The most frequently reported adverse reactions are lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies down.
Other Adverse reactions include:
Central Nervous System: Drowsiness, mental clouding, lethargy, impairment
of mental and physical performance, anxiety, fear, dysphoria, psychic dependence,
Gastrointestinal System: Prolonged administration of Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500
tablets may produce constipation.
Genitourinary System: Ureteral spasm, spasm of vesical sphincters and
urinary retention have been reported with opiates.
Respiratory Depression: Hydrocodone bitartrate may produce dose-related
respiratory depression by acting directly on the brain stem respiratory centers
Special Senses: Cases of hearing impairment or permanent loss have been
reported predominantly in patients with chronic overdose.
Dermatological: Skin rash, pruritus.
The following adverse drug events may be borne in mind as potential effects of acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis.
Potential effects of high dosage are listed in the OVERDOSAGE
DRUG ABUSE AND DEPENDENCE:
Controlled Substance: Lortab 2.5 (hydrocodone bitartrate and acetaminophen tablets) /500 tablets (Hydrocodone Bitartrate
and Acetaminophen Tablets, USP, 2.5 mg/500 mg) are classified as a Schedule
III controlled substance.
Abuse and Dependence: Psychic dependence, physical dependence, and tolerance
may develop upon repeated administration of narcotics; therefore, this product
should be prescribed and administered with caution. However, psychic dependence
is unlikely to develop when hydrocodone bitartrate and acetaminophen tablets
are used for a short time for the treatment of pain.
Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.
Patients receiving narcotics, 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.