Methotrexate 25 mg/mL
Methotrexate · INJECTION, SOLUTION · Teva Parenteral Medicines, Inc.
Methotrexate is a injection, solution containing methotrexate at 25 mg/mL, taken intra-arterial. Manufactured by Teva Parenteral Medicines, Inc..
Key Facts
- Brand Name
- Methotrexate
- Generic Name
- Methotrexate
- NDC Code (Product)
0703-3678- Manufacturer
- Teva Parenteral Medicines, Inc.
- Strength
- 25 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRA-ARTERIAL, INTRAMUSCULAR, INTRATHECAL, INTRAVENOUS
- Marketing Status
- Application #
- ANDA040843
- Marketing Start
- 08/01/2012
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Sandoz Incorporated
Presence of Particulate Matter: Found during examination of retention samples.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Hospira Inc.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Infusion Options, Inc.
Lack of Assurance of Sterility
Mylan Institutional LLC
Presence of Particulate Matter
Edge Pharma, LLC
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Pharmacy Innovations
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Methotrexate tablets are a diydrofolate reductase inhibitor indicated for the: • Treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen (1.1) • Treatment of adults with mycosis fungoides (1.1) • Treatment of adults with relapsed or refractory non-Hodgkin lymphoma as part of a metronomic combination regimen (1.1) • Treatment of adults with rheumatoid arthritis (1.2) • Treatment of pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA) (1.3) • Treatment of adults with severe psoriasis (1.4) 1.1 Neoplastic Diseases Methotrexate tablets are indicated for the: • treatment of adults and pediatric patients with acute lymphoblastic leukemia (ALL) as part of a combination chemotherapy maintenance regimen • treatment of adults with mycosis fungoides (cutaneous T-cell lymphoma) as a single agent or as part of a combination chemotherapy regimen • treatment of adults with relapsed or refractory non-Hodgkin lymphomas as part of a metronomic combination chemotherapy regimen 1.2 Rheumatoid Arthritis Methotrexate tablets are indicated for the treatment of adults with rhe…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Instruct patients and caregivers to take the recommended dosage as directed, because medication errors have led to deaths. (2.1, 5.9) • Verify pregnancy status in females of reproductive potential before starting methotrexate tablets. (4, 5.1) • ALL: The recommended dosage is 20 mg/m 2 orally once weekly as a part of a combination chemotherapy maintenance regimen. (2.2) • Mycosis fungoides: The recommended dosage is 25 to 75 mg orally once weekly as monotherapy; 10 mg/m 2 orally twice weekly as part of combination chemotherapy. (2.2) • Relapsed or refractory non-Hodgkin lymphoma: The recommended dosage is 2.5 mg orally two to four times per week as part of metronomic combination chemotherapy. (2.2) • Rheumatoid Arthritis: The recommended starting dosage is 7.5 mg orally once weekly; adjust dose to achieve an optimal response. (2.3) • pJIA: The recommended starting dosage is 10 mg/m 2 orally once weekly; adjust dose to achieve an optimal response. (2.4) • Psoriasis: The recommended dosage is 10 to 25 mg orally once weekly until adequate response is achieved. (2.5) 2.1 Important Dosage and Safety Information Verify pregnancy status in females of reproduc…
Contraindications
4 CONTRAINDICATIONS Methotrexate tablets are contraindicated in: • Pregnant women receiving methotrexate tablets for treatment of non-neoplastic diseases [see Warnings and Precautions (5.1), and Use in Specific Populations (8.1, 8.3)]. • Patients with a history of severe hypersensitivity reactions, including anaphylaxis, to methotrexate. [see Warnings and Precautions (5.2)]. • In pregnancy for non-neoplastic diseases (4) • History of severe hypersensitivity to methotrexate (4)
Drug Interactions
7 DRUG INTERACTIONS Refer to the full prescribing information for drug interactions with methotrexate. (7) 7.1 Effects of Other Drugs on Methotrexate Drugs that Increase Methotrexate Exposure Coadministration of methotrexate with the following products may increase methotrexate plasma concentrations, which may increase the risk of methotrexate severe adverse reactions. In some cases, the coadministration of methotrexate with these products may also subsequently reduce active metabolite formation, which may decrease the clinical effectiveness of methotrexate. Increased organ specific adverse reactions may also occur when methotrexate is coadministered with hepatotoxic or nephrotoxic products. If coadministration cannot be avoided, monitor closely for methotrexate adverse reactions when coadministered with: Oral antibiotics (including neomycin) Antifolate drugs (e.g., dapsone, pemetrexed, pyrimethamine and sulfonamides) Oral or intravenous penicillin or sulfonamide antibiotics Aspirin and other nonsteroidal anti- inflammatory drugs Hepatotoxic products Highly protein-bound drugs (e.g., oral anticoagulants, phenytoin, salicylates, sulfonamides, sulfonylureas, and tetracyclines) Proton…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.2)] Myelosuppression [see Warnings and Precautions (5.3)] Gastrointestinal Toxicity [see Warnings and Precautions (5.4)] Hepatotoxicity [see Warnings and Precautions (5.5)] Pulmonary Toxicity [see Warnings and Precautions (5.6)] Dermatologic Reactions [see Warnings and Precautions (5.7)] Renal Toxicity [see Warnings and Precautions (5.8)] Serious Infections [see Warnings and Precautions (5.11)] Neurotoxicity [see Warnings and Precautions (5.12)] Secondary Malignancies [see Warnings and Precautions (5.13)] Tumor Lysis Syndrome [see Warnings and Precautions (5.14)] Increased Risk of Adverse Reactions Due to Third-Space Accumulation [see Warnings and Precautions (5.17)] Common adverse reactions include ulcerative stomatitis, leukopenia, nausea, abdominal distress. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials and other studies are conducted under widely va…
Frequently Asked Questions
What is Methotrexate used for?
Methotrexate contains Methotrexate. It is a injection, solution taken intra-arterial. Consult your doctor for specific uses.
Is Methotrexate a controlled substance?
Methotrexate is not classified as a controlled substance by the DEA.
What is the generic name for Methotrexate?
The generic name for Methotrexate is Methotrexate. There are 6 other brand versions of Methotrexate.
What is the NDC code for Methotrexate 25 mg/mL?
The NDC (National Drug Code) for Methotrexate 25 mg/mL is 0703-3678, listed by Teva Parenteral Medicines, Inc..