Registered Tanzania · TMDA

Gentian Violet

METHYLROSANILIUM CHLORIDE 0.5 % w/v

TZ 18 AD 0004 Solution 3.5

What it does

Methylrosanilium is a medication used to treat certain medical conditions.

Commonly used for: bladder disorders, urinary tract issues

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

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Registration & product details

Registration no.
TZ 18 AD 0004
Registration date
2023-03-28
Expiry date
2028-03-27
Status
Registered/Compliant
Active ingredient
METHYLROSANILIUM CHLORIDE 0.5 % w/v
Dosage form
Solution
Strength
3.5
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Sri Balaji Pharma
Applicant / LTR
SRI BALAJI PHARMA LIMITED
Country of origin
TANZANIA
Manufacturer location
Plot No-12, Next to Noble Motors, Vingunguti, Julius K. Nyerere Rd, Dar es Salaam, Tanzania

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:42:00 · updated 2026-10-19 03:00:44

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Methylrosanilium is a medication used to treat certain medical conditions.

What it treats

  • bladder disorders
  • urinary tract issues

How it works

Methylrosanilium works by affecting the muscles in the bladder, helping to relieve symptoms.

Who it's for

This medication is generally prescribed for adults experiencing bladder-related problems.

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

Clinical monograph: methylrosanilium

Methylrosanilium, also known as methylene blue, is a synthetic dye with various clinical applications, particularly in the treatment of methemoglobinemia. It acts as a reducing agent, converting methemoglobin back to hemoglobin, thereby restoring the oxygen-carrying capacity of the blood. Additionally, methylrosanilium has been used in diagnostic procedures and as a potential treatment for other conditions due to its properties as an antimicrobial and antioxidant agent.

Indications

  • Methemoglobinemia
  • Urinary tract infections
  • Diagnostic aid in certain surgical procedures
  • Potential treatment for other conditions such as malaria

Dosage

Children: Paediatric dosing must be determined based on the specific condition and clinical guidelines. Refer to the BNF for Children for appropriate dosing information.

Adults: Dosage should be guided by the specific clinical condition being treated, considering factors such as severity and patient response. Refer to the relevant clinical guidelines for detailed dosing recommendations.

Mechanism of action

Methylrosanilium functions primarily by acting as a reducing agent. It donates electrons to methemoglobin, reducing it back to hemoglobin, which restores its ability to bind oxygen. This mechanism is particularly beneficial in conditions where methemoglobin levels are elevated.

Pharmacodynamics

The pharmacodynamic properties of methylrosanilium involve its role in reducing methemoglobin, which is formed when iron in hemoglobin is oxidized to the ferric state. The restoration of hemoglobin function leads to improved oxygen delivery to tissues. The drug exhibits a dose-dependent response, where higher concentrations may also exert additional effects such as antimicrobial activity.

Pharmacokinetics

Methylrosanilium is rapidly absorbed when administered intravenously, with peak plasma concentrations occurring shortly after administration. It is distributed throughout the body, including the central nervous system and tissues, and is metabolized primarily in the liver. The elimination half-life of methylrosanilium varies but is typically around 5 to 6 hours. Renal excretion plays a significant role in its clearance, thus dosing adjustments may be necessary in patients with renal impairment.

Contra-indications

  • Hypersensitivity to methylrosanilium or any of its components
  • Severe renal impairment
  • Pregnancy unless clearly needed

Adverse effects

  • Hypotension
  • Bradycardia
  • Nausea
  • Vomiting
  • Dizziness
  • Headache
  • Allergic reactions

Interactions

  • Antihypertensive agents may enhance the hypotensive effect
  • Concurrent use with other vasodilators can increase the risk of adverse effects
  • May interact with anesthetic agents

Precautions

  • Use with caution in patients with pre-existing cardiovascular diseases
  • Monitor blood pressure regularly during treatment
  • Caution in patients with a history of hypersensitivity reactions

Pregnancy

Methylrosanilium is not recommended during pregnancy unless the potential benefits outweigh the risks.

Breast-feeding

It is unknown whether methylrosanilium is excreted in human milk. Caution is advised if used during breastfeeding.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Injection solution

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