5. DOSAGE AND ADMINISTRATION:
Administration:
Taken orally after meals. Can be used directly or mixed with water. Shake well before use.
Dosage:
Adults and children over 12 years: 10 ml × 3 times/day
Children 6 to 12 years: 5 ml × 2–3 times/day
Children 2 to 5 years: 2.5 ml × 3 times/day
Children under 2 years: 2.5 ml × 2 times/day
Take the medication with plenty of water.
6. PHARMACODYNAMICS:
Ambroxol is a metabolite of Bromhexine and has similar effects and uses.
It is considered an expectorant and mucolytic agent, though its effectiveness has not been fully proven.
Some studies suggest that Ambroxol improves symptoms and reduces acute exacerbations in bronchitis.
Recent studies indicate that the drug is effective in patients with mild to moderate airway obstruction but has no significant benefits for those with severe COPD.
7. PHARMACOKINETICS:
Ambroxol is rapidly and almost completely absorbed at therapeutic doses.
Peak plasma concentrations are reached within 0.5–3 hours after administration.
The drug is approximately 90% bound to plasma proteins.
It quickly distributes from the bloodstream to tissues, with the highest concentration found in the lungs.
About 30% of the oral dose undergoes first-pass metabolism.
Ambroxol is primarily metabolized in the liver, and approximately 90% of the drug is excreted via the kidneys.
8. CONTRAINDICATIONS:
Do not use Amcosol for children under 5 years old.
Do not use in individuals allergic to Ambroxol hydrochloride or any component of the medication.
Since oral administration of Amcosol may cause mild gastrointestinal irritation, it should be avoided in individuals with active peptic ulcer disease.
9. SIDE EFFECTS:
Possible adverse effects include nausea, vomiting, abdominal pain, bloating, heartburn, indigestion, and mild gastrointestinal irritation.
In some cases, skin reactions such as rash, hives, and irritation may occur.
Rare side effects include elevated transaminase enzymes and increased risk of tooth decay due to dry mouth.
If any of these side effects occur, or if other unusual symptoms develop, consult a doctor immediately to adjust the dosage or discontinue use if necessary. Severe symptoms require immediate medical attention.
Report any adverse effects to a healthcare provider.
10. PRECAUTIONS:
General Warnings:
Caution is advised in individuals with peptic ulcers, as Ambroxol hydrochloride has been found to dissolve fibrin clots, potentially increasing the risk of gastrointestinal bleeding.
No studies have assessed the effects of this drug on driving and operating machinery; consult a doctor before use in such cases.
Use in Pregnant and Breastfeeding Women:
There are no specific studies on the effects of this drug on fetal development or its excretion in breast milk. Pregnant and breastfeeding women should only use this medication if prescribed by a doctor and if absolutely necessary.
11. DRUG INTERACTIONS:
Amcosol may interact with antibiotics such as Amoxicillin, Erythromycin, and Cefuroxime, significantly increasing their concentrations in lung tissue, which may affect the body.
Do not take antibiotics or any other medication alongside Amcosol without consulting a doctor to ensure safe and effective use and to prevent unwanted side effects.
12. STORAGE:
Store in a cool, dry place. Avoid direct sunlight and high temperatures.
13. SHELF LIFE:
36 months from the manufacturing date.
Developed by: Audace Pharma Co., Ltd
