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Drug Catalog - Product Detail

MYCOPHENOLATE SODIUM TAB DR 180 MG (MYCOPHENOLIC ACID EQUIV) 120 CT

NDC Mfr Size Str Form
16729-0261-29 ACCORD HEALTHCARE 120 180MG TABLET
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Generic Name
MYCOPHENOLIC ACID
Substance Name
MYCOPHENOLATE SODIUM
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA202555
Description
11 DESCRIPTION Mycophenolic acid delayed release tablets, USP are an enteric formulation of mycophenolate sodium that delivers the active moiety mycophenolic acid (MPA). Mycophenolic acid delayed release 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 empirical formula is C17H19O6Na. The molecular weight is 342.32 g/mol 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 0.1 N hydrochloric acid. Mycophenolic acid delayed release tablets, USP are available for oral use as delayed release tablets containing either 180 mg or 360 mg of mycophenolic acid. Inactive ingredients include colloidal anhydrous silica, croscarmellose sodium, microcrystalline cellulose, magnesium stearate, povidone (K-30) and talc. The enteric coating of the tablet consists of colloidal anhydrous silica, FD&C Blue #2 aluminum lake (180 mg), iron oxide yellow, iron oxide red (360 mg), methacrylic acid copolymer type C, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate. The imprinting ink of the tablet consists of shellac, and iron oxide black. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Mycophenolic acid delayed release tablets, USP 360 mg tablet: Peach colored, oblong shaped, biconvex, enteric-coated tablets imprinted with M2 on one side and plain on the other side, containing 360 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120’s count comes with a child-resistant closure……………………NDC 16729-189-29 Bottles of 500's count……………………………………………………………NDC 16729-189-16 180 mg tablet: Lime green colored, round shaped, biconvex, beveled edged enteric-coated tablets imprinted with M3 on one side and plain on the other side, containing 180 mg mycophenolic acid (MPA) as mycophenolate sodium. Bottles of 120’s count comes with a child-resistant closure……………………NDC 16729-261-29 Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container (USP). Handling Keep out of reach and sight of children. Mycophenolic acid delayed release tablets should not be crushed or cut in order to maintain the integrity of the enteric coating [see Dosage and Administration ( 2.3 ) ]. Teratogenic effects have been observed with mycophenolate sodium [see Warnings and Precautions ( 5.1 ) ]. 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.
Indications & Usage
1 INDICATIONS AND USAGE Mycophenolic acid is an antimetabolite immunosuppressant indicated for prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. ( 1.1 ) Use in combination with cyclosporine and corticosteroids. ( 1.1 ) Limitations of Use: Mycophenolic acid delayed-release tablets and mycophenolate mofetil tablets and capsules should not be used interchangeably. ( 1.2 ) 1.1 Prophylaxis of Organ Rejection in Kidney Transplant Mycophenolic acid delayed release tablets are indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. Mycophenolic acid delayed release tablets are 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 delayed release tablet is to be used in combination with cyclosporine and corticosteroids. 1.2 Limitations of Use Mycophenolic acid delayed release tablets and mycophenolate mofetil (MMF) tablets and capsules should not be used interchangeably without physician supervision because the rate of absorption following the administration of these two products is not equivalent.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION In adults: 720 mg by mouth, twice daily (1,440 mg total daily dose) on an empty stomach, 1 hour before or 2 hours after food intake. ( 2.1 ) In children: 5 years of age and older (who are at least 6 months post kidney transplant), 400 mg/m 2 by mouth, twice daily (up to a maximum of 720 mg twice daily). ( 2.2 ) Do not crush, chew, or cut tablet prior to ingestion. ( 2.3 ) 2.1 Dosage in Adult Kidney Transplant Patients The recommended dose of mycophenolic acid delayed release tablet is 720 mg administered twice daily (1,440 mg total daily dose). 2.2 Dosage in Pediatric Kidney Transplant Patients The recommended dose of mycophenolic acid delayed release tablets in conversion (at least 6 months post-transplant) pediatric patients age 5 years and older is 400 mg/m 2 body surface area (BSA) administered twice daily (up to a maximum dose of 720 mg administered twice daily). 2.3 Administration Mycophenolic acid delayed release tablets should be taken on an empty stomach, 1 hour before or 2 hours after food intake [see Clinical Pharmacology ( 12.3 ) ]. Mycophenolic acid delayed release tablets should not be crushed, chewed, or cut prior to ingesting. The tablets should be swallowed whole in order to maintain the integrity of the enteric coating. Pediatric patients with a BSA of 1.19 to 1.58 m 2 may be dosed either with three mycophenolic acid delayed release 180 mg tablets, or one 180 mg tablet plus one 360 mg tablet twice daily (1,080 mg daily dose). Patients with a BSA of >1.58 m 2 may be dosed either with four mycophenolic acid delayed release 180 mg tablets, or two mycophenolic acid delayed release 360 mg tablets twice daily (1,440 mg daily dose). Pediatric doses for patients with BSA <1.19 m 2 cannot be accurately administered using currently available formulations of mycophenolic acid delayed release tablets.