MTS
Generic Name
Methotrexate
Manufacturer
Generic Pharma Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| mts 10 mg tablet | ৳ 16.00 | ৳ 160.00 |
Description
Overview of the medicine
Methotrexate is an antimetabolite and antifolate drug used in the treatment of various cancers, autoimmune diseases like rheumatoid arthritis, and psoriasis. It works by inhibiting cell proliferation and inflammation.
Uses & Indications
Dosage
Adults
Dosage is highly variable depending on the indication. For rheumatoid arthritis/psoriasis, typical oral dose is 7.5-20 mg once weekly. For oncological uses, doses can be significantly higher and administered more frequently.
Elderly
Elderly patients may require reduced doses due to decreased renal and hepatic function. Close monitoring for toxicity is essential.
Renal_impairment
Significant dose reduction or discontinuation is necessary in patients with renal impairment. Consult product information for specific creatinine clearance guidelines.
How to Take
Take oral tablets with a glass of water, usually once weekly on a consistent day. For some indications, it may be administered intramuscularly, intravenously, or intrathecally by a healthcare professional.
Mechanism of Action
Methotrexate inhibits dihydrofolate reductase (DHFR), an enzyme that participates in the tetrahydrofolate synthesis. This inhibition prevents the reduction of dihydrofolate to tetrahydrofolate, leading to impaired DNA synthesis, repair, and cellular replication.
Pharmacokinetics
Onset
For anti-inflammatory effects in rheumatoid arthritis/psoriasis, onset is typically 3-6 weeks. For oncological indications, effects can be more acute.
Excretion
Primarily excreted unchanged in the urine (50-90%), with a small amount excreted in bile. Renal impairment significantly prolongs excretion.
Half life
Plasma elimination half-life is typically 3-10 hours for low doses and 8-15 hours for high doses.
Absorption
Oral absorption is dose-dependent and variable (20-90%). Peak plasma concentrations are reached in 1-4 hours.
Metabolism
Undergoes limited hepatic metabolism to 7-hydroxymethotrexate (an active but less potent metabolite) and polyglutamates.
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal impairment
- Severe hepatic impairment (cirrhosis, alcoholism)
- Pre-existing blood dyscrasias (e.g., significant anemia, leukopenia, thrombocytopenia)
- Active infection
- Immunodeficiency syndromes
- Active peptic ulcer disease
Drug Interactions
Salicylates (e.g., aspirin)
May reduce renal excretion of methotrexate, increasing its levels and potential toxicity.
Proton Pump Inhibitors (PPIs)
May increase methotrexate concentrations, particularly at high doses. Consider temporary discontinuation of PPIs or careful monitoring.
Trimethoprim/Sulfamethoxazole
Increases methotrexate levels and toxicity by inhibiting renal tubular secretion and interfering with folate metabolism. Avoid co-administration.
NSAIDs (e.g., ibuprofen, naproxen)
Concomitant use with NSAIDs can increase methotrexate levels and toxicity, especially at higher doses. Use with caution and monitor for signs of toxicity.
Folic acid supplements (taken inappropriately)
While often co-prescribed, incorrect timing can reduce methotrexate efficacy or increase toxicity. Take as directed by your doctor, usually 24-48 hours after methotrexate.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe bone marrow suppression, hepatotoxicity, stomatitis, and gastrointestinal irritation. Management involves prompt administration of leucovorin (folinic acid) rescue, hydration, and alkalinization of urine to promote excretion. Supportive care is essential.
Pregnancy & Lactation
Pregnancy Category X: Methotrexate is highly teratogenic and is contraindicated in pregnancy. Women of childbearing potential should use effective contraception during therapy and for at least 6 months after. Breastfeeding is also contraindicated due to potential harm to the infant.
