Advisability of Use During Pregnancy

Precautions for Use

CAUTION

Possible Effects on Laboratory Tests

Natural Diseases or Disorders That May Be Activated by This Drug

Adverse Effects That May Mimic Natural Diseases or Disorders

Possible Effects on Sexual Function

Possible Adverse Effects(unusual, unexpected and infrequent reactions) If any of the following develop, consult your physician promptly for guidance.

Mild Adverse Effects

Allergic Reactions: Skin rash, hives, itching.

Headache, dizziness, altered or blurred vision, ringing in the ears, depres­sion.

Mouth sores, indigestion, nausea, vomiting, constipation, diarrhea. Serious Adverse Effects

Allergic Reactions: Anaphylaxis, severe skin reactions.

Idiosyncratic Reactions: Drug-induced meningitis with fever and coma.

Active peptic ulcer, with or without bleeding.

Liver damage with jaundice.

Kidney damage with painful urination, bloody urine, reduced urine for­mation.

Rare bone marrow depression - fatigue, weakness, fever, sore throat, abnormal bleeding or bruising.

Altered timing and pattern of menstruation (30%); excessive menstrual

bleeding. Male breast enlargement and tenderness.

Possible Delayed Adverse Effects: Mild anemia due to "silent" blood loss from the stomach (less than that caused by aspirin).

Liver reaction may suggest viral hepatitis.

Peptic ulcer disease, ulcerative colitis.

Complete blood cell counts: decreased red cells, hemoglobin, white cells

and platelets.

Blood cholesterol level: increased. Blood lithium level: increased. Blood uric acid level: increased. Liver function tests: increased liver enzymes (ALT/GPT, AST/GOT and

alkaline phosphatase), increased bilirubin. Kidney function tests: increased blood creatinine and urea nitrogen

(BUN) levels. Fecal occult blood test: positive.

1. Dosage should always be limited to the smallest amount that pro­-
duces reasonable improvement.

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

By Infants and Children: Safety and effectiveness for use by those under 12 years of age have not been established.

By Those over 60 Years of Age: Small doses are advisable until tolerance is determined. Observe for any indications of liver or kidney toxicity, fluid retention, dizziness, confusion, impaired memory, stomach bleed­ing or constipation.

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

Animal studies: No birth defects reported in rats or rabbits.

Human studies: Information from adequate studies of pregnant women is not available.

Avoid this drug during the last 3 months. Use it during the first 6 months only if clearly needed. Ask physician for guidance.

The manufacturer does not recommend the use of this drug during preg­nancy.

Advisability of Use if Breast-Feeding

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

Habit-Forming Potential: None.

Effects of Overdosage: Drowsiness, dizziness, ringing in the ears, nausea, vomiting, diarrhea, confusion, unsteadiness, stupor progressing to coma.

Possible Effects of Long-Term Use: Fluid retention.

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.

While Taking This Drug, Observe the Following Foods: No restrictions.

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

Ibuprofen 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.

Ibuprofen taken concurrently with the following drugs may increase

the risk of bleeding; avoid these combinations:

aspirin.

dipyridamole (Persantine).

indomethacin (Indocin).

sulfinpyrazone (Anturane).

valproic acid (Depakene). Driving, Hazardous Activities: This drug may cause drowsiness or dizziness.

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: Use caution until sensitivity is determined. Questionable

photosensitivity has been reported.

Дата добавления: 2015-06-25