Each 5 mL (1 teaspoonful) contains: Levodropropizine 30 mg.
Cough Suppressant.
Pharmacology: Pharmacodynamics: Action: Levodropropizine, the (-)-(S)-isomer of dropropizine, is a cough suppressant with peripheral action. It decreases the excitability of tracheobronchial receptors thus suppressing the cough reflex.
Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract.
Bioavailability: >75%. Time to peak plasma concentration: 0.75 hours (range: 0.25-2 hours).
Distribution: Plasma protein binding: 11-14%.
Excretion: Via urine (35% as unchanged drug and metabolites). Elimination half-life: 2.3 ± 0.5 hours.
For the symptomatic relief of cough.
Adults and children over 12 years of age: Two teaspoonfuls/10 mL (equivalent to 60 mg of Levodropropizine) up to 3x daily at intervals of at least 6 hours.
Children over 2 years of age: The pediatric dose is 1 mg/kg 3x daily, for a total daily dose of 3 mg/kg at intervals of at least 6 hours.
For convenience, the following approximate dosages can be used: 10-20 kg body weight: 3 mL up to 3x daily.
20-30 kg body weight: 5 mL up to 3x daily.
The preparation is administered orally.
The medication should be taken between meals, since the effect of concomitant food consumption has not yet been determined.
Treatment Duration: The treatment should be taken until the cough clears up, or directed by a physician, for a period not exceeding seven days. If symptoms persist after this period, treatment should be stopped and a physician should be consulted.
No specific information available on the treatment of overdosage with levodropropizine. In case of overdose, symptomatic and supportive therapies and measures should be provided with special attention to cardiac, respiratory, renal and hepatic functions, and fluid and electrolytic balance.
Excessive mucus discharge and limited mucociliary function. Severe liver impairment.
Care should be taken for patients with serious renal insufficiency.
Notice to diabetics: 10 mL of levodropropizine contains 2 g sucrose (equal to 0.2 bread units).
The safety and efficacy of levodropropizine in children less than 24 months has not yet been established.
Drivers of vehicles and machine operators are warned of the possibility of drowsiness with the use of this drug.
The following side effects sometimes occur:
Gastrointestinal tract: Nausea; Vomiting; Heartburn; Abdominal discomfort; Diarrhea.
Central Nervous System: Exhaustion, faintness; Somnolence, clouding of consciousness (stupor); Numbness; Dizziness; Headache.
Cardiovascular System: Palpitations.
Hypersensitivity reactions may occur in predisposed patients because levodropropizine contains parabens.
Allergic skin reactions were observed in very rare cases.
Consult a physician or pharmacist in the event other side effects appear.
No interactions with benzodiazepines were observed during clinical trials, however, care should be taken when sedative drugs are simultaneously administered to particularly sensitive individuals.
Store at temperatures not exceeding 30°C. Discard the product after 1 month of opening.
R05DB27 - levodropropizine ; Belongs to the class of other cough suppressants.
Extusiv syr 30 mg/5 mL
120 mL x 1's
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