Azibact
Generic Name
Azithromycin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| azibact 200 mg suspension | ৳ 130.00 | N/A |
Description
Overview of the medicine
Azithromycin is a macrolide antibiotic used to treat various bacterial infections, including those of the respiratory tract, skin, and ears. This 200 mg/5 ml oral suspension is particularly suitable for pediatric use.
Uses & Indications
Dosage
Adults
For respiratory tract, skin & soft tissue infections: 500 mg (12.5 ml) as a single dose on day 1, followed by 250 mg (6.25 ml) once daily on days 2-5, or 500 mg (12.5 ml) once daily for 3 days. For Chlamydia: 1g (25 ml) as a single dose.
Elderly
Similar to adult dose. No specific dosage adjustment is recommended for elderly patients with normal renal and hepatic function, but monitoring is advised.
Renal_impairment
No dosage adjustment is needed for mild to moderate renal impairment (creatinine clearance >10 mL/min). Use with caution in severe renal impairment (creatinine clearance <10 mL/min).
How to Take
Shake the bottle well before each use. Administer orally using the provided measuring spoon or cup, with or without food. To reconstitute, add the specified amount of cooled boiled water to the powder and shake vigorously.
Mechanism of Action
Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby interfering with the translation of mRNA. This action is primarily bacteriostatic, but can be bactericidal at high concentrations.
Pharmacokinetics
Onset
Antibacterial effects typically begin within 2-3 hours after the first dose.
Excretion
Primarily excreted unchanged in the bile (about 50% of the dose) over several days. A small amount (about 6%) is excreted via urine.
Half life
The terminal plasma elimination half-life is long, ranging from 2 to 4 days, due to extensive tissue uptake and slow release.
Absorption
Rapidly absorbed from the gastrointestinal tract, with peak plasma concentrations occurring 2-3 hours post-dose. Bioavailability is approximately 37%.
Metabolism
Partially metabolized in the liver via N-demethylation to inactive metabolites. It is not significantly metabolized by the cytochrome P450 system.
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
Digoxin
May increase serum digoxin levels. Monitor digoxin levels if coadministered.
Antacids
Aluminum- and magnesium-containing antacids can reduce the peak plasma concentrations of azithromycin. Administer azithromycin at least 1 hour before or 2 hours after antacids.
Warfarin
Azithromycin may potentiate the effects of oral anticoagulants like warfarin, leading to increased bleeding risk. INR monitoring is recommended.
Nelfinavir
Coadministration with nelfinavir leads to increased azithromycin serum concentrations. No dosage adjustment of azithromycin is recommended.
Storage
Store the dry powder below 30°C in a dry place, protected from light and moisture. After reconstitution, store the suspension at room temperature (below 30°C) and do not freeze. Keep out of reach of children.
Overdose
Symptoms of azithromycin overdose may include severe nausea, vomiting, diarrhea, and reversible hearing loss. Management involves symptomatic and supportive care. Gastric lavage and general supportive measures may be necessary.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Azithromycin is excreted in breast milk; use with caution during lactation, considering the potential risks to the infant versus the benefits to the mother.
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
Digoxin
May increase serum digoxin levels. Monitor digoxin levels if coadministered.
Antacids
Aluminum- and magnesium-containing antacids can reduce the peak plasma concentrations of azithromycin. Administer azithromycin at least 1 hour before or 2 hours after antacids.
Warfarin
Azithromycin may potentiate the effects of oral anticoagulants like warfarin, leading to increased bleeding risk. INR monitoring is recommended.
Nelfinavir
Coadministration with nelfinavir leads to increased azithromycin serum concentrations. No dosage adjustment of azithromycin is recommended.
Storage
Store the dry powder below 30°C in a dry place, protected from light and moisture. After reconstitution, store the suspension at room temperature (below 30°C) and do not freeze. Keep out of reach of children.
Overdose
Symptoms of azithromycin overdose may include severe nausea, vomiting, diarrhea, and reversible hearing loss. Management involves symptomatic and supportive care. Gastric lavage and general supportive measures may be necessary.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed. Azithromycin is excreted in breast milk; use with caution during lactation, considering the potential risks to the infant versus the benefits to the mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
The dry powder has a shelf life of 2 years from the date of manufacture. The reconstituted suspension is stable for 5-7 days when stored at room temperature (below 30°C).
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Azithromycin has been extensively studied in numerous clinical trials globally, demonstrating its efficacy and safety across a wide range of bacterial infections in both adult and pediatric populations. Trials have focused on its short-course regimens and long tissue half-life benefits.
Lab Monitoring
- Liver function tests (LFTs) should be performed in patients with pre-existing hepatic impairment or those who develop symptoms of liver dysfunction.
- ECG monitoring may be considered in patients at risk for QT prolongation.
- Renal function tests may be considered in patients with severe renal impairment.
Doctor Notes
- Emphasize the importance of completing the full course of treatment to patients to prevent antibiotic resistance.
- Be mindful of potential QT prolongation, particularly in patients with known risk factors for arrhythmia or those on other QT-prolonging drugs.
- Advise parents/caregivers on proper reconstitution and administration techniques for pediatric suspension.
Patient Guidelines
- Complete the entire prescribed course of medication, even if symptoms improve or disappear, to prevent recurrence of infection and development of antibiotic resistance.
- Shake the suspension well before each dose.
- Store reconstituted suspension as directed and discard any unused portion after the recommended period.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs and herbal supplements.
Missed Dose Advice
Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Azithromycin may cause dizziness or visual disturbances in some patients. Patients should be advised to exercise caution before driving or operating machinery if they experience these effects.
Lifestyle Advice
- Maintain good personal hygiene to help prevent the spread of infections.
- Stay well-hydrated by drinking plenty of fluids.
- Avoid alcohol during the treatment course as it may exacerbate side effects like nausea or dizziness.
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