Prescription Drug Name:
Hydrocodone Bitartrate & Acetaminophen
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3
form for oral administration.
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:
crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic.
It has the following structural formula:
10 mg/325 mg
……………………. 325 mg
colloidal silicon dioxide, croscarmellose sodium, D and C Yellow No. 10 lake,
magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch,
and stearic acid. May also contain crospovidone. Meets USP Dissolution Test 1.
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1
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
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.
displayName: PHARMACOKINETICS SECTION
FDA Article Code: 43682-4
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
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
INDICATIONS AND USAGE
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9
Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of
moderate to moderately severe pain.
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3
previously exhibited hypersensitivity to hydrocodone or acetaminophen.
cross-sensitivity to hydrocodone.
displayName: WARNINGS SECTION
FDA Article Code: 34071-1
dose-related respiratory depression by acting directly on the brain stem
respiratory center. Hydrocodone also affects the center that controls
respiratory rhythm, and may produce irregular and periodic breathing.
capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in
the presence of head injury, other intracranial lesions or a preexisting
increase in intracranial pressure. Furthermore, narcotics produce adverse
reactions which may obscure the clinical course of patients with head
clinical course of patients with acute abdominal conditions.
hydrocodone, an opioid agonist, and is a Schedule III controlled substance.
Opioid agonists have the potential for being abused and are sought by abusers
and people with addiction disorders, and are subject to diversion.
similar to other opioid agonists, legal or illicit. This should be considered
when prescribing or dispensing hydrocodone bitartrate and acetaminophen tablets
in situations where the physician or pharmacist is concerned about an increased
risk of misuse, abuse or diversion (see
displayName: WARNINGS AND PRECAUTIONS SECTION
FDA Article Code: 43685-7
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.
caution should be exercised when hydrocodone bitartrate and acetaminophen
tablets are used postoperatively and in patients with pulmonary disease.
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
Information for Patients:
displayName: INFORMATION FOR PATIENTS SECTION
FDA Article Code: 34076-0
physical abilities required for the performance of potentially hazardous tasks
such as driving a car or operating machinery; patients should be cautioned
when taken with this combination product, and should be avoided.
long as it is prescribed, in the amounts prescribed, and no more frequently than
displayName: LABORATORY TESTS SECTION
FDA Article Code: 34075-2
In patients with severe hepatic or renal disease, effects of therapy should be
monitored with serial liver and/or renal function tests.
displayName: DRUG INTERACTIONS SECTION
FDA Article Code: 34073-7
Acetaminophen may produce false-positive test results for urinary
Carcinogenesis, Mutagenesis, Impairment of Fertility:
displayName: CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION
FDA Article Code: 34083-6
No adequate studies have been conducted in animals to determine whether
hydrocodone or acetaminophen have a potential for carcinogenesis, mutagenesis,
or impairment of fertility.
displayName: PREGNANCY SECTION
FDA Article Code: 42228-7
women. Hydrocodone bitartrate and acetaminophen tablets should be used during
pregnancy only if the potential benefit justifies the potential risk to the
prior to delivery will be physically dependent. The withdrawal signs 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 the duration of
maternal opioid use or dose. There is no consensus on the best method of
Labor and Delivery:
displayName: LABOR & DELIVERY SECTION
FDA Article Code: 34079-4
As with all narcotics, administration of hydrocodone bitartrate and
acetaminophen tablets to the mother shortly before delivery may result in some
degree of respiratory depression in the newborn, especially if higher doses are
displayName: NURSING MOTHERS SECTION
FDA Article Code: 34080-2
Acetaminophen is excreted in breast milk in small amounts, but the significance
of its effects on nursing infants is not known. It is not known whether
hydrocodone is excreted in human milk. Because many drugs are excreted in human
milk and because of the potential for serious adverse reactions in nursing
infants from hydrocodone and acetaminophen, a decision should be made whether to
discontinue nursing or to discontinue the drug, taking into account the
importance of the drug to the mother.
displayName: PEDIATRIC USE SECTION
FDA Article Code: 34081-0
Safety and effectiveness in pediatric patients have not been established.
displayName: GERIATRIC USE SECTION
FDA Article Code: 34082-8
tablets did not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between the
elderly and younger patients. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac
function, and of concomitant disease or other drug therapy.
substantially excreted by the kidney. Thus the risk of toxic reactions may be
greater in patients with impaired renal function due to the accumulation of the
parent compound and/or metabolites in the plasma. Because elderly patients are
more likely to have decreased renal function, care should be taken in dose
selection, and it may be useful to monitor renal function.
patients generally should be started on low doses of hydrocodone bitartrate and
acetaminophen tablets and observed closely.
