Each 100 mL of syrup contains levodropropizine 0.6 g. It also contains sucrose, citric acid monohydrate, sodium hydroxide, liquorice flavor, purified water, methyl parahydroxybenzoate and propyl parahydroxybenzoate as excipients.
Levodropropizine is a non-opioid peripherally active antitussive with proven efficacy.
Clinical studies showed the good tolerability of levodropropizine and it does not interfere with respiratory function. Clinical data on the direct comparison of levodropropizine and codeine are not available. A study of dihydrocodeine and levodropropizine showed that both drugs were equally effective as antitussive agents, but levodropropizine had fewer sedative side effects.
Symptomatic treatment of cough.
Adults and Children >12 years: 1 measuring cup with 10 mL (equivalent to 60 mg of levodropropizine) up to 3 times daily at intervals of at least 6 hrs.
Children >2 years: The pediatric dose is 1 mg/kg 3 times daily, for a total daily dose of 3 mg/kg.
For convenience, the following approximate dosages can be used: 10-20 kg body weight: 3 mL up to 3 times daily; 20-30 kg body weight: 5 mL up to 3 times daily.
Levopront is administered orally. It should be taken between meals, since the effect of concomitant food consumption have not yet been determined.
Treatment Duration: Levopront should be taken until the cough clears up or as directed by a physician for a period not to exceed 7 days. If symptoms have not stopped after this period, treatment should be stopped and a physician should be consulted.
A measuring cup with marks for 3, 5 and 10 mL is included in the package.
Patients with a known or possible hypersensitivity to Levopront; with excessive discharge of mucous; with limited mucociliary function (Kartagener's syndrome, ciliary dyskinesia); and when liver function is severely limited.
Use in pregnancy & lactation: Levopront is not recommended during pregnancy and lactation.
Care should be taken for patients with serious renal insufficiency.
Diabetics: 10 mL of Levopront contains 3.5 g sucrose (equal to 0.3 bread units).
Effects on the Ability to Drive or Operate Machinery: Drivers of vehicles and machine operators are warned of the possibility of drowsiness with the use of Levopront.
Use in children: The safety and efficacy of levodropropizine in children <24 months has not been established.
Levopront is not recommended during pregnancy and lactation.
The following side effects sometimes occur:
Gastrointestinal Tract: Nausea, vomiting, heartburn, abdominal discomfort and diarrhea.
Central Nervous System: Exhaustion, faintness, somnolence, clouding of consciousness (sopor), numbness, dizziness and headache.
Cardiovascular System: Palpitations.
Hypersensitivity reactions may occur in predisposed patients because Levopront contains parabens.
Allergic skin reactions were observed in very rare cases.
Consult the physician or the 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.
Do not store above +30°C (86°F).
R05DB27 - levodropropizine ; Belongs to the class of other cough suppressants.
Syrup 0.6% x 60 mL, 120 mL.