Ascoril Mono (Tablets) Instructions for Use

Marketing Authorization Holder

Glenmark Impex, LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

ATC Code

R05CB02 (Bromhexine)

Active Substance

Bromhexine (Rec.INN registered by WHO)

Dosage Form

Ascoril Mono

Tablets 4 mg: 10, 20, 25, 30, 40, 50, 60, 75, 80, 90, 100, 120, 125, 150, 160, 200, 250, 300, 400, or 500 pcs.

Dosage Form, Packaging, and Composition

Tablets white or almost white, round, flat-cylindrical, with a bevel and a score line.

Excipients : lactose monohydrate (milk sugar) – 80.23 mg, corn starch – 11.54 mg, povidone K25 – 3.46 mg, magnesium stearate – 0.77 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – contour cell packs (1) – cardboard packs.
20 pcs. – contour cell packs (2) – cardboard packs.
20 pcs. – contour cell packs (3) – cardboard packs.
20 pcs. – contour cell packs (4) – cardboard packs.
20 pcs. – contour cell packs (5) – cardboard packs.
20 pcs. – contour cell packs (10) – cardboard packs.
25 pcs. – contour cell packs (1) – cardboard packs.
25 pcs. – contour cell packs (2) – cardboard packs.
25 pcs. – contour cell packs (3) – cardboard packs.
25 pcs. – contour cell packs (4) – cardboard packs.
25 pcs. – contour cell packs (5) – cardboard packs.
25 pcs. – contour cell packs (10) – cardboard packs.
30 pcs. – contour cell packs (1) – cardboard packs.
30 pcs. – contour cell packs (2) – cardboard packs.
30 pcs. – contour cell packs (3) – cardboard packs.
30 pcs. – contour cell packs (4) – cardboard packs.
30 pcs. – contour cell packs (5) – cardboard packs.
30 pcs. – contour cell packs (10) – cardboard packs.
40 pcs. – contour cell packs (1) – cardboard packs.
40 pcs. – contour cell packs (2) – cardboard packs.
40 pcs. – contour cell packs (3) – cardboard packs.
40 pcs. – contour cell packs (4) – cardboard packs.
40 pcs. – contour cell packs (5) – cardboard packs.
40 pcs. – contour cell packs (10) – cardboard packs.
50 pcs. – contour cell packs (1) – cardboard packs.
50 pcs. – contour cell packs (2) – cardboard packs.
50 pcs. – contour cell packs (3) – cardboard packs.
50 pcs. – contour cell packs (4) – cardboard packs.
50 pcs. – contour cell packs (5) – cardboard packs.
50 pcs. – contour cell packs (10) – cardboard packs.

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Group

Mucolytic expectorant

Pharmacological Action

Mucolytic agent with expectorant action. It reduces the viscosity of bronchial secretions by depolarizing the acidic polysaccharides contained in it and by stimulating the secretory cells of the bronchial mucosa that produce secretions containing neutral polysaccharides.

It is believed that Bromhexine promotes the formation of surfactant.

Pharmacokinetics

Bromhexine is rapidly absorbed from the gastrointestinal tract and undergoes intensive metabolism during the first pass through the liver. Bioavailability is about 20%. In healthy patients, C_max in plasma is determined after 1 hour.

It is widely distributed in body tissues. About 85-90% is excreted in the urine, mainly in the form of metabolites. The metabolite of bromhexine is ambroxol.

The binding of bromhexine to plasma proteins is high. T_1/2 in the terminal phase is about 12 hours.

Bromhexine penetrates the blood-brain barrier. It penetrates the placental barrier in small amounts.

Only small amounts are excreted in the urine with a T_1/2 of 6.5 hours.

The clearance of bromhexine or its metabolites may be reduced in patients with severe hepatic and renal impairment.

Indications

Diseases of the respiratory tract accompanied by the formation of difficult-to-separate viscous secretions: tracheobronchitis, chronic bronchitis with a broncho-obstructive component, bronchial asthma, cystic fibrosis, chronic pneumonia.

ICD codes

Dosage Regimen

Orally for adults and children over 10 years old – 8 mg 3-4 times/day. For children under 2 years old – 2 mg 3 times/day; for children aged 2 to 6 years – 4 mg 3 times/day; for children aged 6 to 10 years – 6-8 mg 3 times/day. If necessary, the dose can be increased for adults to 16 mg 4 times/day, for children – to 16 mg 2 times/day.

By inhalation for adults – 8 mg, for children over 10 years old – 4 mg, for children aged 6-10 years – 2 mg. For children under 6 years old – used in doses up to 2 mg. Inhalations are performed 2 times/day.

The therapeutic effect may appear on the 4th-6th day of treatment.

Parenteral administration is recommended for treatment in severe cases, as well as in the postoperative period to prevent the accumulation of thick sputum in the bronchi. Administer 2 mg subcutaneously, intramuscularly or intravenously 2-3 times/day slowly over 2-3 minutes.

Adverse Reactions

From the digestive system: dyspeptic phenomena, transient increase in the activity of hepatic transaminases in the blood serum.

From the central nervous system: headache, dizziness.

Dermatological reactions: increased sweating, skin rash.

From the respiratory system: cough, bronchospasm.

Contraindications

Hypersensitivity to bromhexine.

Use in Pregnancy and Lactation

Contraindicated in the first trimester of pregnancy. Use in the second and third trimesters of pregnancy and during breastfeeding is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or infant.

Use in Hepatic Impairment

Should be used with caution in patients with impaired liver function.

Use in Renal Impairment

Should be used with caution in patients with impaired renal function.

Pediatric Use

Use with caution in children – according to indications, in age-appropriate recommended doses and dosage forms.

Special Precautions

In case of gastric ulcer, as well as with a history of gastric bleeding, Bromhexine should be used under medical supervision.

Use with caution in patients suffering from bronchial asthma.

Bromhexine should not be used simultaneously with medicines containing codeine, as this makes it difficult to cough up liquefied sputum.

It is used as part of combined herbal preparations with essential oils (including eucalyptus oil, anise oil, peppermint oil, menthol).

Drug Interactions

Bromhexine is incompatible with alkaline solutions.

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.