Levopront, 6 mg/ml syrup 120 ml

Pharmacotherapeutic group: other antitussive drugs

ATX code: R05DB27

Pharmacological properties

Pharmacodynamics

A cough suppressant. Anticough activity is caused by peripheral action on tracheobronchial tree. The mechanism of the anti-cough action of levodropropyzine is to inhibit nerve impulse transmission within the C-fibers by inhibiting the release of neuropeptide sensors from the C-fibers in vitro.

The drug does not cause suppression of the respiratory center and does not affect mucociliary clearance in humans. In patients with chronic respiratory failure, levodropropyzine has no suppressive effect on the respiratory system during both spontaneous breathing and hypercapnic ventilation.

Pharmacokinetics

The bioavailability of levodropropyzine when taken orally is over 75%.

Levodropropyzine is rapidly absorbed and distributed in the human body after oral administration.

The binding to plasma proteins is low (11-14%).

Half-life is 1-2 hours. It is excreted by the kidneys both as unchanged and as metabolites (conjugated levodropropyzine and conjugated rhydroxylevodropyzine). After 48 hours, excretion of levodropropyzine and the above metabolites by the kidneys is about 35% When repeated administration of the drug no changes in pharmacokinetic parameters and cumulation of levodropropyzine were noted.

Significant changes in pharmacokinetic profile in children, elderly patients, patients with renal dysfunction of mild or moderate severity have not been identified.

Indications

Symptomatic treatment of cough.

Active ingredient

Levodropropyzine

Composition

Ingredients per 1 ml:

Active ingredient:

Levodropropisin – 6.0 mg,

Excipients:

sucrose – 400 mg,

methylparahydroxybenzoate – 1.3 mg,

propylparahydroxybenzoate – 0.2 mg,

citric acid monohydrate – 9.6 mg,

sodium hydroxide – 3.6 mg,

cherry flavoring – 2.5 mg,

purified water – up to 1 ml.

How to take, the dosage

Inwards.

To open the bottle, firmly press the cap while turning it counterclockwise.

A measuring cup with Z, 5 and 10 ml marks is included for accurate measurement of the dose of the product.

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

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

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

The drug should be taken between meals.

The duration of treatment should not exceed seven days. If symptoms last longer than 7 days, you should see a doctor.

Interaction

Levodropropsin does not enhance the pharmacological effect of central nervous system (CNS) medications (e.g. benzodiazepines, alcohol, phenytoin, imipramine), does not modify the effect of oral anticoagulants (e.g. warfarin) and does not affect the hypoglycemic effect of insulin. However, in patients with individual hypersensitivity, there may be depressant effect on the

CNS when concomitant use of Levopront with sedatives.

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

Special Instructions

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

Levopront does not contain gluten.

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

Influence on the ability to drive vehicles, machinery

Caution should be exercised when driving vehicles and operating machinery.

Synopsis

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

Contraindications

– Hypersensitivity to levodropropyzine or other drug components

– Diseases associated with bronchial hypersecretion

– Decreased mucociliary function (Cartagena syndrome, ciliary dyskinesia)

– Pregnancy

– Breastfeeding period

– Infants under 2 years of age;

– Fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltose deficiency

With caution

In patients with severe renal impairment (creatinine clearance less than 35 ml/min), with significant hepatic impairment, in elderly patients, when concomitantly taken with sedatives, in diabetes.

Side effects

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

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

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

Nervous system disorders: fainting, unsteadiness of gait, vertigo, tremor, paresthesias, tonic-clonic seizures and minor epileptic seizures.

VIight organ disorders: mydriasis, bilateral blindness.

Cardiac disorders: palpitations, tachycardia, atrial behemia.

Vascular disorders: arterial hypotension.

Respiratory system, chest and mediastinum disorders: dyspnea, cough, 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 site of administration: general malaise, generalized edema, asthenia.

Overdose

Symptoms: nausea, abdominal pain.

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

Pregnancy use

Levopront is contraindicated in pregnancy and during breastfeeding.