Maclar
Generic Name
Clarithromycin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| maclar 500 mg injection | ৳ 600.00 | N/A |
Description
Overview of the medicine
Maclar 500 mg Injection contains Clarithromycin, which is a macrolide antibiotic used to treat various bacterial infections, including respiratory tract infections, skin and soft tissue infections, and some sexually transmitted diseases. It works by stopping the growth of bacteria.
Uses & Indications
Dosage
Adults
The usual recommended dose for adults is 500 mg IV every 12 hours. For severe infections, the dose may be increased based on clinical judgment. IV infusion should be administered over 60 minutes.
Elderly
No specific dose adjustment is required for elderly patients with normal renal function. For elderly patients with renal impairment, dose adjustment is necessary as described for renal impairment.
Renal_impairment
For patients with creatinine clearance less than 30 mL/min, the dose should be halved, or the dosing interval extended. For example, 250 mg every 12 hours or 500 mg every 24 hours.
How to Take
Maclar 500 mg Injection is for intravenous (IV) infusion only. It should be reconstituted with sterile water for injection and then diluted in a compatible intravenous solution (e.g., 0.9% sodium chloride, 5% dextrose). Administer over a period of 60 minutes.
Mechanism of Action
Clarithromycin exerts its antibacterial action by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. This action is primarily bacteriostatic, but it can be bactericidal against certain organisms at higher concentrations.
Pharmacokinetics
Onset
Peak plasma concentrations are achieved within 2-3 hours after oral administration; onset of action for IV is more rapid.
Excretion
Approximately 20-40% of the dose is excreted unchanged in the urine, with the remainder excreted via hepatic and biliary routes. The active metabolite is also excreted renally.
Half life
The elimination half-life of clarithromycin is approximately 5-7 hours. The active metabolite, 14-hydroxyclarithromycin, has a half-life of 7-9 hours.
Absorption
Rapidly absorbed after intravenous administration, leading to high systemic bioavailability.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 3A4 (CYP3A4) enzyme system to its active 14-hydroxyclarithromycin metabolite and other inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to clarithromycin, other macrolide antibiotics, or any component of the formulation.
- Co-administration with colchicine in patients with renal or hepatic impairment.
- Co-administration with statins (e.g., lovastatin, simvastatin) due to increased risk of rhabdomyolysis.
- Co-administration with ticagrelor, ranolazine, ergotamine, dihydroergotamine, or oral midazolam.
- History of QT prolongation or ventricular arrhythmia, including torsades de pointes.
Drug Interactions
Digoxin
Increased digoxin levels, monitor digoxin concentrations.
Warfarin
Increased anticoagulant effect, monitor INR.
Colchicine
Increased exposure to colchicine, leading to toxicity. Avoid co-administration in renal/hepatic impaired patients.
Midazolam (oral)
Significantly increased midazolam exposure. Avoid co-administration.
CYP3A4 Inhibitors/Inducers
Clarithromycin is a strong CYP3A4 inhibitor and can interact with many drugs metabolized by this enzyme.
Statins (Lovastatin, Simvastatin)
Increased risk of myopathy/rhabdomyolysis. Avoid co-administration.
Storage
Store the dry powder for injection below 30°C, protected from light and moisture. Do not freeze. Reconstituted solution should be used within 24 hours if stored at room temperature or within 48 hours if refrigerated (2-8°C).
Overdose
Overdose of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, nausea, vomiting, and diarrhea. Management involves supportive care and symptomatic treatment. Gastric lavage may be considered if ingestion was recent. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted in human milk; caution should be exercised when administered to a nursing mother.
Side Effects
Contraindications
- Hypersensitivity to clarithromycin, other macrolide antibiotics, or any component of the formulation.
- Co-administration with colchicine in patients with renal or hepatic impairment.
- Co-administration with statins (e.g., lovastatin, simvastatin) due to increased risk of rhabdomyolysis.
- Co-administration with ticagrelor, ranolazine, ergotamine, dihydroergotamine, or oral midazolam.
- History of QT prolongation or ventricular arrhythmia, including torsades de pointes.
Drug Interactions
Digoxin
Increased digoxin levels, monitor digoxin concentrations.
Warfarin
Increased anticoagulant effect, monitor INR.
Colchicine
Increased exposure to colchicine, leading to toxicity. Avoid co-administration in renal/hepatic impaired patients.
Midazolam (oral)
Significantly increased midazolam exposure. Avoid co-administration.
CYP3A4 Inhibitors/Inducers
Clarithromycin is a strong CYP3A4 inhibitor and can interact with many drugs metabolized by this enzyme.
Statins (Lovastatin, Simvastatin)
Increased risk of myopathy/rhabdomyolysis. Avoid co-administration.
Storage
Store the dry powder for injection below 30°C, protected from light and moisture. Do not freeze. Reconstituted solution should be used within 24 hours if stored at room temperature or within 48 hours if refrigerated (2-8°C).
Overdose
Overdose of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, nausea, vomiting, and diarrhea. Management involves supportive care and symptomatic treatment. Gastric lavage may be considered if ingestion was recent. There is no specific antidote.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted in human milk; caution should be exercised when administered to a nursing mother.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years when stored as per manufacturer's instructions. Reconstituted and diluted solutions have shorter stability; refer to specific product insert.
Availability
Pharmacies, Hospitals
Approval Status
Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Clarithromycin has undergone extensive clinical trials demonstrating its efficacy and safety in various bacterial infections. Ongoing research may explore new indications or formulations.
Lab Monitoring
- Liver function tests (e.g., ALT, AST) if treatment is prolonged or in patients with hepatic impairment.
- Renal function tests (e.g., creatinine, BUN) in patients with renal impairment.
- INR monitoring in patients receiving concomitant warfarin.
- ECG monitoring in patients at risk for QT prolongation.
Doctor Notes
- Assess renal and hepatic function before and during treatment, especially in patients with pre-existing impairment.
- Carefully review the patient's medication history to identify potential drug interactions, particularly with CYP3A4 substrates.
- Monitor for signs of QT prolongation and advise patients to report any palpitations or syncopal episodes.
- Educate patients on the importance of completing the full course of therapy.
Patient Guidelines
- Ensure proper hydration during treatment.
- Report any severe or persistent side effects, especially severe diarrhea, rash, or jaundice.
- Inform your doctor about all other medications you are taking to avoid potential drug interactions.
- Complete the full course of treatment as prescribed, even if symptoms improve, to prevent antibiotic resistance.
Missed Dose Advice
If a dose of Maclar Injection is missed, administer it as soon as remembered. However, if it is almost time for the next scheduled dose, skip the missed dose and continue with the regular dosing schedule. Do not double the dose.
Driving Precautions
Clarithromycin may cause dizziness or confusion in some patients, which could impair the ability to drive or operate machinery. Patients should be advised to exercise caution until they know how they react to the medication.
Lifestyle Advice
- Avoid alcohol consumption if it causes discomfort or exacerbates gastrointestinal side effects. Maintain good hygiene to prevent spread of infection.
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