Colistimethate Sodium 1 million I.U. powder for solution for Injection/Inhalation


  1. Name of the medicinal product

Colistimethate 1 million International Units (IU)
Colistimethate 2 million International Units (IU)
Colistimethate 3 million International Units (IU)
Colistimethate 4.5 million International Units (IU)

Powder for solution for injection, infusion or inhalation.

  1. Qualitative and quantitative composition

Each vial contains 1 million IU Colistimethate Sodium.
Each vial contains 2 million IU Colistimethate Sodium.
Each vial contains 3 million IU Colistimethate Sodium.
Each vial contains 4.5 million IU Colistimethate Sodium.

For excipients, see 6.1.

  1. Pharmaceutical form

Powder for solution for injection, infusion or inhalation.

Sterile white powder in a 10ml colourless glass vial with a red ‘flip-off’ cap.

  1. Clinical particulars

4.1 Therapeutic indications

Colistimethate by intravenous administration is indicated in adults and children including neonates for the treatment of serious infections due to selected aerobic Gram-negative pathogens in patients with limited treatment options (see sections 4.2, 4.4, 4.8 and 5.1).

Colistimethate by inhalation is also indicated for the management of adult and paediatric chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (see section 5.1).

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

4.2 Posology and method of administration


The dose to be administered and the treatment duration should take into account the severity of the infection as well as the clinical response. Therapeutic guidelines should be adhered to.

The dose is expressed in IU of colistimethate sodium (CMS). A conversion table from CMS in IU to mg of CMS as well as to mg of colistin base activity (CBA) is included at the end of this section.


The following dose recommendations are made based on limited population-pharmacokinetic data in critically ill patients (see section 4.4):

Adults and adolescents

Maintenance dose 9 million IU/day in 2-3 divided doses

In patients who are critically ill, a loading dose of 9 MIU should be administered.

The most appropriate time interval to the first maintenance dose has not been established.

Modelling suggests that loading and maintenance doses of up to 12 MIU may be required in patients with good renal function in some cases. Clinical experience with such doses is however extremely limited, and safety has not been established.

The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy.

Renal impairment

Dose adjustments in renal impairment are necessary, but pharmacokinetic data available for patients with impaired renal function is very limited.

The following dose adjustments are suggested as guidance.

Dose reductions are recommended for patients with creatinine clearance < 50 ml/min:

Twice daily dosing is recommended.

Creatinine clearance


Daily dose
< 50- 305.5- 7.5 MIU
<30- 104.5- 5.5 MIU
<103.5 MIU

MIU = million IU

Haemodialysis and continuous haemo(dia)filtration

Colistin appears to be dialyzable through conventional haemodialysis and continuous venovenous haemo(dia)filtration (CVVHF, CVVHDF). There are extremely limited data from population PK studies from very small numbers of patients on renal replacement therapy. Firm dose recommendations cannot be made. The following regimes could be considered.


No-HD days: 2.25 MIU/day (2.2-2.3 MIU/day).

HD days: 3 MIU/day on haemodialysis days, to be given after the HD session.

Twice daily dosing is recommended.


As in patients with normal renal function. Three times daily dosing is recommended.

Hepatic impairment

There are no data in patients with hepatic impairment. Caution is advised when administering colistimethate sodium in these patients.


No dose adjustments in older patients with normal renal function are considered necessary.

Paediatric population

The data supporting the dose regimen in paediatric patients are very limited. Renal maturity should be taken into consideration when selecting the dose. The dose should be based on lean body weight.

Children ≤ 40kg

75,000-150,000 IU/kg/day divided into 3 doses.

For children with a body weight above 40 kg, use of the dosing recommendation for adults should be considered.

The use of doses >150,000 IU/kg/day has been reported in children with cystic fibrosis.

There are no data regarding the use or magnitude of a loading dose in critically ill children.

No dose recommendations have been established in children with impaired renal function.

Intrathecal and intraventricular administration

Based on limited data, the following dose is recommended in adults:

Intraventricular route

125,000 IU/day

Intrathecally administered doses should not exceed those recommended for intraventricular use.

No specific dosing recommendation can be made in children for intrathecal and intraventricular routes of administration.

Method of administration

Colistimethate is administered intravenously as a slow infusion over 30 – 60 minutes.

Patients with a totally implantable venous access device (TIVAD) in place may tolerate a bolus injection of up to 2 million units in 10ml given over a minimum of 5 minutes (see section 6.6).

Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution. For dose preparation, particularly where combination of multiple vials is needed, reconstitution of the required dose must be performed using strict aseptic technique (see section 6.6).

Dose conversion table:

In the EU, the dose of colistimethate sodium (CMS) must be prescribed and administered only as IU. The product label states the number of IU per vial.

Confusion and medication errors have occurred because of the different expressions of dose in terms of potency. The dose is expressed in the US, and other parts of the world, as milligrams of colistin base activity (mg CBA).

The following conversion table is prepared for information and the values must be considered nominal and approximate only.

CMS conversion table

Potency≈ mass of CMS (mg) *
IU≈ mg CBA
12 5000.41
150 000512
1 000 0003480
4 500 000150360
9 000 000300720

* Nominal potency of the drug substance = 12,500 IU/mg


It is recommended that colistimethate sodium (CMS) should be administered under the supervision of physicians with appropriate experience in its use.


The dosage can be adjusted depending on the severity of the condition and clinical response.

Recommended dose range:

Administration via inhalation

Adults, adolescents and children ≥ 2 years

1-2 MIU two to three times per day (max 6 MIU/day)

Children < 2 years

0.5-1 MIU twice daily (max 2 MIU/ day)

Relevant clinical guidance on treatment regimens, including duration of treatment, periodicity and co-administration of other antibacterial agents should be adhered to.


Dose adjustment is not considered necessary

Renal impairment

Dose adjustment is not considered necessary, however caution is advised in patients with renal impairment (see sections 4.4 and 5.2).

Hepatic impairment

Dose adjustment is not considered necessary

Method of administration

For inhalation use.

Colistimethate sodium undergoes hydrolysis to the active substance colistin in aqueous solution. For special precautions for disposal and handling of reconstituted solutions, see section 6.6.

If other treatments are being taken, they should be taken in the order recommended by the physician.

See above for Dose conversion table.

4.3 Contraindications

Hypersensitivity to colistimethate sodium (colistin) or to polymyxin B.

4.4 Special warnings and precautions for use

Consideration should be given to co-administering intravenous colistimethate sodium with another antibacterial agent whenever this is possible, taking into account the remaining susceptibilities of the pathogen(s) under treatment. As the development of resistance to intravenous colistin has been reported in particular when it is used as a monotherapy, co- administration with other antibacterial should also be considered in order to prevent the emergence of resistance.

There are limited clinical data on the efficacy and safety of intravenous colistimethate sodium. The recommended doses in all subpopulations are equally based on limited data (clinical and pharmacokinetic/ pharmacodynamics data). In particular there are limited safety data for the use of high doses (> 6MIU/day) and the use of a loading dose, and for special populations (patients with renal impairment and the paediatric population). Colistimethate sodium should only be used when other, more commonly prescribed antibiotics are not effective or not appropriate.

Renal function monitoring should be performed at the start of treatment and regularly during treatment in all patients. The dose of colistimethate sodium should be adjusted according to creatinine clearance (see section 4.2). Patients who are hypovolaemic or those receiving other potentially nephrotoxic drugs are at increased risk of nephrotoxicity from colistin (see sections 4.5 and 4.8). Nephrotoxicity has been reported to be associated with cumulative dose and treatment duration in some studies. The benefit of prolonged treatment duration should be balanced against the potentially increased risk of renal toxicity.

Caution is advised when administering colistimethate sodium to infants < 1 year of age as renal function is not fully mature in this age group. Further, the effect of immature renal and metabolic function on the conversion of colistimethate sodium to colistin is not known.

In case of an allergic reaction, treatment with colistimethate sodium must be discontinued and appropriate measures implemented.

High serum concentrations of colistimethate sodium, which may be associated with overdosage or failure to reduce the dosage in patients with renal impairment, have been reported to lead to neurotoxic effects such as facial paraesthesia, muscle weaknessvertigo, slurred speech, vasomotor instability, visual disturbances, confusion, psychosis and apnoea. Monitoring should be performed for perioral paraesthesia and paraesthesia in the extremities, which are signs of overdose (see section 4.9).

Colistimethate sodium is known to reduce the presynaptic release of acetyl-choline at the neuro-muscular junction and should be used in patients with myasthenia gravis with the greatest caution and only if clearly needed.

Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnoea and neuromuscular blockade following administration of colistimethate sodium.

Colistimethate sodium should be used with extreme caution in patients with porphyria.

Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all anti-bacterial agents and may occur with colistimethate sodium. They may range from mild to life-threatening in severity. It is important to consider this diagnosis in patients who develop diarrhoea during or after the use of colistimethate sodium (see section 4.8). Discontinuation of therapy and the administration of specific treatment for Clostridium difficile should be considered. Medicinal products that inhibit peristalsis should not be given.

Intravenous colistimethate sodium does not cross the blood brain barrier to a clinically relevant extent. The use of intrathecal or intraventricular administration of colistimethate sodium in the treatment of meningitis was not systematically investigated in clinical trials and is supported by case reports only. Data supporting the posology are very limited. The most commonly observed adverse effect of CMS administration was aseptic meningitis (see section 4.8).

Bronchospasm may occur on inhalation of antibiotics. This may be prevented or treated with appropriate use of beta2-agonists. If troublesome, treatment should be withdrawn.

4.5 Interaction with other medicinal products and other forms of interaction

Concomitant use of intravenous colistimethate sodium with other medications that are potentially nephrotoxic or neurotoxic should be undertaken with great caution.

Caution should be taken with concomitant use with other formulations of colistimethate sodium as there is little experience and there is a possibility of summative toxicity.

No in vivo interaction studies have been performed. The mechanism of conversion of colistimethate sodium to the active substance, colistin, is not characterised. The mechanism of colistin clearance, including renal handling, is equally unknown. Colistimethate sodium or colistin did not induce the activity of any P 450 (CYP) enzyme tested (CYP1A2, 2B6, 2C8, 2C9, 2C19 and 3A4/5) in in vitro studies in human hepatocytes.

The potential for drug-drug interactions should be borne in mind when Colistimethate is co-administered with drugs known to inhibit or induce drug metabolising enzymes or drugs known to be substrates for renal carrier mechanisms.

Due to the effects of colistin on the release of acetylcholine, non-depolarising muscle relaxants should be used with caution in patients receiving colistimethate sodium as their effects could be prolonged (see section 4.4).

Co-treatment with colistimethate sodium and macrolides such as azithromycin and clarithromycin, or fluoroquinolones such as norfloxacin and ciprofloxacin should be undertaken with caution in patients with myasthenia gravis (see section 4.4).

Concomitant use of colistimethate sodium with other medicinal products of neurotoxic and/or nephrotoxic potential should be avoided. These include the aminoglycoside antibiotics such as gentamicin, amikacin, netilmicin and tobramycin. There may be an increased risk of nephrotoxicity if given concomitantly with cephalosporin antibiotics.

4.6 Pregnancy and lactation

There are no adequate data from the use of colistimethate sodium in pregnant women. Single dose studies in human pregnancy show that colistimethate sodium crosses the placental barrier and there may be a risk of foetal toxicity if repeated doses are given to pregnant patients. Animal studies are insufficient with respect to the effect of colistimethate sodium on reproduction and development (see Section 5.3 – Preclinical safety data). Colistimethate sodium should be used in pregnancy only if the benefit to the mother outweighs the potential risk to the fetus.

Colistimethate sodium is secreted in breast milk. Colistimethate sodium should be administered to breastfeeding women only when clearly needed.

4.7 Effects on ability to drive and use machines

During parenteral treatment with colistimethate sodium neurotoxicity may occur with the possibility of dizziness, confusion or visual disturbance. Patients should be warned not to drive or operate machinery if these effects occur.

4.8 Undesirable effects

Systemic treatment

The likelihood of adverse events may be related to the age, renal function and condition of the patient.

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%). In seriously ill hospitalised non-CF 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.

Inhalation treatment

Inhalation may induce coughing or bronchospasm.

Sore throat or mouth has been reported and may be due to Candida albicans infection or hypersensitivity. Skin rash may also indicate hypersensitivity, if this occurs treatment should be withdrawn.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

4.9 Overdose

Overdose can result in neuromuscular blockade that can lead to muscular weakness, apnoea and possible respiratory arrest. Overdose can also cause acute renal failure characterised by decreased urine output and increased serum concentrations of BUN and creatinine.

There is no specific antidote, manage by supportive treatment. Measures to increase the rate of elimination of colistin e.g. mannitol diuresis, prolonged haemodialysis or peritoneal dialysis may be tried, but effectiveness is unknown.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: antibacterials for systemic use, other antibacterials, polymyxins.

