Mucopect/Mucopect Retard

Mucopect/Mucopect Retard

ambroxol

Manufacturer:

PT. Aventis Pharma
Full Prescribing Info
Contents
Ambroxol HCl.
Description
Ambroxol HCl is trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride.
Action
Ambroxol is a mucolytic agent, which is able to ease the thick and sticky fluid secretion from the respiratory tract.
Preclinically, ambroxol has been shown to increase respiratory tract secretion. Ambroxol is a mucolytic which acts to liquefy respiratory tract secretion by enhancing pulmonary surfactant production and stimulates ciliary activity. These actions result in improved mucus flow and transport (mucociliary clearance). Enhancement of fluid secretion and mucociliary clearance facilitates expectoration and eases cough.
Indications/Uses
Secretolytic therapy in acute and chronic bronchopulmonary diseases associated with abnormal mucus secretion and impaired mucus transport.
Dosage/Direction for Use
The dosage recommendations for children are based on a total daily dose of 1.2-1.6 mg/kg body weight.
Mucopect: Tablet: Adults and Children >12 years: 1 tab 2-3 times daily. Children 6-12 years: ½ tab 2-3 times daily.
Syrup 15 mg/5 mL (1 tsp=5 mL): Children 6-12 years: 5 mL (1 tsp) 2-3 times daily; 2-6 years: 2.5 mL (½ tsp) 3 times daily; <2 years: 2.5 mL (½ tsp) 2 times daily. 30 mg/5 mL (1 tsp=5 mL): Adults and Children >12 years: 5 mL (1 tsp) 2-3 times daily. Children 6-12 years: 2.5 mL (½ tsp) 2-3 times daily.
Drops 7.5 mg/mL (1 mL=20 drops): Children ≤2 years: 0.5 mL (10 drops) 2 times daily.
Mucopect drops is recommended to be taken with meals possibly diluted with tea, fruit, milk or water.
Mucopect Retard: Adults: 1 retard cap daily, either in the morning or evening after a meal. The capsules should not be opened or chewed, but swallowed whole with ample liquid. The "carrier tablets" which are occasionally present in the stools have released the active substance during their passage through the digestive system and are therefore without significance.
Overdosage
No symptoms of overdosage have been reported in man to date. If they occur, symptomatic treatment should be provided.
Contraindications
Patients known to be hypersensitive to ambroxol or other components of Mucopect/Mucopect Retard.
Special Precautions
Use with caution in patients who have renal and hepatic dysfunction. In some cases of renal insufficiency, accumulation of ambroxol metabolites takes place in the liver.
Effects on the Ability to Drive or Operate Machinery: It is not known whether ambroxol has an impact in the ability to drive or operate machinery.
Use in pregnancy & lactation: Ambroxol can be administered during pregnancy (especially in the 1st trimester) and lactation only after careful risk/benefit assessment. Administration during pregnancy and lactation still needs further research. Ambroxol should not be used in the long term without physician's advice/consultation.
Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the 1st trimester, should be observed.
The drug enters breast milk; as with any drug, Mucopect/Mucopect Retard should only be used after careful risk/benefit assessment.
Use in children: Mucopect Retard is not suitable for children.
Use In Pregnancy & Lactation
Ambroxol can be administered during pregnancy (especially in the 1st trimester) and lactation only after careful risk/benefit assessment. Administration during pregnancy and lactation still needs further research. Ambroxol should not be used in the long term without physician's advice/consultation.
Nonetheless, the usual precautions regarding the use of drugs during pregnancy, especially during the 1st trimester, should be observed.
The drug enters breast milk; as with any drug, Mucopect/Mucopect Retard should only be used after careful risk/benefit assessment.
Side Effects
Intolerance reactions after ambroxol administration have been reported in rare cases.
Mild gastrointestinal side effects have been reported in some patients.
Allergic reactions have been reported in rare cases and some of these patients have also shown allergic reactions to other substances. Some of the allergic reactions are: Skin rashes, swelling of the face, dyspnea, fever.
Drug Interactions
Administration of ambroxol together with antibiotics (amoxicillin, erythromycin, doxycycline) leads to higher antibiotic concentration in the lung tissue.
No clinically relevant unfavorable interaction with other medications has been reported.
Storage
Store in a cool and dry place. Protect from light.
ATC Classification
R05CB06 - ambroxol ; Belongs to the class of mucolytics. Used in the treatment of wet cough.
Presentation/Packing
Mucopect: Tab 30 mg x 10 x 10's. Syr 15 mg/5 mL x 60 mL x 1's. 30 mg/5 mL x 60 mL x 1's. Drops 7.5 mg/mL x 20 mL x 1's.
Mucopect Retard: Cap 75 mg x 5 x 10's.
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