ADVIL LIQUI-GELS

).

Non-Prescription Experience:

Literature (1992-1999) (at dosages 1200 mg/day) One researcher conducted an extensive analysis of published data concerning the relative safety of non-prescription doses of ibuprofen and acetaminophen. Of a total of 96 randomized and blinded trials, there were 10 trials of seven days’ duration or less where the safety of both drugs was directly compared.

In three of these trials, the incidence of adverse events was higher with acetaminophen; there were no reported adverse events in six trials; and one trial reported a higher incidence with ibuprofen. In this subset of 10 studies, it was reported that gastrointestinal adverse events were found to be the most common type of event reported and were predominantly dyspepsia, nausea, or vomiting.

None of the GI events appeared to warrant follow-up from which the author inferred there were no serious gastrointestinal events. ” A double-blind, placebo-controlled study (N=1246) was conducted to prospectively evaluate the gastrointestinal tolerability, as compared to placebo, of the maximum non-prescription dose and duration (1200 mg/day for 10 consecutive days) of ibuprofen use in healthy subjects representative of a non-prescription analgesic user population.

Gastrointestinal adverse experiences were similar in the placebo and ibuprofen groups (67 out of 413, 16% with placebo vs. 161 out of 833, 19% with ibuprofen). There was no difference between the two groups in the proportion of discontinuing due to a gastrointestinal event.

Gastrointestinal adverse experiences reported by ≥1% of subjects were: dyspepsia, abdominal pain, nausea, diarrhoea, flatulence, and constipation. 4%) subjects had positive occult blood tests: their frequency was comparable between treatments.

When used as directed to treat episodic pain, non-prescription ibuprofen at the maximum dose of 1200 mg/day for 10 days, is well-tolerated. In two multi-trial analyses a meta analysis, and a literature review, single doses of ibuprofen had a low incidence of gastrointestinal drug reactions, comparable to that of acetaminophen and placebo.

Reports from spontaneous reporting systems in the United Kingdom, France and the United States, where a prescription is not needed for ibuprofen at a daily dose up to 1200 mg, confirm the medication’s gastrointestinal safety and acceptability.

5%. Ibuprofen was not statistically different from acetaminophen. 035]. 2 Drug Interactions Overview Advil is not recommended for concomitant use with any other NSAIDs, including ASA. Documented or possible drug interactions with Advil include acetaminophen, digoxin, anticoagulants, oral antidiabetic agents and insulin, antihypertensives, diuretics, methotrexate, lithium and other protein-bound drugs.