While Taking This Drug, Observe the Following. Advisability of Use During Pregnancy

Advisability of Use During Pregnancy

Precautions for Use

CAUTION

1. Dosage should always be limited to the smallest amount that produces reasonable improvement.

2. This drug may mask early indications of infection. Inform your physician if you think you are developing an infection of any kind.

By Infants and Children: This drug frequently causes impairment of kidney function in infants. Fatal liver reactions have occurred in children between 6 and 12 years of age; avoid the use of this drug in this age group.

By Those over 60 Years of Age: Adverse effects are very common in this age group. Small doses are advisable until tolerance is determined. Observe for any indications of liver or kidney toxicity, fluid retention, dizziness, confusion, impaired memory, depression, peptic ulcer or diarrhea, often with rectal bleeding.

Pregnancy Category: D (tentative). See Pregnancy Code inside back cover.

Animal studies: Significant toxicity and birth defects reported in mice and rats.

Human studies: Information from adequate studies of pregnant women is not available. However, birth defects have been attributed to the use of this drug during pregnancy.

The manufacturer recommends that this drug not be taken during pregnancy.

Advisability of Use if Breast-Feeding

Presence of this drug in breast milk: Yes. Avoid drug or refrain from nursing.

The manufacturer recommends that this drug not be taken while breast feeding.

Habit-Forming Potential: None.

Effects of Overdosage: Drowsiness, agitation, confusion, nausea, vomiting, diarrhea, disorientation, seizures, coma.

Possible Effects of Long-Term Use: Eye changes: deposits in the cornea, alterations in the retina.

Suggested Periodic Examinations While Taking This Drug (at physician's

discretion)

Complete blood cell counts, liver and kidney function tests, complete eye examinations if vision is altered in any way.

Foods: No restrictions.

Nutritional Support: Take 50 mg of vitamin С (ascorbic acid) daily.

Beverages: No restrictions. May be taken with milk.

> Alcohol: Use with caution. The irritant action of alcohol on the stomach

lining, added to the irritant action of this drug in sensitive individuals, can increase the risk of stomach ulceration and/or bleeding. Tobacco Smoking: No interactions expected.

> Other Drugs

Indomethacin may increase the effects of

• acetaminophen (Tylenol, etc.), and increase the risk of kidney damage;
avoid prolonged use of this combination.

• anticoagulants (Coumadin, etc.), and increase the risk of bleeding;
monitor prothrombin time, adjust dose accordingly.

• lithium, and cause lithium toxicity.
Indomethacin may decrease the effects of

• beta blocker drugs (see Drug Class, Section Four), and reduce their
antihypertensive effectiveness.

• bumetanide (Bumex).

• captopril (Capoten).

• ethacrynic acid (Edecrin).

• furosemide (Lasix).

Indomethacin taken concurrently with the following drugs may in­crease the risk of bleeding; avoid these combinations: aspirin.

diflunisal (Dolobid). dipyridamole (Persantine). sulfinpyrazone (Anturane). valproic acid (Depakene).

Driving, Hazardous Activities: This drug may cause drowsiness, dizziness or impaired vision. Restrict activities as necessary.

Aviation Note: The use of this drug may be a disqualification for piloting. Consult a designated Aviation Medical Examiner.

Exposure to Sun: No restrictions.

Дата добавления: 2015-06-25