Profitus^® (Solution) Instructions for Use

Marketing Authorization Holder

Pik-Pharma, LLC (Russia)

Manufactured By

Pik-Pharma Lek, LLC (Russia)

ATC Code

R05DB27 (Levodropropizine)

Active Substance

Levodropropizine (Rec.INN registered by WHO)

Dosage Form

Profitus®

Oral solution 6 mg/ml

Dosage Form, Packaging, and Composition

Oral solution

100 ml – bottles – cardboard packs /with a measuring cup/ – Over-the-counter

Clinical-Pharmacological Group

Antitussive drug

Pharmacotherapeutic Group

Drugs used for cough and colds; antitussives, excluding combinations with expectorants; other antitussives

Pharmacological Action

Antitussive agent. The antitussive activity is due to a peripheral action on the tracheobronchial tree.

The mechanism of the antitussive action of levodropropizine involves slowing the transmission of nerve impulses within C-fibers, suppressing the release of neuropeptide sensors from C-fibers in vitro.

Levodropropizine does not cause depression of the respiratory center and does not affect mucociliary clearance in humans.

In patients with chronic respiratory failure, Levodropropizine does not have a suppressive effect on the respiratory system, both during spontaneous breathing and during hypercapnic ventilation.

Pharmacokinetics

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

The bioavailability of levodropropizine when taken orally is more than 75%.

Plasma protein binding is insignificant (11-14%).

T_1/2 is 1-2 hours.

It is excreted by the kidneys both unchanged and in the form of metabolites (conjugated Levodropropizine and conjugated p-hydroxylevodropropizine).

After 48 hours, the renal excretion of levodropropizine and the above metabolites is about 35%.

No changes in its pharmacokinetic parameters or accumulation were noted with repeated administration of levodropropizine.

Indications

Symptomatic treatment of dry, non-productive cough (including in pharyngitis, laryngitis, acute tracheitis and tracheobronchitis, influenza, bronchopneumonia, chronic obstructive bronchitis, bronchial asthma, pulmonary emphysema, allergic and infectious-inflammatory diseases of the respiratory tract).

ICD codes

Dosage Regimen

Administer orally.

Use the provided measuring cup for accurate dosing.

Shake the bottle well before each use.

Adhere to a minimum 6-hour interval between doses.

Do not exceed three administrations per day.

For adults and children over 14 years, administer 60 mg (10 ml) per dose.

For children aged 6 to 14 years, administer 36 mg (6 ml) per dose.

For children aged 2 to 5 years, administer 18 mg (3 ml) per dose.

Dosing for children under 2 years is contraindicated.

Adjust dosage based on body weight within the specified single-dose range of 18-60 mg.

Limit the total duration of treatment to a maximum of 7 days.

Discontinue use if cough persists beyond this period and consult a physician.

Exercise caution in patients with severe renal impairment (creatinine clearance less than 35 ml/min).

Exercise caution in patients with severe hepatic impairment.

Exercise caution in elderly patients and those concurrently using sedatives.

Adverse Reactions

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

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

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

Eye disorders: mydriasis, bilateral blindness.

Cardiovascular disorders: palpitations, tachycardia, atrial bigeminy, arterial hypotension.

Respiratory disorders: shortness of breath, cough, airway edema.

Gastrointestinal disorders: stomach pain, abdominal pain, nausea, vomiting, diarrhea, glossitis, aphthous stomatitis.

Hepatobiliary disorders: cholestatic hepatitis.

Metabolism and nutrition disorders: hypoglycemic coma.

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

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

General disorders: general malaise, generalized edema, asthenia.

Contraindications

Hypersensitivity to levodropropizine; diseases associated with bronchial hypersecretion; reduced mucociliary function (Kartagener’s syndrome, ciliary dyskinesia); pregnancy, breastfeeding period; children under 2 years of age.

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

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Use with caution in patients with severe hepatic impairment.

Use in Renal Impairment

Use with caution in patients with severe renal failure (creatinine clearance less than 35 ml/min).

Pediatric Use

Contraindicated for use in children under 2 years of age.

Geriatric Use

Use with caution in elderly patients.

Special Precautions

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

Effect on ability to drive vehicles and operate machinery

Should be used with caution in patients engaged in potentially hazardous activities requiring high speed of psychomotor reactions.

Drug Interactions

Levodropropizine does not enhance the pharmacological effect of drugs acting on the central nervous system (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, a depressant effect on the central nervous system is possible with the simultaneous use of levodropropizine with sedatives.

Clinical studies have not demonstrated any interactions with drugs used in the treatment of bronchopulmonary diseases, such as beta₂-adrenergic agonists, methylxanthines and their derivatives, corticosteroids, antibiotics, mucolytic and antihistamine agents.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.