Inhalation/RespiratoryChronic pulmonary infections due to Pseudomonas aeruginosaAdult: Dosage is expressed in terms of colistimethate sodium (CMS) in international units; CMS 30,000 international units is equivalent to 1 mg colistin base activity (CBA) and approx 2.4 mg CMS. In patients with cystic fibrosis: As powder for nebuliser solution: 1-2 million units bid or tid. Max: 6 million units daily. As inhalation powder in hard capsules: 1.6625 million units 12 hourly. All doses are given using the inhalation delivery system provided. Dosage expressions and recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: In patients with cystic fibrosis: As powder for nebuliser solution: <2 years 500,000 to 1 million units bid (Max: 2 million units daily); ≥2 years Same as adult dose. As inhalation powder in hard capsules: ≥6 years Same as adult dose. All doses are given using the inhalation delivery system provided. Dosage expressions and recommendations may vary among countries and individual products (refer to specific product guidelines).
IntravenousSevere Gram-negative infectionsAdult: Dosage is expressed in terms of colistimethate sodium (CMS) in international units; CMS 30,000 international units is equivalent to 1 mg colistin base activity (CBA) and approx 2.4 mg CMS. 9-12 million units daily in 2-3 divided doses; a loading dose of 9-12 million units must be given to critically ill patients. Alternative dosing recommendation: Patients weighing ≤60 kg: 50,000 units/kg daily up to Max of 75,000 units/kg daily given in 3 divided doses; >60 kg: 1-2 million units tid up to Max of 6 million units in 24 hours. All doses are given via slow IV infusion over 30-60 minutes. Dosage expressions and recommendations may vary among countries and individual products (refer to specific product guidelines).
Child: Patients weighing ≤60 kg: 50,000 units/kg daily up to Max of 75,000 units/kg daily given in 3 divided doses; >60 kg: 1-2 million units tid up to Max of 6 million units in 24 hours. All doses are given via slow IV infusion over 30-60 minutes. Dosage expressions and recommendations may vary among countries and individual products (refer to specific product guidelines).
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Intravenous:
Dosage is expressed in terms of CMS in international units; CMS 30,000 international units is equivalent to 1 mg CBA and approx 2.4 mg CMS.
For patients weighing ≥60 kg:
| CrCl (mL/min) |
Dosage |
| <10 |
1 million units 18-24 hourly. |
| 10-<20 |
1 million units 12-18 hourly. |
| 20-50 |
1-2 million units 8 hourly. |
Doses are given via slow IV infusion over 30-60 minutes. Dosage expressions and recommendations may vary among countries and individual products (refer to specific product guidelines).
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Powder for solution for IV inj: Reconstitute vial with not more than 10 mL NaCl 0.9% solution or sterile water for inj. IV infusion: Further dilute the reconstituted solution with 50 mL NaCl 0.9% solution. Powder for nebuliser solution: Reconstitute with 2-4 mL of sterile water for inj or NaCl 0.9% solution. Avoid shaking vigorously. Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).
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Hypersensitivity to colistimethate sodium, colistin or polymyxin B.
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Patient with myasthenia gravis, porphyria, hyperactive airways (inhalation). Colistimethate sodium and colistin base are not interchangeable; verify the prescribed dosage expression before use. Renal impairment. Children. Pregnancy and lactation.
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Significant: Fungal or bacterial superinfection, including pseudomembranous colitis and Clostridioides difficile-associated diarrhoea (prolonged use); nephrotoxicity (dose-dependent); pseudo-Bartter syndrome; neurotoxicity, including transient and reversible neurological disturbances (e.g. paraesthesia, vertigo, slurred speech); respiratory arrest; bronchoconstriction, cough or bronchospasm (inhalation).
Ear and labyrinth disorders: Tinnitus (inhalation).
Gastrointestinal disorders: Dysgeusia, nausea, vomiting (inhalation).
Immune system disorders: Hypersensitivity reactions (e.g. skin rash, angioedema).
Investigations: Decreased FEV.
