Almost colorless, clear orange-flavored syrup.
Each 5 mL (1 mL teaspoonful) contains: Levodropropizine 30 mg.
Pharmacology: Pharmacodynamics: Levodropropizine carries out its antitussive activity through an inhibitory action on the release of sensor neuropeptides from C-fibres.
Pharmacokinetics: Absorption and Distribution: Levodropropizine is rapidly absorbed in humans after oral administration and is rapidly distributed in the organism. Radioactivity after oral administration is 93%. The binding with human plasma proteins is 11%-14% and half-life is about 1-2 hours.
Metabolism and Excretion: Levodropropizine is mainly excreted in urine as an unaltered product and its metabolites (conjugated levodropropizine, and free and conjugated p-hydroxy-levodropropizine). The urinary secretion of the product and metabolites in 48 hours is equal to about 35% of the administered dose.
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 of 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.
No significant side effects have been reported after the administration of a single dose of up to 240 mg of the drug and up to 120 mg three times a day for 8 consecutive dates. With 360 mg daily dose of levodropropizine, patient showed a not severe abdominal pain and vomiting. In case of overdose, apply immediate symptomatic therapy and adopt the usual emergency measures.
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 month has not yet been established.
Drivers of vehicles and machine operators are warned of the possibility of drowsiness with the use of this drug.
Pregnancy: Pregnancy Category D: Teratogenesis, reproduction, and fertility studies as well peri- and post-natal studies did not reveal any specific toxic effect. Nevertheless, as in animal toxicology studies with the 24 mg/kg dose, a mild delay in the body weight increase and in growth has been observed. As levodropropizine is able to cross the placental barrier in rats, it is contraindicated in women wanting to get pregnant or already pregnant as its safety of use is not documented.
Lactation: Studies in rats show that levodropropizine can be found in the mother's milk until 8 hours after administration. Levodropropizine is contraindicated during lactation.
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 the physician or the pharmacist in the event other side effects appear.
Seek medical attention immediately at the first sign of any adverse drug reaction.
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.
LevoGen syr 30 mg/5 mL
(orange flavor) 120 mL x 1's; (orange flavor) 30 mL x 1's; (orange flavor) 60 mL x 1's
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