3 months to expiry Ghana · FDA Ghana

MOFECON -S TABLETS (Each tablet contains Mycophenolic Acid 360mg)

MYCOPHENDIC ACID

FDA/SD.233-101126 MYCOPHENDIC ACID 360MG

What it does

Mycophenolic acid is used to prevent the body from rejecting transplanted organs, such as kidneys, by suppressing the immune system.

Commonly used for: organ transplant rejection prevention, kidney transplant, heart transplant, liver transplant

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
FDA/SD.233-101126
Registration date
2023-10-09
Expiry date
2026-11-01
Status
3 months to expiry
Active ingredient
MYCOPHENDIC ACID
Dosage form
MYCOPHENDIC ACID
Strength
360MG
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Concord Biotech
Country of origin
-
Manufacturer location
16th Floor, B-Wing, Mondeal Heights, Iscon Cross Road, S.G. Highway, Ramdev Nagar, Ahmedabad, Gujarat 380015, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:32:59 · updated 2026-10-20 04:00:06

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

Mycophenolic acid is used to prevent the body from rejecting transplanted organs, such as kidneys, by suppressing the immune system.

What it treats

  • organ transplant rejection prevention
  • kidney transplant
  • heart transplant
  • liver transplant

How it works

It works by lowering the activity of the immune system, helping to prevent it from attacking the new organ.

Who it's for

This medicine is for people who have received an organ transplant and need support to ensure their body accepts the new organ.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: mycophendic

Mycophenolic acid, often referred to as mycophenolate, is an immunosuppressive agent primarily used to prevent organ rejection in transplant patients. It functions by inhibiting lymphocyte proliferation and is particularly effective in reducing the risk of acute rejection in kidney, heart, and liver transplants. Mycophenolate is often used in combination with other immunosuppressants to enhance efficacy and minimize the risk of rejection.

Indications

  • Prevention of organ rejection in kidney transplants
  • Prevention of organ rejection in heart transplants
  • Prevention of organ rejection in liver transplants
  • Autoimmune diseases (off-label use)

Dosage

Children: Refer to specific guidelines or clinical protocols for pediatric dosing, which may

Adults: Refer to specific guidelines or clinical protocols for dosage, as dosing may vary based on the indication and patient characteristics.

Mechanism of action

Mycophenolate acts as an inhibitor of inosine monophosphate dehydrogenase (IMPDH), an enzyme critical for the de novo synthesis pathway of purines. By inhibiting IMPDH, mycophenolate selectively targets lymphocytes, which are highly dependent on this pathway for proliferation and function, thereby reducing their activation and proliferation. This mechanism leads to a decrease in the production of antibodies and a reduction in the overall immune response.

Pharmacodynamics

The pharmacodynamic effects of mycophenolate include a reduction in the proliferation of T and B lymphocytes, which are essential for immune responses. This immunosuppressive effect helps to prevent organ transplant rejection. The response to mycophenolate can vary among individuals, and monitoring of immunologic markers may be required to adjust therapy appropriately.

Pharmacokinetics

Mycophenolate is administered orally or intravenously and is extensively metabolized in the liver to mycophenolic acid, which is the active form. It has a bioavailability of approximately 60% when taken orally. The drug is highly protein-bound (about 97%) and has a volume of distribution of approximately 40 liters. The elimination half-life of mycophenolic acid is about 16 to 18 hours, with renal excretion of metabolites being the primary route of elimination. Factors such as renal function and concurrent medications can influence the pharmacokinetics of mycophenolate.

Contra-indications

  • Hypersensitivity to mycophenolate mofetil or any of its components
  • Pregnancy

Adverse effects

  • Gastrointestinal disturbances (nausea, vomiting, diarrhea)
  • Increased risk of infections
  • Hematological abnormalities (leukopenia, thrombocytopenia, anemia)
  • Elevated liver enzymes
  • Headache
  • Hypertension
  • Rash

Interactions

  • Antacids containing magnesium or aluminum may decrease absorption
  • Cholestyramine may reduce absorption
  • Other immunosuppressants may increase risk of infections and malignancies

Precautions

  • Monitor blood counts regularly due to risk of cytopenias
  • Use with caution in patients with a history of gastrointestinal disorders
  • Consider potential for teratogenic effects in women of childbearing age
  • Vaccination status should be reviewed prior to therapy

Pregnancy

Mycophenolate is contraindicated in pregnancy due to risk of teratogenicity and miscarriage.

Breast-feeding

Mycophenolate is excreted in breast milk; use caution and consider risks versus benefits.

Storage

Store at room temperature, protect from moisture and light.

Formulations

  • Mycophenolate mofetil capsules
  • Mycophenolate mofetil tablets
  • Mycophenolate mofetil oral suspension

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.