Levodropropizine Syrup
Rapitus
COMPOSITION
Each 5 ml contains: Levodropropizine BP 30 mg Flavoured syrup base q.s.
DESCRIPTION
Levodropropizine is an antitussive agent with predominantly peripheral action, which acts by inhibiting the cough reflex by reducing the excitability of the tracheobronchial receptors. It is a cough suppressant with a bronchial myorelaxant action, producing an improvement in pulmonary ventilation; it is free from the secondary reactions of the antitussive agents having central action, especially respiratory depression and the emetic effect. It also has a lytic action on the bronchospasms produced by histamine and therefore some activity on coughs of allergic origin. The drug does not depress the respiratory function or mucociliary clearance.
PHARMACOLOGY
Levodropropizine reduced cough induced by citric acid aerosol in healthy volunteers. The anti-tussive effect is maintained at least for 6 hours. When used in its therapeutic dosage, the product does not manifest any sedative effects on the central nervous system. It is likewise free of undesirable effects on the respiratory tract.
PHARMACOKINETICS
In the studies on pharmacokinetics carried out in rats and in human beings, the kinetics and the metabolic profile had similar results. Levodropropizine is rapidly absorbed and distributed in man after oral administration. Repeated administration in human beings indicated that an interval of administration of 6-8 hours does not alter the kinetic prof le of a single dose.
INDICATIONS
Symptomatic treatment of unproductive, irritating and dry cough, as a result of obstructive (bronchitis) and constrictive (laryngitis, tracheitis) pathologies and also as a result of coughs associated with the process having an infectious basis.
DOSAGE
Adults and children above 12 years of age: 10 ml of the syrup (one measuring cup full) three times a day with an interval not less than 6 hours between doses. Children above 2 years of age: The paediatric dosage is 1 mg/kg up to three times a day, totalling to a daily dose of 3 mg/kg.
During treatment: The treatment must be continued as prescribed medically until the cough disappears. However, if after 4 or 5 days of treatment the cough does not disappear or other symptoms appear, one should again refer to the doctor. The cough is a symptom and must be studied in order to treat it in accordance with the causal pathology.
CONTRAINDICATIONS
Levodropropizine is contraindicated in patients manifesting hypersensitivity to any of the components tn its formula. The administration of levodropropizine must be avoided in patients with bronchial hypersecretion and reduced mucociliary function (Kartagener syndrome or ciliary dyskinesia) and in patients with severe hepatic insufficiency. Levodropropizine must not be used during pregnancy and lactation.
DRUG INTERACTIONS
Pharmacology studies in animals showed that levodropropizine does not enhance the effect of active substances on the central nervous system (benzodiazepines, phenytoin, imipramine). In clinical pharmacology studies, the benzodiazepine association does not modify the EEG profile (electroencephalogram). Still, it is necessary to be cautious in the simultaneous administration of sedative drugs, particularly in sensitive patients. Clinical data does not show interaction with drugs used in the treatment of bronchopulmonary pathologies such as BETA-agonists, methylxanthine derivatives, corticosteroids, antibiotics, mucoregulators and antihistamines.
PRECAUTIONS
In patients with severe renal insufficiency (creatinine clearance below 35 ml/min), it must be administered with caution after evaluating the risks vs. benefit.
Levodropropizine contains sugar in its formulation and therefore, should to be used with caution in diabetic patients.
ADVERSE REACTIONS
In controlled clinical studies, 4 in 100 patients showed temporary undesirable effects, which disappeared after treatment was discontinued. Gastrointestinal problems such as nausea, pyrosis, dyspepsia, abdominal discomfort, diarrhoea and vomiting, central nervous system disorders such as tiredness and/or asthenia, fatigue, somnolence, numbness, cephalic disorders and dizziness and cardiovascular system disorders such as: cardiopathy and palpitations, and in very rare occasions, cutaneous allergic reactions occurred.
WARNINGS
Levodropropizine must not be used for prolonged periods. After a brief period of treatment with no appreciable results, the patient must consult a doctor. Although levodropropizine rarely causes sedation, the patient must avoid driving or operating machinery. The patient must be informed regarding the possibility of occurrence of this rare side effect. In children less than two years of age, its safety and security has not yet been established.
OVERDOSE
There are no reports of adverse effects with an overdose of levodropropizine of up to 240 mg in single administrations and up to 120 mg three times a day for 8 consecutive days. In case of over dosage, there can be slight and transitory tachycardia. In this case, gastric washing should be done and activated carbon must be used, fluids given parenterally and other means of support be given.
ALL DRUGS MUST BE KEPT OUT OF REACH OF CHILDREN.