Advertisement
Advertisement
Sybron

Sybron

ambroxol

Manufacturer:

Medhaus

Distributor:

Medhaus
Full Prescribing Info
Contents
Ambroxol hydrochloride.
Description
Each 5 mL syrup contains: Ambroxol Hydrochloride 15 mg.
Each mL oral drops contains: Ambroxol Hydrochloride 6 mg.
Ambroxol Hydrochloride is a derivative of the mucolytic, Bromhexine, which has been found to posses secretolytic and mucokinetic properties. It acts by increasing the production of serum concentrations of the bronchial mucus-secreting glands in the respiratory tract. Through its pulmonary surfactant stimulating activity, Ambroxol Hydrochloride accelerates mucus transport, promoting expulsion of thick, tenacious secretions from the respiratory tract.
During treatment with Ambroxol Hydrochloride, chronically inflamed bronchial mucosa tend to return to normal. The patients cough and sputum volumes is reduced; expectoration is facilitated; and breathing is eased considerably.
The good tolerability of Ambroxol Hydrochloride permits its long-term use.
Indications/Uses
For treatment of acute and chronic diseases of the respiratory tract associated with abnormal bronchial secretions, particularly in exacerbations of chronic bronchitis, asthmatic bronchitis, and bronchial asthma.
Dosage/Direction for Use
Syrup: Daily dose of 60 to 120 mg in 2 to 3 divided doses by mouth or as prescribed by the physician.
Adult and Children over 10 years: 10 mL (2 teaspoonfuls) three times a day.
Children below 10 years: 6-10 years old: 5 mL (1 teaspoonful) three times a day;
2-5 years old: 2.5 mL (½ teaspoon) three times a day.
Or as prescribed by the physician.
Oral drops: Infant ≤1 yr: 0.5-1.25 mL three times a day. Or as prescribed by the physician.
Contraindications
Patient who has hypersensitivity to this drug or its components.
Special Precautions
Should be used with care in patients with a history of peptic ulceration.
Adverse Reactions
Ambroxol Hydrochloride is generally well tolerated. Occasional incidence of headache, polyuria, and fatigue has been reported. Also mild gastrointestinal disturbances such as nausea, vomiting, and diarrhea may occur.
Gastrointestinal: Occasionally mild upper gastrointestinal adverse events including dyspepsia, nausea, vomiting, heartburn, and dry mouth may occur. Rarely stomach upset, abdominal fullness, abdominal pain, diarrhea, constipation, anorexia, etc. may occur.
Hypersensitivity: Allergic reactions have been rarely reported such as skin rash and severe acute anaphylactoid reaction (including anaphylactic shock). Urticaria, urticarial erythema, itching, vascular edema, face swelling, dyspnea, chills, etc. may occur.
Respiratory: Suppurative rhinitis with leukocytosis may occur.
Neural: Occasionally paresthesia of the tongue and taste changes have been reported. Rarely oral paralysis and paralysis of arm may occur.
Drug Interactions
No report of drug interaction. Ambroxol Hydrochloride can be administered with other drugs, particularly the standard medication for bronchitis syndrome such as corticosteroids, bronchospasmolytics, diuretics, and antibiotics.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Cough & Cold Preparations
ATC Classification
R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Form
Sybron oral drops 6 mg/mL
Packing/Price
15 mL x 1's (P64/bottle)
Form
Sybron syr 15 mg/5 mL
Packing/Price
60 mL x 1's (P70/bottle)
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement