Trexall
Generic Name
Methotrexate 50 mg Injection
Manufacturer
Generic Pharmaceuticals (e.g., Teva, Pfizer, Sandoz)
Country
Global (manufactured in various countries)
Loading images...
Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| trexall 50 mg injection | ৳ 150.00 | N/A |
Description
Overview of the medicine
Methotrexate is an antimetabolite and antifolate drug used in the treatment of various cancers, severe psoriasis, and severe active rheumatoid arthritis. It works by inhibiting folic acid metabolism.
Uses & Indications
Dosage
Adults
Dosage varies significantly based on indication, route (IM, IV, SC, IT), and patient factors. For rheumatoid arthritis or psoriasis, typical doses are 7.5-20 mg once weekly. For oncological indications, doses can range from low daily doses to very high doses (e.g., 100 mg/m² to 12 g/m²) requiring leucovorin rescue.
Elderly
Use with caution; lower doses may be required due to decreased renal and hepatic function. Close monitoring of adverse effects and organ function is essential.
Renal_impairment
Dose adjustment required based on creatinine clearance. Contraindicated in severe renal impairment (CrCl < 30 mL/min). Methotrexate elimination is significantly reduced, leading to increased toxicity.
How to Take
Can be administered via intramuscular (IM), intravenous (IV), subcutaneous (SC), or intrathecal (IT) routes. The specific route depends on the indication and patient condition. IT administration should only be performed by experienced clinicians.
Mechanism of Action
Methotrexate inhibits dihydrofolate reductase (DHFR), an enzyme that converts dihydrofolate to tetrahydrofolate, a crucial cofactor for DNA and RNA synthesis. This inhibition leads to a depletion of nucleotide precursors and therefore inhibits cell proliferation.
Pharmacokinetics
Onset
Varies by indication: days to weeks for anti-inflammatory/immunosuppressive effects; more rapid for acute cytotoxic effects.
Excretion
Primarily renal, with approximately 50-90% excreted unchanged in urine within 24 hours. Small amounts excreted in bile.
Half life
Dose-dependent; typically 3-10 hours for low doses (e.g., RA/psoriasis), up to 8-15 hours or longer for high doses (e.g., oncology).
Absorption
Rapidly and completely absorbed following parenteral administration (IM, SC). Bioavailability is nearly 100%.
Metabolism
Minimal hepatic metabolism to 7-hydroxymethotrexate (inactive metabolite) and polyglutamated forms (active intracellularly).
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal or hepatic impairment
- Pre-existing blood dyscrasias (e.g., significant anemia, leukopenia, thrombocytopenia)
- Active infections (especially opportunistic infections)
- Alcoholism or alcoholic liver disease
- Immunodeficiency syndromes
- Known hypersensitivity to methotrexate
Drug Interactions
Phenytoin
May decrease phenytoin levels; methotrexate levels may also be affected.
Live vaccines
Avoid, due to immunosuppressive effects and risk of infection.
Retinoids (e.g., acitretin)
Increased risk of hepatotoxicity.
Trimethoprim/sulfamethoxazole (Co-trimoxazole)
Increased risk of bone marrow suppression due to synergistic antifolate effects.
NSAIDs, salicylates, sulfonamides, proton pump inhibitors (PPIs)
Can reduce methotrexate excretion, leading to increased methotrexate levels and toxicity.
Storage
Store at controlled room temperature (20-25°C), protect from light. Do not freeze. Keep out of reach of children.
Overdose
Overdose symptoms include severe myelosuppression, mucositis, and gastrointestinal toxicity. Management involves immediate administration of leucovorin (folinic acid) to counteract methotrexate effects, along with hydration and urine alkalinization to enhance methotrexate excretion. Medical emergency requiring hospitalisation.
Pregnancy & Lactation
Contraindicated in pregnancy due to severe teratogenic and embryotoxic effects (Pregnancy Category X). Excreted into breast milk, therefore contraindicated during breastfeeding.
