OXYCODONE AND ACETAMINOPHEN- oxycodone and acetaminophen tablet

United States - English - NLM (National Library of Medicine)

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Active ingredient:
OXYCODONE HYDROCHLORIDE (UNII: C1ENJ2TE6C) (OXYCODONE - UNII:CD35PMG570), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
Available from:
EPM Packaging Inc
INN (International Name):
OXYCODONE HYDROCHLORIDE
Composition:
OXYCODONE HYDROCHLORIDE 7.5 mg
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Oxycodone and acetaminophen tablets, USP are indicated for the relief of moderate to moderately severe pain. Oxycodone and acetaminophen tablets, USP should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, USP, or any other component of this product. Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the setting of suspected or known paralytic ileus. Oxycodone and acetaminophen tablets are a Schedule II controlled substance. Oxycodone is a muagonist opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids used in analgesia, can be abused and is subject to criminal diversion. Drug addiction is defined as an abnormal, compulsive use, use for non-medical purp
Product summary:
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
Authorization status:
Abbreviated New Drug Application
Authorization number:
61502-915-06, 61502-915-10, 61502-915-15, 61502-915-20, 61502-915-30, 61502-915-96, 61502-915-97

OXYCODONE AND ACETAMINOPHEN- oxycodone and acetaminophen tablet

EPM Packaging Inc

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Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver

transplant and death. Most of the cases of liver injury are associated with the use of

acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one

acetaminophen-containing product.

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

Central Nervous Sys tem

Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia.

Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation.

These effects are mediated by receptors (notably µ and ?) in the central nervous system for endogenous

opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory

depression through direct activity at respiratory centers in the brain stem and depresses the cough

reflex by direct effect on the center of the medulla.

Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic. The site and mechanism for the

analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is

accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating

centers.

Gas trointes tinal Tract and Other Smooth Mus cle

Oxycodone reduces motility by increasing smooth muscle tone in the stomach and duodenum. In the

small intestine, digestion of food is delayed by decreases in propulsive contractions. Other opioid

effects include contraction of biliary tract smooth muscle, spasm of the Sphincter of Oddi, increased

ureteral and bladder sphincter tone, and a reduction in uterine tone.

Cardiovas cular Sys tem

Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension and

other symptoms, such as pruritus, flushing, red eyes and sweating.

Absorption and Distribution

The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%.

Oxycodone has been shown to be 45% bound to human plasma proteins in vitro. The volume of

distribution after intravenous administration is 211.9 ±186.6 L.

Absorption of acetaminophen is rapid and almost complete from the GI tract after oral administration.

With overdosage, absorption is complete in 4 hours. Acetaminophen is relatively uniformly distributed

throughout most body fluids. Binding of the drug to plasma proteins is variable; only 20% to 50% may

be bound at the concentrations encountered during acute intoxication.

Metabolis m and Elimination

A high portion of oxycodone is N-dealkylated to noroxycodone during first-pass metabolism.

Oxymorphone, is formed by the O-demethylation of oxycodone. The metabolism of oxycodone to

oxymorphone is catalyzed by CYP2D6. Free and conjugated noroxycodone, free and conjugated

oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone.

Approximately 8% to 14% of the dose is excreted as free oxycodone over 24 hours after

administration. Following a single, oral dose of oxycodone, the mean ± SD elimination half-life is 3.51

± 1.43 hours.

Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme. About 80% to

85% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser

extent with sulfuric acid and cysteine. After hepatic conjugation, 90% to 100% of the drug is recovered

in the urine within the first day.

About 4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is

further detoxified by conjugation with glutathione, present in a fixed amount. It is believed that the toxic

metabolite NAPQI (N acetyl-p-benzoquinoneimine, N-acetylimidoquinone) is responsible for liver

necrosis. High doses of acetaminophen may deplete the glutathione stores so that inactivation of the

toxic metabolite is decreased. At high doses, the capacity of metabolic pathways for conjugation with

glucuronic acid and sulfuric acid may be exceeded, resulting in increased metabolism of acetaminophen

by alternate pathways.

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

severe pain.

Oxycodone and acetaminophen tablets, USP should not be administered to patients with known

hypersensitivity to oxycodone, acetaminophen, USP, or any other component of this product.

Oxycodone is contraindicated in any situation where opioids are contraindicated including patients with

significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment)

and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in the

setting of suspected or known paralytic ileus.

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver

transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at

doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing

product. The excessive intake of acetaminophen may be intentional to cause self-harm or unintentional

as patients attempt to obtain more pain relief or unknowingly take other acetaminophen-containing

products.

The risk of acute liver failure is higher in individuals with underlying liver disease and in individuals

who ingest alcohol while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on package labels and not to use more than one

product that contains acetaminophen. Instruct patients to seek medical attention immediately upon

ingestion of more than 4000 milligrams of acetaminophen per day, even if they feel well.

Serious s kin reactions

Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous

pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can

be fatal. Patients should be informed about the signs of serious skin reactions, and use of the drug

should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Hypers ens itivity/ anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of

acetaminophen. Clinical signs include swelling of the face, mouth, and throat, respiratory distress,

urticaria, rash, pruritis, and vomiting. There were infrequent reports of life-threatening anaphylaxis

requiring emergency medical attention. Instruct patients to discontinue Oxycodone and Acetaminophen

Tablets, USP immediately and seek medical care if they experience these symptoms. Do not prescribe

Oxycodone and Acetaminophen Tablets, USP for patients with acetaminophen allergy.

Mis us e, Abus e and Divers ion of Opioids

Oxycodone is an opioid agonist of the morphine-type. Such drugs are sought by drug abusers and

people with addiction disorders and are subject to criminal diversion.

Oxycodone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be

considered when prescribing or dispensing oxycodone and acetaminophen tablets in situations where

the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.

Concerns about misuse, addiction and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled

Substances Authority for information on how to prevent and detect abuse or diversion of this product.

Administration of oxycodone and acetaminophen tablets should be closely monitored for the following

potentially serious adverse reactions and complications:

Res piratory Depres s ion

Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in

oxycodone and acetaminophen tablets, as with all opioid agonists. Elderly and debilitated patients are at

particular risk for respiratory depression as are non-tolerant patients given large initial doses of

oxycodone or when oxycodone is given in conjunction with other agents that depress respiration.

Oxycodone should be used with extreme caution in patients with acute asthma, chronic obstructive

pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients,

even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In

these patients alternative non-opioid analgesics should be considered, and opioids should be employed

only under careful medical supervision at the lowest effective dose.

In case of respiratory depression, a reversal agent such as naloxone hydrochloride may be utilized (see

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.

General

Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should

be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory

depression, altered mental state and postural hypotension.

Acute Abdominal Conditions

The administration of oxycodone and acetaminophen tablets or other opioids may obscure the diagnosis

or clinical course in patients with acute abdominal conditions.

Oxycodone and acetaminophen tablets should be given with caution to patients with CNS depression,

elderly or debilitated patients, patients with severe impairment of hepatic, pulmonary, or renal function,

hypothyroidism, Addison's disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium

tremens, kyphoscoliosis with respiratory depression, myxedema and toxic psychosis.

Oxycodone and acetaminophen tablets may obscure the diagnosis or clinical course in patients with

acute abdominal conditions. Oxycodone may aggravate convulsions in patients with convulsive

disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Following administration of oxycodone and acetaminophen tablets, anaphylactic reactions have been

reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to

morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.

Interactions with Other CNS Depres s ants

Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers,

centrally-acting antiemetics, 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.

Interactions with Mixed Agonis t/Antagonis t Opioid Analges ics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine and butorphanol) should be administered

with caution to a patient who has received or is receiving a course of therapy with a pure opioid

agonist analgesic such as oxycodone. In this situation, mixed agonist/antagonist analgesics may reduce

the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms in these patients.

Ambulatory Surgery and Pos toperative Us e

Oxycodone and other morphine-like opioids have been shown to decrease bowel motility. Ileus is a

common postoperative complication, especially after intraabdominal surgery with use of opioid

analgesia. Caution should be taken to monitor for decreased bowel motility in postoperative patients

receiving opioids. Standard supportive therapy should be implemented.

Us e in Pancreatic/Biliary Tract Dis eas e

Oxycodone may cause spasm of the Sphincter of Oddi and should be used with caution in patients with

biliary tract disease, including acute pancreatitis. Opioids like oxycodone may cause increases in the

serum amylase level.

Tolerance and Phys ical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in

the absence of disease progression or other external factors). Physical dependence is manifested by

withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist.

Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following:

restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia and mydriasis. Other

symptoms also may develop, including: irritability, anxiety, backache, joint pain, weakness, abdominal

cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or

heart rate.

