Polymyxin B

Clinical data from the use of polymyxin B sulphate in pregnant women is not available. Polymyxin B for injection should not be used during pregnancy unless the expected benefit to the mother outweighs any possible risk to the fetus. Animal studies are also lacking with respect to embryotoxicity and/or teratogenicity of polymyxin B sulphate.

It is not known whether polymyxin B sulphate is secreted in breast or animal milk. Because of the potential for unknown effects of the drug in infants being nursed by mothers taking polymyxin B sulphate, a decision should be made to either discontinue nursing or discontinue treatment, taking into account the importance of polymyxin B sulphate injection drug treatment to the mother and the possible risk to the infant.

Information not available.

Adverse Drug Reaction Overview

The most common drug-related adverse reactions are nephrotoxicity and neurotoxicity, pain at the injection site, urticaria, and electrolyte imbalance.

Clinical Trial Adverse Drug Reactions

Prospective clinical trials were not conducted for polymyxin B sulphate. Therefore drug-related adverse reactions that could occur are derived from adverse drug reporting from retrospective clinical studies.

Renal and Urinary Disorders: albuminuria, cylindruria (urinary cast), azotemia (a diminishing urine output and rising BUN).

Nervous System Disorders: facial flushing, dizziness progressing to ataxia, drowsiness, circumoral, lingual and peripheral paresthesia (stocking-glove distribution), apnea due to concurrent use of curariform muscle relaxants or other neurotoxic drugs, or inadvertent overdosage, signs of meningeal irritation presenting as convulsions and signs of meningismus with intrathecal administration (e.g., fever, headache, seizure, stiff neck and increased cell count and protein in cerebrospinal fluid following intrathecal/intraventricular administration of polymyxin B sulphate).

Immune System Disorders: urticarial rash at intramuscular injection sites. Allergic hypersensitivity following topical application of polymyxin B sulphate has been reported.

General Disorders & Administration Site Conditions: pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.

Less Common Clinical Trial Adverse Drug Reactions (<1%)

Information not available.

Abnormal Hematologic and Clinical Chemistry Findings

Electrolyte imbalance (including hyponatremia, hypochloremia and hypocalcemia) has been reported during parenteral therapy in patients with serious underlying malignant disease.

Eosinophilia has been reported, but the significance of this finding is not established.

Post-Market Adverse Drug Reactions

Eye Disorder: ophthalmic application of polymyxin B sulphate has reported low-grade conjunctivitis

Gastrointestinal Disorders: pseudomembraneous colitis

Immune System Disorders: bronchoconstriction following administration of nebulized polymyxins, anaphylactoid reactions, rash/pruritus, dermatitis and drug fever

Nervous System Disorders: facial paralysis, partial deafness, visual disturbance, vertigo, seizure and neuromuscular weakness and neuromuscular blockade

Renal and Urinary Disorders: acute renal failure