Clarithromycin


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Respiratory tract infections; Skin and soft tissue infections Usual dose: As conventional tab: 250 mg bid, may be increased to 500 mg bid for severe infections. As modified-release tab: 500 mg once daily, may be increased to 1,000 mg/day for severe infections. Usual treatment duration: 7-14 days. H. pylori eradication associated with peptic ulcer disease As conventional tab: Triple therapy regimen in combination with another antibiotic and a PPI: 500 mg bid for 7-14 days. Dual therapy regimen in combination with omeprazole: 500 mg tid for 14 days, followed by omeprazole for an additional 14 days. Mycobacterium avium complex infections Treatment of disseminated cases in patients with advanced HIV infection in combination with other antimycobacterial agents: As conventional tab or oral susp: 500 mg 12 hourly, may continue therapy if clinical response is observed. IV Respiratory tract infections; Skin and soft tissue infections Usual dose: 500 mg 12 hourly given via infusion over 60 minutes for 2-5 days, then switch to oral clarithromycin therapy whenever possible.
Dosage Details
Intravenous
Respiratory tract infections, Skin and soft tissue infections
Adult: Usual dose: 500 mg 12 hourly given via infusion over 60 minutes for 2-5 days, then switch to oral clarithromycin therapy whenever possible.

Oral
Respiratory tract infections, Skin and soft tissue infections
Adult: Usual dose: As conventional tab: 250 mg bid, may be increased to 500 mg bid for severe infections. As modified-release tab: 500 mg once daily, may be increased to 1,000 mg daily for severe infections. Usual treatment duration: 7-14 days.
Child: <12 years As oral susp: Recommended dose: 7.5 mg/kg bid, up to Max 500 mg bid. Usual treatment duration: 5-10 days, depending on the pathogen involved and severity of infection. Dosage requirements may vary based on patient age and weight (refer to detailed product guideline). ≥12 years Same as adult dose.

Oral
Mycobacterium avium complex infections
Adult: Treatment of disseminated cases in patients with advanced HIV infection in combination with other antimycobacterial agents: As conventional tab or oral susp: 500 mg 12 hourly, may continue therapy if clinical response is observed. May discontinue therapy if the patient is at low risk of disseminated infection.
Child: Treatment of disseminated cases in patients with advanced HIV infection in combination with other antimycobacterial agents: As conventional tab or oral susp: 7.5 mg/kg 12 hourly, up to 500 mg 12 hourly.

Oral
Eradication of H. pylori associated with peptic ulcer disease
Adult: As conventional tab: Triple therapy regimen in combination with another antibiotic (e.g. metronidazole, amoxicillin) and a PPI (e.g. omeprazole, lansoprazole): 500 mg bid for 7-14 days. Dual therapy regimen in combination with omeprazole: 500 mg tid for 14 days, followed by omeprazole for an additional 14 days.
Special Patient Group
Patients with renal impairment concurrently taking atazanavir, or ritonavir-containing regimens:
CrCl (mL/min)
Dosage
30-60
Reduce dose by 50%. Max: 1,000 mg/day.
<30
Reduce dose by 75%. Max: 1,000 mg/day.
Renal Impairment
Oral:
Respiratory tract infections; Skin and soft tissue infections:
CrCl (mL/min) Dosage
<30
As conventional tab: Reduce to half of the usual dose. As modified-release tab: Contraindicated.

Eradication of H. pylori associated with peptic ulcer disease; Mycobacterium avium complex infections:
CrCl (mL/min)
Dosage
<30
Reduce to half of the usual dose.

Intravenous:

