METHOTREXATE SODIUM tablet

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

METHOTREXATE SODIUM (UNII: 3IG1E710ZN) (METHOTREXATE - UNII:YL5FZ2Y5U1)

Inapatikana kutoka:

Bryant Ranch Prepack

INN (Jina la Kimataifa):

METHOTREXATE SODIUM

Tungo:

METHOTREXATE 2.5 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Methotrexate Tablets are indicated for the: Methotrexate Tablets are indicated for the treatment of adults with rheumatoid arthritis . Methotrexate Tablets are indicated for the treatment of pediatric patients with polyarticular Juvenile Idiopathic Arthritis (pJIA). Methotrexate Tablets are indicated for the treatment of adults with severe psoriasis. Methotrexate Tablets are contraindicated in: Risk Summary Methotrexate Tablets are 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. general population, the estimated background risk of major birth defects and miscarriage in clinically recogni

Bidhaa muhtasari:

NDC: 63629-1472-1: 30 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-2: 12 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-3: 20 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-4: 100 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-5: 36 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-6: 24 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-7: 90 Tablets in a BOTTLE, PLASTIC NDC: 63629-1472-8: 4 Tablets in a BOTTLE, PLASTIC

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

METHOTREXATE SODIUM- METHOTREXATE SODIUM TABLET
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
METHOTREXATE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
METHOTREXATE TABLETS.
METHOTREXATE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1953
WARNING: EMBRYO-FETAL TOXICITY, HYPERSENSITIVITY REACTIONS, AND SEVERE
ADVERSE REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
Boxed Warning
5/2020
Indications and Usage (1)
5/2020
Dosage and Administration (2)
5/2020
Contraindications (4)
5/2020
Warnings and Precautions (5)
5/2020
INDICATIONS AND USAGE
Methotrexate Tablets are a diydrofolate reductase inhibitor indicated
for the:
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DOSAGE AND ADMINISTRATION
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METHOTREXATE TABLETS CAN CAUSE EMBRYO-FETAL TOXICITY, INCLUDING FETAL
DEATH. FOR
NON-NEOPLASTIC DISEASES, METHOTREXATE TABLETS ARE CONTRAINDICATED IN
PREGNANCY.
FOR NEOPLASTIC DISEASES, ADVISE PATIENTS OF REPRODUCTIVE POTENTIAL OF
THE POTENTIAL
RISK TO A FETUS AND TO USE EFFECTIVE CONTRACEPTION. (4, 5.1, 8.1, 8.3)
METHOTREXATE TABLETS ARE CONTRAINDICATED IN PATIENTS WITH A HISTORY OF
SEVERE
HYPERSENSITIVITY REACTIONS TO METHOTREXATE, INCLUDING ANAPHYLAXIS. (4,
5.2)
SERIOUS ADVERSE REACTIONS, INCLUDING DEATH, HAVE BEEN REPORTED WITH
METHOTREXATE.
CLOSELY MONITOR FOR ADVERSE REACTIONS OF THE BONE MARROW,
GASTROINTESTINAL TRACT,
LIVER, LUNGS, SKIN, AND KIDNEYS. WITHHOLD OR DISCONTINUE METHOTREXATE
TABLETS AS
APPROPRIATE. (5.3, 5.4, 5.5, 5.6, 5.7, 5.8)
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 juve