TEICOPLANIN

What it is

Teicoplanin Sandoz 400 mg injection is a sterile lyophilised powder equivalent to 400 mg teicoplanin. The reconstituted injection is administered intravenously or intramuscularly. Teicoplanin is a glycopeptide antibiotic produced by Actinoplanes teichomyceticus.

Approved indications

— Bone infections (osteomyelitis) due to Staphylococci or Streptococci — Joint infections (septic arthritis) due to Staphylococci or Streptococci — Blood infections (non-cardiac bacteraemia, septicaemia) due to Staphylococci or Streptococci

Dosing overview

A loading dose regimen of three doses at 12 hourly intervals is recommended for rapid attainment of steady state plasma levels, followed by once daily maintenance dosage. Uncomplicated bacteraemia typically requires two to four weeks of treatment; septic arthritis or osteomyelitis typically requires three to six weeks. The dose is adjusted on bodyweight regardless of patient weight.

Key safety warnings

Serious, life-threatening hypersensitivity reactions, sometimes fatal, have been reported with teicoplanin including anaphylactic shock. If an allergic reaction occurs, treatment should be discontinued immediately and appropriate emergency measures initiated. Teicoplanin should be administered with caution in patients known to be hypersensitive to vancomycin since cross hypersensitivity reactions, including fatal anaphylactic shock, may occur. Life-threatening and fatal cutaneous reactions, including Stevens-Johnson syndrome, Toxic Epidermal Necrolysis and Drug reaction with eosinophilia and systemic symptoms, have been reported with teicoplanin. Patients should be informed about signs and symptoms of serious skin manifestations and monitored closely. If symptoms of these conditions are present, teicoplanin treatment should be discontinued immediately. Nephrotoxicity and renal failure have been reported in patients treated with teicoplanin. Safety data show increased rates of nephrotoxicity when high teicoplanin loading doses such as 12 mg/kg body weight twice a day are administered. Patients with renal insufficiency, or with risk factors for nephrotoxicity, patients receiving the high loading dose regimen, and patients receiving teicoplanin with other nephrotoxic products should be carefully monitored. Thrombocytopenia has been reported with teicoplanin. Periodic haematological examinations including complete cell blood count are recommended during treatment. Hearing impairment has been reported with teicoplanin. Periodic auditory function tests are advised especially in cases of prolonged treatment, patients with renal insufficiency and patients receiving teicoplanin with other ototoxic products.

Contraindications

Teicoplanin Sandoz is contraindicated in patients with known hypersensitivity to teicoplanin or any excipients associated with this product.

Regulatory history

Teicoplanin Sandoz received initial approval on 11 August 2010.