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Methotrexate Vial
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Methotrexate Vial Quick Finder
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, BENZYL ALCOHOL TOXICITY, and OTHER SERIOUS ADVERSE REACTIONS
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1 INDICATIONS AND USAGE
1.1 Acute Lymphoblastic Leukemia
Methotrexate Injection is indicated for the treatment...
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosage and Safety Information
- Use only...
3 DOSAGE FORMS AND STRENGTHS
Injection: Methotrexate Injection is a clear, yellow solution and is supplied in single-dose vials (preservative-free) and multiple-dose vials (with preservative) in the following strengths:
...4 CONTRAINDICATIONS
Methotrexate Injection is contraindicated in:
- Patients with history of severe hypersensitivity to methotrexate [see Warnings and Precautions (...
5 WARNINGS AND PRECAUTIONS
5.1 Embryo-Fetal Toxicity
Based on published reports and its mechanism of action,...
6 ADVERSE REACTIONS
The following adverse reactions are described, or described in greater detail, in other sections:
- Hypersensitivity Reactions [see Warnings and...
7 DRUG INTERACTIONS
7.1 Effects of Other Drugs on Methotrexate
Drugs that Increase...
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Methotrexate Injection...
10 OVERDOSAGE
Manifestations
Overdosage, including fatal overdosage, has occurred with methotrexate [see...
11 DESCRIPTION
Methotrexate is a folate analog metabolic inhibitor with the chemical name of N-[4-[[(2,4-diamino-6-pteridinyl) methyl]methylamino]benzoyl]-L-glutamic acid and a molecular weight...
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this...
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
Methotrexate has been evaluated in a number of animal studies for carcinogenic...
15 REFERENCES
- "OSHA Hazardous Drugs." OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Methotrexate Injection is a clear, yellow, sterile solution available with preservative...
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Embryo-Fetal...
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