The most frequently reported adverse reactions include
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, mood
Prolonged administration of Lorcet® 10/650 may produce
Ureteral spasm, spasm of vesical sphincters and urinary
retention have been reported with opiates.
Hydrocodone bitartrate may produce dose-related respiratory
depression by acting directly on the brain stem respiratory centers. (see OVERDOSAGE).
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
Misuse, Abuse, and Diversion of Opioids
Lorcet® 10/650 tablets contain hydrocodone, an opioid
agonist, and are a Schedule III controlled substance. Lorcet® 10/650, and other
opioids used in analgesia can be abused and are subject to criminal diversion.
Addiction is a primary, chronic, neurobiologic disease, with
genetic, psychosocial, and environmental factors influencing its development
and manifestations. It is characterized by behaviors that include one or more
of the following: impaired control over drug use, compulsive use, continued use
despite harm, and craving. Drug addiction is a treatable disease utilizing a
multidisciplinary approach, but relapse is common.
“Drug seeking” behavior is very common in addicts and drug
abusers. Drug-seeking tactics include emergency calls or visits near the end of
office hours, refusal to undergo appropriate examination, testing or referral,
repeated “loss” of prescriptions, tampering with prescriptions and reluctance
to provide prior medical records or contact information for other treating
physician (s). “Doctor shopping” to obtain additional prescriptions is common
among drug abusers and people suffering from untreated addiction.
Abuse and addiction are separate and distinct from physical
dependence and tolerance. Physical dependence usually assumes clinically
significant dimensions only after several weeks of continued opioid use,
although a mild degree of physical dependence may develop after a few days of
opioid 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.
Physicians should be aware that abuse of opioids can occur in the absence of
true addiction and is characterized by misuse for non-medical purposes, often
in combination with other psychoactive substances. Lorcet® 10/650, like other
opioids, may be diverted for non-medical use. Record-keeping of prescribing information,
including quantity, frequency, and renewal requests is strongly advised.
Proper assessment of the patient, proper prescribing
practices, periodic reevaluation of therapy, and proper dispensing and storage
are appropriate measures that help to limit abuse of opioid drugs.
Patients receiving narcotics, antihistamines,
antipsychotics, antianxiety agents, or other CNS depressants (including
alcohol) concomitantly with Lorcet® 10/650 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
Drug/Laboratory Test Interactions
Acetaminophen may produce false-positive test results for
urinary 5-hydroxyindoleacetic acid.