PRECAUTIONS
General:Special
Risk Patients:As with any narcotic analgesic agent, hydrocodone bitartrate and
acetaminophen tablets 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.
Cough
Reflex:Hydrocodone suppresses the cough reflex; as with all narcotics,
caution should be exercised when hydrocodone bitartrate and acetaminophen
tablets are used postoperatively and in patients with pulmonary disease.
Hydrocodone Bitartrate and Acetaminophen Tablets 7.5 mg/500 mg contain
FDandC Yellow No. 5 (tartrazine) which may cause allergic-type reactions
(including bronchial asthma) in certain susceptible persons. Although the
overall incidence of FDandC Yellow No. 5 (tartrazine) sensitivity in the
general population is low, it is frequently seen in patients who also have
aspirin hypersensitivity.
Information for Patients:Hydrocodone, like all narcotics, may impair the mental and/or
physical abilities required for the performance of potentially hazardous tasks
such as driving a car or operating machinery; patients should be cautioned
accordingly.
Alcohol and other CNS depressants may produce an additive CNS depression,
when taken with this combination product, and should be avoided.
Hydrocodone may be habit-forming. Patients should take the drug only for as
long as it is prescribed, in the amounts prescribed, and no more frequently than
prescribed.
Laboratory Tests:In patients with severe hepatic or renal disease, effects of
therapy should be monitored with serial liver and/or renal function tests.
Drug Interactions:Patients receiving other narcotic analgesics, antihistamines,
antipsychotics, antianxiety agents, or other CNS depressants (including alcohol)
concomitantly with hydrocodone bitartrate and acetaminophen tablets may exhibit
an additive CNS depression. When combined therapy is contemplated, the dose of
one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants with hydrocodone
preparations may increase the effect of either the antidepressant or
hydrocodone.
Drug/Laboratory Test Interactions:Acetaminophen may produce false-positive test results for urinary
5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of
Fertility:No adequate studies have been conducted in animals to determine
whether hydrocodone or acetaminophen have a potential for carcinogenesis,
mutagenesis, or impairment of fertility.
Pregnancy:Teratogenic
Effects:Pregnancy Category C:
There are no adequate and well-controlled studies in pregnant
women. Hydrocodone bitartrate and acetaminophen tablets should be used during
pregnancy only if the potential benefit justifies the potential risk to the
fetus.
Nonteratogenic Effects: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 hydrocodone bitartrate
and acetaminophen tablets to the mother shortly before delivery may result in
some degree of respiratory depression in the newborn, especially if higher doses
are used.
Nursing Mothers: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.
Pediatric Use:Safety and effectiveness in pediatric patients have not been
established.
Geriatric Use:Clinical studies of hydrocodone bitartrate and acetaminophen
tablets 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.
Hydrocodone and the major metabolites of acetaminophen are known to be
substantially excreted by the kidney. Thus the risk of toxic reactions may be
greater in patients with impaired renal function due to the accumulation of the
parent compound and/or metabolites in the plasma. 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 function.
Hydrocodone may cause confusion and over-sedation in the elderly; elderly
patients generally should be started on low doses of hydrocodone bitartrate and
acetaminophen tablets and observed closely.
