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EPM Packaging Inc

Dosage Form

N/A

Manufacturer

EPM Packaging Inc

Important Safety Information

This medication contains important usage instructions, warnings, and side effect information that you should review before use.

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Hepatotoxicity:
Acetaminophen has been as s ociated with cas es of acute liver failure, at times res ulting in
liver trans plant and death. Mos t of the cas es of liver injury are as s ociated with the us e of
acetaminophen at dos es that exceed 4000 milligrams per day, and often involve more than
one acetaminophen-containing product.

Hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately
severe pain.

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.
Other adverse reactions include:
Central Nervous Sys tem: Drowsiness, mental clouding, lethargy, impairment of mental and physical
performance, anxiety, fear, dysphoria, psychic dependence, mood changes.
Gas trointes tinal Sys tem: Prolonged administration of hydrocodone bitartrate and acetaminophen tablets
may produce constipation.
Genitourinary Sys tem: Ureteral spasm, spasm of vesical sphincters and urinary retention have been
reported with opiates.
Res piratory Depres s ion: Hydrocodone bitartrate may produce dose-related respiratory depression by
acting directly on the brain stem respiratory centers (see OVERDOSAGE).
Special Sens es : 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 section.
DRUG ABUSE AND DEPENDENCE
Mis us e, Abus e, and Divers ion of Opioids :
Hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a
Schedule II controlled substance. Hydrocodone bitartrate and acetaminophen tablets, 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. 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 strongly advised.
Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and
proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen.
Signs and Symptoms :
Hydrocodone:
Serious overdose with hydrocodone is characterized by respiratory 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.
Acetaminophen:
In acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious
adverse effect. Renal tubular necrosis, hypoglycemic coma and coagulation defects may also occur.
Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting,
diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be
apparent until 48 to 72 hours post-ingestion.
Treatment:
A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal
polydrug overdose, and consultation with a regional poison control center is recommended. Immediate
treatment includes support of cardiorespiratory function and measures to reduce drug absorption.
Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed as
indicated. Assisted or controlled ventilation should also be considered.
For hydrocodone overdose, primary attention should be given to the reestablishment of adequate
respiratory exchange through provision of a patent airway and the institution of assisted or controlled
ventilation. The narcotic antagonist naloxone hydrochloride is a specific antidote against respiratory
depression which may result from overdosage or unusual sensitivity to narcotics, including
hydrocodone. Since the duration of action of hydrocodone may exceed that of the antagonist, the patient
should be kept under continued 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.
Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine
(NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have
occurred within a few hours of presentation. Serum acetaminophen levels should be obtained
immediately if the patient presents 4 hours or more after ingestion to assess potential risk of
hepatotoxicity; acetaminophen levels drawn less than 4 hours post-ingestion may be misleading. To
obtain the best possible outcome, NAC should be administered as soon as possible where impending or
evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude
oral administration.
Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing
absorption of the drug must be readily performed since the hepatic injury is dose dependent and occurs
early in the course of intoxication.

HYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP
CII
Rx only

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 nonopiate,
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&C
Red #40, FD&C Yellow #6, and sucrose. Meets USP Dissolution Test 2.
Hydrocodone Bitartrate and Acetaminophen Tablets , USP 7.5 mg/325 mg
Each tablet contains:
Hydrocodone Bitartrate ............. 7.5 mg
Acetaminophen ......................... 325 mg
In addition, each tablet contains the following inactive ingredients: croscarmellose sodium, FD&C Red
#40 aluminum lake, FD&C Yellow #6 aluminum lake, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, povidone, pregelatinized starch, sodium lauryl sulfate, and stearic acid.
Meets USP Dissolution Test 2.
Hydrocodone Bitartrate and Acetaminophen Tablets , USP 10 mg/325 mg
Each tablet contains:
Hydrocodone Bitartrate ............ 10 mg
Acetaminophen ......................... 325 mg
In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide,
croscarmellose sodium, D&C Yellow #10 lake, magnesium stearate, microcrystalline cellulose,
povidone, pregelatinized starch, and stearic acid. May also contain crospovidone. Meets USP
Dissolution Test 1.

What it looks like

Photos of the product and/or packaging supplied by the manufacturer.

Package codes (NDC)

61502-914-06
61502-914-10
61502-914-15
61502-914-20
61502-914-30
61502-914-96
61502-914-97

Full prescribing information (for healthcare professionals)

CLINICAL PHARMACOLOGY SECTION

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.

CLINICAL STUDIES SECTION

Clinical studies of hydrocodone bitartrate and acetaminophen 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.
Hydrocodone and the major metabolites of acetaminophen are known to be 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.
Hydrocodone may cause confusion and over-sedation in the elderly; elderly patients generally should
be started on low doses of hydrocodone bitartrate and acetaminophen tablets and observed closely.

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Important Safety Information

Serious warning (boxed)Boxed warningThe FDA's most prominent safety warning.

What this medicine is forThe uses this medicine is approved for.

How to take itDosage and administration instructions.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 u…

Do not use if…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 hy…

Possible side effectsThe 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 advers…

If you take too much (overdose)Following an acute overdosage, toxicity may result from hydrocodone or acetaminophen. Signs and Symptoms : Hydrocodone: Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respirat…

What's in this medicineHYDROCODONE BITARTRATE AND ACETAMINOPHEN TABLETS, USP CII Rx only Hydrocodone bitartrate and acetaminophen is supplied in tablet form for oral administration. Hydrocodone bitartrate is an opioid analgesic and antitussive…

Package label

How it's suppliedHydrocodone 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; and supplied…

What it looks like

Package codes (NDC)

CLINICAL PHARMACOLOGY SECTION

CLINICAL STUDIES SECTION

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