ADVERSE REACTIONS
The most frequently reported adverse reactions arelightheadedness, dizziness, sedation, nausea and vomiting. These effectsseem to be more prominent in ambulatory than in nonambulatory patients, andsome of these adverse reactions may be alleviated if the patient lies down.
Other adverse reactions include:
Central Nervous System
Drowsiness, mental clouding, lethargy, impairmentof mental and physical performance, anxiety, fear, dysphoria, psychic dependence,mood changes.
Gastrointestinal System
Prolonged administration of VICODIN HP Tablets mayproduce constipation.
Genitourinary System
Ureteral spasm, spasm of vesical sphincters andurinary retention have been reported with opiates.
Respiratory Depression
Hydrocodone bitartrate may produce dose-relatedrespiratory depression by acting directly on the brain stem respiratory centers(see OVERDOSAGE).
Special Senses
Very rare cases of hearing impairment or loss havebeen reported in patients predominantly receiving very high doses of hydrocodone/acetaminophenfor long periods of time.
Dermatological
Skin rash, pruritus.
The following adverse drug events may be borne in mind aspotential effects of acetaminophen: allergic reactions, rash, thrombocytopenia,agranulocytosis.
Potential effects of highdosage are listed in the OVERDOSAGE section.
DRUG ABUSE AND DEPENDENCE
Controlled Substance
VICODIN HP Tablets are classified as a ScheduleCS-III controlled substance.
Abuse and Dependence
Psychic dependence, physical dependence, and tolerancemay develop upon repeated administration of narcotics; therefore, VICODINHP Tablets should be prescribed and administered with caution. However, psychicdependence is unlikely to develop when VICODIN HP Tablets are used for a shorttime for the treatment of pain.
Physical dependence,the condition in which continued administration of the drug is required toprevent the appearance of a withdrawal syndrome, assumes clinically significantproportions only after several weeks of continued narcotic use, although somemild degree of physical dependence may develop after a few days of narcotictherapy. Tolerance, in which increasingly large doses are required in orderto produce the same degree of analgesia, is manifested initially by a shortenedduration of analgesic effect, and subsequently by decreases in the intensityof analgesia. The rate of development of tolerance varies among patients.
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