An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.

Methylene blue (Domitazol)™ is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.

Methemoglobin is a form of hemoglobin (HEEM o glo bin). Hemoglobin is a substance in blood that carries oxygen and distributes it to your tissues and organs. However, methemoglobin is not a type of hemoglobin that is useful in carrying oxygen.

Domitazol is indicated for the treatment of pediatric
Domitazol is indicated for the treatment of pediatric

Methemoglobin normally exists in small amounts in the blood. However, when methemoglobin levels increase, the blood is less efficient in circulating oxygen. The resulting lack of oxygen throughout the body can cause symptoms such as pale or blue-colored skin.

Methemoglobinemia is a condition in which methemoglobin is present in high levels in the blood. Methemoglobinemia usually occurs when a person is exposed to certain drugs or chemicals such as nitrites. It may also be caused by a genetic disorder.

Methylene blue (Domitazol) injection is used to treat methemoglobinemia. It works by converting methemoglobin to a more efficient type of hemoglobin to better carry oxygen throughout the body.

Methylene blue (Domitazol) oral is used to treat methemoglobinemia and urinary tract infections. It works as a mild antiseptic to kill bacteria in the urinary tract. You will most likely also be given an antibiotic medication to treat your infection.

Methylene blue (Domitazol) is also used as a dye or staining agent to make certain body fluids and tissues easier to view during surgery or on an x-ray or other diagnostic exam.

Dosage And Administration

  • Ensure patent venous access prior to administration of Methylene blue (Domitazol)™. Do not administer Methylene blue (Domitazol)™ subcutaneously.
  • Monitor vital signs, electrocardiogram and methemoglobin levels during treatment with Methylene blue (Domitazol)™ and through resolution of methemoglobinemia.
  • Administer Methylene blue (Domitazol)™ 1 mg/kg intravenously over 5-30 minutes.
  • If the methemoglobin level remains greater than 30% or if clinical signs and symptoms persist, a repeat dose of Methylene blue (Domitazol)™ 1 mg/kg may be given one hour after the first dose.
  • If methemoglobinemia does not resolve after 2 doses of Methylene blue (Domitazol)™, consider initiating alternative interventions for treatment of methemoglobinemia.

Preparation And Storage

Each mL of Methylene blue (Domitazol)™ contains 5 mg Methylene blue (Domitazol)

Each 10 mL ampule of Methylene blue (Domitazol)™ contains 50 mg Methylene blue (Domitazol).

Methylene blue (Domitazol)™ is hypotonic and may be diluted before use in a solution of 50 mL 5% Dextrose in Water (D5W) in order to avoid local pain, particularly in the pediatric population. Use the diluted solution immediately after preparation.

Do not mix with sodium chloride 9 mg/mL (0.9%) solution for injection, because it has been demonstrated that chloride reduces the solubility of Methylene blue (Domitazol).

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Keep the ampule in the original package to protect from light.

How supplied

Dosage Forms And Strengths

Injection: 50 mg/10 mL (5 mg/mL) clear dark blue solution in single-dose ampules

Storage And Handling

Methylene blue (Domitazol)™ is supplied in 10 mL single-dose ampules. Each 10 mL ampule contains 50 mg of Methylene blue (Domitazol) as a clear dark blue solution. A box contains five ampules placed in a tray. Box of 5 ampules: NDC 0517-0374-05


Store at 20°C to 25°C (68°F to 77°F). Any unused product or waste material should be disposed of in accordance with local practice.

Do not refrigerate or freeze.

Keep the ampule in the original package to protect from light.

Manufactured for: PROVEPHARM SAS, 22 rue Marc Donadille 13013 Marseille, France. Manufactured by: CENEXI 52 rue Marcel et Jacques Gaucher 94120 Fontenay sous Bois, FRANCE. Distributed by: American Regent Shirley, NY. Revised: Apr 2016

Do not use Methylene blue (Domitazol) if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

Many drugs can interact with Methylene blue (Domitazol). Tell your doctor about all other medications you use. You may need to stop using certain medicines before using Methylene blue (Domitazol) (in some cases for up to 5 weeks before you start Methylene blue (Domitazol)). During your treatment with Methylene blue (Domitazol), do not start or stop using any other medications unless your doctor tells you to.

You should not use this medication if you are allergic to Methylene blue (Domitazol), or if you have severe kidney problems.

Before using Methylene blue (Domitazol), tell your doctor if you have kidney disease, or glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Also tell your doctor about all other medications you use, especially antacids, diuretics (water pills), sodium bicarbonate, or acetazolamide (Diamox).

If you take an antidepressant or psychiatric medication, call your doctor right away if you have signs of a serious drug interaction, including: confusion, memory problems, feeling hyperactive (mentally or physically), loss of coordination, muscle twitching, shivering, sweating, diarrhea, and/or fever.

Methylene blue (Domitazol) will most likely cause your urine or stools to appear blue or green in color. This is a normal side effect of the medication and will not cause any harm.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Methylene blue (Domitazol).

A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.

Use: Labeled Indications

Methemoglobinemia (acquired) (Methylene blue (Domitazol) only): Treatment of pediatric and adult patients with acquired methemoglobinemia

Methemoglobinemia (drug induced) (generic only): Treatment of drug-induced methemoglobinemia

Off Label Uses

Chromoendoscopy (diagnostic aid)

Data from a limited number of patients studied suggest that Methylene blue (Domitazol) may be beneficial for enhancing diagnostic views during chromoendoscopic procedures (eg, esophageal, gastric, colon). Additional trials may be necessary to further define the role of Methylene blue (Domitazol) in the treatment of this condition.

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