Trexall
Generic Name
Methotrexate 10 mg Tablet
Manufacturer
Teva Pharmaceuticals
Country
United States
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| trexall 10 mg tablet | ৳ 15.00 | ৳ 150.00 |
Description
Overview of the medicine
Trexall (methotrexate) is an antimetabolite and immunosuppressant used to treat certain types of cancer (e.g., acute lymphoblastic leukemia, choriocarcinoma, breast cancer, lung cancer), severe psoriasis, and rheumatoid arthritis.
Uses & Indications
Dosage
Adults
For Rheumatoid Arthritis/Psoriasis: 7.5 mg to 20 mg orally once weekly. For oncology indications, dosages vary widely (e.g., 15-30 mg daily for 5 days or high-dose regimens) and are determined by the specific cancer and protocol.
Elderly
Use with caution and consider lower doses due to potential for decreased renal function and reduced folate stores. Monitor closely for adverse effects.
Renal_impairment
Dose adjustment required or contraindicated depending on the degree of renal impairment. Methotrexate clearance is reduced, increasing toxicity risk.
How to Take
Trexall tablets are taken orally. For rheumatoid arthritis and psoriasis, it is typically taken once weekly, on the same day each week. For oncology indications, follow the specific protocol provided by your doctor. It can be taken with or without food. Ensure adequate hydration.
Mechanism of Action
Methotrexate works by inhibiting dihydrofolate reductase (DHFR), an enzyme involved in the synthesis of tetrahydrofolate. This leads to inhibition of DNA synthesis, repair, and cellular replication, primarily in actively proliferating cells like cancer cells and immune cells.
Pharmacokinetics
Onset
For rheumatic conditions and psoriasis, clinical effects may be observed within 3-6 weeks, with full effect in 8-12 weeks. For oncology, onset is faster depending on regimen.
Excretion
Primarily renal excretion (50-90% unchanged drug within 24 hours). A small amount is excreted via bile.
Half life
Low dose: 3-10 hours. High dose: 8-15 hours. Prolonged with renal impairment.
Absorption
Oral absorption is dose-dependent; generally good bioavailability for doses less than 30 mg/m². Peak plasma concentrations occur within 1-2 hours.
Metabolism
Limited hepatic metabolism to polyglutamates (active metabolites) and 7-hydroxymethotrexate (less active).
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal impairment
- Severe hepatic impairment (cirrhosis, alcoholism)
- Pre-existing blood dyscrasias (e.g., bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia)
- Immunodeficiency syndromes
- Active infectious disease (e.g., active tuberculosis, HIV)
- Hypersensitivity to methotrexate
Drug Interactions
Folic acid supplements
May reduce methotrexate efficacy if given concurrently for non-rescue purposes. However, specific folic acid supplementation is often prescribed to reduce side effects.
NSAIDs and Salicylates
May increase methotrexate levels and toxicity, especially with high doses. Avoid concurrent use or monitor closely.
Retinoids (e.g., acitretin)
Increased risk of hepatotoxicity.
Proton Pump Inhibitors (PPIs)
May reduce methotrexate clearance, leading to increased plasma concentrations and potential toxicity.
Trimethoprim/Sulfamethoxazole
Increases risk of myelosuppression.
Penicillins, Sulfonamides, Ciprofloxacin
May reduce renal clearance of methotrexate, increasing serum levels.
Storage
Store at controlled room temperature (20°C to 25°C), away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of methotrexate overdose primarily involve myelosuppression and gastrointestinal toxicity (e.g., severe stomatitis, diarrhea). Management includes immediate administration of leucovorin (folinic acid) rescue to counteract the effects of methotrexate, and supportive care (hydration, alkalinization of urine to prevent renal precipitation). Hemodialysis may be considered in severe cases.
Pregnancy & Lactation
Trexall is contraindicated in pregnancy due to significant embryo-fetal toxicity and teratogenic effects (Category X). Women of childbearing potential should use effective contraception during and for a period after treatment. It is also contraindicated during breastfeeding as methotrexate is excreted into breast milk.
