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methylene blue

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Overview

What is PROVAYBLUE?

PROVAYBLUE is an oxidation-reduction agent. PROVAYBLUE (methylene blue) is a sterile solution intended for intravenous administration. Each PROVAYBLUE , 10 mL ampule contains 50 mg Proveblue methylene blue and water for injection q.s. Each mL of solution contains 5 mg methylene blue and water for injection q.s.

Methylene blue is 3,7-bis(dimethylamino)phenothiazin-5-ium, chloride. The molecular formula of methylene blue is C H ClN S and its molecular weight is 319.86 g/mol. Its structural formula is:

PROVAYBLUE™ is a clear dark blue solution with a pH value between 3.0 and 4.5. The osmolality is between 10 and 15 mOsm/kg.



What does PROVAYBLUE look like?



What are the available doses of PROVAYBLUE?

50 mg/10 mL (5 mg/mL) single-dose ampule. ( )

What should I talk to my health care provider before I take PROVAYBLUE?

How should I use PROVAYBLUE?

PROVAYBLUE USP 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 [ ].

Administer 1 mg/kg intravenously over 5-30 minutes. ( )

If methemoglobin level remains above 30% or if clinical symptoms persist, give a repeat dose of up to 1 mg/kg one hour after the first dose. ( )


What interacts with PROVAYBLUE?

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What are the warnings of PROVAYBLUE?

Sorry No Records found


What are the precautions of PROVAYBLUE?

Sorry No Records found


What are the side effects of PROVAYBLUE?

Sorry No records found


What should I look out for while using PROVAYBLUE?

PROVAYBLUE is contraindicated in the following conditions:

PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors

(


What might happen if I take too much PROVAYBLUE?

Hypotension, wheezing and reduced oxygenation have been reported in patients who received methylene blue class products in single doses of 3 mg/kg or more.

Administration of large intravenous doses (cumulative dose ≥ 7 mg/kg ) of a methylene blue class product caused nausea, vomiting, precordial pain, dyspnea, tachypnea, chest tightness, tachycardia, apprehension, tremor, mydriasis, blue staining of the urine, the skin and mucous membranes, abdominal pain, dizziness, paresthesia, headache, confusion, mild methemoglobinemia (up to 7%) and electrocardiogram changes (T-wave flattening or inversion) These effects lasted 2-12 hours following administration.

A severe overdosage (single dose of 20 mg/kg or more) of a methylene blue class product caused severe intravascular hemolysis, hyperbilirubinemia and death.

In case of overdose of PROVAYBLUE , maintain the patient under observation until signs and symptoms have resolved, monitor for cardiopulmonary, hematologic and neurologic toxicities, and institute supportive measures as necessary.


How should I store and handle PROVAYBLUE?

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.PROVAYBLUE is supplied in 10 mL single-dose ampules. Each 10 mL ampule contains 50 mg of methylene blue as a clear dark blue solution. A box contains five ampules placed in a tray. Box of 5 ampules: NDC 0517-0374-05PROVAYBLUE is supplied in 10 mL single-dose ampules. Each 10 mL ampule contains 50 mg of methylene blue as a clear dark blue solution. A box contains five ampules placed in a tray. Box of 5 ampules: NDC 0517-0374-05


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Methylene blue is a water soluble thiazine dye that promotes a non-enzymatic redox conversion of metHb to hemoglobin. In situ, methylene blue is first converted to leucomethylene blue (LMB) via NADPH reductase. It is the LMB molecule which then reduces the ferric iron of metHb to the ferrous state of normal hemoglobin.

Non-Clinical Toxicology
PROVAYBLUE is contraindicated in the following conditions:

PROVAYBLUE may cause serious or fatal serotonergic syndrome when used in combination with serotonergic drugs. Avoid concomitant use of PROVAYBLUE with selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and monoamine oxidase inhibitors

(

There is evidence that the anticonvulsant action of phenytoin is antagonized by folic acid. A patient whose epilepsy is completely controlled by phenytoin may require increased doses to prevent convulsions if folic acid is given.

Folate deficiency may result from increased loss of folate, as in renal dialysis and/or interference with metabolism (e.g., folic acid antagonists such as methotrexate); the administration of anticonvulsants, such as diphenylhydantoin, primidone, and barbiturates; alcohol consumption and, especially, alcoholic cirrhosis; and the administration of pyrimethamine and nitrofurantoin.

False low serum and red cell folate levels may occur if the patient has been taking antibiotics, such as tetracycline, which suppress the growth of

The development of serotonin syndrome has been reported with use of methylene blue class products. Most reports have been associated with concomitant use of serotonergic drugs (e.g., selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors). Some of the reported cases were fatal. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, and hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, and incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Avoid concomitant use of PROVAYBLUE with serotonergic drugs.

Patients treated with PROVAYBLUE should be monitored for the emergence of serotonin syndrome. If symptoms of serotonin syndrome occur, discontinue use of PROVAYBLUE , and initiate supportive treatment. Inform patients of the increased risk of serotonin syndrome and advise them to not to take serotonergic drugs within 72 hours after the last dose of PROVAYBLUE .

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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