Special Risk Patients
As with any narcotic analgesic agent, NORCO 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.
Hydrocodone suppresses the cough reflex; as with all
narcotics, caution should be exercised when NORCO tablets are used
postoperatively and in patients with pulmonary disease.
In patients with severe hepatic or renal disease, effects
of therapy should be monitored with serial liver and/or renal function tests.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No adequate studies have been conducted in animals to
determine whether NORCO has a potential for carcinogenesis, mutagenesis, or
impairment of fertility.
Pregnancy Category C: There are no adequate and
well-controlled studies in pregnant women. NORCO should be used during
pregnancy only if the potential benefit justifies the potential risk to the
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. There is no consensus on the best
method of managing withdrawal.
Labor And Delivery
As with all narcotics, administration of this product to
the mother shortly before delivery may result in some degree of respiratory
depression in the newborn, especially if higher doses are used.
Acetaminophen is excreted in breast milk in small
amounts, but the significance of its effects on nursing infants is not known.
It is not known whether hydrocodone 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 hydrocodone and acetaminophen, 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.
Safety and effectiveness in pediatric patients have not
Clinical studies of hydrocodone bitartrate 5 mg and
acetaminophen 500 mg 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.