Ibuprofen Prescribing Information
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS).
- Ibuprofen tablets is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).
- 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).
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Ibuprofen tablets are indicated for relief of mild to moderate pain.
Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea.
Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk.
The dose should be tailored to each patient, and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond.
In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis. The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose response relationship exists with single doses up to 800 mg (See CLINICAL PHARMACOLOGYfor effects of food on rate of absorption).
The availability of three tablet strengths facilitates dosage adjustment.
In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.
For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen.
Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic- like reactions to NSAIDs have been reported in such patients (see WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma).
Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
The most frequent type of adverse reaction occurring with ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%.
In controlled studies when ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.
Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with ibuprofen tablets has not been established.
Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table.
Incidence Greater Than 1% (but less than 3%) Probable Causal Relationship Reactions occurring in 3% to 9% of patients treated with ibuprofen tablets. (Those reactions occurring in less than 3% of the patients are unmarked.) | Precise Incidence Unknown (but less than 1%) Probable Causal Relationship Reactions are classified under “Probable Causal Relationship (PCR)” if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under “Causal Relationship Unknown” if seven or more events have been reported but the criteria for PCR have not been met. | Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown |
GASTROINTESTINAL Nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating and flatulence) | Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis | |
CENTRAL NERVOUS SYSTEM Dizziness, headache, nervousness | Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS) | Paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri |
DERMATOLOGIC Rash (including maculopapular type), pruritus | Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia | Toxic epidermal necrolysis, photoallergic skin reactions |
SPECIAL SENSES Tinnitus | Hearing loss, amblyopia (blurred| and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS) | Conjunctivitis, diplopia, optic neuritis, cataracts |
HEMATOLOGIC | Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS) | Bleeding episodes (e.g., epistaxis, menorrhagia) |
METABOLIC/ENDOCRINE Decreased appetite | Gynecomastia, hypoglycemic reaction, acidosis | |
CARDIOVASCULAR Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS) | Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations | Arrhythmias (sinus tachycardia, sinus bradycardia) |
ALLERGIC | Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS) | Serum sickness, lupus erythematosus syndrome. Henoch-Schonlein vasculitis, angioedema |
RENAL | Acute renal failure (see PRECAUTIONS), decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria | Renal papillary necrosis |
MISCELLANEOUS | Dry eyes and mouth, gingival ulcer, rhinitis |
Skin and Appendages: Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).
Ibuprofen tablets contain the active ingredient ibuprofen, which is (±) - 2 - (
The structural formula is represented below:
Ibuprofen tablets, a nonsteroidal anti-inflammatory drug (NSAID), is available in 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, talc, magnesium stearate, Opadry II contains hypromellose, polyethylene glycol, sodium citrate, lactose monohydrate and titanium dioxide.