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Mycophenolate Mofetil 500 mg Capsule Bottle 100 Capsules

  • Manufacturer Name : STRIDES PHARMA, INC
  • MFG # : 64380072506
  • NDC : 64380072506
  • Distributor Name : AmeriSource Bergen
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Additional Information

Product NameMycophenolate Mofetil 500 Mg Capsule Bottle 100 Capsules
ApplicationImmunosuppressive Agent
Generic Drug NameMycophenolate Mofetil
MOA (Mechanism of Action)Inhibits inosine monophosphate dehydrogenase, blocking guanine nucleotide synthesis, suppressing lymphocyte proliferation
Strength500 mg
Side EffectsGastrointestinal disturbances, infections, and blood cell abnormalities.
PrecautionsRegular monitoring of blood cell counts required. Avoid live vaccines.
Pregnancy CategoryCategory D (Risk to fetus)
Container TypeBottle
Quantity100 Capsules
UsesPrevention of organ transplant rejection, including kidney, liver, and heart transplants.

Description

Mycophenolate Mofetil 500 mg is an immunosuppressive agent used primarily in the prevention of organ transplant rejection. It is commonly prescribed for patients who have undergone kidney, heart, or liver transplants. This drug works by inhibiting the proliferation of T and B lymphocytes, which are key components of the immune system responsible for rejecting transplanted organs.

The active ingredient, mycophenolate mofetil, is a prodrug that is converted to mycophenolic acid (MPA) in the body. MPA acts by inhibiting inosine monophosphate dehydrogenase, an enzyme essential for the de novo synthesis of guanine nucleotides. By halting the production of these nucleotides, mycophenolate mofetil suppresses the growth and activation of lymphocytes, thereby reducing the likelihood of transplant rejection.

This medication is available in 500 mg capsules, packaged in bottles containing 100 capsules. It is typically prescribed for long-term use, and the dosage is adjusted based on the individual patient's condition and response to treatment. The drug must be taken exactly as directed by the healthcare provider to avoid complications such as infections or malignancies.

Product Properties:

Description Mycophenolate mofetil oral, 250 MG
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 1
FDA Approval Date 06/10/2010
FDA Therap Equiv AB
HCPCS J7517
Market Entry Date 01/14/2014
Medical Coverage COVERED WITH CARRIER DISCRETION
Termination Date -
Unit TAB
Units Per Pkg 100
Active Ingredients 5014 mycophenolate mofetil 128794945
AHFS Class 92440000 IMMUNOSUPPRESSIVE AGENTS
DEA Class NC
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 32599 mycophenolate mofetil ORAL TABLET 500 MG
Inactive Ingredients 10138 blue dye; 10141 red dye; 2537 povidone 9003398
OMP Family -
Product Category RX Pharmaceuticals
Strength 500MG
Common Brand Name COMMON BRAND NAME(S): Cellcept
Drug Interaction DRUG INTERACTIONS: See also How to Use section. Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab). This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. If you are using hormonal birth control, you should use an additional non-hormonal form of birth control while using this medication. Discuss your options with your doctor or pharmacist. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
Allocation Period -
Case Quantity 48
Drug Form Pack Size 100
Form TABLET
Hazard Code -
Listed Chemical -
NIOSH Code NT2 NON-ANTINEOPLASTIC DRUGS THAT MEET 1 OR MORE OF NIOSH CRITERIA FOR HAZARDOUS DRUG INCLUDING (MSHG)
Orange Book AB Products meeting necessary bioequivalence requirements.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 100
How to Use HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking mycophenolate and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth as directed by your doctor, usually twice daily on an empty stomach, 1 hour before or 2 hours after meals. Swallow the medication whole. Do not crush or chew. If you are taking the capsules, do not open them before swallowing. If the capsule comes apart or if there is dust from the tablets, avoid inhaling the powder or dust, and avoid direct contact with the skin or eyes. If contact occurs, wash the affected skin area well with soap and water or rinse your eyes with plain water. Consult your pharmacist for details. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets or powder from the capsules. The dosage is based on your medical condition and response to treatment. In children, it is also based on body size. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Keep taking this medication even if you feel well. Do not stop taking mycophenolate without first talking to your doctor. Certain products may make it harder for your body to absorb mycophenolate if they are taken at the same time. Do not take this medication at the same time as antacids containing aluminum and/or magnesium, cholestyramine, colestipol, or calcium-free phosphate binders (such as aluminum products, lanthanum, sevelamer). Ask your pharmacist for more details. Do not change brands or forms of mycophenolate unless directed by your doctor.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as blood counts, drug levels, kidney function, pregnancy test) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details. Attend a transplant education class or support group. Learn to recognize the signs and symptoms of organ rejection and tell your doctor right away if they occur.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (my-coh-FEN-oh-late MOW-fet-ill)
Precautions PRECAUTIONS: See also Warning section. Before taking mycophenolate mofetil, tell your doctor or pharmacist if you are allergic to it; or to mycophenolic acid; or to mycophenolate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: cancer, liver disease (such as hepatitis B, hepatitis C), kidney disease, current/past infections (such as herpes, shingles), stomach/intestinal problems (such as ulcers), rare genetic disorders (such as Lesch-Nyhan or Kelley-Seegmiller syndromes). This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Mycophenolate can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. Tell your health care professional that you are using mycophenolate mofetil before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose). To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Do not donate blood while using mycophenolate and for 6 weeks after stopping this drug. Do not donate sperm while using mycophenolate and for 90 days after stopping this drug. Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets or powder from the capsules. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may order a pregnancy test before starting this medication, after 8 to 10 days on treatment, and during routine follow-up visits. You should not become pregnant while using mycophenolate. Mycophenolate may harm an unborn baby. Women of childbearing age should ask about reliable forms of birth control while using this medication and for 6 weeks after the last dose. Men with female partners of childbearing age should use reliable forms of birth control while using this medication and for 3 months after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: See also Warning section. Constipation, nausea, headache, diarrhea, vomiting, stomach upset, gas, tremor, dizziness, drowsiness, or trouble sleeping may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: unusual tiredness, fast/irregular heartbeat, easy bleeding/bruising, swelling of the feet or ankles, joint pain/stiffness, muscle pain. Get medical help right away if you have any very serious side effects, including: stomach/abdominal pain that doesn't go away, black stools, vomit that looks like coffee grounds, chest pain, shortness of breath/rapid breathing. This medication may increase your risk of getting a rare but very serious (possibly fatal) brain infection (progressive multifocal leukoencephalopathy-PML). Get medical help right away if you have any of these side effects: clumsiness, loss of coordination/balance, weakness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty talking/walking, seizure, vision changes. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Mycophenolate is used in combination with other medications to keep your body from attacking and rejecting your transplanted organ (such as kidney, liver, heart). It belongs to a class of medications called immunosuppressants. It works by weakening your body's defense system (immune system) to help your body accept the new organ as if it were your own.

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Mycophenolate Mofetil 500 mg Capsule Bottle 100 Capsules is manufactured by STRIDES PHARMA, INC.
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