Methotrexate
Generic Name: methotrexate
Brand Names:
Methotrexate
11 DESCRIPTION Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N -[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C 20 H 22 N 8 O 5 and the molecular weight is 454.45 g/mol. The structural formula is: Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium.
Overview
11 DESCRIPTION Methotrexate, USP is dihydrofolate reductase inhibitor with the chemical name of L-glutamic acid, N -[4-[[(2,4-diamino-6-pteridinyl)methyl]methylamino]benzoyl]. The molecular formula is C 20 H 22 N 8 O 5 and the molecular weight is 454.45 g/mol. The structural formula is: Methotrexate tablets, USP for oral use are available in bottles of 36 and 100 tablets. Each tablet contains 2.5 mg methotrexate, USP equivalent to 2.74 mg methotrexate sodium.
Uses
1 INDICATIONS AND USAGE Methotrexate tablets is a dihydrofolate 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...
Dosage
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.
Side Effects
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 Reacti...
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.
Warnings
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non- neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . 5 WARNINGS AND PRECAUTIONS Serious Infections: Monitor patients for infection during and after treatment with methotrexate tablets. Withhold or discontinue methotrexate tablets for serious infections as appropriate. ( 5.11 ) Neurotoxicity: Monitor patients for neurotoxicity and withhold or discontinue methotrexate tablets as appropriate. ( 5.12 ) Secondary Malignancies: Can occur with methotrexate. ( 5.13 ) Tumor Lysis Syndrome: Institute appropriate prophylactic measures in patients at risk for tumor lysis syndrome prior to initiation of methotrexate tablets. ( 5.14 ) Immunizations and Risk Live Vaccines: Immunizations with live vaccines is not recommended. Follow current vaccination practice guidelines. 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 a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see Warnings and Precautions ( 5.2 )] .
Pregnancy
8.1 Pregnancy Risk Summary Methotrexate is contraindicated in pregnant women with non-neoplastic diseases [see Contraindications ( 4 )] . Based on published reports and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. There are no animal data that meet current standards for nonclinical developmental toxicity studies. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-5457 NDC: 50090-5457-9 36 TABLET in a BOTTLE
Frequently Asked Questions
What is Methotrexate used for?▼
1 INDICATIONS AND USAGE Methotrexate tablets is a dihydrofolate 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...
What are the side effects of Methotrexate?▼
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 Reacti...
Can I take Methotrexate during pregnancy?▼
8.1 Pregnancy Risk Summary Methotrexate is contraindicated in pregnant women with non-neoplastic diseases [see Contraindications ( 4 )] . Based on published reports and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , methotrexate can cause embryo-fetal toxicity and fetal death when administered to a pregnant woman. There are no animal data that meet current standards for nonclinical developmental toxicity studies. Advise pregnant women with neoplastic diseases of the potential risk to a fetus. In the U.S.
What are the important warnings for Methotrexate?▼
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS AND SEVERE ADVERSE REACTIONS Methotrexate can cause embryo-fetal toxicity, including fetal death. For non- neoplastic diseases, methotrexate is contraindicated in pregnancy. For neoplastic diseases, advise females and males of reproductive potential to use effective contraception [see Contraindications ( 4 ), Warnings and Precautions ( 5.1 ), Use in Specific Populations ( 8.1 , 8.3 )] . 5 WARNINGS AND PRECAUTIONS Serious Infections: Monitor patients for infection during and after treatment with methotrexate tablets. Withhold or discontinue methotrexate tablets for serious infections as appropriate. ( 5.11 ) Neurotoxicity: Monitor patients for neurotoxicity and withhold or discontinue methotrexate tablets as appropriate. ( 5.12 ) Secondary Malignancies: Can occur with methotrexate. ( 5.13 ) Tumor Lysis Syndrome: Institute appropriate prophylactic measures in patients at risk for tumor lysis syndrome prior to initiation of methotrexate tablets. ( 5.14 ) Immunizations and Risk Live Vaccines: Immunizations with live vaccines is not recommended. Follow current vaccination practice guidelines. 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 a severe hypersensitivity reactions, including anaphylaxis, to methotrexate [see Warnings and Precautions ( 5.2 )] .
Related Medications
Anacardium Orientale, Aurum Muriaticum Natronatum, Camphora, Dna, Germanium Metallicum, Helleborus Niger, Hydrogen, Lac Caninum, Lac Materna Humanum, Lithium Carbonicum, Lithium Carbonicum, Magnesia Oxydata, Natrum Carbonicum, Neon, Oxytocin, Placenta Totalis Suis, Rhus Glabra, Saccharum Officinale, Stramonium, Thuja Occidentalis
anacardium orientale, aurum muriaticum natronatum, camphora, dna, germanium metallicum, helleborus niger, hydrogen, lac caninum, lac materna humanum, lithium carbonicum, lithium carbonicum, magnesia oxydata, natrum carbonicum, neon, oxytocin, placenta totalis suis, rhus glabra, saccharum officinale, stramonium, thuja occidentalis
Oxytocic [EPC]
PURPOSE: Anacardium Orientale – Desire for Intimacy , Aurum Muriaticum Natronatum – Feeling Unloved, Camphora – Forsaken Feeling, DNA - Isolation, Germanium Metallicum - Isolation, Helleborus Niger - Disconnection, Hydrogen - Loneliness, Lac Caninum - Alienation, Lac Materna Humanum – Lack of Mother Child Bonding, Lithium Carbonicum – Feeling Unloved, Magnesia Oxydata – Desire for Intimacy, Natrum Carbonicum – Forsaken Feeling, Neon - Isolation, Oxytocin – Lack of Mother Child Bonding, Placenta
Cangrelor
cangrelor
P2Y12 Platelet Inhibitor [EPC]
11 DESCRIPTION KENGREAL is a direct-acting P2Y 12 platelet receptor inhibitor that blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation. The chemical structure is similar to adenosine triphosphate (ATP). The chemical name of KENGREAL is tetrasodium salt of N6-[2-(methylthio)ethyl]-2-[(3,3,3,-trifluoropropyl)-5’-adenylic acid, monanhydride with (dichloromethylene) bisphosphonic acid.
Laurus Nobilis, Condurango, Rhamnus Frangula, Menyanthes Trifoliata, Absinthium, Jateorhiza Palmata, Argentum Metallicum, Antimonium Crudum
laurus nobilis, condurango, rhamnus frangula, menyanthes trifoliata, absinthium, jateorhiza palmata, argentum metallicum, antimonium crudum
Non-Standardized Plant Allergenic Extract [EPC]
Uses For the temporary relief of symptoms associated with stomach acidity, gas, belching and lack of appetite.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.