Clarith
Generic Name
Clarithromycin
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| clarith 500 mg tablet | ৳ 30.00 | ৳ 300.00 |
Description
Overview of the medicine
Clarithromycin is a macrolide antibiotic used to treat a wide range of bacterial infections, including respiratory tract infections, skin and soft tissue infections, and infections caused by Helicobacter pylori.
Uses & Indications
Dosage
Adults
The usual recommended dose is 250 mg or 500 mg twice daily for 7 to 14 days, depending on the infection severity and type. For H. pylori eradication, it is typically used as part of a triple therapy regimen.
Elderly
Similar to adult dosage; however, caution should be exercised and dosage adjustment may be necessary in elderly patients with significant renal impairment.
Renal_impairment
For patients with severe renal impairment (creatinine clearance < 30 mL/min), the dosage should be halved (e.g., 250 mg once daily or 250 mg twice daily for severe infections), and the treatment duration should not exceed 14 days.
How to Take
Take tablets orally, with or without food. Extended-release tablets should be taken with food. Do not crush, chew, or break extended-release tablets.
Mechanism of Action
Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit of susceptible microorganisms, thereby preventing translocation of peptides.
Pharmacokinetics
Onset
Clinical improvement usually observed within a few days of starting treatment.
Excretion
Excreted through both renal (approximately 20-40% as unchanged drug and active metabolite) and biliary routes.
Half life
Approximately 3-7 hours for the 500 mg dose, with its active metabolite (14-hydroxyclarithromycin) having a similar half-life.
Absorption
Rapidly absorbed from the gastrointestinal tract, bioavailability is approximately 50-55%. Food may delay absorption but does not affect overall bioavailability.
Metabolism
Extensively metabolized in the liver, primarily by the cytochrome P450 3A (CYP3A) enzyme system, producing an active metabolite, 14-hydroxyclarithromycin.
Side Effects
Contraindications
- Known hypersensitivity to clarithromycin, erythromycin, or any macrolide antibiotic.
- History of cholestatic jaundice/hepatic dysfunction associated with prior clarithromycin use.
- Concomitant administration with cisapride, pimozide, astemizole, terfenadine due to risk of QT prolongation and cardiac arrhythmias.
- Concomitant administration with colchicine in patients with renal or hepatic impairment.
- Concomitant administration with ticagrelor, ranolazine, or ergotamine/dihydroergotamine.
Drug Interactions
Digoxin
Increased serum digoxin levels, monitor for digoxin toxicity.
Warfarin
Potentiation of anticoagulant effects, leading to an increased risk of bleeding. Close INR monitoring is required.
Colchicine
Increased exposure to colchicine, leading to increased risk of colchicine toxicity, especially in renal/hepatic impairment.
Oral Hypoglycemic Agents / Insulin
Risk of hypoglycemia due to potential interaction, monitor blood glucose.
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy, including rhabdomyolysis, due to inhibition of CYP3A4-mediated statin metabolism.
CYP3A4 Inducers (e.g., rifampicin, phenytoin)
May decrease clarithromycin plasma levels, reducing its therapeutic effect.
CYP3A4 Inhibitors (e.g., protease inhibitors, itraconazole)
May increase clarithromycin plasma levels and side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include gastrointestinal complaints (nausea, vomiting, diarrhea, abdominal pain). Management involves gastric lavage and general supportive measures. Hemodialysis and peritoneal dialysis are not effective.
Pregnancy & Lactation
Pregnancy Category C. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk, so caution should be exercised when clarithromycin is administered to a nursing woman.
Side Effects
Contraindications
- Known hypersensitivity to clarithromycin, erythromycin, or any macrolide antibiotic.
- History of cholestatic jaundice/hepatic dysfunction associated with prior clarithromycin use.
- Concomitant administration with cisapride, pimozide, astemizole, terfenadine due to risk of QT prolongation and cardiac arrhythmias.
- Concomitant administration with colchicine in patients with renal or hepatic impairment.
- Concomitant administration with ticagrelor, ranolazine, or ergotamine/dihydroergotamine.
Drug Interactions
Digoxin
Increased serum digoxin levels, monitor for digoxin toxicity.
Warfarin
Potentiation of anticoagulant effects, leading to an increased risk of bleeding. Close INR monitoring is required.
Colchicine
Increased exposure to colchicine, leading to increased risk of colchicine toxicity, especially in renal/hepatic impairment.
Oral Hypoglycemic Agents / Insulin
Risk of hypoglycemia due to potential interaction, monitor blood glucose.
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy, including rhabdomyolysis, due to inhibition of CYP3A4-mediated statin metabolism.
CYP3A4 Inducers (e.g., rifampicin, phenytoin)
May decrease clarithromycin plasma levels, reducing its therapeutic effect.
CYP3A4 Inhibitors (e.g., protease inhibitors, itraconazole)
May increase clarithromycin plasma levels and side effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include gastrointestinal complaints (nausea, vomiting, diarrhea, abdominal pain). Management involves gastric lavage and general supportive measures. Hemodialysis and peritoneal dialysis are not effective.
Pregnancy & Lactation
Pregnancy Category C. Clarithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is excreted in human milk, so caution should be exercised when clarithromycin is administered to a nursing woman.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, specific details on packaging.
Availability
Pharmacies, Hospitals
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have demonstrated the efficacy and safety of clarithromycin in various bacterial infections across different patient populations, leading to its widespread approval and use.
Lab Monitoring
- Liver function tests (especially in patients with pre-existing hepatic impairment or prolonged use).
- Renal function tests (for patients with renal impairment, dosage adjustment may be needed).
- INR monitoring (for patients on warfarin).
- Blood glucose monitoring (for patients on oral hypoglycemic agents/insulin).
Doctor Notes
- Educate patients on the importance of completing the full course of therapy.
- Advise patients about potential gastrointestinal side effects and taste perversion.
- Monitor for signs of QT prolongation, especially in patients with cardiac risk factors or on concomitant QT-prolonging drugs.
- Counsel patients on potential drug interactions, particularly with statins, warfarin, and colchicine.
Patient Guidelines
- Complete the entire course of medication, even if symptoms improve, to prevent resistance and relapse.
- Do not share your medication with others.
- Report any severe or persistent side effects to your doctor immediately.
- Take extended-release tablets with food and swallow whole.
Missed Dose Advice
If a dose is missed, 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 make up for a missed one.
Driving Precautions
Clarithromycin may cause dizziness, vertigo, or confusion in some individuals, which could impair the ability to drive or operate machinery. Patients should be aware of their reaction to the drug before engaging in such activities.
Lifestyle Advice
- Maintain good hygiene to prevent further infections.
- Stay hydrated by drinking plenty of fluids.
- Avoid alcohol consumption during treatment as it may exacerbate GI side effects.
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