OXYCODONE AND ACETAMINOPHEN Tablets USP

DESCRIPTION

id: 65e7f020-b9cc-2595-e053-2991aa0a41de
displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride, USP 5mg*

Acetaminophen, USP 325 mg

*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. Oxycodone Hydrochloride, USP 7.5 mg*

Acetaminophen, USP 325 mg

*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. Oxycodone Hydrochloride, USP 7.5 mg*

Acetaminophen, USP 500 mg

*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. Oxycodone Hydrochloride, USP 10 mg*

Acetaminophen, USP 325 mg

* 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. Oxycodone Hydrochloride, USP 10 mg*

Acetaminophen, USP 650 mg

* 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. In addition, each tablet also contains the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, pregelatinized starch or starch 826 and stearic acid. The 7.5 mg/500 mg tablets and 10 mg/650 mg tablets also contain croscarmellose sodium, and povidone. 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 is
_{C18H21NO4•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, 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 is C
₈H
₉NO
₂ and the molecular weight is 151.17. It may be represented by the following structural formula:

INDICATIONS AND USAGE

id: 65e7f020-b9ce-2595-e053-2991aa0a41de
displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

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

CONTRAINDICATIONS

id: 65e7f020-b9cf-2595-e053-2991aa0a41de
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Oxycodone and acetaminophen tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, 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.

ADVERSE REACTIONS

id: 65e7f020-b9d2-2595-e053-2991aa0a41de
displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

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 Cardiovascular Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias Central and Peripheral Nervous System Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, seizures, anxiety, mental impairment, agitation, cerebral edema, confusion, dizziness Fluid and Electrolyte Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal 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 Vestibular Hearing loss, tinnitus Hematologic Thrombocytopenia Hypersensitivity Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction Metabolic and Nutritional Hypoglycemia, hyperglycemia, acidosis, alkalosis Musculoskeletal Myalgia, rhabdomyolysis Ocular Miosis, visual disturbances, red eye Psychiatric Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, depression, suicide Respiratory System 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

DRUG ABUSE AND DEPENDENCE

id: 65e7f020-b9d3-2595-e053-2991aa0a41de
displayName: DRUG ABUSE AND DEPENDENCE SECTION
FDA Article Code: 42227-9

Oxycodone and acetaminophen tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist 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 multi-disciplinary 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 infection. 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 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. 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.

DOSAGE AND ADMINISTRATION

id: 65e7f020-b9d5-2595-e053-2991aa0a41de
displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

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 are given orally. Oxycodone and acetaminophen tablets 5 mg/325 mg; Oxycodone and acetaminophen tablets 7.5 mg/500 mg; Oxycodone and acetaminophen tablets 10 mg/650 mg The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams. Oxycodone and acetaminophen tablets 7.5 mg/325 mg; Oxycodone and acetaminophen tablets 10 mg/325 mg The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

HOW SUPPLIED

id: 65e7f020-b9fa-2595-e053-2991aa0a41de
displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Each oxycodone and acetaminophen tablet USP 7.5 mg/325 mg contains oxycodone hydrochloride 7.5 mg (equivalent to 6.7228 mg oxycodone) and acetaminophen 325 mg. It is available as a white to off-white caplet shaped tablet debossed with “M522” on one side and “7.5/325” on the other side. NDC 60760-933-30 BOTTLES OF 30 60760-933-60 BOTTLES OF 60

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

id: 65e7f020-b9d8-2595-e053-2991aa0a41de
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4