PROVAYBLUE Dosage & Rx Info | Uses, Side Effects

Provayblue Generic Name & Formulations

Legal Class

General Description

Methylene blue 10mg/2mL, 50mg/10mL; soln for IV inj.

Pharmacological Class

Oxidation-reduction agent.

How Supplied

Single-dose ampules, single-dose vials—5

Storage

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Do not refrigerate or freeze.

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

Manufacturer

American Regent, Inc.

Generic Availability

Mechanism of Action

Methylene blue is a water soluble thiazine dye that promotes a non-enyzmatic 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.

Provayblue Indications

Indications

Acquired methemoglobinemia.

Provayblue Dosage and Administration

Adults and Children

Give 1mg/kg IV over 5–30mins; may repeat 1hr after the first dose if methemoglobin level remains >30% or if clinical signs/symptoms persist. Consider alternatives if unresolved after 2 doses. Moderate or severe renal impairment (eGFR 15–59mL/min/1.73m²): max single dose of 1mg/kg; no repeat dose.

Provayblue Contraindications

Contraindications

Glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia.

Provayblue Boxed Warnings

Boxed Warning

Serotonin syndrome with concomitant use of serotonergic drugs and opioids.

Provayblue Warnings/Precautions

Warnings/Precautions

Monitor for emergence of serotonin syndrome; discontinue if occurs and initiate supportive treatment. Discontinue and initiate supportive treatment if severe hypersensitivity reactions occur (eg, anaphylaxis, angioedema, urticaria, bronchospasm). Discontinue and consider alternative treatments if severe hemolysis occurs. Moderate to severe renal impairment. Hepatic impairment: monitor. Elderly: use the lowest number of doses. Pregnancy: monitor newborns. Nursing mothers: not recommended (during and for up to 8 days after treatment).

Provayblue Pharmacokinetics

Distribution

Volume of distribution: 255 ± 58 L. Mean plasma protein bound: ~94%.

Metabolism

Hepatic (CYP1A2, 2C19, 2D6). Predominant in vitro pathway appears to be UGT-mediated conjugation (eg, UGT1A4, UGT1A9).

Elimination

Renal (~40%). Half-life: ~24 hours.

Provayblue Interactions

Interactions

Increased risk of serotonin syndrome with SSRIs, SNRIs, MAOIs, bupropion, buspirone, clomipramine, mirtazapine, linezolid, opioids, dextromethorphan. Avoid concomitant serotonergic drugs within 72hrs after the last ProvayBlue dose; if unavoidable, choose the lowest possible dose and monitor closely for up to 4hrs after administration. May underestimate the oxygen saturation reading by pulse oximetry; obtain an arterial blood sample for testing instead. May cause a fall in the Bispectral Index (BIS); use alternative methods for assessing depth of anesthesia if ProvayBlue is used during surgery. May interfere with interpreting any urine test that relies on a blue indicator (eg, dipstick test for leucocyte esterase).

Provayblue Adverse Reactions

Adverse Reactions

Headache, hypokalemia, diarrhea, hypomagnesemia, myoclonus, nausea, seizure-like phenomena; hypersensitivity reactions, hemolytic anemia.

Provayblue Clinical Trials

See Literature

Provayblue Note

Not Applicable

Provayblue Patient Counseling