In general, opioids should not be abruptly discontinued (see DOSAGE AND ADMINISTRATION:

Ces s ation of Therapy).

Information for Patients /Caregivers

The following information should be provided to patients receiving oxycodone and acetaminophen

tablets by

their physician, nurse, pharmacist, or caregiver:

Do not take oxycodone and acetaminophen tablets if you are allergic to any of its ingredients.

If you develop signs of allergy such as a rash or difficulty breathing, stop taking oxycodone and

acetaminophen and contact your healthcare provider immediately.

Do not take more than 4,000 milligrams of acetaminophen per day. Call your doctor if you took

more than the recommended dose.

1. Patients should be aware that oxycodone and acetaminophen tablets contain oxycodone, which is a

morphine-like substance.

2. Patients should be instructed to keep oxycodone and acetaminophen tablets in a secure place out of

the reach of children. In the case of accidental ingestions, emergency medical care should be sought

immediately.

3. When oxycodone and acetaminophen tablets are no longer needed, the unused tablets should be

destroyed by flushing down the toilet.

4. Patients should be advised not to adjust the medication dose themselves. Instead, they must consult

with their prescribing physician.

5. Patients should be advised that oxycodone and acetaminophen tablets may impair mental and/or

physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating

heavy machinery).

6. Patients should not combine oxycodone and acetaminophen tablets with alcohol, opioid analgesics,

tranquilizers, sedatives, or other CNS depressants unless under the recommendation and guidance of

a physician. When co-administered with another CNS depressant, oxycodone and acetaminophen

tablets can cause dangerous additive central nervous system or respiratory depression, which can

result in serious injury or death.

7. The safe use of oxycodone and acetaminophen tablets during pregnancy has not been established;

thus, women who are planning to become pregnant or are pregnant should consult with their

physician before taking oxycodone and acetaminophen tablets.

8. Nursing mothers should consult with their physicians about whether to discontinue nursing or

discontinue oxycodone and acetaminophen tablets because of the potential for serious adverse

reactions to nursing infants.

9. Patients who are treated with oxycodone and acetaminophen tablets for more than a few weeks

should be advised not to abruptly discontinue the medication. Patients should consult with their

physician for a gradual discontinuation dose schedule to taper off the medication.

10. Patients should be advised that oxycodone and acetaminophen tablets are a potential drug of abuse.

They should protect it from theft, and it should never be given to anyone other than the individual for

whom it was prescribed.

Although oxycodone may cross-react with some drug urine tests, no available studies were found

which determined the duration of detectability of oxycodone in urine drug screens. However, based on

pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is

roughly estimated to be one to two days following drug exposure.

Urine testing for opiates may be performed to determine illicit drug use and for medical reasons such as

evaluation of patients with altered states of consciousness or monitoring efficacy of drug rehabilitation

efforts. The preliminary identification of opiates in urine involves the use of an immunoassay screening

and thin-layer chromatography (TLC). Gas chromatography/mass spectrometry (GC/MS) may be utilized

as a third-stage identification step in the medical investigational sequence for opiate testing after

immunoassay and TLC. The identities of 6-keto opiates (e.g., oxycodone) can further be differentiated

by the analysis of their methoxime-trimethylsilyl (MO-TMS) derivative.

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.

Serious adverse reactions that may be associated with oxycodone and acetaminophen tablet use include

respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension and shock (see

OVERDOSAGE).

The most frequently observed non-serious adverse reactions include lightheadedness, dizziness,

drowsiness or 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 euphoria, dysphoria, constipation and pruritus.

Hypersensitivity reactions may include: Skin eruptions, urticarial, erythematous skin reactions.

Hematologic reactions may include: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia.

Rare cases of agranulocytosis has likewise been associated with acetaminophen use. In high doses, the

most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular

necrosis and hypoglycemic coma also may occur.

