Folitrax 5mg Tablet 10’S

INTRODUCTION

FOLITRAX 5MG contains methotrexate which belong to a group of medicines called folate antagonist. It can be used to treat severe cases of psoriasis and rheumatoid arthritis. It can also be used to treat several kinds of cancer. Psoriasis is an autoimmune disorder that causes your skin cells to grow and multiply much quickly than normal cells. Methotrexate kills the rapidly multiplying cells in the skin. In rheumatoid arthritis, methotrexate reduce inflammation in joints by altering body’s defence mechanism in immune system. In cancer, methotrexate inhibits the enzymes responsible for nucleotide synthesis and prevents cell division.

Always take this medicine as directed by your physician. Swallow the medicine as a whole with a glass of water. Do not crush or chew the medicine. Your doctor will decide the dose and duration of the therapy depending upon your health condition. This medicine should be used with caution in children and in elderly patient. Consult your doctor before taking this medicine. The common side effects are nausea or vomiting, anorexia (eating disorder), a skin rash with reddening of the skin, hair loss.

USES OF FOLITRAX 5MG

• Treat severe cases of psoriasis and rheumatoid arthritis if other treatments are not effective
• Treat several kinds of cancer, including acute leukemias, non-Hodgkin’s lymphoma, soft tissue and bone sarcomas, solid tumors like breast, lung, head and neck, bladder, cervical, ovarian and testicular cancer

HOW FOLITRAX 5MG WORKS

Methotrexate inhibits the enzymes responsible for nucleotide synthesis including dihydrofolate reductase, thymidylate synthase, aminoimidazole caboxamide ribonucleotide transformylase (AICART) and amido phosphoribosyl transferase which prevents cell division and leads to anti-inflammatory actions.

Since cellular proliferation in malignant tissues (cancerous tissue) are greater than in most normal tissues, methotrexate may impair malignant growth without causing any irreversible damage to normal tissues. Methotrexate has immunosuppressive effects, and this might be a result of inhibition of lymphocyte multiplication. In psoriasis, it kills the rapidly multiplying skin cells.

DIRECTIONS FOR USE

Always take FOLITRAX 5MG as directed by your physician. Your doctor will decide the dose and duration of the therapy depending upon your age, weight and condition. Swallow the medicine as a whole with a glass of water. Do not crush or chew.

SIDE EFFECTS OF FOLITRAX 5MG

HOW TO MANAGE SIDE EFFECTS

Nausea or vomiting:

Try taking this medicine with, or just after, a meal. Stick to simple meals.

Diarrhea:

Drink lots of fluids, such as water or squash, to avoid dehydration. Do not take any other medicines without speaking to a doctor.

Stomach pain:

Try to rest and relax. You can eat and drink slowly or have smaller and frequent meals. Keeping a heat pad on your stomach may also help. If still pain persists, speak to your doctor.

WARNING & PRECAUTIONS

INTERACTIONS

Talk to your doctor, if you are taking,

• Non-steroidal anti-inflammatory drugs (e.g. ibuprofen, indomethacin or aspirin)
• Diuretics (used to increase water output) e.g. furosemide, hydrochlorothiazide
• Medicines used to treat epilepsy (e.g. phenytoin, carbamazepine and valproate)
• Medicines used to treat diabetes e.g. metformin
• Medicines used to treat gout e.g. probenecid or sulfinpyrazone
• Medicines used to treat stomach ulcers e.g. omeprazole or pantoprazole
• Medicines used to suppress immune response e.g. leflunomide or ciclosporin
• Other medicines against cancer (e.g. cisplatin)
• Antibiotics (used to treat bacterial infections) including penicillin, sulphonamides, trimethoprim/sulfamethoxazole, neomycin, ciprofloxacin, doxycycline, tetracyclines, chloramphenicol
• Olanzapine (used to treat schizophrenia)
• Pyrimethamine (used to treat malaria)
• Digoxin (used to treat heart failure)
• Theophylline (used to treat asthma)
• P-aminobenzoic acid (used to treat skin disorders)
• Corticosteroids used for the treatment of arthritis, allergic reactions or skin diseases
• Retinoids used for the treatment of skin disorders e.g. acitretin
• Vitamin preparations containing folic acid or similar products

SYNOPSIS

MORE INFORMATION

Store below 20-25°C and keep out of reach of children.

FAQs ABOUT FOLITRAX 5MG

Will FOLITRAX 5MG affects fertility?

Yes. This medicine may temporarily affect sperm and egg production and cause infertility.

Can FOLITRAX 5MG be used in pregnant women?

No. This medicine is strictly not recommended for use in pregnant women. Consult your doctor before taking.

REFERENCES

1. KD. Tripathi. Anticancer drugs. Immunosuppressant drugs. Essentials of medical pharmacology. Seventh edition. 2013. Page – 862-863, 882-883.

2. Bruce. A. Chabner, Joseph Bertino, James Cleary, Taylor Ortiz, Andrew Lane, Jeffery G. Supko and David Ryan. Cytotoxic Agents. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page –1820-1821.

3. Craig Burkhart, Dean Morrell and Lowell Goldsmith. Dermatological pharmacology. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 12th Edition. New York McGraw Hill Medical 2011. Page – 1820-1821.

4. Gerald G. Briggs and Roger K. Freeman. M. A reference guide to fetal and neonatal risk: Drugs in Pregnancy and Lactation. Tenth Edition. 2015. Page – 2492-2501.

5. Amneal Pharmaceuticals, LLC. BE Study in Patients – Methotrexate Tablets. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on October 2016] [Accessed 23rd November 2020] https://clinicaltrials.gov/ct2/show/NCT02940561

6. Can-Fite BioPharma. Oral CF101 Tablets and Methotrexate Treatment in Rheumatoid Arthritis Patients. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on March 2018] [Accessed 23rd November 2020] https://clinicaltrials.gov/ct2/show/NCT00556894

7. Michael E. Weinblatt. Methotrexate in Rheumatoid Arthritis: A Quarter Century of Development. NCBI; PMC US National Library of Medicine, National Institute of Health. 2013. [Accessed 23rd November 2020] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3715949/

8. Haupt Pharma Wolfratshausen GmbH. Electronic Medicines Compendium (EMC); [Revised on June 2018] [Accessed 23rd November 2020] https://www.medicines.org.uk/emc/files/pil.511.pdf

9. EXCELLA GmbH. U.S. Food & Drug Administration. [Revised on January 2016] [Accessed 23rd November 2020] https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/008085s066lbl.pdf