Ibuprofen

Trade Names:Advil- Tablets 200 mg

Trade Names:Advil Liqui-Gels- Capsules 200 mg

Trade Names:Advil Migraine- Capsules 200 mg

Trade Names:Children's Advil- Suspension 100 mg per 5 mL

Trade Names:Children's Motrin- Tablets, chewable 50 mg- Suspension 100 mg per 5 mL

Trade Names:Ibuprofen- Capsules 200 mg- Tablets 200 mg- Tablets 400 mg- Tablets 600 mg- Tablets 800 mg- Tablets, chewable 100 mg

Trade Names:Ibutab- Tablets 200 mg

Trade Names:Infant's Motrin- Oral drops 40 mg/mL

Trade Names:Junior Strength Motrin- Tablets 100 mg- Tablets, chewable 100 mg

Trade Names:Motrin Migraine Pain- Tablets 200 mg

Trade Names:PediaCare Fever- Suspension 100 mg per 5 mL- Oral drops 40 mg/mL

Trade Names:Pediatric Advil Drops- Suspension 100 mg per 2.5 mL

Pharmacology

Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

Pharmacokinetics

Absorption

T _max is 1 to 2 h. Bioavailability is less than 80%.

Elimination

Plasma t _½ is 1.8 to 2 h. 45% to 79% is eliminated through the urine. Cl is 3 to 35 L/h.

Indications and Usage

Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis, mild to moderate pain, primary dysmenorrhea, reduction of fever, migraine.

Contraindications

Treatment of perioperative pain in the setting of coronary artery bypass graft surgery; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs; hypersensitivity to any component of the product.

Dosage and Administration

PO 300 to 800 mg 3 times daily to 4 times daily, not to exceed 3.2 g/day.

PO 400 mg every 4 to 6 h as needed.

PO 400 mg every 4 h as needed.

39.2°C (102.5°F) and less, recommended dose PO 5 mg/kg; more than 39.2°C (102.5°F), recommended dose PO 10 mg/kg; max daily dose 40 mg/kg.

PO 200 mg every 4 to 6 h. Do not exceed 1.2 g in 24 h, or take for pain for more than 10 days or for fever for more than 3 days, unless directed by health care provider. Use smallest effective dose.

PO 400 mg with a glass of water. If symptoms persist or worsen, contact health care provider. Do not exceed 400 mg in 24 h or for longer than 10 days unless directed by health care provider.

PO If possible, use weight to dose; otherwise, use age. May repeat dose every 6 to 8 h. Do not use more than 4 times per day.

• Children 12 to 17 lbs or 6 to 11 mo of age, give 50 mg.
• Children 18 to 23 lbs or 12 to 23 mo of age, give 75 mg.
• Children 24 to 35 lbs or 2 to 3 yr of age, give 100 mg.
• Children 36 to 47 lbs or 4 to 5 yr of age, give 150 mg.
• Children 48 to 59 lbs or 6 to 8 yr of age, give 200 mg.
• Children 60 to 71 lbs or 9 to 10 yr of age, give 250 mg.
• Children 72 to 95 lbs or 11 yr of age, give 300 mg.

Storage/Stability

Store at 68° to 77°F.

Drug Interactions

Antihypertensive effect of ACE inhibitors may be diminished.

Protein binding of ibuprofen may be reduced; in addition, the risk of gastric erosion and bleeding may be increased.

Antihypertensive effect may be decreased.

Ibuprofen may increase digoxin serum levels.

Diuretic effects may be decreased.

May increase lithium levels.

May increase methotrexate levels.

May increase risk of gastric erosion and bleeding.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Edema, fluid retention (greater than 1% and less than 3%).

CNS

Dizziness (3% to 9%); headache, nervousness (greater than 1% and less than 3%).

Dermatologic

Rash including maculopapular (3% to 9%); pruritus (greater than 1% and less than 3%).

EENT

Tinnitus (greater than 1% and less than 3%).

GI

Epigastric pain, heartburn, nausea (3% to 9%); abdominal cramps or pain, abdominal distress, constipation, diarrhea, fullness of GI tract (bloating, flatulence), indigestion, nausea and vomiting (greater than 1% and less than 3%).

Metabolic-Nutritional

Decreased appetite (greater than 1% and less than 3%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Elderly

Increased risk of adverse reactions.

Renal Function

Use is not recommended in patients with advanced kidney disease. Long-term treatment with NSAIDs may result in renal papillary necrosis and other renal injury.

Special Risk Patients

Use with caution in patients with fluid retention, hypertension, or heart failure.

Anaphylactoid reactions

Do not administer to patients with aspirin triad, which occurs typically in asthmatic patients who experience rhinitis with or with nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs.

Asthma

Patients with asthma may have aspirin-sensitive asthma, which may be associated with severe and sometimes fatal bronchospasm. Ibuprofen should not be administered to patients with this type of aspirin-sensitivity because of possible cross-reactivity.

Hypertension

New hypertension or worsening of preexisting hypertension, either of which may contribute to increased risk of CV events, may occur.

Platelet function

NSAIDs inhibit platelet aggregation and have been reported to prolong bleeding time.

Skin reactions

Serious and sometimes fatal skin adverse reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, may occur.

Overdosage

Symptoms

Acute renal failure, apnea, cyanosis, drowsiness, epigastric pain, GI irritation/bleeding, lethargy, metabolic acidosis, nausea, sweating, tinnitus, vomiting.

Patient Information

• Tell patient to take medication soon after meals or with food, milk, or antacids.
• Tell patient to avoid alcohol and medications containing aspirin, such as cold remedies.
• Advise patient to discontinue drug and immediately notify health care provider if any of the following occur: persistent or recurrent GI upset or stomach pain; skin rash or itching; vomiting blood; bloody or black stools; rapid weight gain or swelling; changes in urine patterns; joint pain; fever; bleeding or unusual bruising; unexplained tiredness or fatigue; intestinal flu-like symptoms; yellowing of the skin or eyes; visual changes.
• Advise patient to seek emergency medical assistance if any of the following occur: shortness of breath or trouble breathing; chest pain; weakness in one part or on one side of body; slurred speech; swelling of the face or throat.
• Instruct patient not to take OTC preparation for more than 3 days when treating fever and more than 10 days when treating pain, and to notify health care provider if condition does not improve.
• Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.

Copyright © 2009 Wolters Kluwer Health.