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4
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.
lethargy, impairment of mental and physical performance, anxiety, fear,
dysphoria, psychic dependence, mood changes.
hydrocodone bitartrate and acetaminophen tablets may produce constipation.
vesical sphincters and urinary retention have been reported with opiates.
produce dose-related respiratory depression by acting directly on the brain stem
respiratory centers (see
permanent loss have been reported predominantly in patients with chronic
of acetaminophen: allergic reactions, rash, thrombocytopenia,
DRUG ABUSE AND DEPENDENCE
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9
hydrocodone, an opioid agonist, and is a Schedule III controlled substance.
Hydrocodone bitartrate and acetaminophen tablets, and other opioids, used in
analgesia can be abused and are subject to criminal diversion.
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 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.
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. Hydrocodone bitartrate and acetaminophen tablets,
like other opioids, may be diverted for non-medical use. Record-keeping of
prescribing information, including quantity, frequency, and renewal requests is
re-evaluation of therapy, and proper dispensing and storage are appropriate
measures that help to limit abuse of opioid drugs.
displayName: OVERDOSAGE SECTION
FDA Article Code: 34088-5
hydrocodone or acetaminophen.
depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes
respiration, cyanosis), extreme somnolence progressing to stupor or coma,
skeletal muscle flaccidity, cold and clammy skin, and sometimes bradycardia and
hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest
and death may occur.
hepatic necrosis is the most serious adverse effect. Renal tubular necrosis,
hypoglycemic coma, and thrombocytopenia may also occur.
nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory
evidence of hepatic toxicity may not be apparent until 48 to 72 hours
less than 10 grams, or fatalities with less than 15 grams.
is a potentially lethal polydrug overdose, and consultation with a regional
poison control center is recommended.
measures to reduce drug absorption. Vomiting should be induced mechanically, or
with syrup of ipecac, if the patient is alert (adequate pharyngeal and laryngeal
reflexes). Oral activated charcoal (1 g/kg) should follow gastric emptying. The
first dose should be accompanied by an appropriate cathartic. If repeated doses
are used, the cathartic might be included with alternate doses as required.
Hypotension is usually hypovolemic and should respond to fluids. Vasopressors
and other supportive measures should be employed as indicated. A cuffed
endotracheal tube should be inserted before gastric lavage of the unconscious
patient and, when necessary, to provide assisted respiration.
ventilation. In severe cases of intoxication, peritoneal dialysis, or preferably
hemodialysis may be considered. If hypoprothrombinemia occurs due to
acetaminophen overdose, vitamin K should be administered intravenously.
associated with opioid overdose. Naloxone hydrochloride 0.4 mg to 2 mg is given
parenterally. Since the duration of action of hydrocodone may exceed that of the
naloxone, the patient should be kept under continuous surveillance and repeated
doses of the antagonist should be administered as needed to maintain adequate
respiration. A narcotic antagonist should not be administered in the absence of
clinically significant respiratory or cardiovascular depression.
should be administered as early as possible. Serum acetaminophen levels should
be obtained, since levels four or more hours following ingestion help predict
acetaminophen toxicity. Do not await acetaminophen assay results before
initiating treatment. Hepatic enzymes should be obtained initially, and repeated
at 24-hour intervals.
DOSAGE AND ADMINISTRATION
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7
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
10 mg/325 mg
needed for pain. The total daily dosage should not exceed 6 tablets.
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5
10 mg/325 mg
tablets, debossed “3601” on one side and debossed “V” on the reverse side. The
tablets are supplied in containers of 10, 20, and 30.
a child-resistant closure.