- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Powder for solution for infusion containing clarithromycin
Lower respiratory tract infections
Skin and soft tissue infections
Upper respiratory tract infections
Treatment of infections caused by susceptible organisms where parenteral therapy is required in the following conditions:
Lower respiratory tract infections e.g. acute and chronic bronchitis, pneumonia
Upper respiratory tract infections e.g. sinusitis, pharyngitis, tonsillitis
Skin and soft tissue infections
Intravenous therapy may be given for two to five days and should be changed to oral therapy when appropriate.
500mg twice daily.
Children aged 12 to 18 years: 500mg twice daily.
Children aged 1 month to 12 years (unlicensed): 7.5mg/kg every 12 hours for up to five days. Maximum of 500mg per dose.
Patients with Renal Impairment
Use with caution in patients with renal impairment. In patients with renal impairment an increase in clarithromycin plasma levels and its active metabolite have been observed.
Creatinine clearance less than 30ml/minute
Reduce dose to half of the normal dose.
For intravenous infusion only. Administer into one of the larger proximal veins as an intravenous infusion over 60 minutes, using a solution concentration of 2 mg/ml.
Family history of long QT syndrome
History of torsade de pointes
History of ventricular arrhythmias
Long QT syndrome
Severe hepato-renal syndrome
Precautions and Warnings
Children under 12 years
Bradycardia with pulse rate at rest < 50 beats per minute
Ischaemic heart disease
Renal impairment - creatinine clearance below 30 ml/minute
Severe cardiac dysfunction
May exacerbate myasthenia gravis
Reduce dose in patients with creatinine clearance below 30ml/min
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Ineffective for H. influenzae infections with concurrent tipranavir
Not licensed for use in children under 12 years
Must be given as an intravenous infusion
Take cultures for sensitivity testing before and regularly during treatment
Consider pseudomembranous colitis if patient presents with severe diarrhoea
Advise patients to report signs of hepatic damage (malaise, jaundice etc.)
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue if overgrowth of resistant organisms occurs
Discontinue if severe hypersensitivity reactions occur
Discontinue if symptoms of hepatic disease occur
Discontinue therapy if marked diarrhoea occurs
Advise patient not to take St John's wort concurrently
Due to a risk of prolonged QT interval, clarithromycin should not be used in patients with the following conditions:
Coronary artery disease
History of ventricular arrhythmia
Severe cardiac impairment
Bradycardia (less than 50 bpm)
Sensitivity testing should be performed when prescribing clarithromycin for community-acquired pneumonia due to emerging resistance of Streptococcus pneumoniae to macrolides. In hospital-acquired pneumonia, clarithromycin should be used in combination with additional appropriate antibiotics.
Before initiating treatment for skin and soft tissue infections of mild to moderate severity, sensitivity testing should be preformed. Skin and soft tissue infections are most often caused by Staphylococcus aureus and Streptococcus pyogenes, both of which may be resistant to macrolides. Currently, macrolides are only considered appropriate in some skin and soft tissue infections, such as those caused by Corynebacterium minutissimum (erythrasma), acne vulgaris, erysipelas and in situations where penicillin treatment cannot be used.
Cases of fatal hepatic failure have been reported. Some patients may have had pre-existing hepatic disease or may have been taking other hepatotoxic medicinal products. Patients should be advised to stop treatment and contact their doctor if signs and symptoms of hepatic disease develop, such as anorexia, jaundice, dark urine, pruritis, or tender abdomen.
Clarithromycin inhibits the enzyme CYP3A4, which is involved in the metabolism of colchicine. Therefore if these drugs are given concurrently, colchicine toxicity may occur. Toxicity is more likely to occur in the elderly or in those with renal impairment and death has occurred in some cases. If these drugs are administered concurrently, the patient should be monitored for signs of colchicine toxicity.
Clarithromycin may cause antibiotic-associated diarrhoea (including Clostridium difficile associated diarrhoea), colitis and pseudomembranous colitis. If diarrhoea occurs during or soon after treatment then these diagnoses should be considered. Careful medical history is necessary since Clostridium difficile associated diarrhoea has been reported to occur over two months after the administration of antibacterial agents. If severe or bloody diarrhoea occurs during treatment, clarithromycin should be discontinued and appropriate therapy instituted. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of Clostridium difficile, and surgical evaluation should be instituted as clinically indicated.
Pregnancy and Lactation
Use clarithromycin with caution during pregnancy.
Briggs reports the available human pregnancy data on the use of clarithromycin during pregnancy suggests that the risk, if it exists, is low. However the animal reproduction data suggest high risk. Schaefer suggests clarithromycin is a second choice macrolide for use during pregnancy. The manufacturers suggest clarithromycin should not be used during pregnancy unless the benefits outweigh the risks.
Safety in human pregnancy has not been established. Clarithromycin crosses the human placenta. The mean transplacental transfer of clarithromycin was 6.1% in an in vitro experiment using perfused term placentas. The possibility of adverse effects on embryofoetal development cannot be excluded based on variable results obtained from studies in mice, rats, rabbits and monkeys.
The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Use clarithromycin with caution in breastfeeding.
Drugs and Lactation Database (LactMed) considers clarithromycin acceptable during breastfeeding due to low levels of clarithromycin in breast milk. The small amounts in milk are unlikely to cause adverse effects in the infant. However, the infant should be monitored for possible effects on the gastrointestinal flora, such as diarrhoea, thrush or nappy rash. Unconfirmed epidemiologic evidence indicates that the risk of hypertrophic pyloric stenosis in infants might be increased by maternal use of macrolide antibiotics during breastfeeding. The manufacturers suggest clarithromycin should not be used in breastfeeding unless the benefits outweigh the risks.
Clarithromycin and its active metabolite are excreted in human breast milk.
Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Alanine aminotransferase increased
Altered liver function tests
Aspartate aminotransferase increased
Blood urea increased
Discolouration of teeth and tongue
Exacerbation of myasthenia gravis
Gastroesophageal reflux disease
Increase in alkaline phosphatase
Increase in lactate dehydrogenase
Increases in hepatic enzymes
Injection site reactions
Loss of consciousness (transient)
Overgrowth by non-susceptible organisms
Prolongation of QT interval
Prothrombin time increased
Serum creatinine increased
Torsades de pointes
Toxic epidermal necrolysis
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2013
Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.
Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.
Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.
Summary of Product Characteristics: Clarithromycin 500 mg Powder for Concentrate for Solution for Infusion. Teva UK Ltd. Revised June 2011.
Summary of Product Characteristics: Klaricid IV 500 mg. Abbott Laboratories Ltd. Revised July 2013.
NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 23 June 2017.
US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Clarithromycin. Last revised: September 7, 2013
Last accessed: September 10, 2013.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.