Methotrexate Sodium description, usages, side effects, indications, overdosage, supplying and lots more!

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Methotrexate Sodium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING


PRECAUTIONS
CONTRAINDICATIONS

Drug Interactions
Organ System Toxicity




Organ System Toxicity



METHOTREXATE SODIUM DESCRIPTION


Methotrexate Sodium



INACTIVE INGREDIENT



CLINICAL PHARMACOLOGY







PHARMACOKINETICS















INDICATIONS & USAGE

Neoplastic Diseases




Psoriasis


Rheumatoid Arthritis including Polyarticular-Course Juvenile Rheumatoid Arthritis

Drug Interactions

METHOTREXATE SODIUM CONTRAINDICATIONS

PRECAUTIONSBoxed WARNINGS.)
Because of the potential for serious adverse reactions from methotrexate in breast fed infants, it is contraindicated in nursing mothers.
Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes should not receive methotrexate.
Patients with psoriasis or rheumatoid arthritis who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia, should not receive methotrexate.
Patients with a known hypersensitivity to methotrexate should not receive the drug.

WARNINGS

SEE BOXED WARNINGS.


PRECAUTIONS

General
Boxed WARNINGSOVERDOSAGE


INFORMATION FOR PATIENTS





LABORATORY TESTS


Organ System Toxicity



DRUG INTERACTIONS












CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY



PREGNANCY

CONTRAINDICATIONS

NURSING MOTHERS

CONTRAINDICATIONS

PEDIATRIC USE


CLINICAL PHARMACOLOGYADVERSE REACTIONSDOSAGE AND ADMINISTRATION

GERIATRIC USE

Drug InteractionsBoxed WARNINGSADVERSE REACTIONS
Organ System Toxicity
















METHOTREXATE SODIUM ADVERSE REACTIONS

















Adverse Reactions in Double-Blind Rheumatoid Arthritis Studies
PRECAUTIONS



PRECAUTIONS


Adverse Reactions in Psoriasis


Adverse Reactions in JRA Studies


OVERDOSAGE






DOSAGE & ADMINISTRATION

Neoplastic Diseases










Psoriasis, Rheumatoid Arthritis, and Juvenile Rheumatoid Arthritis







Information for PatientsPRECAUTIONSPRECAUTIONSCONTRAINDICATIONS
ADVERSE REACTIONS






STORAGE AND HANDLING





HANDLING AND DISPOSAL


HOW SUPPLIED




REFERENCES









PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Methotrexate Sodium

Methotrexate Sodium

Methotrexate Sodium

Methotrexate Sodium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-406(NDC:0555-0572)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
METHOTREXATE SODIUM METHOTREXATE 2.5 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
ANHYDROUS LACTOSE
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
STARCH, CORN
propylene glycol
SODIUM CARBONATE MONOHYDRATE
talc

Product Characteristics

Color Size Imprint Code Shape
yellow 8 mm B;572 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-406-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA081099 2011-07-21


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Be sure to consult your doctor before taking any medication!
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