Other adverse reactions obtained from postmarketing experiences with oxycodone and acetaminophen

tablets are listed by organ system and in decreasing order of severity and/or frequency as follows:

Body as a Whole

Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia,

thirst, headache, increased sweating, accidental overdose, non-accidental overdose

Cardiovas cular

Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias

Central and Peripheral Nervous Sys tem

Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation,

cerebral edema, confusion, dizziness

Fluid and Electrolyte

Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

Gas trointes tinal

Dyspepsia, taste disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry

mouth, flatulence, gastrointestinal disorder, nausea, vomiting, pancreatitis, intestinal obstruction, ileus

Hepatic

Transient elevations of hepatic enzymes, increase in bilirubin, hepatitis, hepatic failure, jaundice,

hepatotoxicity, hepatic disorder

Hearing and Ves tibular

Hearing loss, tinnitus

Hematologic

Thrombocytopenia

Hypers ens itivity

Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid

reaction

Metabolic and Nutritional

Hypoglycemia, hyperglycemia, acidosis, alkalosis

Mus culos keletal

Myalgia, rhabdomyolysis

Ocular

Miosis, visual disturbances, red eye

Ps ychiatric

Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of

consciousness, nervousness, hallucination, somnolence, depression, suicide

Res piratory Sys tem

Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, aspiration, hypoventilation, laryngeal

edema

Skin and Appendages

Erythema, urticaria, rash, flushing

Urogenital

Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, urinary retention

Oxycodone and acetaminophen tablets are a Schedule II controlled substance. Oxycodone is a muagonist

opioid with an abuse liability similar to morphine. Oxycodone, like morphine and other opioids

used in analgesia, can be abused and is subject to criminal diversion.

Drug addiction is defined as an abnormal, compulsive use, use for non-medical purposes of a substance

despite physical, psychological, occupational or interpersonal difficulties resulting from such use, and

continued use despite harm or risk of harm. Drug addiction is a treatable disease, utilizing a

multidisciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with

chronic pain but may be more common in individuals who have a past history of alcohol or substance

abuse or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is

poorly managed. It is considered an iatrogenic effect of ineffective pain management. The health care

provider must assess continuously the psychological and clinical condition of a pain patient in order to

distinguish addiction from pseudoaddiction and thus, be able to treat the pain adequately.

Physical dependence on a prescribed medication does not signify addiction. Physical dependence

involves the occurrence of a withdrawal syndrome when there is sudden reduction or cessation in drug

use or if an opiate antagonist is administered. Physical dependence can be detected after a few days of

opioid therapy. However, clinically significant physical dependence is only seen after several weeks of

relatively high dosage therapy. In this case, abrupt discontinuation of the opioid may result in a

withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of

the drug over a 2-week period will prevent withdrawal symptoms. The severity of the withdrawal

syndrome depends primarily on the daily dosage of the opioid, the duration of therapy and medical

status of the individual.

The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized

by yawning, anxiety, increased heart rate and blood pressure, restlessness, nervousness, muscle aches,

tremor, irritability, chills alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation,

rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and

insomnia, and pronounced weakness and depression.

“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. Physicians

should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of

physical dependence in all addicts. In addition, 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. Oxycodone, like other opioids, has been diverted for non-medical use.

Careful recordkeeping 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.

Like other opioid medications, oxycodone and acetaminophen tablets are subject to the Federal

Controlled Substances Act. After chronic use, oxycodone and acetaminophen tablets should not be

discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.

Interactions with Alcohol and Drugs of Abus e

Oxycodone may be expected to have additive effects when used in conjunction with alcohol, other

opioids, or illicit drugs that cause central nervous system depression.

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.

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.

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

OXYCODONE AND ACETAMINOPHEN

oxycodone and acetaminophen tablet

Product Information

Product T ype

HUMAN PRESCRIPTION

DRUG

Ite m Code (Source )

NDC:6 150 2-

9 15(NDC:6 516 2-20 7)

Route of Administration

ORAL

DEA Sche dule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

O XYCO DO NE HYDRO CHLO RIDE (UNII: C1ENJ2TE6 C) (OXYCODONE -

UNII:CD35PMG570 )

OXYCODONE

HYDROCHLORIDE

7.5 mg

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

Product Characteristics

Color

white (OFF WHITE)

S core

no sco re

S hap e

CAPSULE

S iz e

Flavor

Imprint Code

IP20 7

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 150 2-9 15-9 7

50 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

2

NDC:6 150 2-9 15-9 6

10 0 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

3

NDC:6 150 2-9 15-30

30 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

4

NDC:6 150 2-9 15-20

20 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

5

NDC:6 150 2-9 15-15

15 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

6

NDC:6 150 2-9 15-10

10 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

7

NDC:6 150 2-9 15-0 6

6 in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

0 1/28 /20 16

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 40 778

0 1/28 /20 16

Labeler -

EPM Packaging Inc (079124340)

Registrant -

EPM Packaging Inc (079124340)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

EPM Packaging Inc

0 79 124340

re pa c k(6 150 2-9 15)

EPM Packaging Inc

Revised: 1/2016

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