Mechanism of action

Colistin is a cyclic polypeptide antibacterial agent belonging to the polymyxin group. Polymyxins work by damaging the cell membrane and the resulting physiological effects are lethal to the bacterium. Polymyxins are selective for aerobic Gram-negative bacteria that have a hydrophobic outer membrane.


Resistant bacteria are characterised by modification of the phosphate groups of lipopolysaccharide, which become substituted with ethanolamine or aminoarabinose. Naturally resistant Gram-negative bacteria, such as Proteus mirabilis and Burkholderia cepacia, show complete substitution of their lipid phosphate by ethanolamine or aminoarabinose.

Cross resistance between colistin (polymyxin E) and polymyxin B is expected. Since the mechanism of action of the polymyxins is different from that of other antibacterial agents, resistance to colistin and polymyxin by the above mechanism alone would not be expected to result in resistance to other drug classes.

PK/PD relationship

Polymyxins have been reported to have a concentration-dependent bactericidal effect on susceptible bacteria. fAUC/ MIC is considered to be correlated with clinical efficacy.

EUCAST BreakpointsSusceptible (S)Resistant (R) a
AcinetobacterS≤2R>2 mg/L
EnterobacteriaceaeS≤2R>2 mg/L
Pseudomonas sppS≤4R>4 mg/L

a Breakpoints apply to dosage of 2-3 MIU x 3. A loading dose (9 MIU) may be needed.


The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.

Commonly susceptible species
Acinetobacter baumannii

Haemophilus influenzae

Klebsiella spp

Pseudomonas aeruginosa

Species for which acquired resistance may be a problem
Stenotrophomonas maltophilia

Achromobacter xylosoxidans (formerly Alcaligenes xylosoxidans)

Inherently resistant organisms
Burkholderia cepacia and related species.

Proteus species

Providencia species

Serratia species

5.2 Pharmacokinetic properties


The information on the pharmacokinetics of colistimethate sodium (CMS) and colistin is limited. There are indications that pharmacokinetics in critically ill patients differ from those in patients with less severe physiological derangement and from those in healthy volunteers. The following data are based on studies using HPLC to determine CMS/colistin plasma concentrations.

After infusion of colistimethate sodium the inactive pro-drug is converted to the active colistin. Peak plasma concentrations of colistin have been shown to occur with a delay of up to 7 hours after administration of colistimethate sodium in critically ill patients.

Absorption from the gastrointestinal tract does not occur to any appreciable extent in the normal individual.

When given by nebulisation, variable absorption has been reported that may depend on the aerosol particle size, nebuliser system and lung status. Studies in healthy volunteers and patients with various infections have reported serum levels from nil to potentially therapeutic concentrations of 4mg/l or more. Therefore, the possibility of systemic absorption should always be borne in mind when treating patients by inhalation.


The volume of distribution of colistin in healthy subjects is low and corresponds approximately to extracellular fluid (ECF). The volume of distribution is relevantly enlarged in critically ill subjects. Protein binding is moderate and decreases at higher concentrations. In the absence of meningeal inflammation, penetration into the cerebrospinal fluid (CSF) is minimal, but increases in the presence of meningeal inflammation.

Both CMS and colistin display linear PK in the clinically relevant dose range.


It is estimated that approximately 30% of colistimethate sodium is converted to colistin in healthy subjects, its clearance is dependent on creatinine clearance and as renal function decreases, a greater portion of CMS is converted to colistin. In patients with very poor renal function (creatinine clearance <30 ml/min), the extent of conversion could be as high as 60 to 70%. CMS is eliminated predominantly by the kidneys via glomerular filtration. In healthy subjects, 60% to 70% of CMS is excreted unchanged in the urine within 24 hours.

The elimination of the active colistin is incompletely characterised. Colistin undergoes extensive renal tubular reabsorption and may either be cleared non-renally or undergo renal metabolism with the potential for renal accumulation. Colistin clearance is decreased in renal impairment, possibly due to increased conversion of CMS.

Half-life of colistin in healthy subjects and those with cystic fibrosis is reported to be around 3h and 4h, respectively, with a total clearance of around 3L/h. In critically ill patients, half-life has been reported to be prolonged to around 9-18h.

5.3 Preclinical safety data

Data on potential genotoxicity are limited and carcinogenicity data for colistimethate sodium are lacking. Colistimethate sodium has been shown to induce chromosomal aberrations in human lymphocytes, in vitro. This effect may be related to a reduction in mitotic index, which was also observed.

