Trexall
Generic Name
Methotrexate
Manufacturer
Teva Pharmaceuticals
Country
United States (primary market for Trexall brand)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| trexall 25 mg tablet | ৳ 5.00 | ৳ 50.00 |
Description
Overview of the medicine
Trexall (Methotrexate) is an antimetabolite and immunosuppressant. It is used in the treatment of various cancers, severe psoriasis, and severe active rheumatoid arthritis. It works by interfering with the growth of certain cells in the body.
Uses & Indications
Dosage
Adults
Dosage is highly variable depending on the indication, patient's condition, and route of administration. For RA/Psoriasis, doses are typically once weekly, often starting at 7.5-15 mg/week and gradually increasing. 25 mg tablets may be used in higher weekly doses for RA/Psoriasis (often divided) or in various oncology protocols.
Elderly
Use with caution; dose adjustments may be necessary due to decreased renal/hepatic function and potential for increased toxicity. Closely monitor for adverse effects.
Renal_impairment
Dose reduction or discontinuation is required in patients with significant renal impairment due to reduced excretion and increased risk of toxicity. Severe impairment is a contraindication.
How to Take
For non-oncological indications (RA, Psoriasis), Trexall is typically taken orally ONCE WEEKLY on the same day each week. For oncology, dosage and administration frequency vary greatly and may be daily, weekly, or in cyclical regimens. Always follow your doctor's instructions precisely. Taking daily for non-oncological indications can lead to severe, even fatal, toxicity.
Mechanism of Action
Methotrexate inhibits dihydrofolate reductase (DHFR), an enzyme that participates in the tetrahydrofolate synthesis. This prevents the formation of reduced folates, which are essential for DNA synthesis, repair, and cellular replication. This leads to antiproliferative, cytotoxic, and immunosuppressive effects.
Pharmacokinetics
Onset
Varies by indication; for RA/Psoriasis, effects may be observed within 3-6 weeks.
Excretion
Primarily renal (active tubular secretion and glomerular filtration), some biliary excretion.
Half life
Approximately 3-10 hours for low-dose therapy, longer for high-dose oncology therapy.
Absorption
Rapidly absorbed from the GI tract (oral bioavailability varies with dose, generally 30-70% for low doses).
Metabolism
Hepatic (polyglutamation to active metabolites, and minor metabolism to 7-hydroxymethotrexate).
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal or hepatic impairment
- Pre-existing blood dyscrasias (e.g., bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia)
- Active serious infection, including tuberculosis or active peptic ulcer disease
- Alcoholism or alcoholic liver disease
- Known hypersensitivity to methotrexate
Drug Interactions
Alcohol
Increased risk of hepatotoxicity.
Phenytoin
Methotrexate may displace phenytoin from protein binding, increasing phenytoin levels and toxicity. Phenytoin can decrease methotrexate efficacy.
NSAIDs and Salicylates
May increase methotrexate levels and toxicity, especially with high doses. Use with caution.
Retinoids (e.g., acitretin)
Increased risk of hepatotoxicity.
Proton Pump Inhibitors (PPIs)
May increase methotrexate levels, especially with high doses. Monitor closely.
Trimethoprim/Sulfamethoxazole
Increases myelosuppression and potentially nephrotoxicity.
Folic acid supplements (high dose)
While often used to reduce side effects, very high doses may reduce methotrexate efficacy.
Storage
Store at controlled room temperature (20°C to 25°C or 68°F to 77°F). Protect from light and moisture. Keep out of reach of children and pets. Do not freeze.
Overdose
Overdose of methotrexate can lead to severe toxicity, including myelosuppression, mucositis, and liver/kidney damage. The primary antidote is leucovorin (folinic acid), which should be administered promptly to counteract the toxic effects. Hydration and urinary alkalinization may also be used in some cases.
Pregnancy & Lactation
Pregnancy Category X. Methotrexate is contraindicated in pregnancy due to significant risk of fetal death and severe birth defects. Effective contraception must be used by both male and female patients during and for a specified period after treatment. It is also contraindicated during breastfeeding as it is excreted in breast milk and can cause serious adverse reactions in the infant.
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal or hepatic impairment
- Pre-existing blood dyscrasias (e.g., bone marrow hypoplasia, leukopenia, thrombocytopenia, significant anemia)
- Active serious infection, including tuberculosis or active peptic ulcer disease
- Alcoholism or alcoholic liver disease
- Known hypersensitivity to methotrexate
Drug Interactions
Alcohol
Increased risk of hepatotoxicity.
