Primace
Generic Name
Azithrolactin
Manufacturer
Medix Pharma Ltd.
Country
Bangladesh
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| primace 125 mg tablet | ৳ 2.50 | ৳ 25.00 |
Description
Overview of the medicine
Primace 125 mg Tablet contains Azithrolactin, a macrolide antibiotic used to treat a variety of bacterial infections, especially in pediatric patients.
Uses & Indications
Dosage
Adults
Not the primary strength for adult use. Higher strengths (250-500 mg) are typically used for adults. If prescribed, follow physician's guidance.
Elderly
No specific dosage adjustment needed for elderly patients with normal renal and hepatic function. Consult doctor.
Children
10 mg/kg orally once daily for 3 days, or 10 mg/kg on day 1 followed by 5 mg/kg on days 2-5. Maximum single dose: 500 mg.
Renal_impairment
No dosage adjustment required for mild to moderate renal impairment (creatinine clearance > 10 mL/min). Use with caution in severe impairment.
Hepatic_impairment
Use with caution in severe hepatic impairment, as Azithrolactin is primarily eliminated by the liver; dosage adjustment may be needed.
How to Take
Take orally, with or without food. To minimize gastrointestinal upset, it can be taken with food. Follow your doctor's instructions regarding the timing of doses.
Mechanism of Action
Azithrolactin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby preventing translocation of peptide bonds and growth of bacteria.
Pharmacokinetics
Onset
Antibacterial effects usually begin within 1-2 hours of administration.
Excretion
Mainly excreted unchanged in bile, with a small amount excreted via urine (approximately 6% of the dose).
Half life
The terminal elimination half-life is approximately 68 hours.
Absorption
Rapidly absorbed from the gastrointestinal tract; bioavailability is approximately 37%. Peak plasma concentrations typically reached within 2-3 hours.
Metabolism
Primarily hepatic, with extensive first-pass metabolism, forming inactive metabolites.
Side Effects
Contraindications
- Known hypersensitivity to azithrolactin, erythromycin, any macrolide or ketolide antibiotic, or any component of the formulation.
- History of cholestatic jaundice/hepatic dysfunction associated with prior azithrolactin use.
Drug Interactions
Digoxin
May increase serum digoxin levels. Monitor digoxin concentrations.
Warfarin
May increase the anticoagulant effect of warfarin. Monitor INR closely.
QT prolonging drugs
Increased risk of QT interval prolongation and torsades de pointes. Co-administration with other QT prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, terfenadine) is not recommended.
Antacids (containing aluminum or magnesium)
Decrease peak plasma concentrations of azithrolactin. Administer azithrolactin at least 1 hour before or 2 hours after antacids.
Storage
Store below 30°C in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe nausea, vomiting, diarrhea, and reversible hearing loss. Gastric lavage and general supportive measures are recommended. Hemodialysis is not effective for removal.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed after careful risk-benefit assessment. Excreted in breast milk; use with caution during lactation.
Side Effects
Contraindications
- Known hypersensitivity to azithrolactin, erythromycin, any macrolide or ketolide antibiotic, or any component of the formulation.
- History of cholestatic jaundice/hepatic dysfunction associated with prior azithrolactin use.
Drug Interactions
Digoxin
May increase serum digoxin levels. Monitor digoxin concentrations.
Warfarin
May increase the anticoagulant effect of warfarin. Monitor INR closely.
QT prolonging drugs
Increased risk of QT interval prolongation and torsades de pointes. Co-administration with other QT prolonging drugs (e.g., Class IA and III antiarrhythmics, cisapride, terfenadine) is not recommended.
Antacids (containing aluminum or magnesium)
Decrease peak plasma concentrations of azithrolactin. Administer azithrolactin at least 1 hour before or 2 hours after antacids.
Storage
Store below 30°C in a cool, dry place, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose may include severe nausea, vomiting, diarrhea, and reversible hearing loss. Gastric lavage and general supportive measures are recommended. Hemodialysis is not effective for removal.
Pregnancy & Lactation
Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed after careful risk-benefit assessment. Excreted in breast milk; use with caution during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Pharmacies nationwide
Approval Status
Approved by DGDA (Bangladesh)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Azithrolactin has undergone extensive clinical trials demonstrating its efficacy and safety across various bacterial infections, particularly in pediatric populations for the 125mg strength.
Lab Monitoring
- Liver function tests (LFTs) if prolonged use or pre-existing hepatic impairment.
- Renal function tests if pre-existing renal impairment.
- INR if co-administered with warfarin to monitor for increased bleeding risk.
- ECG monitoring if risk factors for QT prolongation are present.
Doctor Notes
- Ensure patient education on the importance of completing the full course of therapy to prevent resistance.
- Counsel patients on potential gastrointestinal side effects and methods to mitigate them (e.g., taking with food).
- Monitor for signs of liver dysfunction or prolonged QT interval, especially in patients with pre-existing conditions.
Patient Guidelines
- Take Primace 125 mg Tablet exactly as prescribed by your doctor and complete the entire course of treatment, even if you start feeling better.
- Do not save unused medicine for a later infection or share it with others.
- Report any unusual or severe side effects, especially severe diarrhea, rash, or signs of liver problems, to your doctor immediately.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next scheduled 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
Primace 125 mg Tablet may cause dizziness or vision disturbances in some individuals. Exercise caution when driving or operating machinery until you know how this medication affects you.
Lifestyle Advice
- Maintain good hydration throughout the treatment period.
- Avoid alcohol consumption during treatment as it may exacerbate gastrointestinal side effects.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Primace Brand
Other medicines available under the same brand name
Primace
Capsule
Primace
Tablet
Primace
Capsule
Primace
Capsule
Primace
Tablet
Primace
Capsule
Primace
Tablet