Reproductive toxicity studies in rats and mice do not indicate teratogenic properties. However, colistimethate sodium given intramuscularly during organogenesis to rabbits at 4.15 and 9.3 mg/kg resulted in talipes varus in 2.6 and 2.9% of fetuses respectively. These doses are 0.5 and 1.2 times the maximum daily human dose. In addition, increased resorption occurred at 9.3 mg/kg.

There are no other preclinical safety data of relevance to the prescriber which are additional to safety data derived from patient exposure and already included in other sections of the SPC.

  1. Pharmaceutical particulars

6.1 List of excipients


6.2 Incompatibilities

Mixed infusions, injections and nebuliser solutions involving colistimethate sodium should be avoided.

6.3 Shelf life

Before opening:

3 years.

Reconstituted solutions:

Hydrolysis of colistimethate is significantly increased when reconstituted and diluted below its critical micelle concentration of about 80,000 IU per ml.

Solutions below this concentration should be used immediately

For solutions for bolus injection or nebulisation, the chemical and physical in-use stability of reconstituted solution in the original vial, with a concentration ≥ 80,000 IU/mL, has been demonstrated for 24 hours at 2 to 8°C.

From a microbiological point of view, unless the method of opening/ reconstitution/ dilution precludes the risk of microbial contamination, the product should be used immediately.

If not used immediately, in-use storage times and conditions are the responsibility of user.

Solutions for infusion, which have been diluted beyond the original vial volume and / or with a concentration < 80,000 IU/mL should be used immediately.

For solutions for intrathecal and intraventricular administration, the reconstituted product should be used immediately.

6.4 Special precautions for storage

Do not store above 25°C.

Keep the vials in the outer carton in order to protect from light.

For storage of solutions following reconstitution refer to 6.3.

6.5 Nature and contents of container

Type I, 10 ml nominal capacity glass vial with red ‘flip-off’ cap supplied in cartons of ten vials.

6.6 Special precautions for disposal and other handling

For bolus injection:

Reconstitute the contents of the vial with not more than 10ml water for injection or 0.9% sodium chloride.

For infusion:

The contents of the reconstituted vial may be diluted, usually with 50ml 0.9% sodium chloride.

When the intrathecal and intraventricular routes of administration are used, the volume administered should not exceed 1 ml (reconstituted concentration 125,000 IU/ml).

For inhalation by nebuliser:

Reconstitute the contents of the vial with either water for injections to produce a hypotonic solution or a 50:50 mixture of water for injections and 0.9% sodium chloride to produce an isotonic solution or with 0.9% sodium chloride to produce a hypertonic solution.

The volume of reconstitution should be according to the instructions for use of nebuliser administration device, and is normally not more than 4ml.

The output from the nebuliser may be vented to the open air or a filter may be fitted. Nebulisation should take place in a well ventilated room.

During reconstitution swirl gently to avoid frothing.

Solutions are for single use only and any remaining solution should be discarded.

  1. Manufactured By:
    Taj Pharmaceuticals Ltd.
    at: Plot. No. 220, Mahagujarat
    Industrial Estate, At & Post-Moraiya,
    Tal-Sanand, Dist- Ahmedabad Gujarat (India)

Colistimethate Sodium 1 million I.U./ 2 million I.U./ 3 million I.U./ 4.5 million I.U. powder for solution for Injection/Inhalation



Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it
  • If you have further questions, please ask your doctor, nurse or
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section


In this leaflet:

  1. What Colistimethate is and what it is used for
  2. What you need to know before you are given Colistimethate
  3. How Colistimethate is given
  4. Possible side-effects
  5. How to store Colistimethate
  6. Contents of the pack and other information


  1. What colistimethate is and what it is usedfor

Colistimethate is given by injection to treat some types of serious infections caused by certain bacteria. Colistimethate is used when other antibiotics are not suitable.


  1. What you need to know before you are given colistimethate

Colistimethate is not suitable for everyone. Some people must not have this injection. Do not have the injection:

If you are allergic (hypersensitive) to colistimethate, colistin or to other polymyxins.

If you are unsure about anything, ask your doctor before you have the injection.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before using Colistimethate

  • If you have or have had kidney
  • If you suffer from myasthenia gravis
  • If you suffer from porphyria

In premature and new-born babies, special care should be taken when using Colistimethate as the kidneys are not yet fully developed.

