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 hydrocodone and chlorpheniramine |
| Tussionex Pennkinetic Extended-Release Suspension |
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Pharmaceutical
company:
UCB
www.pharma.ucb-group.com |
NEW WARNING
The Food and Drug Administration (FDA) issued an alert about reports of serious adverse effects, including death, related to the misuse of the cough suppressant Tussionex Pennkinetic Extended-Release Suspension, which contains hydrocodone and chlorpheniramine. The events reported involved use in children younger than age 6, dosing more frequently than every 12 hours, and use of inappropriate dosing measurements leading to inadvertent overdose. The FDA has provided the following drug prescribing guidelines to help prevent these problems: The drug is contraindicated in children younger than age 6; the drug shouldn’t be prescribed for use more often than every 12 hours; patients, or their parents or guardians, should be advised to use a medication dosing syringe or other device designed for measuring liquid medications, not tableware, to measure and give the correct dose. They also advise that patients and parents or guardians be instructed in these guidelines and be directed to contact their health care provider if the person taking the drug experiences trouble breathing, a slow heartbeat, excessive sleepiness, or cold, clammy skin. The drug is safe and effective when used as approved. The manufacturer has agreed to strengthen the prescribing information to highlight the guidelines listed above.
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