Coliracin

/ Rafa

Coliracin injection is usually administered IM or IV.
Coliracin must be reconstituted before use.
Dosage: The dose and the treatment duration are determined by the severity and type of infection and the age, weight and renal function of the patient as well as the clinical response. Should clinical or bacteriological response be slow, the dose may be increased as indicated by the patient’s condition.
A minimum of 5 days treatment is generally recommended. For the treatment of respiratory exacerbations in cystic fibrosis patients, treatment should be continued for up to 12 days.
The recommended dosage in children and adults up to 60kg is 50,000 units/kg/day to maximum of 75,000 units/kg/day. The total daily dose should be divided into three doses given at approximately 8-hour intervals. Serum levels should be measured if used in the newborn.
The recommended dosage in patients over 60kg: 1-2 million units three times a day. The maximum dose is 6 million units in 24 hours.
Dosage should be in line with relevant treatment guidelines. Limited pharmacokinetic data from critically ill patients suggest that use of a loading dose and higher than standard doses may be appropriate. For severe infections and in critically ill patients doses up to 9 million IU per day in divided doses, have been reported in the literature. Clinical efficacy and safety data with these
regimens are very limited and caution is advised.
See prescribing information for full details.

Antibiotic for treatment of infections caused by micro-organisms sensitive to colistin.

Hypersensitivity to the active substance or other polymyxins.

Impaired renal function. Ability to perform potentially-hazardous tasks requiring mental alertness or physical coordination, may be impaired. Administration in excess of renal excretory capacity will lead to high serum levels.

Respiratory arrest, paresthesia, tingling of the extremities and/or of the tongue and generalized itching or urticaria, drug fever, dizziness, vertigo, giddiness, ataxia, blurred vision and slurring of speech may occur. Other neurotoxic effects, including mental confusion, coma, psychosis and seizures have also been reported, especially in patients receiving high dosage or in patients with renal impairment. Gastrointestinal upset may occur.

Other antibacterial agents. Aminoglycosides, amphotericin B, polymyxin, vancomycin, muscle reactants.

Pregnancy: Safety in human pregnancy has not been established. Animal studies are insufficient with respect to the effects on reproduction and development. There is evidence that that colistimethate sodium crosses the placenta and consequently there is potential of fetal toxicity if administered during pregnancy. Hence, Coliracin should only be given during pregnancy if the benefits outweigh any potential risk.
Lactation: Colistimethate sodium is excreted in breast milk; breast feeding is not recommended during therapy.

Overdose may cause renal insufficiency, renal failure, apnea, muscle weakness, vertigo, slurred speech, vasomotor instability, visual disturbances, confusion and psychosis.
No antidote is available.
Management of overdose is by means of supportive treatment and measures designed to increase clearance of colistimethate sodium such as inducing an osmotic diuresis with mannitol, peritoneal dialysis or prolonged haemodialysis.