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warnings
WARNINGS Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function. Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care. Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic. Electrolyte and Acid/Base Abnormalities Postmarketing cases of renal tubulopathy (i.e., Pseudo-Bartter syndrome) have been identified with the use of intravenous colistimethate sodium (see ADVERSE REACTIONS ). All cases reported hypokalemia and metabolic alkalosis. Other common findings included hypocalcemia, hypomagnesemia, increased potassium in the urine, normal serum creatinine, and normal blood pressure. Consider electrolyte monitoring during treatment. Normalization of electrolyte abnormalities may require drug discontinuation. Overdosage can result in renal insufficiency, muscle weakness, and apnea (see OVERDOSAGE section). See PRECAUTIONS, Drug Interactions subsection for use concomitantly with other antibiotics and curariform drugs. Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines. See DOSAGE AND ADMINISTRATION section for use in renal impairment. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Colistimethate for Injection, USP and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, ...
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adverse reactions
ADVERSE REACTIONS The following adverse reactions have been reported: Gastrointestinal: gastrointestinal upset Nervous System: tingling of extremities and tongue, slurred speech, dizziness, vertigo, paresthesia and seizures Integumentary: generalized itching, urticaria and rash Body as a Whole: fever and anaphylaxis Laboratory Deviations: increased blood urea nitrogen (BUN), elevated creatinine and decreased creatinine clearance Respiratory System: respiratory distress and apnea Renal System: electrolyte and acid/base abnormalities (i.e., Pseudo-Bartter syndrome), nephrotoxicity and decreased urine output For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact Xellia Pharmaceuticals Inc at 1-833-295-6953, or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch/.