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal impairment
- Severe hepatic impairment (cirrhosis, alcoholism)
- Pre-existing blood dyscrasias (e.g., bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia)
- Immunodeficiency syndromes
- Active infectious disease (e.g., active tuberculosis, HIV)
- Hypersensitivity to methotrexate
Drug Interactions
Folic acid supplements
May reduce methotrexate efficacy if given concurrently for non-rescue purposes. However, specific folic acid supplementation is often prescribed to reduce side effects.
NSAIDs and Salicylates
May increase methotrexate levels and toxicity, especially with high doses. Avoid concurrent use or monitor closely.
Retinoids (e.g., acitretin)
Increased risk of hepatotoxicity.
Proton Pump Inhibitors (PPIs)
May reduce methotrexate clearance, leading to increased plasma concentrations and potential toxicity.
Trimethoprim/Sulfamethoxazole
Increases risk of myelosuppression.
Penicillins, Sulfonamides, Ciprofloxacin
May reduce renal clearance of methotrexate, increasing serum levels.
Storage
Store at controlled room temperature (20°C to 25°C), away from light and moisture. Keep out of reach of children.
Overdose
Symptoms of methotrexate overdose primarily involve myelosuppression and gastrointestinal toxicity (e.g., severe stomatitis, diarrhea). Management includes immediate administration of leucovorin (folinic acid) rescue to counteract the effects of methotrexate, and supportive care (hydration, alkalinization of urine to prevent renal precipitation). Hemodialysis may be considered in severe cases.
Pregnancy & Lactation
Trexall is contraindicated in pregnancy due to significant embryo-fetal toxicity and teratogenic effects (Category X). Women of childbearing potential should use effective contraception during and for a period after treatment. It is also contraindicated during breastfeeding as methotrexate is excreted into breast milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 2-3 years from the date of manufacture, specific expiry date will be printed on the packaging.
Availability
Globally available
Approval Status
FDA Approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Methotrexate has been extensively studied for decades, and ongoing clinical trials investigate new indications, formulations, and combinations, particularly in oncology and autoimmune diseases. Information on specific trials can be found on clinicaltrials.gov.
Lab Monitoring
- Complete Blood Count (CBC) with differential (before, during, and after therapy)
- Liver Function Tests (LFTs) (e.g., AST, ALT, albumin, bilirubin)
- Renal Function Tests (e.g., serum creatinine, BUN, estimated GFR)
- Chest X-ray (periodically to monitor for pulmonary toxicity)
- Hepatitis B/C screening (pre-treatment)
Doctor Notes
- Emphasize the critical importance of once-weekly dosing for RA/psoriasis to avoid fatal toxicity.
- Monitor CBC, LFTs, and renal function regularly.
- Ensure adequate folic acid supplementation is prescribed and administered appropriately (typically not on the same day as methotrexate).
- Educate patients on symptoms of toxicity (e.g., mouth sores, persistent cough, fever) and when to seek urgent medical attention.
- Counsel on contraception for women of childbearing potential.
Patient Guidelines
- Take Trexall exactly as prescribed by your doctor, usually once a week on a consistent day.
- Do NOT take Trexall daily for non-oncology indications; daily use can lead to severe, potentially fatal, toxicity.
- Take folic acid supplements as directed by your doctor to reduce side effects, but not on the day of methotrexate administration unless otherwise advised.
- Report any unusual symptoms immediately, such as severe mouth sores, persistent cough, fever, unexplained bleeding or bruising, or yellowing of skin/eyes.
- Avoid alcohol consumption while on Trexall.
- Ensure adequate hydration.
Missed Dose Advice
If you miss a dose of Trexall for RA or psoriasis, take it as soon as you remember, but only if it is within 1-2 days of your scheduled dose. If it's closer to your next scheduled dose, skip the missed dose and continue with your regular schedule. Do not double the dose to catch up. For oncology, contact your doctor immediately.
Driving Precautions
Trexall may cause dizziness, fatigue, or confusion in some individuals. If you experience these effects, avoid driving or operating heavy machinery.
Lifestyle Advice
- Avoid excessive alcohol consumption to minimize liver toxicity.
- Use sun protection (e.g., sunscreen, protective clothing) as methotrexate can increase photosensitivity.
- Maintain good oral hygiene to prevent mouth sores.
- Avoid live vaccines during treatment.
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