WARNINGS
Respiratory Depression
At high doses or in sensitive patients, hydrocodonemay produce dose-related respiratory depression by acting directly on thebrain stem respiratory center. Hydrocodone also affects the center that controlsrespiratory rhythm, and may produce irregular and periodic breathing.
Head Injury and Increased Intracranial Pressure
The respiratory depressant effects of narcoticsand their capacity to elevate cerebrospinal fluid pressure may be markedlyexaggerated in the presence of head injury, other intracranial lesions ora preexisting increase in intracranial pressure. Furthermore, narcotics produceadverse reactions which may obscure the clinical course of patients with headinjuries.
Acute Abdominal Conditions
The administration of narcotics may obscure thediagnosis or clinical course of patients with acute abdominal conditions.
General
Special Risk Patients
As with any narcotic analgesic agent, VICODINHP 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. Theusual precautions should be observed and the possibility of respiratory depressionshould be kept in mind.
Cough Reflex
Hydrocodone suppresses the cough reflex; as withall narcotics, caution should be exercised when VICODIN HP Tablets are usedpostoperatively and in patients with pulmonary disease.
Information for Patients
Hydrocodone, like all narcotics, may impair themental and/or physical abilities required for the performance of potentiallyhazardous tasks such as driving a car or operating machinery; patients shouldbe cautioned accordingly. Alcohol and other CNS depressants may produce anadditive CNS depression, when taken with this combination product, and shouldbe avoided.
Hydrocodone may be habit forming. Patients should take the drug only for as long as it is prescribed, in theamounts 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 functiontests.
Drug Interactions
Patients receiving narcotics, antihistamines, antipsychotics,antianxiety agents, or other CNS depressants (including alcohol) concomitantlywith VICODIN HP Tablets may exhibit an additive CNS depression. When combinedtherapy is contemplated, the dose of one or both agents should be reduced.
The use of MAO inhibitors or tricyclic antidepressants withhydrocodone preparations may increase the effect of either the antidepressantor hydrocodone.
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test resultsfor urinary 5-hydroxyindoleacetic acid.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No adequate studies have been conducted in animalsto 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 pregnantwomen. VICODIN HP Tablets should be used during pregnancy only if the potentialbenefit justifies the potential risk to the fetus.
Nonteratogenic Effects
Babies born to mothers who have been taking opioidsregularly prior to delivery will be physically dependent. The withdrawalsigns 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 theduration of maternal opioid use or dose. There is no consensus on the bestmethod of managing withdrawal.
Labor and Delivery
As with all narcotics, administration of VICODINHP Tablets to the mother shortly before delivery may result in some degreeof respiratory depression in the newborn, especially if higher doses are used.
Nursing Mothers
Acetaminophen is excreted in breast milk in smallamounts, but the significance of its effects on nursing infants is not known. It is not known whether hydrocodone is excreted in human milk. Because manydrugs are excreted in human milk and because of the potential for seriousadverse reactions in nursing infants from hydrocodone and acetaminophen, adecision should be made whether to discontinue nursing or to discontinue thedrug, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in the pediatric populationhave not been established.
Geriatric Use
Clinical studies of VICODIN HP (hydrocodone bitartrateand acetaminophen 10 mg/660 mg) did not include sufficient numbersof subjects aged 65 and over to determine whether they respond differentlyfrom younger subjects. Other reported clinical experience has not identifieddifferences in responses between the elderly and younger patients. In general,dose selection for an elderly patient should be cautious, usually startingat the low end of the dosing range, reflecting the greater frequency of decreasedhepatic, renal, or cardiac function, and of concomitant disease or other drugtherapy.
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