Medication info
Myfortic Extended-Release Tablets 180 mg (Mycophenolate Sodium)

Myfortic Extended-Release Tablets 180 mg (Mycophenolate Sodium)

Prescription medicationTabletOral
Ingredient · strength
Mycophenolate Sodium›192.4mg / 1 tablet
Manufacturer / importer
Novartis Korea Ltd.
Appearance
Green round film-coated tablets
Packaging
50 tablets (10 tablets/PTP packaging x 5)
Approval status
Active

MFDS item code 200307807 · Notified 2003.08.23 · Insurance code 653600400

Summary

Main use
Prevention of acute organ rejection in patients with an allogeneic kidney transplant
Who takes it
Adults · Children
Adult dose
Treatment with this medicine should be initiated as soon as possible after transplantation in patients who have recently received a kidney transplant. ○ Adults: Administer mycophenolic acid 720 mg orally twice daily without chewing (total daily dose: 1,440 mg). This medicine may be taken with or without food; however, take it either on an empty stomach (1 hour before a meal) or 2 hours after a meal, and continue to take it at the same selected time relative to meals. ○ Older adults: No dose adjustment is necessary in older adults. However, the risk of adverse reactions may generally be increased in these patients. The risk of adverse reactions may also be increased in patients receiving this medicine concomitantly with other immunosuppressants. ○ Patients with renal impairment: No dose adjustment is necessary in patients with delayed graft function after transplantation. Patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 ㎡) should be monitored carefully. In these patients, the daily dose should not exceed 1,440 mg. ○ Patients with hepatic impairment: No dose adjustment is necessary in kidney transplant patients with severe hepatic parenchymal disease. ○ Treatment during rejection: Kidney transplant rejection does not alter the pharmacokinetics of mycophenolic acid. Discontinuation or dose reduction of this medicine is not necessary.
Child dose
Safety and efficacy have not been established in patients 18 years of age or younger.

Ingredients

Importer
Novartis Korea Ltd.

Efficacy & effects

Prevention of acute organ rejection in patients with an allogeneic kidney transplant

View approved original text

This medication is used to prevent acute organ rejection in patients undergoing kidney transplantation. It is co-administered with cyclosporine (hydrophobic microemulsion) and corticosteroids to enhance its effect.

How to take

Adult dose

Treatment with this medicine should be initiated as soon as possible after transplantation in patients who have recently received a kidney transplant. ○ Adults: Administer mycophenolic acid 720 mg orally twice daily without chewing (total daily dose: 1,440 mg). This medicine may be taken with or without food; however, take it either on an empty stomach (1 hour before a meal) or 2 hours after a meal, and continue to take it at the same selected time relative to meals. ○ Older adults: No dose adjustment is necessary in older adults. However, the risk of adverse reactions may generally be increased in these patients. The risk of adverse reactions may also be increased in patients receiving this medicine concomitantly with other immunosuppressants. ○ Patients with renal impairment: No dose adjustment is necessary in patients with delayed graft function after transplantation. Patients with severe chronic renal impairment (glomerular filtration rate < 25 mL/min/1.73 ㎡) should be monitored carefully. In these patients, the daily dose should not exceed 1,440 mg. ○ Patients with hepatic impairment: No dose adjustment is necessary in kidney transplant patients with severe hepatic parenchymal disease. ○ Treatment during rejection: Kidney transplant rejection does not alter the pharmacokinetics of mycophenolic acid. Discontinuation or dose reduction of this medicine is not necessary.

Child dose

Safety and efficacy have not been established in patients 18 years of age or younger.

