IBU Tablet Ref.[50966] Active ingredients: Ibuprofen

Carefully consider the potential benefits and risks of IBU tablets and other treatment options before deciding to use IBU 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 IBU 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 IBU tablets with meals or milk.

Rheumatoid arthritis and osteoarthritis, including flare-ups ofchronic disease

Suggested Dosage: 1200 mg-3200 mg daily (400 mg, 600 mg or800 mg tid or qid). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. 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 IBU tablets than do patients with osteoarthritis.

The smallest dose of IBU 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 PHARMACOLOGY for effects of food on rate of absorption).

The availability of three tablet strengths facilitates dosage adjustment. In chronic conditions, a therapeutic response to therapy with IBU tablets is sometimes seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has beenachieved, the patient’s dose should be reviewed and adjusted as required.

Mild to moderate pain

400 mg every 4 to 6 hours as necessary for relief of pain. In controlled analgesic clinical trials, doses of Ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose.

Dysmenorrhea

For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, IBU tablets should be given in adose of 400 mg every 4 hours as necessary for the relief of pain.

Approximately 11⁄2 hours after the reported ingestion of from 7 to 10 Ibuprofen tablets (400 mg), a 19-month old child weighing 12 kgwas seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluidswere given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen. Two hours after ingestion the child’s condition seemed stable; she still respondedonly to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 μg/mL approximately 81⁄2 hoursafter accidental ingestion. At 12 hours she appeared to be completely recovered.

In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae. Blood level in one child 90 minutes after ingestion was 700 μg/mL — about 10 times the peak levels seen in absorption-excretion studies. A 19-year old male who had taken 8,000 mg of ibuprofen over aperiod of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bedrest, he recovered with no reported sequelae.

In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of Ibuprofen tablets.

Store at room temperature. Avoid excessive heat 40°C (104°F).