PHARMACOLOGICAL CLASSIFICATION: A10.1 Antitussives and Expectorants.
PHARMACOLOGICAL ACTION: Diphenhydramine, a representative of the ethanolamines, is a potent and active antagonist which possesses significant atropine-like activity causing drying of the secretions which contribute towards coughing. There is also some bronchial dilation which makes for easier breathing and easier expulsion of sputum.
Aminophylline, a theophylline compound, relaxes various smooth muscles other than those of blood vessels. The most important action in this respect is their ability to relax the smooth muscles of the bronchi, especially if the bronchi have been constricted by histamine or asthma. Ammonium chloride reduces the viscosity of thick, sticky sputum and so aids easier expectoration.
INDICATIONS: Symptomatic treatment of cough.
CONTRA-INDICATIONS: Lotussin Expectorant is contra-indicated in patients with known hypersensitivity to any of the active constituents, coronary thrombosis, hypertension, thyrotoxicosis, in patients receiving monoamine oxidase inhibitors or within 14 days of stopping such treatment.
WARNINGS: This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressant agents.
DOSAGE AND DIRECTIONS FOR USE:
Adults: 5 - 10 mL (one to two 5 mL medicine measures) every 30 minutes for one to two hours, then every two to four hours as needed. Children: 2 - 6 years: 2,5 mL (half a 5 mL medicine measure) every 30 minutes for one to two hours, then every two to four hours as needed. 7 - 16 years: 2,5 mL to 5 mL (half to one 5 mL medicine measure) every 30 minutes for one to two hours, then every two to four hours as needed.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS: Side-effects may occur, the most common being gastric irritation, nervousness and increased tension. Drowsiness may occur, and if affected the patient should not drive or operate machinery. Patients should also avoid alcohol. The possibility of interactions with other medications should also be considered by reference to each active ingredient.
The use of any medication in women of child-bearing potential requires that the benefits of therapy be weighed against its possible hazards to the mother and foetus.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: Identified by reference to the symptoms of overdosage of the individual active ingredients. Treatment of overdosage consists of gastric lavage in the conscious patient and intensive support therapy where necessary.
IDENTIFICATION: Brown viscous liquid with a characteristic odour.
PRESENTATION: Lotussin Expectorant is supplied in amber glass bottles containing 200 mL. The 2,5 L size is also available in HDPE containers.
STORAGE INSTRUCTIONS: Store below 30°C
Keep out of reach of children
REGISTRATION NUMBER: F/10.1/116
NAME AND BUSINESS ADDRESS OF THE APPLICANT: G.D. Searle (South Africa) (Pty) Ltd.
14 Mandy Road
Reuven
Johannesburg
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 13 April 1975
LOTUSSIN EXPECTORANT