Acetylcistein
Effervescent instant
Composition:
Each sachet contains:
Active ingredient:
N-acetylcysteine 200 mg or 600 mg
Inactive ingredients for 200 mg:
Lactose 080, 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, allura red and flaver 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 I 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.
Contra indications :
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, oxalateor urate renal stones especially with acidic urine.
Warnings:
After proper administration of acetyl cysteine, an increased volume of liquefied bronchial secretionsmay 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 asway sftguld becleared by endotracheal aspiration, with or without bronchoscopy. Asthmatics under reatmet withacetylcysteine should be watched carefully. Most patients with bronchospasm are qUickly relievedby the use of bronchodilator given by nebulization. If bronchospam progresses, the medicationshould be discontinued immediately.
Drug Interactions:
Avoid concomitant administration (two hours interval) of the drug with the following:
• Tetracycline hydrochloride, antitussives and 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 cystine renal stones. Avoid diuretics or forced diuresis.
– Caution should be taken in patients who complain from hypertension, heart failure, renal disease,oedema, and 1 cases thaeneed salt restriction+-
Use during pregnancy and lactation:
Acetylcistein should only used if clearly needed due to lack of well – controlled studies.
Over dosage:
No particular symptoms of over dosage have been observed, treatment should be symptomatic and supportive.
Storage:
– Keep away from moisture & at temperature not exceeding 30 0 C.
– Keep medicine out of reach of children.
Package:
10 or 20 tetra laminated aluminum foil sachets packed in a carton box with a pamphlet.
Produced by:
South Egypt Drug Industries Company
SEDICO 6 October City – Egypt
