Ambroxol Hydrochloride Sustained-Release Capsules (Mucosolvan) are a commonly used expectorant in clinical practice, indicated for the treatment of acute and chronic bronchopulmonary diseases, especially in patients with abnormal sputum secretion or impaired mucus clearance.
I. Basic Drug Information and Mechanism of Action
1. Active Ingredient and Dosage Form
Each capsule contains 75 mg of ambroxol hydrochloride. As a sustained-release formulation, it requires only once-daily administration and can maintain a stable plasma drug concentration over an extended period.
2. Pharmacological Effects
Ambroxol promotes respiratory tract sputum excretion through multiple pathways:
it enhances respiratory secretory function, stimulates the synthesis of pulmonary surfactant, and accelerates ciliary movement, thereby improving mucociliary clearance and making sputum easier to expectorate.
3. Pharmacokinetic Characteristics
(1) Rapid and complete oral absorption; plasma protein binding rate is approximately 90%, with the highest concentration detected in lung tissue.
(2) Primarily metabolized by the liver and excreted by the kidneys; the elimination half-life is about 10 hours.
(3) Age, gender, and food do not affect its pharmacokinetics. Plasma concentrations may increase in patients with hepatic dysfunction, but dose adjustment is generally not required.
II. Drug Interactions and Use in Special Populations
1. Drug Interactions
No clinically significant adverse interactions have been reported to date. It can be used in combination with other medications.
2. Pregnant and Lactating Women
(1) Ambroxol hydrochloride crosses the placental barrier and is excreted in breast milk.
(2) Although no clear evidence shows harm to the fetus or infant, use is not recommended for pregnant women (especially during the first trimester) and lactating women.
3. Patients with Hepatic and Renal Impairment
Plasma concentrations may increase in patients with hepatic impairment, but dose adjustment is generally unnecessary;
patients with renal impairment should use this product under medical supervision.
III. Precautions and Adverse Reactions
1. Dosage and Administration
(1) For adults: one capsule once daily. The capsule should be swallowed whole; do not chew or open it.
(2) Indicated for patients with acute or chronic bronchopulmonary diseases accompanied by impaired sputum excretion.
2. Contraindications and Cautions
Contraindicated in patients hypersensitive to ambroxol hydrochloride or any ingredient in the formulation.
Patients with certain rare inherited diseases (e.g., lactose intolerance) should also avoid use.
3. Important Warnings
(1) Rare cases of severe skin reactions have been reported, such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
(2) If new skin or mucosal lesions occur during treatment, discontinue use immediately and seek medical attention.
4. Common Adverse Reactions
Mainly include gastrointestinal discomfort (e.g., dyspepsia, nausea, diarrhea) and allergic reactions (e.g., rash, urticaria).
These reactions are generally mild and resolve after drug discontinuation.
5. Management of Overdose
No specific overdose symptoms have been reported. In case of accidental ingestion, symptomatic treatment should be given based on known side effects, and medical attention should be sought promptly.
