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Products - Cough Preperation

Ambroxol HCl
ZOBRIXOL®

Formulation:

Each Tablet contains 30mg
Each 5mL Syrup contains 15mg
Each 5mL DS Syrup contains 30mg
Each mL Infant Drops contains 6mg
Each sustained-release capsule contains 75mg

Indication:

Respiratory tract disorders with pathologically Increased mucus viscosity, elimination of phlegm during inflammation of the nasal cavity and throat.

Dosage:

Average Daily Dose
(1.2-1.5mg/kg of body weight)

ZOBRIXOL Infant Drops:

6 months & below.................. 0.5mL 2 x a day
7-12 months............................ 1 mL 2 x a day
1-2 years old......................... 1.25mL 2 x a day

ZOBRIXOL 15mg/5mL Syrup:

2-4 years old..........................1/2 tsp. 3 x a day
5-10 years old...................... 1 tsp. 2-3 x a day

ZOBRIXOL 30mg/5mL DS Syrup:

10 years old and adults......... 1 tsp. 3 x a day

ZOBRIXOL 30mg Tablet:

Adults & children over 12 yrs. old...... 1 tab 3 x a day

ZOBRIXOL 75mg SR Capsule:

Adults and children over 12 yrs. old... 1 cap 1 x a day.

Presentation:

Tablet 30mg Ambroxol x 100's
SR capsule 75mg x 50's
Syrup 15/mg/5 mL x 60 mL, 120mL
DS syrup 30 mg/5mL x 60mL
Infant drops 6mg/mL x 15 mL

Therapeutic Class:

Anti-cough preparation

Actions:

Mucokinetic/secretolytic. Ambroxol HCl is a secretolytic. It causes the formation of qulaitatively different mucus of lower viscosity by the mucus-secreting cells leading to a liquefaction of 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:

Ambroxol HCl is completely absrobed after oral administration. It reaches maximum plasma concentration after 9-10 hours. The therapeutic effective plasma levels are slightly higher than 30ng/mL and can be achieved by 2 X 30 mg/day orally (minimum steady state concentration approximately 50ng/mL). Ambroxol 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 amboroxol.

Overdosage:

No symptoms of overdosage have been reported in man to date. Should they occur, symptomatic treatment should be provided.

Contraindication:

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.

Precaution:

Zobrixol should be given cautiously to patients with gastric ulceration.

Side Effects:

Gatrointestinal side effects may occur occasionally and a transient rise in serum aminotransferase has been reported.

Interaction:

Zobrixol should not be taken similutaneously with antitussives (eg. Codeine) because phlegm which has been liquefied by Zobrixol might not be expectorated.

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