Intravenous Respiratory tract infections, Skin and soft tissue infections
Adult: Usual dose: 500 mg bid via IV infusion over 60 minutes for 2-5 days, then switch to oral clarithromycin therapy whenever possible. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: ≥12 years Same as adult dose.
Oral Respiratory tract infections, Skin and soft tissue infections
Adult: As conventional tab: Usual dose: 250 mg bid, may be increased to 500 mg bid in severe infections. As extended-release tab: Usual dose: 500 mg once daily, may be increased to 1,000 mg once daily in severe infections. Usual treatment duration: 5-14 days, depending on the type of infection. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: 6 months to <12 years As oral susp: 7.5 mg/kg bid, up to a Max dose of 500 mg bid. Usual treatment duration: 5-10 days, depending on the pathogen involved and severity of infection; ≥12 years Same as adult dose. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Mycobacterium avium complex infections
Adult: Treatment of disseminated cases in patients with advanced HIV infection in combination with other antimycobacterial agents (e.g. ethambutol): As conventional tab: 500 mg bid. Prophylaxis of disseminated cases in patients with advanced HIV infection: As conventional tab: 500 mg bid. Continue therapy if clinical response is observed; may discontinue therapy if the patient is considered at low risk of disseminated infection. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines). Child: Treatment of disseminated cases in patients with HIV infection in combination with other antimycobacterials (e.g. ethambutol): As oral susp: 7.5-15 mg/kg bid. Max: 500 mg bid. Prophylaxis of disseminated cases in patients with HIV infection: As oral susp: 7.5 mg/kg bid. Max: 500 mg bid. Continue therapy if clinical response is observed; may discontinue therapy if the patient is considered at low risk of disseminated infection. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Eradication of Helicobacter pylori associated with peptic ulcer disease
Adult: Triple therapy regimen in combination with another antibiotic (e.g. amoxicillin) and a PPI (e.g. omeprazole, lansoprazole): As conventional tab: 500 mg bid for 7-14 days. Dual therapy regimen in combination with omeprazole: As conventional tab: 500 mg tid for 14 days. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Oral Acute otitis media
Child: As an alternative for patients who are intolerant to β-lactam antibiotics: 6 months to <12 years As oral susp: 7.5 mg/kg bid, up to a Max dose of 500 mg bid. Dosage and treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
Patients with renal impairment concurrently taking atazanavir or ritonavir-containing regimens:
CrCl (mL/min)
Dosage
<30
Reduce dose by 75%. Max: 1,000 mg daily.
30-60
Reduce dose by 50%. Max: 1,000 mg daily.
Renal Impairment
Oral: Respiratory tract infections; Skin and soft tissue infections:
CrCl (mL/min)
Dosage
<30
As conventional tab: Reduce usual dose by 50%. Avoid use of extended-release tab.
Eradication of Helicobacter pylori associated with peptic ulcer disease; Mycobacterium avium complex infections:
CrCl (mL/min)
Dosage
<30
As conventional tab: Reduce usual dose by 50%.
Intravenous:
CrCl (mL/min)
Dosage
<30
Reduce usual dose by 50%.
Administration
standard release tab & oral susp: May be taken with or without food. XL & MR tab: Should be taken with food. Swallow whole, do not chew/crush.
Reconstitution
Granules for oral susp: Reconstitute with the appropriate volume of water as indicated on the label. Shake until all particles are suspended. Powder for solution for IV infusion: Reconstitute vial labelled as 500 mg with 10 mL of sterile water for inj. Further dilute the reconstituted solution in at least 250 mL of compatible diluent (e.g. dextrose 5% in water, NaCl 0.9%, lactated Ringer's solution) to make a final concentration of 2 mg/mL.
Contraindications
Hypersensitivity to clarithromycin or any macrolide antibiotics. History of cholestatic jaundice or hepatic dysfunction associated with previous clarithromycin use; history of QT prolongation (congenital or documented acquired), ventricular cardiac arrhythmia (including torsades de pointes); electrolyte disturbances (e.g. hypokalaemia, hypomagnesaemia). Severe hepatic failure in combination with renal impairment. Concomitant use with ergot alkaloids (e.g. ergotamine, dihydroergotamine), HMG-CoA reductase inhibitors extensively metabolised by CYP3A4 (e.g. lovastatin, simvastatin), lurasidone, oral midazolam, astemizole, cisapride, pimozide, domperidone, terfenadine, ticagrelor, ranolazine, colchicine, and lomitapide.
Special Precautions
Patient with CAD, severe cardiac insufficiency, clinically relevant bradycardia or conduction disturbances; myasthenia gravis. Patient taking other drugs known to prolong QT interval (e.g. class IA or III antiarrhythmic agents). Patient taking atazanavir or patient with renal impairment taking atazanavir or ritonavir-containing regimens. Avoid using extended-release tab in patients with CrCl <30 mL/min, as dose cannot be reduced from 500 mg once daily. Hepatic and moderate to severe renal impairment. Children and elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hepatic dysfunction (e.g. increased liver enzymes, hepatocellular and/or cholestatic hepatitis with or without jaundice); severe acute hypersensitivity reactions (e.g. anaphylaxis, acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, Henoch-Schonlein purpura), exacerbation or new onset of symptoms of myasthenia gravis. Gastrointestinal disorders: Abdominal pain, diarrhoea, nausea, vomiting, dysgeusia, dyspepsia. General disorders and administration site conditions: Inj site reactions (e.g. phlebitis, pain, inflammation). Infections and infestations: Candidiasis. Investigations: Prolonged prothrombin time, increased BUN. Nervous system disorders: Headache. Psychiatric disorders: Insomnia. Skin and subcutaneous tissue disorders: Rash, hyperhidrosis. Vascular disorders: Vasodilation (IV). Potentially Fatal: Hepatic failure; pseudomembranous colitis, Clostridioides difficile-associated diarrhoea (CDAD); QT prolongation and arrhythmias (including torsades de pointes).
