clarithromycin lactobionate: clinical use

Prescribing considerations

• Confirm that intravenous treatment is required and the likely or proven organism is susceptible.
• Review all medicines for contraindicated CYP3A, P-glycoprotein and QT-related interactions.
• Use caution with hepatic impairment and moderate-to-severe renal impairment.
• Consider previous macrolide exposure and possible cross-resistance with other macrolides, clindamycin and lincomycin.
• Review promptly if superinfection or antibiotic-associated colitis is suspected.

Contraindications and cautions

• Hypersensitivity to clarithromycin, another macrolide or an excipient
• Previous congenital or acquired QT prolongation, or ventricular arrhythmia including torsades de pointes
• Hypokalaemia or hypomagnesaemia
• Severe hepatic failure combined with renal impairment
• Concomitant use of contraindicated medicines including simvastatin, lovastatin, colchicine, oral midazolam, ergot alkaloids, ticagrelor, ranolazine, lomitapide and specified QT-prolonging medicines

Monitoring

• Renal and hepatic function where clinically indicated
• ECG and electrolytes in patients with cardiac or QT-risk factors
• Infusion site for pain, inflammation and phlebitis
• INR or other bleeding assessment with anticoagulants
• Blood glucose with insulin, glucose-lowering medicines or disopyramide
• Relevant serum concentrations or toxicity signs for narrow-therapeutic-index interacting medicines
• Diarrhoea during treatment and possible delayed antibiotic-associated colitis

Clinical pharmacology

Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It is extensively metabolised in the liver, produces an active 14-hydroxy metabolite, penetrates respiratory tissues and strongly inhibits CYP3A.

Formulation and product differences

• Contains clarithromycin as clarithromycin lactobionate in a powder for intravenous infusion.
• Requires sequential reconstitution and dilution with specified compatible fluids and must not be given as a bolus or intramuscular injection.
• Infusion-site phlebitis, pain and inflammation are formulation-specific adverse reactions.
• The prepared product is for single use and requires aseptic handling.

Solution for infusion

Route: Intravenous

Strengths: 500 mg