Poliz-B Adverse Reactions

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 for injection. 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.
General disorders & Administration site conditions: 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: 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.