Oxycodone and acetaminophen tablets, USP are indicated for the relief of moderate to moderately
severe pain.

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may
occasionally be necessary to exceed the usual dosage recommended below in cases of more severe
pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant,
the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone
and acetaminophen tablets, USP are given orally.
Oxycodone and acetaminophentablets , USP 7.5 mg/325 mg
The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of
acetaminophen, USP should not exceed 4 grams.
Strength Maximal Daily Dos e
Oxycodone and acetaminophen tablets, USP 7.5 mg/325 mg 8 Tablets
Ces s ation of Therapy
In patients treated with oxycodone and acetaminophen tablets, USP for more than a few weeks who no
longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal
in the physically dependent patient.

Opioid analgesics may enhance the neuromuscular-blocking action of skeletal muscle relaxants and
produce an increase in the degree of respiratory depression.
Patients receiving CNS depressants such as other opioid analgesics, general anesthetics,
phenothiazines, other tranquilizers, centrally-acting anti-emetics, sedative-hypnotics or other CNS
depressants (including alcohol) concomitantly with oxycodone and acetaminophen tablets may exhibit an
additive CNS depression. When such combined therapy is contemplated, the dose of one or both agents
should be reduced. The concurrent use of anticholinergics with opioids may produce paralytic ileus.
Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, naltrexone and butorphanol) should be
administered with caution to a patient who has received or is receiving a pure opioid agonist such as
oxycodone. These agonist/antagonist analgesics may reduce the analgesic effect of oxycodone or may
precipitate withdrawal symptoms.
Drug/Drug Interactions with Acetaminophen
Alcohol, ethyl: Hepatotoxicity has occurred in chronic alcoholics following various dose levels
(moderate to excessive) of acetaminophen.
Anticholinergics: The onset of acetaminophen effect may be delayed or decreased slightly, but the
ultimate pharmacological effect is not significantly affected by anticholinergics.
Oral Contraceptives: Increase in glucuronidation resulting in increased plasma clearance and a
decreased half-life of acetaminophen.
Charcoal (activated): Reduces acetaminophen absorption when administered as soon as possible after
overdose.
Beta-Blockers (Propranolol): Propranolol appears to inhibit the enzyme systems responsible for the
glucuronidation and oxidation of acetaminophen. Therefore, the pharmacologic effects of
acetaminophen may be increased.
Loop diuretics: The effects of the loop diuretic may be decreased because acetaminophen may
decrease renal prostaglandin excretion and decrease plasma renin activity.
Lamotrigine: Serum lamotrigine concentrations may be reduced, producing a decrease in therapeutic
effects.
Probenecid: Probenecid may increase the therapeutic effectiveness of acetaminophen slightly.
Zidovudine: The pharmacologic effects of zidovudine may be decreased because of enhanced nonhepatic
or renal clearance of zidovudine.
Drug/Laboratory Tes t Interactions
Depending on the sensitivity/specificity and the test methodology, the individual components of
oxycodone and acetaminophen tablets may cross-react with assays used in the preliminary detection of
cocaine (primary urinary metabolite, benzoylecgonine) or marijuana (cannabinoids) in human urine. A
more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover,
clinical considerations and professional judgment should be applied to any drug-of-abuse test result,
particularly when preliminary positive results are used.
Acetaminophen may interfere with home blood glucose measurement systems; decreases of >20% in
mean glucose values may be noted. This effect appears to be drug, concentration and system dependent.
Carcinogenes is , Mutagenes is , Impairment of Fertility
Carcinogenesis
Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been
performed.
Mutagenesis
The combination of oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone
alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration
assay with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay.
Oxycodone was clastogenic in the human lymphocyte chromosomal assay in the presence of metabolic
activation and in the mouse lymphoma assay with or without metabolic activation.
Fertility
Animal studies to evaluate the effects of oxycodone on fertility have not been performed.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal reproductive studies have not been conducted with oxycodone and acetaminophen. It is also not
known whether oxycodone and acetaminophen can cause fetal harm when administered to a pregnant
woman or can affect reproductive capacity. Oxycodone and acetaminophen should not be given to a
pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible
hazards.
Nonteratogenic Effects
Opioids can cross the placental barrier and have the potential to cause neonatal respiratory depression.
Opioid use during pregnancy may result in a physically drug-dependent fetus. After birth, the neonate
may suffer severe withdrawal symptoms.
Labor and Delivery
Oxycodone and acetaminophen tablets are not recommended for use in women during and immediately
prior to labor and delivery due to its potential effects on respiratory function in the newborn.
Nurs ing Mothers
Ordinarily, nursing should not be undertaken while a patient is receiving oxycodone and acetaminophen
tablets because of the possibility of sedation and/or respiratory depression in the infant. Oxycodone is
excreted in breast milk in low concentrations, and there have been rare reports of somnolence and
lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product. Acetaminophen is
also excreted in breast milk in low concentrations.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Special precaution should be given when determining the dosing amount and frequency of oxycodone
and acetaminophen tablets for geriatric patients, since clearance of oxycodone may be slightly reduced
in this patient population when compared to younger patients.
Hepatic Impairment
In a pharmacokinetic study of oxycodone in patients with end-stage liver disease, oxycodone plasma
clearance decreased and the elimination half-life increased. Care should be exercised when oxycodone
is used in patients with hepatic impairment.
Renal Impairment
In a study of patients with end stage renal impairment, mean elimination half-life was prolonged in
uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should be
used with caution in patients with renal impairment.

