Ibuprofen

(i BYU proh fen)

Introduced: 1969

Class: Mild analgesic, anti-inflammatory

Prescription: USA: Varies

Controlled Drug: USA: No Canada: Yes

Available as Generic: Yes

Brand Names: Advil, Apo-Ibuprofen, Children's Advil, CoAdvil [CD], Nuprin, PediaProfen,

Principal Uses

As a Single Drug Product: Used primarily to relieve mild to moderately severe pain associated with (1) musculoskeletal injuries; (2) acute and chronic gout, rheumatoid arthritis and osteoarthritis; (3) dental, obstet­rical and orthopedic surgery; (4) menstrual cramps; (5) vascular (mi-grainelike) headaches; and (6) to reduce fever.

How This Drug Works: Not completely established. It is thought that this drug reduces the tissue concentrations of prostaglandins (and related compounds), chemicals involved in the production of inflammation and pain.

Available Dosage Forms and Strengths

Caplets — 200 mg

Oral suspension — 100 mg per 5-ml teaspoonful

Tablets — 200 mg, 300 mg, 400 mg, 600 mg, 800 mg

Usual Adult Dosage Range: 200 to 800 mg 3 or 4 times/day. Total daily dosage should not exceed 3200 mg (3600 mg in selected individuals). Note: Actual dosage and administration schedule must be deter­mined by the physician for each patient individually.

Dosing Instructions: Take either on an empty stomach or with food or milk to prevent stomach irritation. Take with a full glass of water and re­main upright (do not lie down) for 30 minutes. The tablet may be crushed for administration.

Usual Duration of Use: Continual use on a regular schedule for 1 to 2 weeks is usually necessary to determine this drug's effectiveness in relieving the discomfort of arthritis. Long-term use requires supervision and periodic evaluation by the physician. Consult your physician on a regu­lar basis.

This Drug Should Not Be Taken If

• you have had an allergic reaction to it previously.

• you are subject to asthma or nasal polyps caused by aspirin.

• you have active peptic ulcer disease or any form of gastrointestinal bleeding.

• you have a bleeding disorder or a blood cell disorder.

• you have severe impairment of kidney function.

Inform Your Physician Before Taking This Drug If

• you are allergic to aspirin or to other aspirin substitutes.

• you have a history of peptic ulcer disease or any type of bleeding disorder.

• you have impaired liver or kidney function.

• you have high blood pressure or a history of heart failure.

• you are taking any of the following: acetaminophen, aspirin or other aspirin substitutes, anticoagulants, oral antidiabetic drugs.

Possible Side-Effects (natural, expected and unavoidable drug actions) Fluid retention (weight gain); pink, red, purple or rust coloration of urine (of no significance).

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.

Possible Effects on Sexual Function

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).

Adverse Effects That May Mimic Natural Diseases or Disorders

Liver reaction may suggest viral hepatitis.

Natural Diseases or Disorders That May Be Activated by This Drug

Peptic ulcer disease, ulcerative colitis.

Possible Effects on Laboratory Tests

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.

CAUTION

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.

Precautions for Use

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.

Advisability of Use During Pregnancy

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.

TEXT 10. Read the following text attentively and choose the sentences containing the word “diarrhea”. Translate them in writing.