Composition

Each sachet contains: Active ingredient:

• N-acetylcysteine 200 mg or 600 mg.

Inactive ingredients for 200 mg: Lactose D80, saccharin sodium, citric acid anhydrous, sodium bicarbonate, sodium carbonate and flavour lemon.

Inactive ingredients for 600 mg: Citric acid anhydrous, mannitol, sodium bicarbonate, sodium carbonate anhydrous, trimagnesium dicitrate anhydrous, saccharin sodium, aspartame, povidone k25, allure red and flavor blackberry.

Pharmacological Actions

N-acetylcysteine has a mucolytic action, which acts directly by splitting of the disulfide bonds of mucoproteins and thus reduces sputum viscosity and facilitates its expectoration by the tracheobronchial cilia.

N-acetylcysteine improves the pulmonary defense mechanism, phagocytic capacity of alveolar macrophages and so protects the lungs from inflammation via its direct anti-oxidant property and indirectly as a precursor in glutathione synthesis.

Pharmacokinetics

Following oral administration, acetylcistein is readily absorbed from the gastrointestinal tract with peak plasma concentration attained within 2 – 3 hours. Concentrations in the lung are similar to those in plasma and about 20 % of a dose is excreted in the urine daily .

Acetylcistein effervescent instant is a new pharmaceutical form that ensures rapid dissolution. maximal absorption, high bioavailability, perfectly calibrated dosage and optimum stability.

Indications

• Mucolytic therapy in cases associated with hyperviscous mucous secretions.
• Upper respiratory tract disorders e.g. Chronic sinusitis and secretory otitis media (glue ear).
• Bronchopulmonary diseases e.g. Bronchitis, asthmatic bronchitis, bronchiectasis, cystic fibrosis (mucoviscidosis), pneumonia, pneumoconiosis and emphysema .
• The routine cleansing of tracheostomy during anesthesia .
• Manifestations associated with smoking and exposure to other irritant inhalers .

Dosage & Administration

Administered orally under medical supervision, in a dose of adult: one sachet twice daily with meals.

Administration: dissolve the content of the sachet in a half glass of water to get a palatable effervescent solution and drunk immediately.

Contraindications

Hypersensitivity to the active ingredient or to any of the constituents. Acetylcistein is contraindicated for children under 2 years old.

Side effects

It is well-tolerated. Rarely in overdoses nausea, vomiting, diarrhea, stomatitis, heartburn, bronchospasms, angioedema, skin eruption, tachycardia, tinnitus and precipitation of cystine, oxalate or urate renal stones especially with acidic urine.

Warnings

After proper administration of acetylcysteine, an increased volume of liquefied bronchial secretions may occur. When cough is inadequate, the open airway must be maintained by mechanical  secretion if necessary.

When there is a mechanical block due to foreign body or local accumulation, the airway should be cleared by endotracheal aspiration, with or without bronchoscopy.

Asthmatics under treatment with , acetylcysteine should be watched carefully.

Most patients with bronchospasm are quickly relieved  by the use of bronchodilator given by nebulization. If bronchospam progresses, the medication should be discontinued immediately.

Drug Interactions

Avoid concomitant administration (two hours interval) of the drug with the following:

• tetracycline hydrochloride.
• antitussives.
• nitroglycerin.

Precautions

• Patients with a history of peptic ulcer, asthma or hyperoxaluria .
• Maintain fluid intake (6-8 glasses of water daily) to avoid formation of cystone renal stone.
• Avoid diuretics or forced diuresis.
• Caution should be taken in patients who complain from hypertension, heart failure, renal disease, oedema, and all cases that need salt restriction .

Use during pregnancy and lactation

Acetylcistein should only used if clearly needed due to lack of well-controlled studies.