Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension - Overview
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Welcome to the Food and Drug Administration's drug safety update.
I am Mandy Eisemann from F-D-A's Center for Drug Evaluation and Research.
On March 11, 2008 we issued a public health advisory titled: Important Information for the Safe Use of Tussionex Pennkinetic Extended Release Suspension.
FDA is issuing this public health advisory to alert patients, caregivers, and healthcare professionals to important information on the safe and appropriate use of Tussionex Pennkinetic Extended-Release Suspension. Tussionex is a prescription cough medicine containing hydrocodone and the antihistamine, chlorpheniramine that is made to be given every 12 hours because of the extended-release properties of the medicine.
Hydrocodone, the narcotic ingredient in this medicine that controls cough, can cause life-threatening breathing problems and death when given above or more frequently than the recommended dose. Tussionex should not be used in children less than 6 years old.
FDA is highlighting the following important information on the safe use of Tussionex:
- Do not give to children less than 6 years old. FDA has received reports of death due to respiratory depression with use of Tussionex in patients less than 6 years old.
- Healthcare professionals should not prescribe and patients should not take Tussionex more often than every 12 hours. Taking this cough medicine more often than every 12 hours may result in a narcotic overdose. Too much hydrocodone can cause life-threatening breathing problems and death. If the cough is not controlled when taking Tussionex every 12 hours, talk to your doctor before taking more.
- Healthcare professionals who prescribe and patients who use Tussionex should be aware of the signs of hydrocodone overdose including the following: trouble breathing; slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients, parents, or caregivers should get medical attention right away.
- Patients and parents should use a device designed to accurately measure Tussionex. Household teaspoons or tablespoons vary in size and can result in giving too much of the medicine. Use a syringe or spoon specifically designed to measure liquid medicine.
There are cough products containing hydrocodone that can be given every 4 to 6 hours. FDA is reviewing safety information for these products and will provide updates as new information is available.
To hear the full public health advisory, listen to part two of this broadcast.
We urge healthcare providers and patients to report serious side effects that may be associated with the use of Tussionex Pennkinetic Extended Release Suspension to us at the FDA's MedWatch adverse event reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot GOV slash M-E-D-W-A-T-C-H.
Date created: March 13, 2008
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Public Health Advisory: Important Information for the Safe Use of Tussionex Pennkinetic Extended-Release Suspension[ARCHIVED]