Sedobroxol for Treatment of respiratory disorders associated with viscid or excessive mucus

 
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Sedobroxol  Syrup

Composition:

Each 5 ml of oral syrup contains:
Active ingredient:
Ambroxol hydrochloride 15 mg
Inactive ingredients:
Sorbitol 70%, sodium benzoate, citric acid monohydrate, tutti fruitti flavour, purified water.

Pharmacological properties:

– Sedobroxol is a systemically active mucoly1ic agent.
– Following oral administration, onset of action occurs after about 30 minutes.
– the breakdown of acid mucopolysaccharide fibers makes the sputum thinner and less viscous and therefore more easily removed by coughing.
– Although sputum volume eventually decreases, its viscosity remains low for as long as treatment is maintained.

Indications:

Treatment of respiratory disorders associated with viscid or excessive mucus (wet or productive cough): e.g. Tracheobronchitis, emphysema with bronchitis, pneumoconiosis, chronic inflammatory pulmonary conditions, bronchiectasis, bronchitis with bronchospasm
asthma.
N.B:
During acute exacerabations of bronchitis, Sedobroxol should be given with the appropriate antibiotic.

Contra-indication:

Patients with hypersensitivity to the active ingredient (ambroxol hydrochloride), or to bromhexine, orto any ofthe ingredients in the formulation.

Side Effects:

Occasional mild gastro-intestinal irritation and discomfort (e.g. Diarrhea, abdominal fullness, and nausea).
Allergic reactions, primarily skin rashes, occur rarely.

Precautions and warnings:

– Relative caution should be observed in patients with history of gastric or peptic ulceration.
– Use of Sedobroxol therapy is not recommended during the first trimester of pregnancy and breast-feeding mothers.

Dosage and Adminstration:0

Sedobroxol should be administered immediately after meals.
(One teaspoonful=5 ml).
Unless otherwise prescribed by a physician:
Adults, children (over 12 years old):
10 ml (two teaspoonfuls), to be administered 3 times daily.
Children:
Children 7-12 years old: 5 ml (one teaspoonful) 2-3 times daily.
Children 3 -6 years old : 2.5 ml (half a teaspoonful) 3 times daily.
Children 1-2 years old : 2.5 ml (half a teaspoonful) twice daily.

Drug interactions:

Antibiotic concentrations (arnoxicillin, cefuroxime, and erythromycin) in bronchopulmonary secretions and in the sputum are increased with concomitant administration of Sedobroxol .

Storage:

-.Keep at temperature not exceeding 30′ C.
– Keep out of reach and sight of children.

Pack:

Carton box containing amber glass bottle of 60 ml or 120 ml of syrup solution closed with aluminum cap and with insert leaflet.

Produced by :

South Egypt Drug Industries Company ” SEDICO”
6 October City – Egypt

سيدوبروكسول لعلاج اختلالات الجهاز التنفسى المصحوبة بمخاط لزج كثيف

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