Mycophenolic Acid

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Overview

What is Mycophenolic Acid?

Mycophenolic acid delayed-release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid is an immunosuppressive agent. As the sodium salt, MPA is chemically designated as (E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid sodium salt.

Its molecular formula is CHO Na. The molecular weight is 342.32 and the structural formula is

Mycophenolic acid, as the sodium salt, is a white to off-white, crystalline powder and is highly soluble in aqueous media at physiological pH and practically insoluble in 0.1N hydrochloric acid.

Mycophenolic acid is available for oral use as delayed-release tablets containing 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include methylcellulose, sodium lauryl sulfate, stearic acid, colloidal silicon dioxide, hypromellose and polyethylene glycol. The enteric coating of the tablet consists of ferric oxide yellow, triethyl citrate, talc, titanium dioxide (180 mg and 360 mg), indigotine al lake (180 mg), methacrylic acid and ethyl acrylate copolymer dispersion, and ferric oxide red (360 mg).

What does Mycophenolic Acid look like?

What are the available doses of Mycophenolic Acid?

Mycophenolic acid is available as 180 mg and 360 mg tablets. ()

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

How should I use Mycophenolic Acid?

Mycophenolic acid is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant.

Mycophenolic acid is indicated for the prophylaxis of organ rejection in pediatric patients 5 years of age and older who are at least 6 months post kidney transplant.

Mycophenolic acid is to be used in combination with cyclosporine and corticosteroids.

The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 mg total daily dose).

What interacts with Mycophenolic Acid?

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What are the warnings of Mycophenolic Acid?

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What are the precautions of Mycophenolic Acid?

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What are the side effects of Mycophenolic Acid?

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What should I look out for while using Mycophenolic Acid?

Known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients. ()

What might happen if I take too much Mycophenolic Acid?

Signs and Symptoms

There have been anecdotal reports of deliberate or accidental overdoses with mycophenolic acid delayed-release tablets, whereas not all patients experienced related adverse reactions.

In those overdose cases in which adverse reactions were reported, the reactions fall within the known safety profile of the class. Accordingly an overdose of mycophenolic acid delayed-release tablets could possibly result in oversuppression of the immune system and may increase the susceptibility to infection including opportunistic infections, fatal infections and sepsis. If blood dyscrasias occur (e.g., neutropenia with absolute neutrophil count <1.5 x 10/mcL or anemia), it may be appropriate to interrupt or discontinue mycophenolic acid delayed-release tablets.

Possible signs and symptoms of acute overdose could include the following: hematological abnormalities such as leukopenia and neutropenia, and gastrointestinal symptoms such as abdominal pain, diarrhea, nausea and vomiting, and dyspepsia.

Treatment and Management

General supportive measures and symptomatic treatment should be followed in all cases of overdosage. Although dialysis may be used to remove the inactive metabolite mycophenolic acid glucuronide (MPAG), it would not be expected to remove clinically significant amounts of the active moiety, mycophenolic acid, due to the 98% plasma protein binding of mycophenolic acid. By interfering with enterohepatic circulation of mycophenolic acid, activated charcoal or bile sequestrates, such as cholestyramine, may reduce the systemic mycophenolic acid exposure.

How should I store and handle Mycophenolic Acid?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.Mycophenolic acid delayed-release tablets, USP are supplied as:180 mg tablet:Bottles of 120……………………………………………….… NDC 60429-016-12360 mg tablet:Bottles of 120……………………………………………….… NDC 60429-017-12StorageHandling[see Dosage and Administration ()]. Teratogenic effects have been observed with mycophenolate sodium . If for any reason, the mycophenolic acid delayed-release tablets must be crushed, avoid inhalation of the powder, or direct contact of the powder, with skin or mucous membranes.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mycophenolic acid (MPA), an immunosuppressant, is an uncompetitive and reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), and therefore inhibits the pathway of guanosine nucleotide synthesis without incorporation to DNA. T- and B-lymphocytes are critically dependent for their proliferation on synthesis of purines, whereas other cell types can utilize salvage pathways. MPA has cytostatic effects on lymphocytes.

Mycophenolate sodium has been shown to prevent the occurrence of acute rejection in rat models of kidney and heart allotransplantation. Mycophenolate sodium also decreases antibody production in mice.

Non-Clinical Toxicology

Known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or to any of its excipients. ()

Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations.

Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.

Use of mycophenolic acid delayed-release tablets during pregnancy is associated with an increased risk of first trimester pregnancy loss and an increased risk of congenital malformations, especially external ear and other facial abnormalities including cleft lip and palate, and anomalies of the distal limbs, heart, esophagus, kidney, and nervous system .

The following adverse reactions are discussed in greater detail in other sections of the label.

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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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Review

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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

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).

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