Clarith
Generic Name
Clarithromycin 125 mg suspension
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| clarith 125 mg suspension | ৳ 350.00 | N/A |
Description
Overview of the medicine
Clarithromycin 125 mg suspension is a macrolide antibiotic used to treat a wide range of bacterial infections including respiratory tract infections, skin infections, and certain sexually transmitted infections. It works by stopping the growth of bacteria.
Uses & Indications
Dosage
Adults
Generally not indicated for adults, higher strength formulations (e.g., tablets) are preferred. If used, dosage would typically be 250-500 mg twice daily, depending on the infection.
Elderly
Similar to adults; dosage adjustment may be necessary in cases of severe renal impairment.
Renal_impairment
For creatinine clearance < 30 mL/min, the dose should be halved, or the dosing interval should be doubled. Consult a physician.
How to Take
Administer orally, usually twice daily. Can be taken with or without food. Shake the suspension well before each use. For younger children, it can be mixed with a small amount of milk.
Mechanism of Action
Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing the translocation of peptide chains and thus impeding bacterial growth and replication.
Pharmacokinetics
Onset
Onset of antibacterial action varies depending on the infection, typically within hours to days for symptomatic relief.
Excretion
Primarily excreted via urine (20-40%) and bile (10-15%) as unchanged drug and metabolites.
Half life
Approximately 3-7 hours, depending on the dose and formulation.
Absorption
Rapidly absorbed from the gastrointestinal tract. Food may delay the onset of absorption but generally does not affect the extent of bioavailability.
Metabolism
Extensively metabolized in the liver by the CYP3A4 enzyme system to several metabolites, including the active 14-hydroxyclarithromycin.
Side Effects
Contraindications
- Known hypersensitivity to clarithromycin or any other macrolide antibiotic
- Co-administration with cisapride, pimozide, astemizole, terfenadine due to risk of QT prolongation and cardiac arrhythmias
- Co-administration with ergotamine or dihydroergotamine due to risk of acute ergot toxicity
- Severe hepatic impairment with concomitant renal impairment
- History of QT prolongation or ventricular arrhythmia
Drug Interactions
Digoxin
Increased serum digoxin levels, leading to potential toxicity.
Warfarin
Potentiation of anticoagulant effects, requiring increased INR monitoring.
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy, including rhabdomyolysis, due to CYP3A4 inhibition.
Benzodiazepines (e.g., midazolam, triazolam)
Increased and prolonged sedative effects.
Calcium channel blockers (e.g., verapamil, amlodipine)
Increased risk of hypotension and renal injury.
Storage
Store dry powder below 30°C, protected from moisture and light. Do not freeze. Reconstituted suspension should be stored at room temperature (15-30°C) and discarded after 14 days. Keep out of reach of children.
Overdose
Symptoms of overdose may include gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain). Treatment involves gastric lavage and supportive measures. Hemodialysis or peritoneal dialysis are unlikely to be beneficial.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted in breast milk; caution advised during lactation.
Side Effects
Contraindications
- Known hypersensitivity to clarithromycin or any other macrolide antibiotic
- Co-administration with cisapride, pimozide, astemizole, terfenadine due to risk of QT prolongation and cardiac arrhythmias
- Co-administration with ergotamine or dihydroergotamine due to risk of acute ergot toxicity
- Severe hepatic impairment with concomitant renal impairment
- History of QT prolongation or ventricular arrhythmia
Drug Interactions
Digoxin
Increased serum digoxin levels, leading to potential toxicity.
Warfarin
Potentiation of anticoagulant effects, requiring increased INR monitoring.
Statins (e.g., simvastatin, lovastatin)
Increased risk of myopathy, including rhabdomyolysis, due to CYP3A4 inhibition.
Benzodiazepines (e.g., midazolam, triazolam)
Increased and prolonged sedative effects.
Calcium channel blockers (e.g., verapamil, amlodipine)
Increased risk of hypotension and renal injury.
Storage
Store dry powder below 30°C, protected from moisture and light. Do not freeze. Reconstituted suspension should be stored at room temperature (15-30°C) and discarded after 14 days. Keep out of reach of children.
Overdose
Symptoms of overdose may include gastrointestinal disturbances (nausea, vomiting, diarrhea, abdominal pain). Treatment involves gastric lavage and supportive measures. Hemodialysis or peritoneal dialysis are unlikely to be beneficial.
Pregnancy & Lactation
Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Clarithromycin is excreted in breast milk; caution advised during lactation.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months for dry powder. The reconstituted suspension is stable for 14 days when stored at room temperature (15-30°C).
Availability
Pharmacies, hospitals
Approval Status
Approved by DGDA/FDA
Patent Status
Off-patent
WHO Essential Medicine
YesClinical Trials
Extensive clinical trials have established the efficacy and safety of clarithromycin for its approved indications across various age groups, including pediatric populations. Ongoing research explores its role in emerging antimicrobial resistance and novel applications.
Lab Monitoring
- Liver function tests (especially in patients with pre-existing hepatic impairment or during prolonged therapy)
- Renal function monitoring (in patients with renal impairment)
- Prothrombin time/INR if co-administered with warfarin
- Electrolytes (e.g., potassium, magnesium) in patients at risk of QT prolongation
Doctor Notes
- Emphasize the importance of patient adherence to the full prescribed course to prevent treatment failure and emergence of resistance.
- Be vigilant for potential drug interactions, especially with other CYP3A4 substrates, and adjust concomitant medications as necessary.
- Counsel patients/parents on symptoms of C. difficile-associated diarrhea (CDAD) and advise them to seek immediate medical attention if it occurs.
Patient Guidelines
- Complete the full course of antibiotic as prescribed, even if symptoms improve, to prevent recurrence and bacterial resistance.
- Shake the suspension well before each use to ensure proper dosing.
- Do not stop taking the medicine without consulting your doctor.
- Report any severe or persistent side effects (e.g., severe diarrhea, yellowing of skin/eyes, irregular heartbeat) to your doctor immediately.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to catch up.
Driving Precautions
Clarithromycin may cause dizziness, confusion, or vision disturbances in some individuals. Patients should be advised to exercise caution when driving or operating machinery until they know how the medication affects them.
Lifestyle Advice
- Maintain good hydration during treatment.
- Avoid self-medication with other antibiotics without professional advice.
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