Levopront syrup 6mg/ml, 120ml

Composition

Composition per 1 ml: Active ingredient: Levodropropizine-6.0 mg, Excipients: sucrose-400 mg, methyl parahydroxybenzoate-1.3 mg, propyl parahydroxybenzoate-0.2 mg, citric acid monohydrate-9.6 mg, sodium hydroxide-3.6 mg, cherry flavor-2.5 mg, purified water-up to 1 ml

Pharmacological action

Pharmacotherapy group: other antitussive drugs

ATX code: R05DB27

Pharmacological properties

Pharmacodynamics

Antitussive remedy. Antitussive activity is caused by a peripheral effect on the tracheobronchial tree. The mechanism of antitussive action of levodropropizine is to slow down the transmission of nerve impulses inside C-fibers, suppressing the release of neuropeptide sensors from C-fibers in vitro.

The drug does not cause respiratory depression and does not affect mucociliary clearance in humans. In patients with chronic respiratory insufficiency, levodropropizine does not have an overwhelming effect on the respiratory system both during spontaneous breathing and during hypercapnic ventilation.

Pharmacokinetics

The oral bioavailability of levodropropizine is more than 75%.

Levodropropizine is rapidly absorbed and distributed in the human body after oral use.

Binding to plasma proteins is insignificant (11-14%).

The elimination half-life is 1-2 hours. It is excreted by the kidneys both in unchanged form and in the form of metabolites (conjugated levodropropizine and conjugated rhydroxylevodropropizine). After 48 hours, the excretion of levodropropizine and the above-mentioned metabolites by the kidneys is about 35% With repeated use of the drug, there were no changes in pharmacokinetic parameters and accumulation of levodropropizine.

There were no significant changes in the pharmacokinetic profile in children, elderly patients, or patients with mild or moderate renal impairment.

Indications

Symptomatic treatment of cough.

Use during pregnancy and lactation

Levopront is contraindicated during pregnancy and lactation.

Contraindications

* Hypersensitivity to levodropropizine or other components of the drug

· Diseases associated with bronchial hypersecretion

* Decreased mucociliary function (Cartagener syndrome, ciliary dyskinesia)

· Pregnancy

· Breast-feeding period

· Children under 2 years of age;

· fructose intolerance, glucose-galactose malabsorption, sucrose-somaltose insufficiency

With caution

In patients with severe renal impairment (creatinine clearance less than 35 ml / min), with severe hepatic impairment, in elderly patients, with concomitant use with sedatives, with diabetes mellitus.

Side effects

The frequency of reported adverse reactions is unknown (it is not possible to accurately determine the frequency of such events based on available data):

Immune system disorders: allergic and anaphylactic reactions, eyelid edema, angioedema.

Mental disorders: irritability, lethargy, personality changes, or personality disorders.

Nervous system disorders: syncope, gait instability, vertigo, tremor, paresthesia, tonic-clonic seizures, and minor epileptic seizures.

Visual disorders: mydriasis, bilateral blindness.

Disorders of the heart: palpitation, tachycardia, atrial bigeminia.

Vascular disorders: arterial hypotension.

Respiratory, thoracic, and mediastinal disorders: shortness of breath, cough, and airway edema.

Gastrointestinal disorders: stomach pain, abdominal pain, nausea, vomiting, diarrhea.

Liver and biliary tract disorders: cholestatic hepatitis.

Metabolic and nutritional disorders: hypoglycemic coma.

Skin and subcutaneous tissue disorders: urticaria, erythema, exanthema, pruritus, skin reactions, glossitis, aphthous stomatitis, epidermolysis.

Musculoskeletal and connective tissue disorders: weakness in the lower extremities;

General disorders and disorders at the injection site: general malaise, generalized edema, asthenia.

Interaction

Levodropropizine does not enhance the pharmacological effect of drugs acting on the central nervous system (CNS) (for example, benzodiazepines, alcohol, phenytoin, imipramine), does not modify the effect of oral anticoagulants (for example, warfarin) and does not affect the hypoglycemic effect of insulin. However, in patients with individual hypersensitivity, it is possible to depress the

central nervous system when taking Levopront with sedatives at the same time.

Clinical studies have not demonstrated any interactions with drugs used in the treatment of diseases of the bronchopulmonary system, such as beta-2-adrenomimetics, methylxanthines and their derivatives, glucocorticosteroids, antibiotics, mucolytics and antihistamines.

How to take, course of use and dosage

Inside.

To open the bottle, you need to press the cap hard and simultaneously turn it counterclockwise.

To accurately measure the dose of the drug, a measuring cup with marks Z,5 and 10 ml is attached.

Adults and children over 30 kg: 10 ml of syrup (equivalent to 60 mg of levodropropizine) up to three times a day at intervals of at least 6 hours.

Children from 20 to 30 kg: 5 ml of syrup (equivalent to 30 mg of levodropropizine) up to three times a day at intervals of at least 6 hours.

Children from 10 to 20 kg: 1 ml of syrup (equivalent to 18 mg of levodropropizine) up to three times a day at intervals of at least 6 hours.

The drug should be taken in between meals.

The duration of treatment should not exceed seven days. If symptoms persist for more than 7 days, you should consult a doctor.

Overdose

Symptoms: nausea, abdominal pain.

Treatment: symptomatic therapy using standard emergency measures (gastric lavage, taking activated charcoal, etc. ).

Description

Transparent colorless or slightly yellowish solution with a characteristic cherry smell.

Special instructions

Levopront contains 4 g of sucrose per dose (10 ml), which should be taken into account in patients with diabetes mellitus. One dose contains 0.4 XE (bread units).

Levopront is gluten-free.

Levopront contains methylparahydroxybenzoate and propylparahydroxybenzoate, which often lead to allergic rashes. In general, propyl parahydroxybenzoates usually cause delayed-type allergic reactions, such as contact dermatitis, and less often immediate-type allergic reactions with manifestations of urticaria and bronchospasm.

Influence on the ability to drive vehicles and mechanisms

Care should be taken when driving vehicles and working with mechanisms.

Form of production

Syrup 6 mg / ml.

Storage conditions

Keep out of reach of children at a temperature not exceeding 25 ° C.

Shelf

life is 2 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Levodropropizine

Conditions of release from pharmacies

By prescription

Dosage form

syrup