Composition:

Each Mucotec capsule contains 150 mg or 300 mg Erdosteine.

Pharmacodynamics:

Mucotec, Erdosteine, is a thiol derivative with mucolytic, muco-modulator, antibacterial, anti-inflammatory & antioxidant properties.

It contains 2 blocked sulfhydryl groups which are released following first-pass metabolism.  

The 3 active metabolites exhibit mucolytic & free radical scavenging activity.

Erdosteine modulates mucus production & viscosity & increases Mucocilliary transport, thereby, improving expectoration.

It also exhibits inhibitory activity against the effects of free radical produced by cigarette smoking.

Co-administration of Erdosteine & antibiotics in patients with acute infective exacerbation of chronic bronchitis resulted in higher concentrations of the antibiotic in the sputum, leading to earlier & more pronounced amelioration of clinical symptoms compared with placebo.

Pharmacokinetics:

Erdosteine is rapidly absorbed after oral administration.

T-max is 1.2 hours.

Erdosteine is metabolized in the liver into 3 active metabolites eliminated by the kidney.

Elimination half-life of Erdosteine & its 3 metabolites is short (1 to 3 hours).

Food modify the pharmacokinetic parameters.

Therapeutic Indications:

Treatment of patients with acute or chronic bronchopulmonary diseases (such as bronchitis, rhinitis, sinusitis, laryngo-pharyngitis, & exacerbation of chronic diseases), associated with mucus production & transport.

Preventive treatment of stable chronic bronchitis in smoking subjects, in recurrent episodes during winter season & related conditions.

Co-treatment with antibiotics in case of exacerbation with bacterial infections.

Dosage and Administration:

Two capsules of Mucotec 150 mg to be taken twice daily.

One capsule of Mucotec 300 mg to be taken twice daily.

Precautions:

Gastrointestinal ulcers.

Pregnancy: Avoid as its safety in human is not yet established, although, no teratogenic effects are observed in animal studies.

Lactation: Avoid as there is no evidence of its passage in breast-milk.

Contraindications:

Known hypersensitivity reactions to erdosteine.

Severe hepatic & renal insufficiency.

Adverse Reactions:

Low incidence of adverse effects, most of which are gastrointestinal disturbances.

Presentation & Storage:

Mucotec 150 mg capsules are supplied in boxes of 20 capsules each.

Mucotec 300 mg capsules are supplied in boxes of 20 capsules each.

Store at a room temperature away from humidity.