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

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Indomethacin

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Cardiovascular Risk
NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at a greater risk. (See WARNINGS.)
Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Gastrointestinal Risk
NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS.)



INDOMETHACIN DESCRIPTION


Indomethacin



CLINICAL PHARMACOLOGY













INDICATIONS & USAGE









INDOMETHACIN CONTRAINDICATIONS





WARNINGS

































PRECAUTIONS


General











INFORMATION FOR PATIENTS










LABORATORY TESTS



DRUG INTERACTIONS

































DRUG & OR LABORATORY TEST INTERACTIONS



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY






PREGNANCY


Teratogenic Effects




Nonteratogenic Effects




LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE






GERIATRIC USE





INDOMETHACIN ADVERSE REACTIONS









OVERDOSAGE





DOSAGE & ADMINISTRATION

























HOW SUPPLIED









STORAGE AND HANDLING







SPL MEDGUIDE



















































PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Indomethacin

Indomethacin

Indomethacin

Indomethacin CAPSULE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-776(NDC:23155-011)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
INDOMETHACIN INDOMETHACIN 50 mg

Inactive Ingredients

Ingredient Name Strength
D&C RED NO. 28
FD&C BLUE NO. 1
FD&C RED NO. 3
GELATIN
lactose monohydrate
MAGNESIUM STEARATE
povidone
STARCH, CORN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
pink 1 mm HP;11 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-776-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA018851 2011-09-08


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Be sure to consult your doctor before taking any medication!
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