Side Effects
Contraindications
- Pregnancy and breastfeeding
- Severe renal impairment
- Severe hepatic impairment (cirrhosis, alcoholism)
- Pre-existing blood dyscrasias (e.g., significant anemia, leukopenia, thrombocytopenia)
- Active infection
- Immunodeficiency syndromes
- Active peptic ulcer disease
Drug Interactions
Salicylates (e.g., aspirin)
May reduce renal excretion of methotrexate, increasing its levels and potential toxicity.
Proton Pump Inhibitors (PPIs)
May increase methotrexate concentrations, particularly at high doses. Consider temporary discontinuation of PPIs or careful monitoring.
Trimethoprim/Sulfamethoxazole
Increases methotrexate levels and toxicity by inhibiting renal tubular secretion and interfering with folate metabolism. Avoid co-administration.
NSAIDs (e.g., ibuprofen, naproxen)
Concomitant use with NSAIDs can increase methotrexate levels and toxicity, especially at higher doses. Use with caution and monitor for signs of toxicity.
Folic acid supplements (taken inappropriately)
While often co-prescribed, incorrect timing can reduce methotrexate efficacy or increase toxicity. Take as directed by your doctor, usually 24-48 hours after methotrexate.
Storage
Store below 30°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
Symptoms of overdose include severe bone marrow suppression, hepatotoxicity, stomatitis, and gastrointestinal irritation. Management involves prompt administration of leucovorin (folinic acid) rescue, hydration, and alkalinization of urine to promote excretion. Supportive care is essential.
Pregnancy & Lactation
Pregnancy Category X: Methotrexate is highly teratogenic and is contraindicated in pregnancy. Women of childbearing potential should use effective contraception during therapy and for at least 6 months after. Breastfeeding is also contraindicated due to potential harm to the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture.
Availability
Available in pharmacies and hospitals
Approval Status
Approved
Patent Status
Expired
WHO Essential Medicine
YesClinical Trials
Methotrexate has been extensively studied in numerous clinical trials for its efficacy and safety across various indications, including rheumatological disorders and a wide range of cancers. Ongoing research continues to explore new applications and optimize treatment regimens.
Lab Monitoring
- Complete Blood Count (CBC) with differential (before therapy, weekly/bi-weekly during initial therapy, then monthly)
- Liver Function Tests (LFTs) including AST, ALT, albumin, bilirubin (before therapy, then monthly or more frequently)
- Renal Function Tests (serum creatinine, BUN, GFR) (before therapy, then monthly or more frequently)
- Chest X-ray (baseline and as clinically indicated)
Doctor Notes
- Emphasize the once-weekly dosing schedule for non-oncological indications to patients to prevent potentially fatal daily dosing errors.
- Regularly monitor CBC, LFTs, and renal function tests. Adjust dose as per guidelines and patient tolerance.
- Consider folic acid supplementation to reduce gastrointestinal and hematological toxicity, administered 24-48 hours post-methotrexate dose.
- Educate patients on potential severe toxicities (e.g., pulmonary, hepatic, myelosuppression) and when to seek urgent medical attention.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor, particularly adhering to the weekly dosing schedule for non-oncological uses.
- Do not take more than the prescribed dose or take it more frequently than advised.
- If prescribed, take folic acid supplements as directed by your doctor (usually 24-48 hours after methotrexate to minimize side effects without compromising efficacy).
- Report any unusual symptoms or side effects (e.g., mouth sores, persistent cough, unusual bleeding/bruising, jaundice) to your doctor immediately.
- Avoid alcohol consumption during treatment.
- Stay well-hydrated.
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 correct dosing schedule to avoid toxicity.
Driving Precautions
Methotrexate may cause side effects like dizziness, fatigue, or visual disturbances in some patients. If you experience these symptoms, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain good oral hygiene to prevent mouth sores.
- Avoid excessive sun exposure and use sunscreen as methotrexate can cause photosensitivity.
- Stay away from people who are sick with infections, especially during periods of low blood counts.
- Discuss any vaccinations with your doctor before receiving them, as live vaccines are generally contraindicated.
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