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal or hepatic impairment
- Pre-existing blood dyscrasias (e.g., significant anemia, leukopenia, thrombocytopenia)
- Active infections (especially opportunistic infections)
- Alcoholism or alcoholic liver disease
- Immunodeficiency syndromes
- Known hypersensitivity to methotrexate
Drug Interactions
Phenytoin
May decrease phenytoin levels; methotrexate levels may also be affected.
Live vaccines
Avoid, due to immunosuppressive effects and risk of infection.
Retinoids (e.g., acitretin)
Increased risk of hepatotoxicity.
Trimethoprim/sulfamethoxazole (Co-trimoxazole)
Increased risk of bone marrow suppression due to synergistic antifolate effects.
NSAIDs, salicylates, sulfonamides, proton pump inhibitors (PPIs)
Can reduce methotrexate excretion, leading to increased methotrexate levels and toxicity.
Storage
Store at controlled room temperature (20-25°C), protect from light. Do not freeze. Keep out of reach of children.
Overdose
Overdose symptoms include severe myelosuppression, mucositis, and gastrointestinal toxicity. Management involves immediate administration of leucovorin (folinic acid) to counteract methotrexate effects, along with hydration and urine alkalinization to enhance methotrexate excretion. Medical emergency requiring hospitalisation.
Pregnancy & Lactation
Contraindicated in pregnancy due to severe teratogenic and embryotoxic effects (Pregnancy Category X). Excreted into breast milk, therefore contraindicated during breastfeeding.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, when stored as recommended.
Availability
Available in hospitals and pharmacies
Approval Status
Approved by major regulatory bodies (e.g., FDA, DGDA)
Patent Status
Off-patent (Generic versions available)
WHO Essential Medicine
YesClinical Trials
Extensively studied and continues to be investigated for new indications and dosing regimens. Many clinical trials have established its efficacy and safety profile in various oncological and immunological conditions.
Lab Monitoring
- Complete Blood Count (CBC) with differential and platelets (before, during, and after therapy)
- Liver Function Tests (LFTs) including AST, ALT, albumin, bilirubin (before and regularly during therapy)
- Renal Function Tests (RFTs) including serum creatinine, BUN, creatinine clearance (before and regularly during therapy)
- Chest X-ray (baseline and if respiratory symptoms develop)
- Serum methotrexate levels (essential for high-dose therapy and in cases of toxicity)
Doctor Notes
- Emphasize the critical importance of weekly dosing for non-oncological indications to avoid severe toxicity.
- Educate patients on potential severe side effects, including myelosuppression, liver, and lung toxicity, and the need for prompt reporting.
- Strictly monitor CBC, LFTs, and RFTs regularly. Consider liver biopsy for cumulative high doses.
- Ensure appropriate leucovorin rescue protocols are in place for high-dose oncological regimens.
Patient Guidelines
- Take exactly as prescribed by your doctor. Do not change the dose or schedule without consulting your doctor.
- Report any signs of infection (fever, chills, sore throat) or unusual bleeding/bruising immediately.
- Avoid alcohol completely during treatment to minimize liver damage risk.
- Use effective contraception during and for at least 6 months after treatment (for both men and women).
- Maintain good hydration by drinking plenty of fluids.
Missed Dose Advice
If a dose is missed, contact your doctor or pharmacist immediately for advice. Do not take a double dose to make up for a missed dose.
Driving Precautions
Methotrexate may cause side effects like dizziness, fatigue, or blurred vision. If you experience these, avoid driving or operating machinery.
Lifestyle Advice
- Avoid excessive sun exposure and use sun protection, as methotrexate can increase photosensitivity.
- Practice good hygiene to reduce the risk of infection.
- Avoid contact with people who are sick or have infections, especially chickenpox or measles.
Alternative Medicines in Bangladesh
Similar medicines available in the market
Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.
Other Medicines in Trexall Brand
Other medicines available under the same brand name