Musculoskeletal and connective tissue disorders: Arthralgia (inhalation).
Nervous system disorders: Headache, dizziness, ataxia.
Respiratory, thoracic and mediastinal disorders: Chest tightness, dyspnoea, pharyngolaryngeal discomfort, dysphonia, haemoptysis, asthma, wheezing, lower respiratory tract infection (inhalation).
Skin and subcutaneous tissue disorders: Pruritus.
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IM/Inhalation/Respiratory/IV/Parenteral: C
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This drug may cause dizziness, confusion or visual disturbances; if affected, do not drive or operate machinery. Rinse mouth with water after each inhalation.
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Perform culture and susceptibility tests; consult local institutional recommendations before treatment initiation due to antibiotic resistance risks. Monitor renal function (e.g. serum creatinine, BUN, urine output) before and during treatment. Evaluate FEV1 before and after dose administration (inhalation). Assess for signs of neurotoxicity, nephrotoxicity and bronchospasm (inhalation).
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Symptoms: Apnoea, muscle weakness, respiratory arrest and acute renal failure. Management: Supportive treatment. May administer mannitol to induce diuresis and perform peritoneal dialysis or prolonged haemodialysis to increase the rate of drug elimination.
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Increased risk of nephrotoxicity with other nephrotoxic drugs such as aminoglycoside antibiotics (e.g. amikacin, gentamicin, netilmicin, tobramycin) and cephalosporin antibiotics. May prolong effects of non-depolarising muscle relaxants.
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Description: Overview: Colistimethate sodium is an inactive prodrug that is hydrolysed into colistin. It is available in different expressions of dose in terms of potency. Dosage expression of colistimethate sodium varies depending on the country of origin and specific product formulation; the following conversion table is provided for reference only, with values considered nominal and approximate.
| Colistimethate Sodium (units) |
Colistimethate Sodium (mg) |
Colistin Base Activity (mg) |
| 1,000,000 |
80 |
34 |
| 2,000,000 |
160 |
67 |
| 3,000,000 |
240 |
100 |
| 4,500,000 |
360 |
150 |
| 6,000,000 |
480 |
200 |
| 9,000,000 |
720 |
300 |
| 12,000,000 |
960 |
400 |
Mechanism of Action: Colistimethate sodium is hydrolysed into colistin which acts as a cationic detergent and damages the cytoplasmic membrane of the bacteria, thereby causing leakage of intracellular substances and cell death. Pharmacokinetics: Absorption: Time to peak plasma concentration: IV: Colistin: 2 hours (range: 1-4 hours). Distribution: Crosses the placenta and enters breast milk. Volume of distribution: IV: 8.92 L (colistimethate sodium); 12.4 L (colistin). Plasma protein binding: 50%. Metabolism: Undergoes hydrolysis to form colistin (active form). Excretion: Mainly via urine (as unchanged drug). Elimination half-life: Colistimethate sodium: 2-3 hours (IM or IV).
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Powder for solution for inj or infusion: Intact vials: Store between 15-30°C. Protect from light. Reconstituted solution: Store between 2-8°C for 24 hours or below 30°C for up to 6 hours. Powder for nebuliser solution/Inhalation powder in hard capsules: Store below 25°C. Protect from light and moisture. Storage recommendations may vary between individual products (refer to specific product guidelines).
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Brayfield A, Cadart C (eds). Colistin Sulfate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2025. Colistimethate Sodium 2 MIU Powder for Nebuliser Solution (Hikma Farmaceutica [Portugal], S.A.). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2025. Colistimethate Sodium 2 MIU Powder for Solution for Injection/Infusion (Hikma Farmaceutica [Portugal], S.A.). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2025. Colistimethate. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 02/06/2025. Colobreathe 1,662,500 IU Inhalation Powder, Hard Capsules (Essential Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 02/06/2025. Joint Formulary Committee. Colistimethate Sodium. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/06/2025. Vaxcel Polymyxin E 1M IU Powder for Injection, Infusion or Inhalation (Kotra Pharma [M] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/06/2025.
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