CLARIDAR 250MG 14 TAB

Indications

Approved Uses

Susceptible bacterial infections including upper and lower respiratory tract infections (e.g., sinusitis, pharyngitis/tonsillitis, acute bronchitis/exacerbation of chronic bronchitis, community‑acquired pneumonia), skin and soft tissue infections; Helicobacter pylori eradication in combination therapy; treatment and prophylaxis of disseminated Mycobacterium avium complex (MAC) infection in appropriate patients.

Dosage & Administration

Dosing by Condition

[Condition: Pharyngitis/Tonsillitis
Dose: 250 mg orally every 12 hours for 10 days, Condition: Acute Maxillary Sinusitis
Dose: 500 mg orally every 12 hours for 14 days, Condition: Acute Exacerbation of Chronic Bronchitis
Dose: 250-500 mg orally every 12 hours for 7-14 days]

Initial Dose

250 mg every 12 hours.

Maintenance Dose

250-500mg every 12 hours depending on indication and severity

Maximum Dose

Typical maximum for immediate‑release tablets: 1000 mg/day (e.g., 500 mg twice daily); higher total daily doses (up to 2000 mg/day) may be used in specific indications such as MAC treatment under specialist guidance.

Children's Dosage

15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose); for mycobacterial infections: 7.5 mg/kg every 12 hours up to 500 mg every 12 hours.

Dose Adjustment Notes

Renal: if CrCl <30 mL/min, reduce dose by ~50% or extend interval; avoid/closely monitor if severe renal impairment coexists with hepatic dysfunction; no adjustment usually needed for mild-moderate hepatic impairment when renal function is normal.

How to Take

Swallow the 250 mg film‑coated tablet whole with water; may be taken with or without food (food can improve GI tolerability); do not crush or chew.

Side Effects

Common Side Effects

Diarrhea, nausea, vomiting, abdominal pain, dyspepsia, abnormal taste (metallic/bitter), headache, rash

Safety & Warnings

Age Restriction

Not recommended for infants <6 months; can be used in children ≥6 months when clinically indicated (this 250 mg film‑coated tablet is generally for patients able to swallow tablets).

Drug Interactions

Drug Interactions

Major/contraindicated: cisapride, pimozide, astemizole, terfenadine; ergotamine/dihydroergotamine; simvastatin/lovastatin; colchicine (especially with renal/hepatic impairment). Clinically significant: warfarin (↑INR), digoxin (↑levels), carbamazepine/phenytoin (↑levels), theophylline (↑levels), benzodiazepines via CYP3A4 (e.g., midazolam/triazolam), calcium channel blockers (e.g., verapamil/diltiazem-hypotension/bradycardia and ↑drug levels), calcineurin/mTOR inhibitors (tacrolimus/cyclosporine/sirolimus-↑levels), HIV protease inhibitors/boosters (complex bidirectional CYP3A effects), rifampin (↓clarithromycin exposure).

Interaction Severity

MAJOR/Contraindicated: cisapride, pimozide, ergotamine/dihydroergotamine; strong caution/avoid: simvastatin and lovastatin (rhabdomyolysis risk). MODERATE/clinically significant: warfarin (↑INR), digoxin (↑levels), colchicine (potentially severe toxicity-especially renal/hepatic impairment; often avoid), carbamazepine/phenytoin, theophylline, cyclosporine/tacrolimus/sirolimus, certain benzodiazepines (e.g., midazolam/triazolam), calcium channel blockers (e.g., verapamil/diltiazem; hypotension/bradycardia/QT risk).

Food Interaction

No food restriction: may be taken with or without food; taking with food can reduce gastrointestinal upset.

Special Populations

Children

15 mg/kg/day divided every 12 hours for 10 days (up to the adult dose); for mycobacterial infections: 7.5 mg/kg every 12 hours up to 500 mg every 12 hours.

Elderly

Standard adult dosing; however, monitor renal function as age-related decline in renal function may necessitate dose adjustment; increased vigilance for QT prolongation and drug interactions

Kidney Impairment

CrCl <30 mL/min: reduce clarithromycin dose by 50% (or extend interval); if coadministered with atazanavir or ritonavir: CrCl 30-60 mL/min reduce by 50% and CrCl <30 mL/min reduce by 75%.

Storage & Patient Advice

Stopping the Medicine

Complete the full prescribed course even if symptoms improve; do not stop early unless advised by a clinician.

Patient Counseling

Complete the full prescribed course; take with or without food (with food if stomach upset); swallow tablets whole; report severe/persistent diarrhea, jaundice/dark urine, severe rash, or palpitations/syncope; review all medicines for interactions (especially warfarin, digoxin, colchicine, calcium channel blockers, and simvastatin/lovastatin-often must be stopped/changed); do not share antibiotics.

Pharmacology

Mechanism of Action

Inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing the translocation of aminoacyl transfer-RNA and halting peptide chain elongation.

Onset of Action

Peak plasma concentrations occur about 2-3 hours after an immediate‑release dose; clinical improvement is often seen within 48-72 hours for susceptible infections.

Duration of Effect

Approximately 12 hours for immediate‑release clarithromycin (supports twice‑daily dosing).

Half-Life

Clarithromycin terminal half-life is dose-dependent: ~3-4 hours after 250 mg q12h and ~5-7 hours after 500 mg q12h; 14‑hydroxyclarithromycin is ~5-6 hours.

Metabolism

Hepatic via the cytochrome P450 3A (CYP3A) isoenzyme to an active metabolite, 14-hydroxyclarithromycin.

Excretion

Elimination via both renal and biliary/fecal routes; roughly 20-30% excreted unchanged in urine (dose-dependent), with the remainder largely as metabolites in urine and via bile/feces.

Product Information

Available Dosage Forms

For CLARIDAR 250 mg specifically: film‑coated tablet (oral). Clarithromycin as an active ingredient is also available in other markets as modified‑release tablets and oral suspension; IV clarithromycin is not routinely available/approved in many jurisdictions.

Composition per Dose

Each film-coated tablet: 250mg clarithromycin

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Spectrum

Broad-spectrum

Antibiotic Class

Macrolide

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