Caution is advised when prescribing this drug to patients with narrow-angle glaucoma, asthma, or
Special Risk Patients
As with any narcotic agent, TUSSIONEX Pennkinetic Extended-Release Suspension should be used
with caution in elderly or debilitated patients and those with severe impairment of hepatic or renal
function, hypothyroidism, Addison's disease, prostatic hypertrophy, or urethral stricture. The usual
precautions should be observed and the possibility of respiratory depression should be kept in mind.
Information For Patients
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Concomitant Use With Benzodiazepines Or Other CNS Depressants
Inform patients and caregivers that potentially fatal additive effects may occur if TUSSIONEX
Pennkinetic Extended-Release Suspension is used with benzodiazepines or other CNS depressants,
including alcohol. Because of this risk, patients should avoid concomitant use of TUSSIONEX
Pennkinetic Extended-Release Suspension with benzodiazepines or other CNS depressants, including
alcohol (see WARNINGS and DRUG INTERACTIONS).
Neurological Adverse Reactions
Advise patients that TUSSIONEX Pennkinetic Extended-Release Suspension may produce marked
drowsiness and impair the mental and/or physical abilities required for the performance of potentially
hazardous tasks such as driving a car or operating machinery. Advise patients to avoid driving or
operating machinery during treatment with TUSSIONEX Pennkinetic Extended-Release Suspension.
Advise patients not to dilute TUSSIONEX Pennkinetic Extended-Release Suspension with other fluids
and not to mix with other drugs as this may alter the resin-binding and change the absorption rate,
possibly increasing the toxicity.
Advise patients that TUSSIONEX Pennkinetic Extended-Release Suspension should be measured with
an accurate measuring device. A household teaspoon is not an accurate measuring device and could lead
to overdosage. A dosing spoon is provided with the 4 oz (115 mL) packaged product. One side of the
spoon is for a 2.5 mL dose. The other side of the spoon is for a 5 mL dose. Instruct the patient to fill to
level the side of the spoon for the dose that has been prescribed. The spoon should not be overfilled.
Rinse the measuring device or dosing spoon after each use.
Alternatively, a pharmacist can recommend an appropriate measuring device and can provide instructions
for measuring the correct dose.
Hydrocodone suppresses the cough reflex; as with all narcotics, caution should be exercised when
TUSSIONEX Pennkinetic Extended-Release Suspension is used postoperatively, and in patients with
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Carcinogenicity, mutagenicity, and reproductive studies have not been conducted with TUSSIONEX
Pennkinetic Extended-Release Suspension.
Pregnancy Category C
Hydrocodone has been shown to be teratogenic in hamsters when given in doses 700 times the human
dose. There are no adequate and well-controlled studies in pregnant women. TUSSIONEX Pennkinetic
Extended-Release Suspension should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
Babies born to mothers who have been taking opioids regularly prior to delivery will be physically
dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive
reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The
intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose.
Labor And Delivery
As with all narcotics, administration of TUSSIONEX Pennkinetic Extended-Release Suspension to the
mother shortly before delivery may result in some degree of respiratory depression in the newborn,
especially if higher doses are used.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in nursing infants from TUSSIONEX
Pennkinetic Extended-Release Suspension, a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the drug to the mother.
The use of TUSSIONEX Pennkinetic Extended-Release Suspension is contraindicated in children less
than 6 years of age (see CONTRAINDICATIONS and ADVERSE REACTIONS, Respiratory, Thoracic And Mediastinal Disorders).
TUSSIONEX Pennkinetic Extended-Release Suspension should be used with caution in pediatric
patients 6 years of age and older (see WARNINGS, Pediatric Use).
Clinical studies of TUSSIONEX did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported clinical experience
has not identified differences in responses between the elderly and younger patients. In general, dose
selection for an elderly patient should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant
disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug
may be greater in patients with impaired renal function. Because elderly patients are more likely to have
decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal