDICATIONS: GENASMA is indicated for the prevention and symptomatic treatment of asthma.
CONTRA-INDICATIONS: Sensitivity to any of the components. Safety during pregnancy and lactation has not been established. Should not be given to patients receiving treatment with monoamine oxidase inhibitors or within 14 days of termination of treatment. Acute myocardial infarction.
WARNINGS: GENASMA should be avoided or used with extreme caution in patients undergoing anaesthesia with cyclopropane, halothane or other halogenated anaesthetics, as the ephedrine hydrochloride component may cause ventricular fibrillation.
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: One to five capsules in any 24 hour period.
In view of the many factors affecting theophylline clearance, serum concentration monitoring is recommended to ensure concentrations are within the therapeutic range.
Plasma concentrations of theophylline greater than 20 micrograms per mL are considered to be toxic. For optimum therapeutic benefit, the dosage should be titrated to maintain serum levels of theophylline between 10 - 20 micrograms/mL.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Theophylline may cause nausea, vomiting, abdominal pain, gastro-intestinal bleeding, insomnia, headache, anxiety, restlessness, vertigo and palpitations.
Theophylline should be given with caution to patients with peptic ulceration, hyperthyroidism, hypertension, cardiac arrhythmias, congestive heart failure, hepatic dysfunction, chronic alcoholism, acute febrile illness, hypoxia, chronic lung disease and to the elderly.
The toxic effects of theophylline and sympathomimetics or xanthines are additive.
Concomitant administration with other xanthine medications should be avoided. Interaction between theophylline and medicines such as allopurinol, cimetidine, influenza vaccine, propranolol, erythromycin and some other macrolides may necessitate reduction of the theophylline dosage.
Phenytoin and some other anticonvulsants, and cigarette smoking may increase the clearance of theophylline, necessitating an increase in dose or dosing frequency.
Central nervous system side-effects of ephedrine hydrochloride include fear, anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced, and nausea and vomiting may occur.
Cardiovascular side-effects include tachycardia, reflex bradycardia, cardiac arrhythmias, anginal pain, palpitations and cardiac arrest; hypertension or hypotension with dizziness and fainting, and flushing may occur.
Other side-effects of ephedrine hydrochloride are difficulty in micturition and urinary retention, dyspnoea, altered metabolism, including disturbances of glucose metabolism, sweating and hypersalivation. Headache may also occur.
GENASMA should be used with caution in patients hypersusceptible to the effects of ephedrine hydrochloride, particulary those with hyperthyroidism. Ephedrine hydrochloride should also be given with caution to patients with cardiovascular disease such as ischaemic heart disease, arrhythmias or tachycardia, arteriosclerosis, hypertension and aneurysms. Anginal pain may be precipitated in patients with angina pectoris.
Care is required when ephedrine hydrochloride is given to patients with diabetes mellitus or closed-angle glaucoma. Prolonged use of ephedrine hydrochloride has no cumulative effect, but tolerance with dependence has been reported.
Tolerance may develop in asthmatic patients given sympathomimetics for their bronchodilator effects; if tolerance occurs and the patient's condition worsens, alternative or additional therapy should be instituted. The dose of ephedrine hydrochloride should not be increased in such cases.
An increased risk of arrhythmias may occur if ephedrine hydrochloride is given to patients receiving cardiac glycosides, quinidine or tricyclic antidepressants. Ephedrine hydrochloride should be given with care to patients receiving antihypertensive therapy.
Interactions of ephedrine hydrochloride with alpha and beta blocking medicines may be complex.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Theophylline 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 forms of toxicity.
For symptoms of ephedrine hydrochloride overdosage refer to "Side-effects and special precautions". Paranoid psychosis, delusions and hallucinations may also follow ephedrine hydrochloride overdosage. Treatment of overdosage is symptomatic and supportive.
IDENTIFICATION: A capsule with a transparent orange body and a transparent blue cap, containing a white powder.
PRESENTATION: Containers of 40, 100 and 1000.
STORAGE INSTRUCTIONS: Store below 25°C. Protect from light and moisture.
REFERENCE NUMBER: G 1228 (Act 101/1965)
NAME AND BUSINESS ADDRESS OF THE APPLICANT: Alliance Pharma (Pty) Ltd
17 Faraday Street
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 26 September 1974 PM0533 9/00
Updated on this site: October 2001 Current: May 2004 Source: Community Pharmacy