Romycin
Generic Name
Azithromycin
Manufacturer
Generic Manufacturer
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
romycin 500 mg tablet | ৳ 40.00 | ৳ 400.00 |
Description
Overview of the medicine
Azithromycin is a macrolide antibiotic used to treat a wide variety of bacterial infections, including respiratory tract infections, skin and soft tissue infections, and sexually transmitted diseases.
Uses & Indications
Dosage
Adults
For most infections: 500 mg once daily for 3 days OR 500 mg on Day 1, then 250 mg once daily for 4 days. For uncomplicated Chlamydia: 1 gram as a single dose.
Elderly
No specific dose adjustment is generally needed, but monitor renal and hepatic function.
Renal_impairment
No dose adjustment is needed for mild to moderate renal impairment. Use with caution in severe renal impairment (CrCl < 10 mL/min).
How to Take
Romycin 500 mg tablets can be taken orally with or without food. Taking it with food may help to reduce gastrointestinal upset.
Mechanism of Action
Azithromycin acts by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting microbial protein synthesis. This action is primarily bacteriostatic.
Pharmacokinetics
Onset
Peak plasma concentrations reached within 2-3 hours.
Excretion
Mainly excreted unchanged in bile and feces. A small percentage is excreted renally.
Half life
Terminal elimination half-life is 68-72 hours due to extensive tissue distribution and slow release.
Absorption
Rapidly absorbed after oral administration, with high bioavailability. Food may reduce Cmax but not overall absorption.
Metabolism
Partially metabolized in the liver, primarily via N-demethylation by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or any component of the formulation.
- History of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use.
Drug Interactions
Warfarin
Increased anticoagulant effect, monitor INR.
Nelfinavir
Increased serum concentrations of azithromycin, no dose adjustment needed for azithromycin.
Antacids (containing aluminum or magnesium)
May reduce peak serum concentrations of azithromycin; administer azithromycin at least 1 hour before or 2 hours after antacids.
QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, terfenadine)
Increased risk of QT prolongation and cardiac arrhythmias (including Torsades de Pointes).
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe nausea, vomiting, diarrhea, and reversible hearing loss. Management involves gastric lavage, general supportive measures, and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category B. Azithromycin should be used during pregnancy only if clearly needed. Excreted in breast milk, use with caution in nursing mothers and monitor infant for gastrointestinal symptoms like diarrhea, vomiting, or rash.
Side Effects
Contraindications
- Hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or any component of the formulation.
- History of cholestatic jaundice/hepatic dysfunction associated with prior azithromycin use.
Drug Interactions
Warfarin
Increased anticoagulant effect, monitor INR.
Nelfinavir
Increased serum concentrations of azithromycin, no dose adjustment needed for azithromycin.
Antacids (containing aluminum or magnesium)
May reduce peak serum concentrations of azithromycin; administer azithromycin at least 1 hour before or 2 hours after antacids.
QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, terfenadine)
Increased risk of QT prolongation and cardiac arrhythmias (including Torsades de Pointes).
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe nausea, vomiting, diarrhea, and reversible hearing loss. Management involves gastric lavage, general supportive measures, and symptomatic treatment.
Pregnancy & Lactation
Pregnancy Category B. Azithromycin should be used during pregnancy only if clearly needed. Excreted in breast milk, use with caution in nursing mothers and monitor infant for gastrointestinal symptoms like diarrhea, vomiting, or rash.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Generic available, original patent expired
WHO Essential Medicine
YesClinical Trials
Azithromycin has been extensively studied in numerous clinical trials demonstrating its efficacy and safety across various bacterial infections for which it is indicated.
Lab Monitoring
- Liver function tests (especially in patients with pre-existing hepatic impairment or during prolonged treatment)
- Renal function tests (for patients with severe renal impairment)
- Complete Blood Count (if therapy is prolonged or repeated)
Doctor Notes
- Counsel patients on the importance of completing the full course of therapy to prevent resistance and recurrence.
- Be aware of potential QT prolongation, especially in patients with known risk factors (e.g., pre-existing cardiac conditions, concurrent QT-prolonging drugs, electrolyte disturbances).
- Consider alternative antibiotics if a patient presents with symptoms of C. difficile-associated diarrhea (CDAD).
Patient Guidelines
- Complete the entire prescribed course of medication, even if symptoms improve, to prevent the development of antibiotic resistance.
- Do not share this medicine with others, even if they have similar symptoms.
- Inform your doctor about any other medications, supplements, or herbal products you are taking.
- Report any severe or persistent side effects to your healthcare provider immediately.
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 double doses.
Driving Precautions
Azithromycin may cause dizziness or visual disturbances in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good personal hygiene to prevent the spread and recurrence of infections.
- Avoid alcohol consumption during the treatment period as it may exacerbate gastrointestinal side effects.
- Stay hydrated by drinking plenty of fluids.
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