Other medicines and Colistimethate

Colistimethate may not be suitable if you are also taking the following medications. These medications may need to be stopped, you may need a lower dose of Colistimethate or monitoring may be required while taking Colistimethate. Colistimethate levels in blood may need to be monitored to ensure the correct dose is given.

Aminoglycoside antibiotics (including netilmicin, gentamicin, amikacin and tobramycin) and cephalosporins taken concurrently with Colistimethate can affect kidney function and increase the risk of side effects and damage to the kidneys, ears and parts of the nervous system.

Colistimethate can increase the effects of muscle relaxant medications used in general anaesthesia. Anaesthetist should be made aware if you are taking Colistimethate.


If you are taking macrolides for myasthenia gravis (including azithromycin, clarithromycin or erythromycin) or fluoroquinolone antibiotics (including ofloxacin, norfloxacin and ciprofloxacin), taking Colistimethate further increases the risk of muscle weakness and breathing difficulties.


Taking any other colistimethate products as an inhalation at the same time as receiving Colistimethate as an infusion can increase the risk of side effects.


Make sure the doctor knows about any other medicines that you are taking, including medicines that you obtained without a prescription.


Each vial of Colistimethate contains about 5mg of sodium. This means that you could receive up to 60mg sodium each day if you are having the maximum adult dose. This medicine contains less than 1 mmol sodium (23 mg) per vial.

Pregnancy and breastfeeding

  • Colistimethate is not known to harm the unborn child but, like all medicines, it will only be given to a pregnant woman if it is really
  • Small amounts of Colistimethate enter the milk. If you cannot stop breastfeeding while you have the injections, you should watch your baby carefully for any signs of illness and tell your doctor if you notice anything

Driving and operating machinery

Some people have reported side effects such as dizziness, confusion or problems with vision. If you are affected do not drive or operate machinery.


  1. How colistimethate is given

Colistimethate Sodium is given to you by your doctor as an infusion into a vein over 30 – 60 minutes.

The usual daily dose in adults is 9 million units, divided into two or three doses. If you are quite unwell, you will be given a higher dose of 9 million units once at the start of treatment.

In some cases, your doctor may decide to give a higher daily dose of up to 12 million units.

  1. Possible side effects

Like all medicines, Colistimethate can cause side effects although not everybody gets them.

Some side effects can be serious

Tell the doctor or nurse immediately if you notice any of the following symptoms:

  • Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin, or sudden swelling of the face, throat or These can be signs of a severe allergic reaction.


The following side effects have also been reported:

  • Reactions, such as irritation, at the injection site.
  • Kidney problems. These are more likely in patients who already have poor kidneys, or who are given Colistimethate at the same time as other medicines that can affect the kidneys, or who are given a dose that is too high. These problems will normally get better if treatment is stopped, or the dose of Colistimethate is reduced.
  • Neurological problems such as inability to breathe because of paralysis of the chest
    muscles, numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including faintness and flushing), slurred speech, problems with vision, confusion and mental problems (including loss of sense of reality). Side effects that affect the nervous system are more likely to occur when the dose of Colistimethate is too high, in people who have poor kidneys or in those who are also receiving muscle relaxants or other medicines with a similar effect on how the nerves

Reporting of side effects

If you get any side effects, talk to your doctor, nurse or pharmacist. This includes any possible side effects not listed in this leaflet.


  1. How to store colistimethate

Keep this medicine out of the sight and reach of children. The vials of powder must not be stored above 25°C. The vials must be protected from light by storing in the outer carton. The vials must not be used after the expiry date printed on the carton and vial label. Do not freeze.

The solution of Colistimethate should be used immediately, or within 8 hours when stored at temperatures not exceeding 25oC or 24 hours in the refrigerator (2 to 8oC). The vials are for single use. Any unused solution should be discarded.

Colistimethate should not be used if there is any discoloration or cloudiness of the solution.

  1. Contents of the pack and other information

Colistimethate is a creamy white powder for solution for injection in single dose 7ml glass vials. Each carton contains 1 or 10 vials. Each vial contains the active ingredient, Colistimethate (also called colistin) as an amount of powder equivalent to one million international units. There are no other ingredients. The sodium content is 0.228 mMol per vial.


  1. Manufactured By:
    Taj Pharmaceuticals Ltd.
    at: Plot. No. 220, Mahagujarat
    Industrial Estate, At & Post-Moraiya,
    Tal-Sanand, Dist- Ahmedabad Gujarat (India)