Head Injury and Increas ed Intracranial Pres s ure
The respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation
of cerebrospinal fluid pressure, and may be markedly exaggerated in the presence of head injury, other
intracranial lesions or a preexisting increase in intracranial pressure. Oxycodone produces effects on
pupillary response and consciousness which may obscure neurologic signs of worsening in patients
with head injuries.
Hypotens ive Effect
Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood
pressure has been compromised by a depleted blood volume, or after concurrent administration with
drugs which compromise vasomotor tone such as phenothiazines. Oxycodone, like all opioid analgesics
of the morphine-type, should be administered with caution to patients in circulatory shock, since
vasodilation produced by the drug may further reduce cardiac output and blood pressure. Oxycodone
may produce orthostatic hypotension in ambulatory patients.
Hepatotoxicity
Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure
occurred in chronic alcoholics following therapeutic doses.

Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
Signs and Symptoms
Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, depression of
respiration, and loss of consciousness. Serious overdosage with oxycodone 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.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 oxycodone 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.
Oxycodone
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 oxycodone. Since the duration of
action of oxycodone 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.
Acetaminophen
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.

Oxycodone and Acetaminophen Tablets , USP 7.5 mg / 325 mg CII

Each tablet, for oral administration, contains oxycodone hydrochloride, USP and acetaminophen, USP in
the following strengths:
Oxycodone Hydrochloride, USP 7.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl, USP is equivalent to 6.7228 mg of oxycodone.
All strengths of oxycodone and acetaminophen, USP also contain the following inactive ingredients:
colloidal silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone,
pregelatinized corn starch and stearic acid.
Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic which occurs as a
white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for
oxycodone hydrochloride, USP is C H NO •HCl and the molecular weight 351.83. It is derived
from the opium alkaloid thebaine, and may be represented by the following structural formula:
Acetaminophen, USP, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic
which occurs as a white, odorless, crystalline powder, possessing a slightly bitter taste. The molecular
formula for acetaminophen, USP is C H NO and the molecular weight is 151.17. It may be represented
by the following structural formula:
18 21 4
8 9 2

[image: img_2a6814ab-6fa5-1400-e054-00144ff8d46c]

Oxycodone and acetaminophen tablets, USP, 7.5 mg/ 325 mg, are supplied as white to off-white,
capsule shaped, biconvex tablets, debossed “IP207” on obverse and plain on the reverse.
They are available as follows:
Bottles of 30: NDC: 65162-207-03
Bottles of 100: NDC: 65162-207-10
Bottles of 500: NDC: 65162-207-50
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as
required).
DEA Order Form Required.
MFG. ADDRESS
Manufactured by:
Amneal Pharmaceuticals of NY
Hauppauge, NY 11788
Rev. 08-2015-02