Vaxcel Polymyxin E Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Colistimethate Na

Indications/Uses

IV administration for serious infections caused by gram -ve bacteria eg, lower resp & urinary tract. Inhalation for Pseudomonas aeruginosa lung infection in patients w/ cystic fibrosis (CF).

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Dosage/Direction for Use

IV Adult & childn including elderly up to 60 kg 50,000-75,000 u/kg daily divided into 3 doses at approx 8-hr intervals, >60 kg 1-2 MIU tds. Max: 6 MIU in 24 hr. Min duration: 5 days. Patient ≥60 kg Renal impairment CrCl 20-50 mL/min 1-2 MIU every 8 hr, CrCl 10-20 mL/min 1 MIU every 12-18 hr, CrCl <10 mL/min 1 MIU every 18-24 hr. Inhalation Patient w/ CF 500,000 u bd to 2 MIU tds. Childn <2 yr 500,000 u to 1 MIU bd, >2 yr & adult 1-2 MIU bd. Duration: Up to 12 days.

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Overdosage

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Contraindications

Hypersensitivity to colistimethate Na or polymyxin B. Patients w/ myasthenia gravis.

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Special Precautions

Porphyria, nephrotoxicity or neurotoxicity, pseudo-Bartter syndrome, bronchospasm. Monitor & assess baseline renal function, serum electrolytes during treatment. Avoid use w/ colistimethate Na-containing mixed infusions, inj & nebuliser soln. May affect ability to drive & use machines. Renal impairment. Pregnancy & lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypersensitivity reactions eg, skin rash. Systemic treatment: Drug fever, apnoea, transient sensory disturbances eg, facial paraesthesia, vertigo. Inhalation treatment: Induced coughing or bronchospasm, sore throat or mouth.

Drug Interactions

Increased risk of nephrotoxicity w/ cephalosporins. Avoid concomitant use w/ aminoglycosides eg, gentamicin, amikacin, netilmicin, tobramycin. Extreme caution w/ neuromuscular blocking drugs.

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Storage

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Description

View Vaxcel Polymyxin E description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Other Antibiotics

ATC Classification

J01XB01 - colistin ; Belongs to the class of polymyxins. Used in the systemic treatment of infections.

Regulatory Classification

Presentation/Packing

Form

Vaxcel Polymyxin E powd for inj 1 MIU

Packing/Price

10 × 1's

Vaxcel Polymyxin E

colistimethate sodium

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma