Methox
Generic Name
Methotrexate
Manufacturer
Unimed Health Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| methox 10 mg tablet | ৳ 15.06 | ৳ 150.60 |
Description
Overview of the medicine
Methotrexate is an antimetabolite and antifolate drug used in the treatment of certain cancers, severe psoriasis, and rheumatoid arthritis. It works by interfering with the growth of certain cells, particularly rapidly dividing cells like cancer cells, skin cells, and immune cells.
Uses & Indications
Dosage
Adults
Rheumatoid Arthritis/Psoriasis: Typically 7.5 mg to 20 mg orally once weekly. Neoplastic diseases: Highly variable, often much higher doses, and specific protocols.
Elderly
Use with caution; consider lower doses due to potential for decreased renal/hepatic function. Close monitoring is essential.
Renal_impairment
Significant dose reduction or discontinuation required depending on the degree of impairment. Contraindicated in severe renal impairment.
How to Take
Take orally, usually once weekly for autoimmune conditions. It is crucial to adhere to the prescribed weekly schedule to avoid serious side effects. May be taken with or without food. Folic acid supplementation is often co-prescribed, but not on the same day as methotrexate.
Mechanism of Action
Methotrexate inhibits dihydrofolate reductase (DHFR), an enzyme that catalyzes the reduction of dihydrofolate to tetrahydrofolate (THF). THF is essential for purine and pyrimidine synthesis, which are crucial for DNA and RNA synthesis. By inhibiting DHFR, methotrexate depletes THF, thereby inhibiting nucleic acid synthesis and cell division. This mechanism contributes to its cytotoxic, immunosuppressive, and anti-inflammatory effects.
Pharmacokinetics
Onset
Highly variable depending on indication. For RA/psoriasis, therapeutic effects may be observed after 3-6 weeks.
Excretion
Primarily excreted unchanged by the kidneys via glomerular filtration and active tubular secretion (50-90% within 24 hours). A small amount is excreted in bile.
Half life
Low dose (e.g., for RA/psoriasis): 3-10 hours. High dose (e.g., for cancer): 8-15 hours.
Absorption
Oral absorption is variable and dose-dependent. At low doses (e.g., <30 mg/m²), bioavailability is about 50-70%. Higher doses may saturate absorption.
Metabolism
Partially metabolized in the liver to 7-hydroxymethotrexate, which is less active. Also, enterohepatic recirculation occurs.
Side Effects
Contraindications
- Pregnancy and Breastfeeding (Category X)
- Severe renal or hepatic impairment
- Pre-existing blood dyscrasias (e.g., bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia)
- Active infection, immunodeficiency syndromes
- Alcoholism or alcoholic liver disease
Drug Interactions
Phenytoin
May reduce serum phenytoin concentration.
Live vaccines
Avoid due to immunosuppression.
NSAIDs and Salicylates
May decrease renal clearance of methotrexate, leading to increased plasma levels and toxicity.
Retinoids (e.g., Acitretin)
Increased risk of hepatotoxicity.
Proton Pump Inhibitors (PPIs)
May reduce the renal excretion of methotrexate, potentially increasing its plasma concentration and toxicity.
Trimethoprim/Sulfamethoxazole (Co-trimoxazole)
Increased risk of bone marrow suppression due to synergistic antifolate effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe bone marrow suppression, mucositis, stomatitis, and gastrointestinal toxicity. The primary antidote for methotrexate overdose is leucovorin (folinic acid) rescue, administered as soon as possible, ideally within the first hour. Hydration and urinary alkalinization may also be used to enhance methotrexate excretion.
Pregnancy & Lactation
Methotrexate is contraindicated in pregnancy (Category X) due to its teratogenic and embryotoxic effects. Effective contraception must be used by both male and female patients during therapy and for a specified period after discontinuation (at least 3 months for females and males after the last dose). It is also contraindicated during breastfeeding as it is excreted in breast milk and can cause serious adverse reactions in nursing infants.
