Kilbac
Generic Name
Clarithromycin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| kilbac 125 mg tablet | ৳ 15.00 | ৳ 90.00 |
Description
Overview of the medicine
Clarithromycin is a macrolide antibiotic used to treat a wide variety of bacterial infections, including respiratory tract infections, skin and soft tissue infections, and certain gastrointestinal infections.
Uses & Indications
Dosage
Adults
For general infections, 250 mg (two 125 mg tablets) twice daily for 7-14 days. For more severe infections, dosage may be increased to 500 mg twice daily.
Elderly
No specific dose adjustment is generally required for elderly patients unless they have severe renal impairment.
Renal_impairment
In patients with severe renal impairment (creatinine clearance < 30 mL/min), the dose should be reduced by half (e.g., 125 mg twice daily or 250 mg once daily) and the duration of treatment should not exceed 14 days.
How to Take
Kilbac 125 mg tablets should be taken orally, with or without food. To minimize gastrointestinal upset, it may be taken with food.
Mechanism of Action
Clarithromycin inhibits bacterial protein synthesis by reversibly binding to the 50S ribosomal subunit, thereby blocking translocation of peptidyl tRNA.
Pharmacokinetics
Onset
Peak plasma concentrations are typically reached within 2-3 hours after oral dosing.
Excretion
Approximately 20-40% of the dose is excreted unchanged in the urine, and the remainder is excreted via bile and feces.
Half life
The half-life of clarithromycin is approximately 3-7 hours, which can be dose-dependent and prolonged in renal impairment.
Absorption
Rapidly absorbed after oral administration; bioavailability is about 50-55%. Food may delay absorption but does not significantly affect bioavailability.
Metabolism
Extensively metabolized in the liver via the cytochrome P450 3A (CYP3A4) system to an active metabolite, 14-hydroxyclarithromycin, and inactive metabolites.
Side Effects
Contraindications
- Hypersensitivity to clarithromycin, erythromycin, any macrolide antibiotic, or any component of the formulation.
- Concomitant administration with cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, colchicine (in patients with renal/hepatic impairment), or HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (e.g., simvastatin, lovastatin).
- History of QT prolongation or ventricular arrhythmia, including Torsades de Pointes.
Drug Interactions
Digoxin
Increased serum digoxin levels. Monitor digoxin levels carefully.
Warfarin
Enhanced anticoagulant effect, leading to increased risk of bleeding. Close monitoring of INR is required.
Colchicine
Increased exposure to colchicine, leading to toxicity. Contraindicated in patients with renal or hepatic impairment.
Oral Hypoglycemics/Insulin
Risk of severe hypoglycemia. Monitor blood glucose levels.
Statins (e.g., Simvastatin, Lovastatin)
Increased risk of myopathy, including rhabdomyolysis, due to inhibition of CYP3A4-mediated metabolism. Avoid concomitant use.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
In case of overdose, gastric lavage and general supportive measures should be employed. Hemodialysis or peritoneal dialysis is not expected to significantly alter serum levels of clarithromycin.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted into breast milk; caution should be exercised when administered to a nursing mother, or an alternative should be considered.
Side Effects
Contraindications
- Hypersensitivity to clarithromycin, erythromycin, any macrolide antibiotic, or any component of the formulation.
- Concomitant administration with cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine, colchicine (in patients with renal/hepatic impairment), or HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (e.g., simvastatin, lovastatin).
- History of QT prolongation or ventricular arrhythmia, including Torsades de Pointes.
Drug Interactions
Digoxin
Increased serum digoxin levels. Monitor digoxin levels carefully.
Warfarin
Enhanced anticoagulant effect, leading to increased risk of bleeding. Close monitoring of INR is required.
Colchicine
Increased exposure to colchicine, leading to toxicity. Contraindicated in patients with renal or hepatic impairment.
Oral Hypoglycemics/Insulin
Risk of severe hypoglycemia. Monitor blood glucose levels.
Statins (e.g., Simvastatin, Lovastatin)
Increased risk of myopathy, including rhabdomyolysis, due to inhibition of CYP3A4-mediated metabolism. Avoid concomitant use.
Storage
Store in a cool, dry place below 30°C, away from direct sunlight and moisture. Keep out of reach of children.
Overdose
In case of overdose, gastric lavage and general supportive measures should be employed. Hemodialysis or peritoneal dialysis is not expected to significantly alter serum levels of clarithromycin.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted into breast milk; caution should be exercised when administered to a nursing mother, or an alternative should be considered.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Available in pharmacies and hospitals nationwide
Approval Status
Approved by DGDA, Bangladesh
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Ongoing clinical trials continue to investigate clarithromycin's efficacy against emerging resistant strains and its role in new therapeutic regimens, particularly in combination therapies.
Lab Monitoring
- Liver function tests (LFTs) should be monitored in patients with pre-existing hepatic impairment or during prolonged treatment.
- Renal function should be monitored in patients with severe renal impairment.
- INR should be closely monitored in patients taking warfarin concomitantly.
Doctor Notes
- Emphasize strict adherence to the full course of therapy to minimize resistance.
- Counsel patients on potential drug interactions, especially with statins, warfarin, and colchicine. Review current medication list carefully.
- Be aware of the potential for QT prolongation and cardiovascular risks, especially in susceptible populations.
Patient Guidelines
- Complete the full prescribed course of Kilbac, even if symptoms improve, to prevent recurrence of infection and development of antibiotic resistance.
- Do not share this medicine with others, even if they have similar symptoms.
- Inform your doctor or pharmacist about all other medications you are taking, including over-the-counter drugs, herbal supplements, and vitamins.
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 the dose to catch up.
Driving Precautions
Clarithromycin may cause dizziness or confusion. Patients should be advised to exercise caution when driving or operating machinery until they know how Kilbac affects them.
Lifestyle Advice
- Maintain good hydration during treatment.
- Avoid alcohol consumption during treatment as it may exacerbate gastrointestinal side effects.
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