Phenytoin
Methotrexate may displace phenytoin from protein binding, increasing phenytoin levels and toxicity. Phenytoin can decrease methotrexate efficacy.
NSAIDs and Salicylates
May increase methotrexate levels and toxicity, especially with high doses. Use with caution.
Retinoids (e.g., acitretin)
Increased risk of hepatotoxicity.
Proton Pump Inhibitors (PPIs)
May increase methotrexate levels, especially with high doses. Monitor closely.
Trimethoprim/Sulfamethoxazole
Increases myelosuppression and potentially nephrotoxicity.
Folic acid supplements (high dose)
While often used to reduce side effects, very high doses may reduce methotrexate efficacy.
Storage
Store at controlled room temperature (20°C to 25°C or 68°F to 77°F). Protect from light and moisture. Keep out of reach of children and pets. Do not freeze.
Overdose
Overdose of methotrexate can lead to severe toxicity, including myelosuppression, mucositis, and liver/kidney damage. The primary antidote is leucovorin (folinic acid), which should be administered promptly to counteract the toxic effects. Hydration and urinary alkalinization may also be used in some cases.
Pregnancy & Lactation
Pregnancy Category X. Methotrexate is contraindicated in pregnancy due to significant risk of fetal death and severe birth defects. Effective contraception must be used by both male and female patients during and for a specified period after treatment. It is also contraindicated during breastfeeding as it is excreted in breast milk and can cause serious adverse reactions in the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Refer to the manufacturer's packaging for specific shelf life, typically 2-3 years from manufacturing date.
Availability
Available globally in various brands and generic forms
Approval Status
FDA approved
Patent Status
Generic available
WHO Essential Medicine
YesClinical Trials
Methotrexate has been extensively studied in numerous clinical trials for its efficacy and safety across various oncological and autoimmune indications. Ongoing research continues to explore new applications and optimize treatment protocols.
Lab Monitoring
- Complete Blood Count (CBC) with differential (before, weekly/bi-weekly during initiation, then monthly or as needed)
- Liver Function Tests (LFTs) including AST, ALT, albumin, bilirubin (baseline, then monthly or as needed)
- Renal Function Tests (RFTs) including serum creatinine, BUN (baseline, then monthly or as needed)
- Chest X-ray (baseline and if pulmonary symptoms develop)
- Serum Methotrexate levels (especially in high-dose oncology protocols)
- Hepatitis B & C, HIV screening (before initiation, if clinically indicated)
Doctor Notes
- Emphasize the once-weekly dosing schedule for non-oncological indications to prevent fatal toxicity. Verify patient understanding.
- Strict monitoring of CBC, LFTs, and RFTs is critical throughout treatment. Consider liver biopsy if LFTs are persistently abnormal or cumulative dose is high.
- Assess for contraindications, especially pregnancy, active infection, and significant organ dysfunction, before initiating and during treatment.
- Counsel patients on folic acid supplementation, alcohol avoidance, and prompt reporting of any adverse events.
Patient Guidelines
- Take exactly as prescribed by your doctor, especially noting the ONCE WEEKLY schedule for non-oncological uses.
- Take folic acid or leucovorin supplements as directed by your doctor to help reduce side effects, but do not self-medicate.
- Report any unusual symptoms immediately, such as fever, chills, sore throat, easy bruising/bleeding, severe mouth sores, severe diarrhea, persistent cough, yellowing of skin/eyes, or swelling.
- Avoid alcohol completely during treatment due to increased risk of liver damage.
- Ensure adequate hydration during treatment.
Missed Dose Advice
If you miss a dose, contact your doctor immediately for advice. Do not take a double dose to make up for a missed one. It is crucial to maintain the prescribed weekly schedule to avoid toxicity.
Driving Precautions
Trexall may cause dizziness, fatigue, or blurred vision. If you experience these effects, avoid driving or operating heavy machinery until you know how the medication affects you.
Lifestyle Advice
- Protect skin from sun exposure (use sunscreen, wear protective clothing) as methotrexate can increase photosensitivity.
- Avoid close contact with people who are sick or have infections, as your immune system may be weakened.
- Maintain good oral hygiene to prevent mouth sores.
- Discuss all other medications, supplements, and herbal remedies with your doctor before starting Trexall.
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