Schedule change for large packages of ibuprofen

January 10, 2012

Effective Feb. 17, 2012, ibuprofen and its salts containing 400 mg or less per oral dosage unit when sold in package sizes exceeding 18,000 mg will move from Unscheduled status to Schedule III.

Some individuals, particularly the elderly and those who have co-morbid diseases or those with cardiovascular and gastro-intestinal risk factors may be at particular risk of adverse events from inappropriate use of oral NSAIDS. These individuals could benefit from pharmacist advice and clarification on appropriate selection and use of NSAIDs.

Medication

Package size/concentration

Schedule

Ibuprofen and its salts containing 400 mg or less per oral dosage unit

Up to 18,000 mg

Unscheduled (no change)

 

Ibuprofen and its salts containing 400 mg or less per oral dosage unit

Exceeding 18,000 mg

Schedule III (from Unscheduled)

Naproxen sodium 220 mg per oral dosage unit, in products labeled with a recommended maximum daily dose of 440 mg

Up to 6,600 mg

Unscheduled (no change)

Naproxen sodium 220mg per oral dosage unit, in products labeled with a recommended maximum daily dose of 440 mg

Exceeding 6,600 mg

Schedule III (no change)

Diclofenac diethylamine in preparations for topical use on the skin

Not more than the equivalent of 1% diclofenac

Unscheduled (no change)

 

The scheduling change follows a review by the National Drug Scheduling Advisory Committee of non-prescription non-steroidal anti-inflammatory drugs (NSAIDs) available on the Canadian market (excluding ASA and acetaminophen). Following the review, there was consensus that potential for inappropriate use of NSAIDs exists.

For more information on scheduling, go to Practice Resources/AB drug schedules on the ACP website.

Originally published in the January 10, 2012 issue of The Link


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