Kilbac
Generic Name
Clarithromycin 125 mg/5 ml Suspension
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
kilbac 125 mg suspension | ৳ 230.00 | N/A |
Description
Overview of the medicine
Clarithromycin is a macrolide antibiotic used to treat various bacterial infections, including respiratory tract infections, skin infections, and Helicobacter pylori infections. It works by inhibiting bacterial protein synthesis.
Uses & Indications
Dosage
Adults
For children, typically 7.5 mg/kg body weight twice daily (every 12 hours) for 5-14 days, depending on the infection. For 125 mg/5 ml suspension, this means 0.3 mL/kg twice daily. Adults usually require higher strengths (250-500 mg tablets).
Elderly
Similar to adult dosage, but caution with renal impairment.
Renal_impairment
Dosage adjustment is recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min). Dose should be halved or dosing interval doubled.
How to Take
Oral administration. Can be taken with or without food. For best absorption, some recommend taking with food, but it's not strictly necessary. Shake well before use. Use the provided measuring device.
Mechanism of Action
Clarithromycin binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis. This action is generally bacteriostatic, but can be bactericidal at higher concentrations against highly susceptible organisms.
Pharmacokinetics
Onset
2-3 hours to peak plasma concentration.
Excretion
Primarily excreted in urine (20-40% as unchanged drug) and feces (via bile).
Half life
Approximately 3-7 hours for clarithromycin; 5-9 hours for 14-hydroxy clarithromycin (active metabolite).
Absorption
Rapidly absorbed from the gastrointestinal tract, but subject to first-pass metabolism. Bioavailability is approximately 50-55%. Food may delay absorption but does not affect the extent.
Metabolism
Extensively metabolized in the liver by the cytochrome P450 system (CYP3A4) to its active metabolite, 14-hydroxy clarithromycin.
Side Effects
Contraindications
- Hypersensitivity to clarithromycin or other macrolide antibiotics
- History of cholestatic jaundice/hepatic dysfunction associated with clarithromycin
- Co-administration with cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine due to risk of QT prolongation and cardiac arrhythmias
- Severe hepatic impairment with concomitant renal impairment
Drug Interactions
Digoxin
Increased digoxin levels and toxicity.
Warfarin
Increased anticoagulant effect and risk of bleeding.
Colchicine
Increased colchicine toxicity.
Oral contraceptives
May reduce efficacy of contraceptives (rare).
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy/rhabdomyolysis due to increased statin levels.
Benzodiazepines (e.g., midazolam, alprazolam)
Increased sedation and prolonged effects.
QT prolonging drugs (e.g., antiarrhythmics, antipsychotics)
Increased risk of QT prolongation.
Storage
Store dry powder below 30°C. Protect from light and moisture. After reconstitution, store at room temperature (15-30°C) and discard unused portion after 14 days. Do not refrigerate.
Overdose
Symptoms include gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain). Management is supportive and symptomatic, including gastric lavage and close monitoring of vital signs and ECG for QT prolongation.
Pregnancy & Lactation
Pregnancy Category C: Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; use with caution during lactation, or consider alternatives.
Side Effects
Contraindications
- Hypersensitivity to clarithromycin or other macrolide antibiotics
- History of cholestatic jaundice/hepatic dysfunction associated with clarithromycin
- Co-administration with cisapride, pimozide, astemizole, terfenadine, ergotamine, dihydroergotamine due to risk of QT prolongation and cardiac arrhythmias
- Severe hepatic impairment with concomitant renal impairment
Drug Interactions
Digoxin
Increased digoxin levels and toxicity.
Warfarin
Increased anticoagulant effect and risk of bleeding.
Colchicine
Increased colchicine toxicity.
Oral contraceptives
May reduce efficacy of contraceptives (rare).
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy/rhabdomyolysis due to increased statin levels.
Benzodiazepines (e.g., midazolam, alprazolam)
Increased sedation and prolonged effects.
QT prolonging drugs (e.g., antiarrhythmics, antipsychotics)
Increased risk of QT prolongation.
Storage
Store dry powder below 30°C. Protect from light and moisture. After reconstitution, store at room temperature (15-30°C) and discard unused portion after 14 days. Do not refrigerate.
Overdose
Symptoms include gastrointestinal upset (nausea, vomiting, diarrhea, abdominal pain). Management is supportive and symptomatic, including gastric lavage and close monitoring of vital signs and ECG for QT prolongation.
Pregnancy & Lactation
Pregnancy Category C: Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk; use with caution during lactation, or consider alternatives.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months (unreconstituted powder); 14 days after reconstitution (stored at room temperature).
Availability
Pharmacies nationwide
Approval Status
Approved by regulatory authorities
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Extensively studied in various bacterial infections, demonstrating efficacy and safety profiles across different age groups. Ongoing studies explore its anti-inflammatory and immunomodulatory effects.
Lab Monitoring
- Liver function tests (LFTs) in patients with pre-existing hepatic impairment or prolonged therapy.
- Renal function tests in patients with renal impairment.
- ECG monitoring in patients at risk for QT prolongation or with co-administered QT prolonging drugs.
Doctor Notes
- Advise patients to complete the full course of treatment.
- Counsel on potential drug interactions, especially with statins, warfarin, and drugs prolonging the QT interval.
- Monitor liver and renal function in susceptible patients.
- Educate parents/caregivers on proper reconstitution and administration of suspension.
Patient Guidelines
- Complete the full course of antibiotics, even if symptoms improve, to prevent resistance.
- Shake the suspension well before each use.
- Use the provided measuring spoon or cup for accurate dosing.
- Report any severe or persistent side effects to your doctor.
- Do not share this medicine with others.
Missed Dose Advice
If a dose is missed, take it as soon as remembered. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not double the dose.
Driving Precautions
May cause dizziness, confusion, or visual disturbances. Patients should be advised to exercise caution before driving or operating machinery until they are reasonably certain that clarithromycin does not adversely affect them.
Lifestyle Advice
- Maintain good hydration.
- Avoid alcohol during treatment, as it may exacerbate gastrointestinal side effects.
- Avoid grapefruit juice.
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