The U.S. Food and Drug Administration issue an alert next to the
nontoxic and accurate utilization of Tussionex Pennkinetic
Extended-Release Suspension surrounded by rejoinder to numerous
reports of adverse events--including death--associated beside the
misuse and indecorous use of this potent cough medication.
Tussionex be a prescription cough medication contain hydrocodone,
a narcotic section, and the antihistamine chlorpheniramine. The
feature is conceded in favour of use in adults and brood done the
age of six years weak, and should be given no more event and
again than both 12 hours ("extended-release").
"There is a palpable and important activity for overdose if this
medication is unacquainted according to the labeling," said
Curtis Rosebraugh, M.D., M.P.H., acting regulator of the FDA's
Office of Drug Evaluation II. "Today's guidance is an model of
the FDA modernized with linctus manufacturer for the duration of
a product's lifecycle to preserve condition hard carry out
professionals and patients informed of spanking new safekeeping
notes." Adverse point reports associated with Tussionex own
integral life-threatening on the side effects and death in
patients, as well as children. These reports expose physician and
other health
professionals be sometimes prescribe, and patients are sometimes
taking, higher than the recommended dose or taking the medication
more frequently than every 12 hours. The reports also do again
panorama that Tussionex is sometimes prescribed or given to
children lesser numeral than 6 years old, for whom this
medication is not approved.
Highlights of the FDA's guidance to health care
professionals secrete: - Tussionex should not be nearly new (is
contraindicated) in patients less than 6 years old. FDA have
received reports of eradication in children less than 6 years of
age who have be prescribed Tussionex.
- Consult the prescribing hearsay to discover the correct dose
and dose frequency of Tussionex. Tussionex is an extended-release
formulation that should not be prescribed at an break less than
12 hours.
- Discuss with the long-suffering the amount of and frequency of
Tussionex to be given. Instruct patients not to pilfer, and
parents not to administer Tussionex more frequently than every 12
hours.
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- For Tussionex, use a medicine syringe or other appliance
designed to manoeuvre gooey medication. A household teaspoon or
tablespoon should not be used because the spoon alter in
bulkiness and you may receive in stick of well much or too
trifling of the medicine. Ask your doctor or pharmacist if you
are of two minds how to measure the medicine.
- If the cough is not controlled in spitefulness of taking the
prescribed dose at the recommended interval, have a speech to
your doctor.
The factory proprietor of Tussionex Pennkinetic Extended-Release
Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the
labeling, including information that Tussionex should not be
prescribed to or used in children less than 6 years of age, as
resourcefully as the stipulation for accurate dosing.
For more information and the packed subtlety of the FDA's
recommendations, handset round
/cder/drug/infopage/hydrocodone/default.htm This alert complete
not impact short-acting cough products containing hydrocodone
that can be given every 4 to 6 hours. However, the FDA is review
safety information on these other hydrocodone containing cough
products and will contribute update as new information become
inferred for.
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