Colate Adverse Reactions

The likelihood of adverse drug events may be related to various factors such as age, renal function and condition of the patient.
Cystic Fibrosis Patients: In cystic fibrosis patients neurological events have been reported in up to 27% of patients. These are generally mild and resolve during or shortly after treatment. Neurotoxicity may be associated with overdose, failure to reduce the dose in patients with renal insufficiency and concomitant use of either neuromuscular blocking drugs or other drugs with similar neurological effects. Reducing the dose may alleviate symptoms. Effects may include apnoea, transient sensory disturbances (such as facial paraesthesia and vertigo) and, rarely, vasomotor instability, slurred speech, visual disturbances, confusion or psychosis. Adverse effects on renal function have been reported, usually following use of higher than recommended doses in patients with normal renal function, or failure to reduce the dosage in patients with renal impairment or during concomitant use of other nephrotoxic drugs. The effects are usually reversible on discontinuation of therapy.
In cystic fibrosis patients treated within the recommended dosage limits, nephrotoxicity appears to be rare (less than 1%). (See Table 2.)

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Seriously Ill Hospitalized Non-Cystic Fibrosis Patients: In seriously ill hospitalised non-cystic fibrosis patients, signs of nephrotoxicity have been reported in approximately 20% of patients. Hypersensitivity reactions including skin rash and drug fever have been reported. If these occur, treatment should be withdrawn. Local irritation at the site of injection may occur. (See Table 3.)

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The probability of occurrence of adverse drug reaction associated with the use of colistimethate sodium to infants <1 year of age is expected. This is due to underdeveloped renal function for this age group. Furthermore, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known, hence caution is advised.