Ubotrol

FORMULATIONS
Capsule: Each capsule contains:
Ambroxol HCI……………………………  30 mg

PHARMACOKINETICS
Ambroxol HCI is rapidly and completely absorbed after
oral administration and undergoes first pass metabolism
(bioavailability 70%). It reaches maximum plasma
concentration after 9-10 hours. The therapeutic
effective plasma levels are slightly higher than 30mg/ml
and can be reached by 2×30 mg/day orally (minimum
steady state concentration approximately 50mg/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 urine. Less than 10% is eliminated in the form of unchanged ambroxol. Ambroxol HCI is a mucolytic. It causes the formation of qualitatively different mucus of lower viscosity by the mucus-secreting cells leading to 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.

INDICATIONS
Ambroxol is indicated for respiratory tract disorders with pathologically increased mucus viscosity, elimination of phlegm during inflammation of the nasal cavity and throat.

DOSE AND ADMINISTRATION
Adults and children over 12 years:
1 capsule 3 times daily up to 14 days.
For children 6-12 years the following dosage regimen is recommended depending on severity of the disease.
1 capsule 2-3 times daily.
Ambroxol should be taken at mealtimes.
Ambroxol is not recommended for children under 2 years of age without medical advice.
The use of Ambroxol without medical supervision is not intended in patients who suffer from such  condition chronically.

Medical advice should be sought if the symptoms last longer than 14 days and/or if the symptoms increase in spite treatment with Ambroxol.