CrCl (mL/min) Dosage
<30
Reduce to half of the usual dose.
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
Powder for oral susp: Reconstitute with the appropriate volume of water as indicated on the label. Shake well until suspended. Powder for IV infusion: Reconstitute a vial labelled as 500 mg with 10 mL of sterile water for inj. Further add the reconstituted solution to at least 250 mL of compatible diluent (e.g. 5% dextrose in Lactated Ringer’s solution, 5% dextrose, 0.9% NaCl, Lactated Ringer’s, 5% dextrose in 0.3% NaCl, 5% dextrose in 0.45% NaCl) to make a final concentration of approx 2 mg/mL.
Contraindications
Hypersensitivity to clarithromycin or any macrolide antibiotics. History of cholestatic jaundice/hepatic dysfunction associated with previous clarithromycin use; hypokalaemia, history of QT prolongation (congenital or documented acquired), ventricular cardiac arrhythmia including torsades de pointes; severe hepatic failure in combination with renal impairment. Concomitant use with ergot alkaloids (e.g. ergotamine, dihydroergotamine), oral midazolam, astemizole, cisapride, domperidone, pimozide, terfenadine, ticagrelor, ranolazine, lovastatin, simvastatin, colchicine, lomitapide. Modified-release tab: Significant renal impairment (CrCl <30 mL/min).
Special Precautions
Patient with coronary artery disease, severe cardiac insufficiency, clinically relevant bradycardia or conduction disturbances; electrolyte disturbances (e.g. hypomagnesaemia), myasthenia gravis. Patient taking other drugs known to prolong QT interval (e.g. class IA or III antiarrhythmics, antipsychotic agents, antidepressants, fluoroquinolones). Patient with renal impairment concurrently taking atazanavir or ritonavir-containing regimens. Hepatic and moderate to severe renal impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hepatic dysfunction (e.g. increased liver enzymes, hepatocellular and/or cholestatic hepatitis with or without jaundice); exacerbation or new onset 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 or C. difficile-associated diarrhoea (CDAD); QT prolongation, arrhythmias including torsades de pointes; anaphylaxis, severe cutaneous adverse reactions (e.g. acute generalised exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, Henoch-Schonlein purpura or IgA vasculitis).
MonitoringParameters
Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor BUN and serum creatinine; CBC with differential.
Overdosage
Symptoms: Abdominal pain, vomiting, nausea, and diarrhoea. Management: Supportive treatment. Initiate prompt elimination of unabsorbed drugs.
Drug Interactions
May result in significant hypoglycaemia with oral hypoglycaemics (e.g. sulfonylureas, repaglinide, nateglinide) and insulin. Increased risk of haemorrhage and elevated INR and prothrombin time with warfarin. May induce metabolism and decrease efficacy with CYP3A inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital). May reduce the plasma levels with strong CYP450 inducers (e.g. efavirenz, nevirapine, rifabutin, rifapentine). Decreased exposure with etravirine. Increased plasma concentration and exposure with fluconazole. May elevate the serum concentrations of digoxin and CYP450 substrates (e.g. alprazolam, carbamazepine, cilostazol, ciclosporin, methylprednisolone, omeprazole, quetiapine, sildenafil, sirolimus, tacrolimus, vinblastine, theophylline, valproate, tolterodine). May increase the risk of torsades de pointes with quinidine or disopyramide. May decrease the plasma concentrations of zidovudine. Ritonavir significantly inhibits the metabolism of clarithromycin. Concomitant use with atazanavir, itraconazole, saquinavir, or certain Ca channel blockers (e.g. verapamil, amlodipine, diltiazem) may result in bi-directional drug interactions. Increased or prolongation of sedation with triazolam.
Potentially Fatal: Concomitant use with cisapride, pimozide, domperidone, terfenadine, and astemizole may cause QT prolongation or cardiac arrhythmias including ventricular tachycardia or fibrillation, and torsades de pointes. Increased serum concentrations and risk of acute toxicity of ergotamine or dihydroergotamine. Markedly elevated plasma concentrations of oral midazolam. Significantly increased transaminases with lomitapide. Increased risk of myopathy and rhabdomyolysis with lovastatin or simvastatin. Increased serum levels and risk of toxicity of colchicine. May increase serum concentrations of ranolazine; decrease serum concentrations of the active metabolite of ticagrelor.
Food Interaction
May reduce the efficacy with St. John’s wort.
Action
Description: Clarithromycin is a macrolide antibiotic that selectively binds to the 50S ribosomal subunit of susceptible bacteria and prevents the activated amino acids translocation, resulting in inhibition of intracellular protein synthesis.
Pharmacokinetics:
Absorption: Rapidly and well absorbed from the gastrointestinal tract. Bioavailability: Approx 50%. Time to peak plasma concentration: 2-3 hours (immediate-release); 5-8 hours (modified-release).
Distribution: Widely and readily distributed into most body tissues and fluids. Crosses the placenta and enters breast milk. Plasma protein binding: 80%.
Metabolism: Partially metabolised in the liver by CYP3A4 isoenzyme and undergoes extensive first-pass metabolism into 14-hydroxyclarithromycin (active).
Excretion: Via urine (approx 20-40% as unchanged drug; 10-15% as metabolites); faeces (5-10% as unchanged drug). Elimination half-life: Immediate-release: 3-7 hours (clarithromycin); 5-9 hours (14-hydroxyclarithromycin).
Chemical Structure

Chemical Structure Image
Clarithromycin

Source: National Center for Biotechnology Information. PubChem Database. Clarithromycin, CID=84029, https://pubchem.ncbi.nlm.nih.gov/compound/Clarithromycin (accessed on Jan. 21, 2020)

Storage
Conventional/modified-release tab: Store between 15-30°C. Protect from light. Oral susp: Store at 25°C prior to and after reconstitution. Do not refrigerate. Once reconstituted, use within 14 days. Powder for IV infusion: Store below 30°C.
MIMS Class
ATC Classification
J01FA09 - clarithromycin ; Belongs to the class of macrolides. Used in the systemic treatment of infections.
References
Anon. Clarithromycin. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/07/2020.

Axcel 125 mg/5 mL Suspension (Kotra Pharma Sdn Bhd). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my/. Accessed 02/07/2020.

Buckingham R (ed). Clarithromycin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/07/2020.

Clarithromycin 500 mg Film-Coated Tablets (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk/. Accessed 02/07/2020.

Clarithromycin for Suspension (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2020.

Clarithromycin Tablet (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2020.

Clarithromycin Tablet, Film Coated, Extended Release (Lannett Company, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 02/07/2020.

Joint Formulary Committee. Clarithromycin. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/07/2020.

Klacid MR Tablet (Abbott Laboratories). MIMS Singapore. http://www.mims.com/singapore. Accessed 02/07/2020.

Klacid/Klacid Forte Tablet (Abbott Laboratories). MIMS Singapore. http://www.mims.com/singapore. Accessed 02/07/2020.

Klaricid IV 500 mg, Powder for Concentrate for Solution for Infusion (Mylan Products Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 02/07/2020.

Klaricid Paediatric Suspension 125 mg/5mL (Mylan Products Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 02/07/2020.

Klaricid XL 500 mg Tablets (Mylan Products Ltd). MHRA. https://products.mhra.gov.uk/. Accessed 02/07/2020.

Mylan New Zealand Ltd. Klacid Film Coated Tablet, Granules for Oral Suspension, Powder for Injection data sheet 16 April 2018. Medsafe. http://www.medsafe.govt.nz/. Accessed 02/07/2020.

Disclaimer: This information is independently developed by MIMS based on Clarithromycin from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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