Rx Item-Mycophenolic Acid 360Mg Tab 30 By AHP Gen Myfortic

Clinical Information
Gen. Code and Des.
52120 mycophenolate sodium ORAL TABLET DR 360 MG
GCN and Des.
19647 mycophenolate sodium ORAL TABLET DR 360 MG
Strength
360MG ER
Dose Form
TABLET, DELAYED RELEASE (ENTERIC COATED)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
92440000 IMMUNOSUPPRESSIVE AGENTS
Active Ingredients
9984 mycophenolate sodium 37415626







MYCOPHENOLIC ACID- mycophenolic acid tablet, delayed release
Mylan Institutional Inc.

WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES, AND SERIOUS INFECTIONS

Use during pregnancy is associated with increased risks of pregnancy loss and congenital malformations. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)] .
Increased risk of development of lymphoma and other malignancies, particularly of the skin, due to immunosuppression [see Warnings and Precautions (5.4)] .
Increased susceptibility to bacterial, viral, fungal, and protozoal infections, including opportunistic infections [see Warnings and Precautions (5.5, 5.6)] .
Only physicians experienced in immunosuppressive therapy and management of organ transplant patients should prescribe mycophenolic acid delayed-release tablets. Patients receiving mycophenolic acid delayed-release tablets should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.3)] .
1 INDICATIONS AND USAGE

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 tablets are 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.

2 DOSAGE AND ADMINISTRATION

2.1 Dosage in Adult Kidney Transplant Patients
The recommended dose of mycophenolic acid delayed-release tablets is 720 mg administered twice daily (1440 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, one 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 (1080 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 (1440 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.

RX ITEM-Mycophenolic 360Mg Tab 30 By Ame
Item No.:RX371570 NDC No.68084091825 68084-918-25 68084091825 UPC No.:368084918254 NDC No. 68084-0918-25 UPC/GTIN No. 3-68084-91825-4 368084918254 368084-918254 MPN 91825

Mycophenolic 360Mg Tab 30 By American He
Item No.:RX371570 NDC No.68084091825 68084-918-25 68084091825 UPC No.:368084918254 NDC No. 68084-0918-25 UPC/GTIN No. 3-68084-91825-4 368084918254 368084-918254 MPN 91825

MYCOPHENOLATE SODIUM ORAL
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