Zobrixol

Zobrixol

ambroxol

Manufacturer:

Natrapharm

Distributor:

Natrapharm
Full Prescribing Info
Contents
Ambroxol HCl.
Action
Ambroxol HCl is a secretolytic. It causes the formation of a qualitatively different mucus of lower viscosity by the mucus-secreting cells and thus leads to a liquefaction of the mucus in the lumen of the respiratory tract. Expectoration of mucus is facilitated and breathing is eased considerably.
Long-term use is possible because of the good tolerability of the preparation.
Pharmacokinetics: Zobrixol is completely absorbed after oral administration. It reaches maximum plasma concentration after 9-10 hrs. The therapeutically effective plasma levels are slightly higher than 30 mg/mL and can be achieved by 2 x 30 mg/day orally (minimum steady-state concentration approximately 50 mg/mL).
Zobrixol is changed into various inactive metabolites which are mainly eliminated as water-soluble conjugates. After oral administration, 85% of the active substance is eliminated in the urine. Less than 10% is eliminated in the form of unchanged ambroxol.
Indications/Uses
Acute and chronic disorders of the respiratory tract with pathologically increased mucus viscosity eg, acute and chronic bronchitis, asthmatoid bronchitis, bronchial asthma with disturbances of secretion elimination, bronchiectasis and to encourage elimination of phlegm during inflammation of the nasal cavity and throat.
Dosage/Direction for Use
Sustained-Release Capsule: Adults and Children >12 years: 1 cap once daily after meal with plenty of liquid (sufficient supply of liquid supports the expectorant effect of Zobrixol).
Zobrixol SR capsule is not suitable for children <12 years.
Tablet: Adults and Children >12 years: 1 tab thrice daily for the first 2-3 days and then 1 tab twice daily or ½ tab thrice daily. Children 6-12 years: ½ tab 2-3 times a day.
Syrup: Adults and Children >12 years: 10 mL thrice daily during the first 2-3 days, them 10 mL twice daily or 5 mL thrice daily. Children 6-12 years: 5 mL 2-3 times a day; 2-5 years: 2.5 mL 3 times a day; <2 years: 2.5 mL 2 times a day.
DS Syrup: Adults and Children >12 years: 5 mL thrice daily for 2-3 days then 5 mL twice daily for 2.5 mL thrice daily. Children 6-12 years: 2.5 mL 2-3 times a day.
Infant Drops: Children 13-24 months: 1.25 mL twice a day; 7-12 months: 1 mL twice a day; ≤6 months: 0.5 mL twice a day.
Contraindications
Use in pregnancy: Although no evidence has been obtained (even at high dosage levels) of teratological activity, as with any preparation, administration is not recommended during the first 3 months of pregnancy.
Use In Pregnancy & Lactation
Use in pregnancy: Although no evidence has been obtained (even at high dosage levels) of teratological activity, as with any preparation, administration is not recommended during the first 3 months of pregnancy.
Adverse Reactions
Gastrointestinal disturbances, transient rise in serum aminotransferase. In rare cases, weakness, headache and skin rash.
Drug Interactions
Zobrixol should not be taken simultaneously with antitussives (eg, codeine), because it could lead to non-expectoration of phlegm or mucus previously liquefied by Zobrixol.
Storage
Store at room temperature 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
SR cap 75 mg x 50's. Tab 30 mg x 100's. Syrup 15 mg/5 mL x 60 mL, 120 mL. DS syrup 30 mg/5 mL x 60 mL. Infant oral drops 6 mg/mL x 15 mL.
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