Zvezdochka Broncho (Solution) Instructions for Use

Marketing Authorization Holder

Vetprom, AD (Bulgaria)

ATC Code

R05CB06 (Ambroxol)

Active Substance

Ambroxol (Rec.INN registered by WHO)

Dosage Forms

	Zvezdochka Broncho	Oral solution 15 mg/5 ml: 120 ml bottle with a measuring cup
		Oral solution 30 mg/5 ml: 120 ml bottle with a measuring cup

Dosage Form, Packaging, and Composition

Oral solution as a light yellow, clear liquid, with a strawberry odor.

Excipients: citric acid monohydrate – 1 mg, sorbitol liquid 70% – 2250 mg, glycerol – 860 mg, methylparahydroxybenzoate – 6 mg, propylparahydroxybenzoate – 1.5 mg, propylene glycol – 150 mg, strawberry flavor – 2.5 mg, purified water – up to 5 ml.

120 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.

Oral solution as a light yellow, clear liquid, with a raspberry odor.

Excipients: citric acid monohydrate – 2 mg, sorbitol liquid 70% – 2250 mg, glycerol – 860 mg, methylparahydroxybenzoate – 6 mg, propylparahydroxybenzoate – 1.5 mg, propylene glycol – 150 mg, raspberry flavor – 2.5 mg, purified water – up to 5 ml.

120 ml – polyethylene terephthalate bottles (1) with a measuring cup – cardboard packs.

Clinical-Pharmacological Group

Mucolytic and expectorant drug

Pharmacotherapeutic Group

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

Pharmacological Action

Mucolytic and expectorant agent, is an active N-demethylated metabolite of bromhexine. It has secretomotor, secretolytic, and expectorant action. It stimulates the serous cells of the bronchial mucosa, increases the motor activity of the ciliated epithelium by acting on type 2 pneumocytes in the alveoli and Clara cells in the bronchioles, and enhances the production of endogenous surfactant, a surface-active substance that ensures the sliding of bronchial secretion in the airway lumen.

Ambroxol increases the proportion of the serous component in the bronchial secretion, improving its structure and contributing to a decrease in viscosity and liquefaction of sputum; as a result, mucociliary transport is improved and the removal of sputum from the bronchial tree is facilitated.

When Ambroxol is taken orally, the effect, on average, occurs after 30 minutes and lasts for 6-12 hours, depending on the single dose.

Pharmacokinetics

After oral administration, Ambroxol is rapidly and almost completely absorbed. T_max is 1-3 hours. Plasma protein binding is approximately 85%. It crosses the placental barrier and is excreted in breast milk. It is metabolized in the liver to form metabolites (dibromanthranilic acid, glucuronic conjugates), which are excreted by the kidneys. It is excreted mainly by the kidneys – 90% as metabolites, less than 10% unchanged. T_1/2 from plasma is 7-12 hours. T_1/2 of ambroxol and its metabolites is approximately 22 hours.

Due to high protein binding and large V_d, as well as slow back penetration from tissues into the blood, significant elimination of ambroxol does not occur during dialysis or forced diuresis. The clearance of ambroxol in patients with severe hepatic impairment is reduced by 20-40%. In severe renal failure, the T_1/2 of ambroxol metabolites increases.

Indications

Respiratory tract diseases accompanied by the production of viscous sputum and difficulty in expectoration: acute and chronic bronchitis; pneumonia; bronchial asthma; bronchiectasis; COPD.

ICD codes

Dosage Regimen

Administer the oral solution using the provided measuring cup. Adhere strictly to the prescribed concentration (15 mg/5 ml or 30 mg/5 ml) and dosage.

For adults and children over 12 years, take 30 mg (5 ml of the 30 mg/5 ml solution or 10 ml of the 15 mg/5 ml solution) three times daily.

For children from 6 to 12 years, administer 15 mg (5 ml of the 15 mg/5 ml solution) two to three times daily.

For children from 2 to 5 years, administer 7.5 mg (2.5 ml of the 15 mg/5 ml solution) three times daily. Treatment of children under 2 years must be conducted under strict medical supervision.

For children under 2 years, the recommended dose is 7.5 mg (2.5 ml of the 15 mg/5 ml solution) twice daily. Use in this age group only under direct medical supervision.

Take the dose after meals with a sufficient amount of water. Do not take the medication immediately before bedtime.

For acute conditions, the duration of therapy is typically 5 to 7 days. For chronic conditions, the duration is determined by the physician. Do not exceed the recommended daily dose.

In patients with severe renal or hepatic impairment, reduce the frequency of administration or increase the dosing interval as directed by a physician.

Adverse Reactions

Allergic reactions rarely – skin rash, urticaria, exanthema, facial edema, dyspnea, pruritus, fever; frequency unknown – anaphylactic reactions, including anaphylactic shock, angioedema, skin itching, allergic contact dermatitis.

From the digestive system often – nausea; infrequently – vomiting, diarrhea, dyspepsia, abdominal pain.

From the nervous system often – dysgeusia.

From the skin and subcutaneous tissues very rarely – toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome; frequency unknown – acute generalized exanthematous pustulosis.

From the respiratory system often – decreased sensitivity in the oral cavity or pharynx; rarely – dryness of the respiratory mucosa, rhinorrhea; in isolated cases – dryness of the pharyngeal mucosa.

Contraindications

Hypersensitivity to ambroxol or auxiliary components of the drugs; first trimester of pregnancy; lactation period (breastfeeding); children under 6 years of age (for tablets); children under 12 years of age (for prolonged-release dosage forms).

With caution

Impaired bronchial motility and increased mucus secretion (e.g., in the rare immotile cilia syndrome); renal failure and/or severe hepatic failure; gastric and duodenal ulcer (including history); second and third trimesters of pregnancy; children under 2 years of age (oral solution; only as prescribed by a doctor).

Use in Pregnancy and Lactation

Ambroxol is contraindicated in the first trimester of pregnancy. If necessary during the second and third trimesters, the potential benefit of therapy for the mother and the possible risk to the fetus should be assessed.

If it is necessary to use ambroxol during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Hepatic Impairment

Use with caution in severe hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal failure.

Pediatric Use

It can be used in children according to indications, in age-appropriate recommended doses and dosage forms. It is necessary to strictly follow the instructions in the ambroxol drug leaflets regarding contraindications for the use of specific ambroxol dosage forms in children of different ages.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Ambroxol should not be taken simultaneously with antitussive drugs that may inhibit the cough reflex, such as codeine, as this may hinder the removal of liquefied sputum from the bronchi.

Ambroxol should be used with caution in patients with a weakened cough reflex or impaired mucociliary transport due to the possibility of sputum accumulation.

Patients taking Ambroxol are not recommended to perform breathing exercises due to difficulty in expectoration. In patients in serious condition, aspiration of liquefied sputum should be performed.

Ambroxol should not be taken immediately before bedtime.

In patients with bronchial asthma, Ambroxol may intensify coughing.

In patients with severe skin lesions – Stevens-Johnson syndrome or toxic epidermal necrolysis – an influenza-like condition may be observed in the early phase: fever, body aches, rhinitis, cough, pharyngitis. With symptomatic therapy, mucolytic agents such as ambroxol hydrochloride may be erroneously prescribed.

Drug Interactions

Antitussives (e.g., codeine) – due to suppression of the cough reflex, accumulation of sputum in the airway lumen with difficulty in its removal is possible (simultaneous use is not recommended).

Amoxicillin, doxycycline, cefuroxime, erythromycin – increased penetration of antibiotics into the bronchial secretion.

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.