Only for the use of a Registered Specialist or a Hospital or a Laboratory.

Colistimethate Sodium for Injection IP

Coliate 1/2/3/4.5 MIU


Each Vial Contains:

Colistimethate Sodium IP……..1,000,000 IU

(IU: International Units)

Each Vial Contains:

Colistimethate Sodium IP……..2,000,000 IU

(IU: International Units)

Each Vial Contains:

Colistimethate Sodium IP……..3,000,000 IU

(IU: International Units)

Each Vial Contains:

Colistimethate Sodium IP……..4.5,000,000 IU

(IU: International Units)


Sterile powder for solution for injection. Infusion and inhalation

(Inhalation route is not applicable to 3 MIU/4.5 MIU)


Colistimethate sodium for injection IP may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms.

  • Intravenous administration for the treatment of some serious infections caused by multiple-drug resistant gram-negative bacteria, such as lower respiratory tract and urinary tract. Used only when the causative agent is susceptible and other more effective and less toxic anti-infective are contraindicated or ineffective.
  • In patients with cystic fibrosis, inhaled colistimethate sodium may be used to treat serous bacterial lung infections caused by Pseudomonas aeruginosa.


Recommended Dosage

The Dosage is determined by the severity and type of infection, the sensitivity of the causative bacteria and the age, weight and renal function of the patient.

Estimation of serum levels is particularly recommended for patients with renal impairment, neonates and patients with cystic fibrosis. Serum levels of 10-15 mg/I (approximately 125-200 units/ml) shouldbe adequate for most infections.

Administration and Preparation instructions


The normal adult dose should be dissolved in 10 ml of sterile water for injections to form a clear solution and given over a minimum of 5 minutes.

The solution is for single use only and any remaining solution should be discarded.

Swirl gently during reconstitution to avoid frothing.


Colistimethate Sodium can be given as a 50 ml intravenous infusion in 0.9% sodium chloride solution or sterile water for injections.

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.


NEBULIZER (Not applicable for 3 MIU/4.5 MIU)

The required amount of powder is dissolved, preferably, in 2-4 mL of 0.9% sodium chloride solution and poured into the nebulizer. Alternatively, sterile water for injections may be used. The solution will be slightly hazy and may froth if shaken. Usually jet or ultrasonic nebulizers are preferred for antibiotic delivery. These should produce the majority of their output in the respirable particle diameter range of 0.5-5.0 microns when used with a suitable compressor. The instructions of the manufactures should be followed for the operation and care of the nebulizer and compressor. The output from the nebulizer may be vented to the open air or a filter may be fitted. Nebulisation should take place in a well-ventilated room. The solution is for single use only and remaining solution should be discarded.

Children and adults (including the elderly) 

Children< 2 years: 500,000 – 1,000,000 units, twice daily.

Upto 60kg: 50,000 units/kg/day, to a maximum of 75000 units/kg/day. The total daily dose should be divided into three doses given at approximately 8- hour intervals.

Over 60kg: 1-2 million units three times a day. The maximum dose is 6 million units in 24 hours.

Renal Impairment: In moderate or severe renal impairment, excretion of Colistimethate is delayed. Therefore, the dose and the dose interval should be adjusted in order to prevent accumulation. The table below is a guide to dose regiment modifications in patients of 60 kg bodyweight or greater. It is stressed that adjustments may still have to be made on evaluation of the individual patient based on blood levels and evidence of toxicity.

Suggested Dose Adjustment in Renal Impairment

Grade           Creatinine clearance (ml/min)              Over 60 kg bodyweight

Mild                           20-50                                                           1-2 million units every 8hr

Moderate                10-20                                                            1 million units every 12-18 hr

Severe                      <10                                                               1 million units every 18-24 hr




Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. Since Colistimethate

Solutions for Nebulization

Solutions for nebulization have similar in-use stability and may be kept for up to 24 hours stored in a refrigerator i.e 2-8°C. Patients self-treating with nebulized antibiotic should be advised to use solutions immediately after Preparation.

Does not contain any preservatives.


Please see manufacturing date and Expiry date printed on pack. Do not use the product after the expiry date which is stated on the packaging. The expiry date refers to the last day of that month.


10 ml USP Type I glass vial with a rubber stopper and aluminum cap, Packed in a single monocarton along with Patient information Leaflet.


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