Registered Rwanda · Rwanda FDA

POLY-MXB

Polymyxin B Sulphate USP 500000 Units

Rwanda FDA-HBP-MA-0100 Cake/powder for reconstitution 500000 Units

What it does

Polymyxin is an antibiotic used to treat serious infections caused by certain bacteria.

Commonly used for: serious bacterial infections, infections caused by gram-negative bacteria

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

Ask about this medicine

Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
Rwanda FDA-HBP-MA-0100
Registration date
10/12/2023
Expiry date
09/12/2028
Status
Registered
Active ingredient
Polymyxin B Sulphate USP 500000 Units
Strength
500000 Units
Pack size
5 ml Glass vial
Therapeutic class
-
Manufacturer / MAH
Bharat Serums And Vaccines
Country of origin
INDIA
Manufacturer location
3RD Floor, Liberty Tower, Plot No. K-10, behind Reliable Plaza, Kalwa Industrial Estate, Gavate Wadi, MIDC, Airoli, Navi Mumbai, Maharashtra 400708, India

Source: Rwanda Food and Drugs Authority · fetched 2026-03-11 22:07:26 · updated 2026-09-21 02:30:20

Disclaimer: This information is sourced from Rwanda Food and Drugs Authority (Rwanda). Always consult a qualified healthcare professional before using any medication.

About polymyxin

Polymyxin is an antibiotic used to treat serious infections caused by certain bacteria.

What it treats

  • serious bacterial infections
  • infections caused by gram-negative bacteria

How it works

Polymyxin works by attacking the outer membrane of bacteria, causing them to break apart and die.

Who it's for

It is used for people with severe infections that do not respond to other antibiotics.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About units

Units are used to measure the amount of a substance, often in relation to medication doses.

How it works

Units help in quantifying and administering medications accurately.

Who it's for

Anyone needing to understand medication dosages.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: polymyxin

Polymyxin is an antibiotic that belongs to the polymyxin class of antibiotics. It is primarily used for the treatment of infections caused by gram-negative bacteria, particularly those resistant to other antibiotics. Polymyxin is typically used in a clinical setting for serious infections due to its nephrotoxicity and neurotoxicity, which limits its use to severe cases where no alternatives are available.

Indications

  • Pneumonia caused by multidrug-resistant gram-negative bacteria
  • Septicemia caused by gram-negative bacteria
  • Urinary tract infections caused by resistant organisms
  • Skin infections caused by resistant gram-negative bacteria

Dosage

Children: Refer to BNF for Children for appropriate dosing in paediatric patients.

Adults: Refer to local guidelines or BNF for specific dosing recommendations based on the type and severity of infection.

Mechanism of action

Polymyxin exerts its antibacterial effect by disrupting the integrity of the bacterial cell membrane. It binds to the lipopolysaccharides and phospholipids in the outer membrane of gram-negative bacteria, leading to increased permeability and eventual cell lysis.

Pharmacodynamics

Polymyxin has a bactericidal effect against susceptible gram-negative organisms. Its action is concentration-dependent, with higher concentrations leading to a more significant bactericidal effect. Resistance can occur through modifications in the bacterial cell membrane components that reduce drug binding.

Pharmacokinetics

Polymyxin is poorly absorbed from the gastrointestinal tract and is typically administered parenterally (intravenously or intramuscularly) for systemic infections. It has a volume of distribution that suggests extensive tissue penetration but is primarily eliminated by the kidneys. Half-life varies based on renal function, and dose adjustments may be necessary in patients with renal impairment.

Adverse effects

  • Nephrotoxicity
  • Neurotoxicity
  • Allergic reactions
  • Respiratory distress
  • Nausea
  • Vomiting

Interactions

  • Increased nephrotoxicity when used with other nephrotoxic agents such as aminoglycosides or cisplatin
  • Potential for respiratory depression with neuromuscular blocking agents

Precautions

  • Use with caution in patients with renal impairment
  • Monitor renal function during therapy
  • Consider the risk of neurotoxicity, especially with prolonged use

Pregnancy

Polymyxin is classified as category C. Its safety during pregnancy has not been established, thus it should only be used if clearly needed.

Breast-feeding

It is not known if polymyxin is excreted in human milk. Caution is advised when administering to nursing mothers.

Storage

Store at room temperature, away from light and moisture. Protect from freezing.

Formulations

  • Polymyxin B sulfate injection
  • Polymyxin E (colistin) inhalation solution
  • Topical formulations

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: units

Units are a measurement used in pharmacology to quantify the activity of a drug, particularly for substances that have effects that are not easily quantifiable in milligrams or grams. This measurement is often used for hormones, enzymes, and certain antigens, where the biological effect of a drug is more relevant than its weight. Units can vary depending on the substance and the context of its use.

Dosage

Children: Refer to specific drug guidelines as dosing in units varies based on the drug and its clinical application.

Adults: Refer to specific drug guidelines as dosing in units varies based on the drug and its clinical application.

Mechanism of action

The mechanism of action of drugs measured in units depends on the specific substance. For example, insulin (measured in units) facilitates glucose uptake in cells by binding to insulin receptors, activating a signaling pathway that enhances glucose transporter translocation to the cell membrane. This results in a decrease in blood glucose levels. Similarly, other drugs measured in units may exert their effects through receptor binding, enzyme catalysis, or other biochemical interactions.

Pharmacodynamics

Pharmacodynamics describes the effects of the drug on the body and includes the relationship between drug concentration and effect. For substances measured in units, the pharmacodynamic response may be variable and is often dependent on the individual’s sensitivity to the drug, receptor availability, and other pharmacological factors. For instance, the effect of 1 unit of insulin can vary significantly among individuals based on their insulin sensitivity and metabolic state.

Pharmacokinetics

Pharmacokinetics refers to the absorption, distribution, metabolism, and excretion of drugs. For substances measured in units, the pharmacokinetic profile can differ widely. For instance, insulin is rapidly absorbed when administered subcutaneously, distributed throughout the body, metabolized by the liver and kidneys, and its effects can be observed within minutes. Other drugs may have different absorption rates, half-lives, and routes of elimination.

Pregnancy

Consult a healthcare professional. The safety of this drug during pregnancy has not been established.

Breast-feeding

Consult a healthcare professional. The safety of this drug during breastfeeding has not been established.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.