Side Effects
Contraindications
- Pregnancy and Breastfeeding (Category X)
- Severe renal or hepatic impairment
- Pre-existing blood dyscrasias (e.g., bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia)
- Active infection, immunodeficiency syndromes
- Alcoholism or alcoholic liver disease
Drug Interactions
Phenytoin
May reduce serum phenytoin concentration.
Live vaccines
Avoid due to immunosuppression.
NSAIDs and Salicylates
May decrease renal clearance of methotrexate, leading to increased plasma levels and toxicity.
Retinoids (e.g., Acitretin)
Increased risk of hepatotoxicity.
Proton Pump Inhibitors (PPIs)
May reduce the renal excretion of methotrexate, potentially increasing its plasma concentration and toxicity.
Trimethoprim/Sulfamethoxazole (Co-trimoxazole)
Increased risk of bone marrow suppression due to synergistic antifolate effects.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe bone marrow suppression, mucositis, stomatitis, and gastrointestinal toxicity. The primary antidote for methotrexate overdose is leucovorin (folinic acid) rescue, administered as soon as possible, ideally within the first hour. Hydration and urinary alkalinization may also be used to enhance methotrexate excretion.
Pregnancy & Lactation
Methotrexate is contraindicated in pregnancy (Category X) due to its teratogenic and embryotoxic effects. Effective contraception must be used by both male and female patients during therapy and for a specified period after discontinuation (at least 3 months for females and males after the last dose). It is also contraindicated during breastfeeding as it is excreted in breast milk and can cause serious adverse reactions in nursing infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2-3 years from manufacturing date.
Availability
Pharmacies, Hospitals
Approval Status
Approved (FDA, DGDA)
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Methotrexate has been extensively studied since its introduction. Ongoing research explores its role in various autoimmune conditions, combination therapies for cancer, and optimizing dosing strategies to minimize toxicity.
Lab Monitoring
- Complete Blood Count (CBC) with differential (before, weekly/bi-weekly, then monthly)
- Liver Function Tests (LFTs) including ALT, AST, bilirubin, albumin (before, monthly)
- Renal Function Tests (RFTs) including serum creatinine, BUN (before, monthly)
- Chest X-ray (baseline and if pulmonary symptoms develop)
- Hepatitis B & C screening (before initiation)
Doctor Notes
- Emphasize weekly dosing for RA/psoriasis patients to prevent fatal overdose.
- Strict monitoring of CBC, LFTs, and RFTs is mandatory before and during therapy.
- Counsel patients on critical signs/symptoms of toxicity (e.g., mouth sores, fever, unexplained bleeding) and instruct them to report immediately.
- Prescribe folic acid supplementation (e.g., 5-10 mg weekly, not on methotrexate day) to reduce adverse effects.
Patient Guidelines
- Take exactly as prescribed by your doctor, usually ONCE WEEKLY for autoimmune diseases.
- Do NOT take daily for autoimmune conditions; this can lead to fatal overdose.
- Take folic acid supplements as prescribed by your doctor, typically not on the same day as methotrexate.
- Report any signs of infection (fever, chills), unusual bleeding/bruising, or severe mouth sores immediately.
- Avoid alcohol consumption completely during treatment.
Missed Dose Advice
If you miss a dose, contact your doctor or pharmacist immediately for advice. Do not take a double dose to make up for a missed one. Due to the weekly dosing regimen and potential toxicity, specific guidance from a healthcare professional is crucial.
Driving Precautions
Methotrexate may cause side effects like dizziness, fatigue, or confusion in some patients. If you experience these symptoms, avoid driving or operating heavy machinery until you know how the medication affects you.
Lifestyle Advice
- Ensure adequate hydration during treatment.
- Avoid excessive sun exposure and use sunscreen due to potential photosensitivity.
- Discuss all other medications, including over-the-counter drugs and herbal supplements, with your doctor.
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