Document
DailyMed Label: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Title
DailyMed Label: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Date
2011
Document type
DailyMed Prescription
Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic name
hydrocodone bitartrate and acetaminophen
Manufacturer
RedPharm Drug Inc.
Product information
NDC: 67296-0515
Product information
NDC: 67296-0515
Description
DESCRIPTION Hydrocodone bitartrate and acetaminophen is supplied in tablet
form for oral administration.
Hydrocodone bitartrate is an opioid analgesic and antitussive and occurs as
fine, white crystals or as a crystalline powder. It is affected by light. The
chemical name is 4,5α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1)
hydrate (2:5). It has the following structural formula:
Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless,
crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325
mg
Each tablet contains:
Hydrocodone Bitartrate ................. 5 mg Acetaminophen
............................. 325 mg
In addition, each tablet contains the following inactive ingredients:
croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, stearic acid
and sugar spheres which are composed of starch derived from corn, FD and C Red No. 40, FD and C Yellow No. 6, and sucrose. Meets USP Dissolution Test 2.
structural formula
Indications
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of
moderate to moderately severe pain.
Dosage
Dosage should be adjusted according to the severity of the pain and the response
of the patient. However, it should be kept in mind that tolerance to hydrocodone
can develop with continued use and that the incidence of untoward effects is
dose related.
Hydrocodone Bitartrate and Acetaminophen Tablets, USP
5 mg/325 mg The usual adult dosage is one or two tablets every four to six
hours as needed for pain. The total daily dosage should not exceed 12 tablets.
Contraindications
This product should not be administered to patients who have
previously exhibited hypersensitivity to hydrocodone or acetaminophen.
Patients known to be hypersensitive to other opioids may exhibit
cross-sensitivity to hydrocodone.
Warnings
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
FD and C Yellow No. 5 (tartrazine) which may cause allergic-type reactions
(including bronchial asthma) in certain susceptible persons. Although the
overall incidence of FD and C Yellow No. 5 (tartrazine) sensitivity in the
general population is low, it is frequently seen in patients who also have
aspirin hypersensitivity.
Adverse reactions
The most frequently reported adverse reactions are
lightheadedness, dizziness, sedation, nausea and vomiting. These effects seem to
be more prominent in ambulatory than in nonambulatory patients, and some of
these adverse reactions may be alleviated if the patient lies down.
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.
How supplied
Hydrocodone Bitartrate and Acetaminophen Tablets, USP
5 mg/325 mg are supplied as white with orange specks, capsule-shaped, scored
tablets, debossed “3604” on one side and debossed “V” on the reverse side. The
tablets are supplied in containers of 10, 100, 500 and 1000.
Storage: Store at 20°-25°C (68°-77°F) [see USP Controlled Room
Temperature].
Dispense in a tight, light-resistant container as defined in the USP/NF with
a child-resistant closure.
A Schedule CIII Narcotic.
Clinical pharmacology
Hydrocodone is a semisynthetic narcotic analgesic and antitussive
with multiple actions qualitatively similar to those of codeine. Most of these
involve the central nervous system and smooth muscle. The precise mechanism of
action of hydrocodone and other opiates is not known, although it is believed to
relate to the existence of opiate receptors in the central nervous system. In
addition to analgesia, narcotics may produce drowsiness, changes in mood and
mental clouding.
The analgesic action of acetaminophen involves peripheral influences, but the
specific mechanism is as yet undetermined. Antipyretic activity is mediated
through hypothalamic heat regulating centers. Acetaminophen inhibits
prostaglandin synthetase. Therapeutic doses of acetaminophen have negligible
effects on the cardiovascular or respiratory systems; however, toxic doses may
cause circulatory failure and rapid, shallow breathing.
Pharmacokinetics: The behavior of the individual components is described
below.
Hydrocodone:
Following a 10 mg oral dose of hydrocodone administered to five
adult male subjects, the mean peak concentration was 23.6 ± 5.2 ng/mL. Maximum
serum levels were achieved at 1.3 ± 0.3 hours and the half-life was determined
to be 3.8 ± 0.3 hours. Hydrocodone exhibits a complex pattern of metabolism
including O-demethylation, N-demethylation and 6-ketoreduction to the
corresponding 6-α- and 6-β-hydroxymetabolites. See
OVERDOSAGE
for
toxicity information.
Acetaminophen:
Acetaminophen is rapidly absorbed from the gastrointestinal tract
and is distributed throughout most body tissues. The plasma half-life is 1.25 to
3 hours, but may be increased by liver damage and following overdosage.
Elimination of acetaminophen is principally by liver metabolism (conjugation)
and subsequent renal excretion of metabolites. Approximately 85% of an oral dose
appears in the urine within 24 hours of administration, most as the glucuronide
conjugate, with small amounts of other conjugates and unchanged drug. See
OVERDOSAGE
for
toxicity information.
Package label
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1 organization
1 product
Organization
RedPharm Drug Inc.