Perform culture and susceptibility tests when clinically indicated; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor BUN, serum creatinine, LFTs, and ECG (for QTc prolongation). Perform audiogram during prolonged use.
Overdosage
Symptoms: Abdominal pain, nausea, vomiting, and diarrhoea. Management: Supportive treatment. Initiate prompt elimination of unabsorbed drugs.
Drug Interactions
May result in significant hypoglycaemia when used concomitantly with oral hypoglycaemics (e.g. sulfonylureas, repaglinide, nateglinide) and/or insulin. Increased risk of haemorrhage and significant elevations in INR and prothrombin time with warfarin. May decrease efficacy with CYP3A inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital). Concomitant use with etravirine decreased the plasma concentration of clarithromycin while increasing the concentration of its active metabolite. Increased serum concentration with fluconazole and ritonavir. May elevate the serum concentrations of digoxin, theophylline, and CYP3A4 substrates (e.g. alprazolam, triazolam, IV midazolam, carbamazepine, cilostazol, ciclosporin, methylprednisolone, omeprazole, quetiapine, sildenafil, tadalafil, vardenafil, sirolimus, tacrolimus, vinblastine; tolterodine [in CYP2D6 poor metabolisers]). Increased risk of torsades de pointes with quinidine or disopyramide. May decrease the plasma concentration of zidovudine. Concomitant use with atazanavir, itraconazole, saquinavir, or certain Ca channel blockers metabolised by CYP3A4 (e.g. amlodipine, diltiazem, verapamil) may result in increased serum concentrations of both clarithromycin and the concomitant drug. May increase the risk of CV events with hydroxychloroquine or chloroquine. Potentially Fatal: Concomitant use with cisapride, pimozide, domperidone, terfenadine, and astemizole may lead to QT prolongation and cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, and torsades de pointes. Increased risk of myopathy, including rhabdomyolysis, with HMG-CoA reductase inhibitors (e.g. lovastatin, simvastatin). Concomitant use with ergotamine or dihydroergotamine may result in acute ergot toxicity. May increase plasma concentration of oral midazolam. May result in markedly increased transaminases when used concomitantly with lomitapide. Increased serum levels and risk of toxicity of colchicine. May increase the serum concentrations of lurasidone and ticagrelor.
Food Interaction
May decrease efficacy with St. John's wort. Delayed rate but not the extent of absorption with food (conventional form); increased exposure with food relative to fasting conditions (extended-release tab).
Action
Description: Mechanism of Action: Clarithromycin is a macrolide antibiotic that selectively binds to the 50S ribosomal subunit of susceptible bacteria and prevents the translocation of aminoacyl transfer-ribonucleic acid (RNA), resulting in the inhibition of intracellular protein synthesis. Pharmacokinetics: Absorption: Rapidly and well absorbed from the gastrointestinal tract. Food delays rate but not the extent of absorption (conventional form); food increases exposure by approx 30% relative to fasting conditions (extended-release tab). Bioavailability: Approx 50-55%. Time to peak plasma concentration: 2-3 hours (conventional form); 5-8 hours (extended-release tab). Distribution: Widely and readily distributed into body tissues and fluids. Crosses the placenta; enters breast milk (small amounts). Plasma protein binding: Approx 80%. Metabolism: Partially metabolised in the liver by CYP3A4 isoenzyme; undergoes extensive first-pass metabolism into 14-hydroxyclarithromycin (active metabolite). Excretion: Via urine (approx 20-40% as unchanged drug; 10-15% as metabolite); faeces (5-10% as unchanged drug). Elimination half-life: Conventional form: 3-7 hours (clarithromycin); 5-9 hours (14-hydroxyclarithromycin).
Chemical Structure
Clarithromycin Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 84029, Clarithromycin. https://pubchem.ncbi.nlm.nih.gov/compound/Clarithromycin. Accessed May 28, 2024.
Storage
Conventional or extended-release tab: Store below 30°C. Protect from light. Oral susp: Store below 30°C. Do not refrigerate after reconstitution. Powder for solution for IV infusion: Store intact vials below 30°C. Reconstituted solution: Store between 5-25°C and use within 24 hours. Diluted solution: Stable for 6 hours if stored at 25°C or for 24 hours if stored at 5°C. Storage recommendations may vary between products (refer to specific product guidelines).
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
References
Anon. Clarithromycin. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 01/04/2024.Buckingham R (ed). Clarithromycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2024.Clarithromycin for Suspension (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/04/2024.Clarithromycin Tablet (Ajanta Pharma USA Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/04/2024.Clarithromycin Tablet, Film Coated, Extended Release (Actavis Pharma, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 01/04/2024.Clarithromycin. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 01/04/2024.Joint Formulary Committee. Clarithromycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 01/04/2024.Kalixocin Powder for Injection 500 mg (Pahang Pharmacy Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2024.Klacid Granules for Oral Suspension (Abbott Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2024.Klacid MR 500 mg Tablet (Abbott Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2024.Klacid Tablet 500 mg (Abbott Laboratories [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 01/04/2024.Klaricid 500 mg Tablets (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2024.Klaricid IV 500 mg, Powder for Concentrate for Solution for Infusion (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2024.Klaricid Paediatric Suspension 125 mg/5 mL (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2024.Klaricid XL 500 mg Tablets (Mylan Products Ltd.). MHRA. https://products.mhra.gov.uk. Accessed 01/04/2024.Viatris Ltd. Klacid Film Coated Tablet, Granules for Oral Suspension, and Powder for Injection data sheet 12 September 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 01/04/2024.
Sign Out
