Ambolyt-SR
Generic Name
Ambroxol Hydrochloride (Sustained Release)
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| ambolyt sr 75 mg capsule | ৳ 5.50 | ৳ 55.00 |
Description
Overview of the medicine
Ambolyt-SR 75 mg capsule contains Ambroxol Hydrochloride in a sustained-release formulation. It is used to thin and loosen mucus in the airways, making it easier to clear from the lungs, and is indicated for various respiratory conditions involving excessive mucus production.
Uses & Indications
Dosage
Adults
One Ambolyt-SR 75 mg capsule once daily.
Elderly
No special dosage adjustment is required for elderly patients.
Renal_impairment
In cases of severe renal impairment, the dosage frequency may need to be reduced or the dose decreased based on clinical judgment.
How to Take
Swallow the capsule whole with water, do not chew or crush. It can be taken with or without food.
Mechanism of Action
Ambroxol acts as a mucolytic by increasing serous mucus secretion in the respiratory tract, reducing mucus viscosity, and activating the mucociliary clearance mechanism. It also stimulates surfactant production by pneumocytes, which helps maintain alveolar stability and facilitates mucus transport.
Pharmacokinetics
Onset
Onset of action typically within 30 minutes to 2 hours.
Excretion
Mainly excreted renally (approximately 90%), with a small amount excreted in feces. Less than 10% is excreted unchanged.
Half life
Plasma half-life is about 7-12 hours for ambroxol; the sustained-release form ensures a prolonged therapeutic effect over 24 hours.
Absorption
Rapidly and completely absorbed from the gastrointestinal tract following oral administration. Sustained-release formulation ensures prolonged absorption.
Metabolism
Primarily metabolized in the liver, mainly by conjugation to form inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to Ambroxol or any component of the formulation.
- Patients with known severe allergic reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) to mucolytic agents, although these are rare with ambroxol.
Drug Interactions
Antibiotics (e.g., Amoxicillin, Cefuroxime, Erythromycin, Doxycycline)
Ambroxol can enhance the penetration of these antibiotics into bronchial secretions, potentially improving their therapeutic effect.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, diarrhea, and abdominal pain. Treatment is symptomatic and supportive. Gastric lavage and induced emesis are generally not necessary.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy, especially during the first trimester, should be avoided unless clearly necessary and the potential benefits outweigh the risks. Ambroxol is excreted in breast milk; therefore, it is generally not recommended during lactation.
Side Effects
Contraindications
- Hypersensitivity to Ambroxol or any component of the formulation.
- Patients with known severe allergic reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) to mucolytic agents, although these are rare with ambroxol.
Drug Interactions
Antibiotics (e.g., Amoxicillin, Cefuroxime, Erythromycin, Doxycycline)
Ambroxol can enhance the penetration of these antibiotics into bronchial secretions, potentially improving their therapeutic effect.
Storage
Store in a cool and dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include nausea, vomiting, diarrhea, and abdominal pain. Treatment is symptomatic and supportive. Gastric lavage and induced emesis are generally not necessary.
Pregnancy & Lactation
Pregnancy Category C. Use in pregnancy, especially during the first trimester, should be avoided unless clearly necessary and the potential benefits outweigh the risks. Ambroxol is excreted in breast milk; therefore, it is generally not recommended during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 36 months from the date of manufacture, specific to batch.
Availability
Available in pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Off-patent (Generic available)
Clinical Trials
Ambroxol has been extensively studied in clinical trials demonstrating its efficacy and safety as a mucolytic agent across various respiratory conditions.
Lab Monitoring
- No specific routine lab monitoring is required for ambroxol.
Doctor Notes
- Advise patients to maintain adequate hydration to optimize mucolytic effect.
- Counsel patients on proper administration (swallowing whole, not crushing).
- Be aware of rare but serious skin reactions; instruct patients to discontinue and seek medical attention if these occur.
Patient Guidelines
- Take the capsule whole, do not chew or crush it.
- Drink plenty of fluids to help thin mucus.
- Report any severe skin reactions (e.g., rash, blisters) immediately to your doctor.
- Consult your doctor if symptoms do not improve after a few days.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Ambroxol is generally not expected to affect the ability to drive or operate machinery. However, if you experience side effects like dizziness, avoid such activities.
Lifestyle Advice
- Stay hydrated by drinking adequate fluids.
- Avoid smoking, as it irritates the respiratory tract and exacerbates mucus production.
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Global Brand Names
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