KLACID 125/MG/5/ML 100/ML ORAL SUSP

Indications

Approved Uses

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

Dosage & Administration

Initial Dose

250mg every 12 hours for most mild-to-moderate infections

Maintenance Dose

250-500mg every 12 hours depending on infection severity

Children's Dosage

7.5mg/kg every 12 hours (max 500mg per dose); for children 6 months and older. Typical doses: 15kg: 2.5ml (62.5mg) q12h; 20kg: 5ml (125mg) q12h; 30kg: 7.5ml (187.5mg) q12h; 40kg: 10ml (250mg) q12h

How to Take

Reconstitute with water as directed; shake well before each dose. Measure with an oral syringe/medicine spoon. May be taken with or without food (taking with food may improve GI tolerance). For most infections, administer every 12 hours at consistent times; complete the full prescribed course.

How to Prepare

Reconstitute by adding water to the bottle to the marked line (often in two portions), shaking well after each addition until uniformly dispersed; final volume after reconstitution is 60 mL.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1% to <10%): diarrhea, nausea, vomiting, abdominal pain/dyspepsia, abnormal taste (dysgeusia), headache, rash; Uncommon (<1%): QT prolongation, hepatic enzyme elevation/hepatitis, dizziness, insomnia, anxiety (rare but serious: severe cutaneous reactions such as SJS/TEN).

Safety & Warnings

Age Restriction

Safety and efficacy not established in children younger than 6 months (use generally supported from ≥6 months).

Drug Interactions

Drug Interactions

Major interactions include: colchicine (toxicity; especially contraindicated with renal/hepatic impairment), ergotamine/dihydroergotamine (ergotism), cisapride/pimozide/terfenadine/astemizole and other QT-prolongers (torsades risk), simvastatin/lovastatin (myopathy/rhabdomyolysis), warfarin (↑INR), digoxin (↑levels), carbamazepine/phenytoin/theophylline (↑levels), benzodiazepines metabolized by CYP3A (midazolam/triazolam-↑sedation; oral midazolam generally avoid), calcineurin/mTOR inhibitors (tacrolimus/cyclosporine/sirolimus-↑levels), calcium-channel blockers (hypotension/AKI risk), and CYP3A inducers (rifampin/rifabutin-↓clarithromycin).

Interaction Severity

MAJOR/CONTRAINDICATED: cisapride, pimozide, terfenadine/astemizole (where applicable), ergotamine/dihydroergotamine, colchicine in patients with renal/hepatic impairment, and simvastatin/lovastatin (avoid; high rhabdomyolysis risk). MODERATE/SIGNIFICANT: warfarin (↑INR), digoxin (↑levels), carbamazepine (↑levels), cyclosporine/tacrolimus (↑levels), midazolam/triazolam and other CYP3A benzodiazepines (↑sedation), certain calcium channel blockers (hypotension/AKI risk), atorvastatin (myopathy risk-use lowest dose/monitor), theophylline (↑levels), rifampin/rifabutin (↓clarithromycin; complex bidirectional effects). MINOR: antacids (minimal clinical impact).

Food Interaction

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

Special Populations

Children

7.5mg/kg every 12 hours (max 500mg per dose); for children 6 months and older. Typical doses: 15kg: 2.5ml (62.5mg) q12h; 20kg: 5ml (125mg) q12h; 30kg: 7.5ml (187.5mg) q12h; 40kg: 10ml (250mg) q12h

Elderly

Standard adult dosing; however, monitor renal function as age-related decline in CrCl may necessitate dose adjustment if CrCl falls below 30 ml/min

Kidney Impairment

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

Storage & Patient Advice

Preparation Instructions

Reconstitute by adding water to the bottle to the marked line (often in two portions), shaking well after each addition until uniformly dispersed; final volume after reconstitution is 60 mL.

Stopping the Medicine

Complete the full prescribed course even if symptoms improve; do not stop early unless advised due to adverse effects or clinician direction.

Patient Counseling

Shake well before each dose; measure with an oral syringe/spoon; take at the same times each day (usually every 12 hours) and finish the full course. May take with food to reduce stomach upset; metallic/bitter taste can occur. Seek care for severe/persistent diarrhea, rash, jaundice/dark urine, or palpitations/syncope. Review all medicines for interactions (especially warfarin, statins, colchicine, digoxin, antiarrhythmics). After reconstitution, store as directed on the label (commonly at room temperature, not above 30°C per SFDA storage condition) and discard after the labeled in‑use period (often 14 days).

Pharmacology

Mechanism of Action

Binds to the 50S bacterial ribosomal subunit (23S rRNA) and inhibits protein synthesis by blocking translocation/elongation of the peptide chain.

Onset of Action

Peak plasma concentrations occur about 2-3 hours after an oral dose (immediate‑release); clinical improvement is often seen within 48-72 hours depending on infection severity.

Duration of Effect

Clinical dosing interval is typically every 12 hours for immediate‑release clarithromycin; elimination half‑life is dose‑dependent (~3-7 hours) with an active metabolite contributing to antibacterial effect.

Half-Life

Dose-dependent: clarithromycin terminal half-life is ~3-4 hours at 250 mg and ~5-7 hours at 500 mg; 14-hydroxyclarithromycin half-life is typically ~5-6 hours.

Bioavailability

For adult patients, the bioavailability of 10 mL of the 125 mg/5 mL suspension or 10 mL of the 250 mg/5 mL suspension is similar to a 250 mg or 500 mg tablet, respectively.

Metabolism

Hepatic metabolism primarily via CYP3A4 to active metabolite 14-hydroxyclarithromycin (plus other metabolites).

Excretion

Mixed renal and biliary/fecal elimination; approximately 20-40% of an oral dose is excreted unchanged in urine, with the remainder largely excreted via bile/feces as metabolites (and some unchanged).

Product Information

Available Dosage Forms

Clarithromycin is available as: immediate‑release tablets, extended‑release tablets, granules for oral suspension, and powder for concentrate/solution for IV infusion (availability varies by country/market).

Composition per Dose

Each 5ml: 125mg clarithromycin

Generic Availability

Yes

OTC Alternatives

No OTC alternative-clarithromycin is prescription‑only (SFDA legal status: Prescription).

Spectrum

Broad-spectrum

Antibiotic Class

Macrolide

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