Precautions

Women of childbearing potential must take precautions against pregnancy while using this medication, and it should not be taken during pregnancy. The risk of miscarriage or congenital malformations may increase with use during pregnancy. This medication should not be taken while breastfeeding, as it suppresses immune function and increases the risk of infections. Therefore, it should only be used under the supervision of a physician experienced with immune suppressants and in appropriate medical facilities. Patients with hypersensitivity to this medication or those with certain genetic disorders, pregnant or breastfeeding women, and patients with lactose intolerance should not take this medication. Patients with severely impaired kidney function or severe gastrointestinal disorders should use this medication cautiously, as there is a risk of adverse reactions. While taking this medication, side effects such as infections, blood disorders, gastrointestinal issues, and hypertension may occur, so any symptoms should be promptly discussed with healthcare providers. Due to the immunosuppressive effect, there is an increased risk of malignant tumors such as lymphoma and skin cancer, so it is recommended to minimize sun exposure and use sunscreen. This medication may interact with other drugs, so it is essential to inform healthcare providers about any other medications being taken, especially considering additional contraceptive methods when used with oral contraceptives. Women who are pregnant must take a pregnancy test before using this medication, and if pregnancy is confirmed during treatment, they should consult a doctor immediately. Additionally, males should take precautions against pregnancy during and for a period after taking this medication. The safety and efficacy of this medication have not been established in children under 18 years of age, and it should be administered to the elderly with caution, considering their physical function and health status. In case of overdose, excessive immunosuppression can lead to a serious risk of infection, so immediate medical attention is required if any unusual symptoms occur. This medication is enteric-coated and should not be crushed; care should be taken to prevent the powder from coming into contact with skin or mucous membranes. Keep this medication out of reach of children and it is essential for quality maintenance not to transfer it to another container.

Side effects

Viral infection, bacterial infection, fungal infection, urinary tract infection, herpes zoster, oral candidiasis, sinusitis, upper respiratory tract infection, gastroenteritis, herpes simplex, nasopharyngitis, pneumonia, wound infection, sepsis, osteomyelitis, leukopenia, anemia, thrombocytopenia, lymphatic cyst, lymphocytopenia, neutropenia, lymphadenopathy, dizziness, headache, tremor, insomnia, cough, dyspnea, exertional dyspnea, pulmonary fibrosis, pulmonary congestion, wheezing, diarrhea, nausea, dyspepsia, vomiting, constipation, abdominal pain, abdominal distension, flatulence, loose stool, gastritis, intragastric air retention, abdominal tenderness, pancreatitis, belching, halitosis, intestinal obstruction, esophagitis, peptic ulcer, lower intestinal obstruction, tongue depigmentation, gastrointestinal bleeding, xerostomia, cheilitis, parotid duct obstruction, gastroesophageal reflux disease, gingival hyperplasia, peritonitis, fever, fatigue, peripheral edema, influenza-like illness, lower limb edema, pain, chills, thirst, weakness, hypocalcemia, hypokalemia, hyperuricemia, hyperkalemia, hypomagnesemia, anorexia, hyperlipidemia, diabetes, hypercholesterolemia, hypophosphatemia, alopecia, contusion, acne, abnormal liver function tests, tachycardia, pulmonary edema, ventricular extrasystole, hypertension, worsening hypertension, hypotension, conjunctivitis, blurriness, arthralgia, asthenia, myalgia, arthritis, back pain, muscle stiffness, skin papilloma, basal cell carcinoma, Kaposi's sarcoma, lymphoproliferative disease, squamous cell carcinoma, anxiety, abnormal dream, delusional perception, increased serum creatinine, hematuria, renal tubular necrosis, urethral stricture, erectile dysfunction, Cushing's syndrome, hirsutism, elevated blood pressure, muscle cramps, acute inflammatory syndrome related to new purine synthesis inhibitors, rash, anaphylaxis, cold, genital herpes, thrombosis, increased heart rate, itching, liver failure due to reactivation of hepatitis B

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to prevent air and moisture exposure. Additionally, it is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This way, the efficacy and safety of the medication can be preserved for a long time.

Appearance and packaging

Appearance

Green round film-coated tablets

Package unit

50 tablets (10 tablets/PTP packaging x 5)

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.