AscoTusActive (Drops) Instructions for Use

Marketing Authorization Holder

Canonpharma Production, CJS (Russia)

Manufactured By

Grotex, LLC (Russia)

ATC Code

R05FB02 (Antitussive drugs in combination with expectorants)

Active Substances

Guaifenesin (Rec.INN registered by WHO)

Butamirate (Rec.INN registered by WHO)

Dosage Form

AscoTusActive

Oral drops 4 mg+100 mg/1 ml: 10 ml, 25 ml or 50 ml bottle with dropper.

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent or slightly opalescent, viscous liquid from yellow to yellowish-brown in color with a faint characteristic odor.

Excipients: flavoring forest berries 14669 – 2 mg, polysorbate 80 – 1 mg, ethanol (ethyl alcohol) 96% – 300 mg, dry licorice root extract – 0.6 mg, purified water – 7 mg, propylene glycol – up to 1 ml.

10 ml – dark glass bottles (1) with a dropper cap – cardboard packs.
25 ml – dark glass bottles (1) with a dropper cap – cardboard packs.
50 ml – dark glass bottles (1) with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

Antitussive drug with bronchodilator and expectorant action

Pharmacotherapeutic Group

Antitussive agent + expectorant agent

Pharmacological Action

Butamirate dihydrocitrate has a peripheral local anesthetic effect on the sensitive nerve endings of the bronchial mucosa, which provides an antitussive effect.

Guaifenesin increases the secretion of bronchial glands and reduces the viscosity of mucus.

The increase in secretion is due both to a direct effect on the bronchial glands – stimulation of secretion release from the bronchial glands and removal of acidic glycoproteins from acinar cells, and to a reflex pathway, when irritation of afferent parasympathetic fibers of the gastric mucosa and inhibition of the respiratory center occurs.

Increased tone of the n. vagus stimulates the production of bronchial secretion.

The mucus produced by the bronchial glands enhances the activity of the ciliated epithelium, thereby facilitating the evacuation of mucus from the bronchi and its expectoration.

Pharmacokinetics

When taken orally, butamirate dihydrocitrate is rapidly and completely absorbed from the gastrointestinal tract. Plasma protein binding is 94%.

It undergoes metabolism to form 2 metabolites, which also have antitussive activity.

T_1/2 is 6 hours.

Metabolites are excreted mainly (90%) in the urine and only a small part through the intestines.

Guaifenesin is rapidly absorbed from the gastrointestinal tract when taken orally. Plasma protein binding is insignificant.

It is rapidly metabolized to form inactive metabolites, which are excreted in the urine.

T_1/2 is 1 hour.

Indications

Dry, difficult-to-control cough of various etiologies; cough relief in the pre- and postoperative period.

ICD codes

Dosage Regimen

Administer orally. Select the dose based on the patient’s age and body weight.

For children from 6 months to 1 year (body weight up to 10 kg), administer 10 drops (approximately 0.5 ml) four times a day.

For children from 1 to 3 years (body weight 10-15 kg), administer 15 drops (approximately 0.75 ml) three times a day.

For children from 3 to 6 years (body weight 15-22 kg), administer 20 drops (approximately 1.0 ml) three times a day.

For children from 6 to 9 years (body weight 22-30 kg), administer 30 drops (approximately 1.5 ml) three times a day.

For children from 9 to 12 years (body weight 30-40 kg), administer 40 drops (approximately 2.0 ml) three times a day.

For adults and children over 12 years (body weight over 40 kg), administer 40 drops (approximately 2.0 ml) four times a day.

Use the supplied dropper for accurate measurement. Dilute the drops in a small amount of water (approximately 100 ml) before administration.

The maximum duration of treatment without medical consultation is 5 days.

Do not exceed the recommended dosage. If symptoms persist, consult a physician.

Adverse Reactions

Nervous system disorders common – dizziness, headache, drowsiness.

Gastrointestinal disorders common – nausea, vomiting, diarrhea, decreased appetite, stomach pain.

Urinary system disorders: very rare – urolithiasis.

Skin and subcutaneous tissue disorders: very rare – skin rash.

Allergic reactions very rare – urticaria.

Contraindications

Hypersensitivity to the active substances of the combination; myasthenia gravis; children under 6 months of age; first trimester of pregnancy.

Use in Pregnancy and Lactation

The use of the butamirate + Guaifenesin combination is contraindicated in the first trimester of pregnancy; this combination should be used with caution in the second and third trimesters of pregnancy.

The use of the butamirate + Guaifenesin combination during breastfeeding is possible in cases where the expected benefit to the mother outweighs the potential risk to the infant.

Pediatric Use

Contraindicated for use in children under 6 months of age.

Special Precautions

The butamirate + Guaifenesin combination should be used with caution in patients prone to drug dependence, with traumatic brain injury, liver disease, alcoholism, epilepsy, brain diseases, as well as in children and pregnant women (second and third trimesters) and breastfeeding women.

This combination should not be prescribed for productive cough in patients suffering from prolonged or chronic cough (including that caused by smoking), bronchitis or pulmonary emphysema.

During the course of treatment with the butamirate + Guaifenesin combination, alcohol consumption should be avoided.

Effect on the ability to drive vehicles and machinery

When using the butamirate + Guaifenesin combination, caution must be exercised when engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

Guaifenesin enhances the analgesic effect of paracetamol and acetylsalicylic acid; enhances the sedative effect of ethanol, hypnotics, sedatives and general anesthetics on the central nervous system; enhances the effect of muscle relaxants.

When determining the concentration of vanillylmandelic acid and 5-hydroxyindoleacetic acid using nitrosanaphthol as a reagent, falsely elevated results may be obtained.

Therefore, the use of the combination containing Guaifenesin should be discontinued 48 hours before urine collection for this analysis.

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.