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Percocet Tablets (Endo Labs)

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  • Description
  • Chemical Structure
  • Chemical Structure
  • Clinical Pharmacology
  • Indications and Usage
  • Contraindications
  • Warnings
  • Precautions
  • Drug Interactions
  • Adverse Reactions
  • Drug Abuse and Dependence
  • Overdosage
  • Dosage and Administration
  • How Supplied

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  • DESCRIPTION

    Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:

    Oxycodone Hydrochloride, USP.................2.5 mg

    Acetaminophen, USP..................................325 mg

    2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.

    Oxycodone Hydrochloride, USP....................5 mg

    Acetaminophen, USP325 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, USP7.5 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.

    All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. 1 Aluminum Lake. The 7.5 mg/325 mg strength and the 7.5 mg/500 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength and the 10 mg/650 mg strength contains D&C Yellow No. 10 Aluminum Lake.

    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 8 H 9 NO 2 and the molecular weight is 151.17. It may be represented by the following structural formula:

    Oxycodone, 14-hydroxydihydrocodeinone, is a semisynthetic pure opioid agonist which occurs as a white, odorless, crystalline powder having a saline, bitter taste. The molecular formula for oxycodone hydrochloride is C 18 H 21 NO 4 ·HCl and the molecular weight 351.83. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:

    CLINICAL PHARMACOLOGY

    The principal ingredient, oxycodone, is a semisynthetic opioid analgesic with multiple actions qualitatively similar to those of morphine; the most prominent involves the central nervous system and organs composed of smooth muscle. The principal actions of therapeutic value of the oxycodone in PERCOCET are analgesia and sedation.

    Oxycodone is similar to codeine and methadone in that it retains at least one-half of its analgesic activity when administered orally.

    Acetaminophen is a non-opiate, non-salicylate analgesic and antipyretic.

    INDICATIONS AND USAGE

    PERCOCET is indicated for the relief of moderate to moderately severe pain.

    CONTRAINDICATIONS

    PERCOCET should not be administered to patients who are hypersensitive to oxycodone, acetaminophen, or any other components of this product.

    WARNINGS

    Drug Dependence

    Oxycodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychic dependence, physical dependence and tolerance may develop upon repeated administration of PERCOCET, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral opioid-containing medications. Like other opioid-containing medications, PERCOCET is subject to the Federal Controlled Substances Act (Schedule II).

    PRECAUTIONS

    General

    Head Injury and Increased Intracranial Pressure:    The respiratory depressant effects of opioids and their capacity to elevate cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, other intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions which may obscure the clinical course of patients with head injuries.

    Acute Abdominal Conditions:    The administration of PERCOCET (Oxycodone and Acetaminophen Tablets, USP) or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions.

    Special Risk Patients:    PERCOCET should be given with caution to certain patients such as the elderly or debilitated, and those with severe impairment of hepatic or renal function, hypothyroidism, Addison's disease, and prostatic hypertrophy or urethral stricture.

    Information for Patients

    Oxycodone may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The patient using PERCOCET should be cautioned accordingly.

    Drug Interactions

    Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative-hypnotics or other CNS depressants (including alcohol) concomitantly with PERCOCET 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.

    Usage in Pregnancy

    Teratogenic Effects; Pregnancy Category C:    Animal reproductive studies have not been conducted with PERCOCET. It is also not known whether PERCOCET can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. PERCOCET should not be given to a pregnant woman unless in the judgment of the physician, the potential benefits outweigh the possible hazards.

    Nonteratogenic Effects:    Use of opioids during pregnancy may produce physical dependence in the neonate.

    Labor and Delivery:    As with all opioids, administration of PERCOCET to the mother shortly before delivery may result in some degree of respiratory depression in the newborn and the mother, especially if higher doses are used.

    Nursing Mothers

    It is not known whether PERCOCET is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when PERCOCET is administered to a nursing woman.

    Pediatric Use

    Safety and effectiveness in pediatric patients have not been established.

    ADVERSE REACTIONS

    The most frequently observed adverse reactions include 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 euphoria, dysphoria, constipation, skin rash and pruritus. At higher doses, oxycodone has most of the disadvantages of morphine including respiratory depression.

    DRUG ABUSE AND DEPENDENCE

    PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is a Schedule II controlled substance.

    Oxycodone can produce drug dependence and has the potential for being abused (See WARNINGS ).

    OVERDOSAGE

    Acetaminophen

    Signs and Symptoms:    In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma and thrombocytopenia may also occur.

    In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams and fatalities with less than 15 grams. Importantly, young children seem to be more resistant than adults to the hepatotoxic effect of an acetaminophen overdose. Despite this, the measures outlined below should be initiated in any adult or child suspected of having ingested an acetaminophen overdose.

    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:    The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. Patient's estimates of the quantity of a drug ingested are notoriously unreliable. Therefore, if an acetaminophen overdose is suspected, a serum acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals.

    The antidote, N-acetylcysteine, should be administered as early as possible, preferably within 16 hours of the overdose ingestion for optimal results, but in any case, within 24 hours. Following recovery, there are no residual, structural, or functional hepatic abnormalities.

    Oxycodone

    Signs and Symptoms:    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.

    Treatment:    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 opioid antagonist naloxone hydrochloride is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including oxycodone. Therefore, an appropriate dose of naloxone hydrochloride (usual initial adult dose 0.4 mg to 2 mg) should be administered preferably by the intravenous route, and simultaneously with efforts at respiratory resuscitation (see package insert). 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.

    An antagonist should not be administered in the absence of clinically significant respiratory or cardiovascular depression. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated.

    Gastric emptying may be useful in removing unabsorbed drug.

    DOSAGE AND ADMINISTRATION

    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. PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is given orally.

    Percocet 2.5 mg/325 mg

    The usual adult dosage is one or two tablets every six hours. The total daily dose of acetaminophen should not exceed 4 grams.

    Percocet 5 mg/325 mg; Percocet 7.5 mg/325 mg; Percocet 7.5 mg/500 mg; Percocet 10 mg/325 mg; Percocet 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.

    Strength Maximal Daily Dose
    Percocet 2.5 mg/325 mg 12 Tablets
    Percocet 5 mg/325 mg 12 Tablets
    Percocet 7.5 mg/325 mg   8 Tablets
    Percocet 7.5 mg/500 mg   8 Tablets
    Percocet 10 mg/325 mg   6 Tablets
    Percocet 10 mg/650 mg   6 Tablets

    HOW SUPPLIED

    PERCOCET (Oxycodone and Acetaminophen Tablets, USP) are supplied as follows:

    2.5 mg/325 mg
    Bottles of 100
    NDC 63481-627-70
    Pink oval tablet
    Bottles of 500
    NDC 63481-627-85
    embossed with
    "PERCOCET" on one
    side and "2.5" on the other.
    Unit dose package
       of 100 tablets
    NDC 63481-627-75
    5 mg/325 mg
    Bottles of 100
    NDC 63481-623-70
    Blue, round, tablet,
    Bottles of 500
    NDC 63481-623-85
    embossed with
    "PERCOCET" and "5" on
    one side and bisect on
    the other.
    Unit dose package
       of 100 tablets
    NDC 63481-623-75
    7.5 mg/325 mg
    Bottles of 100
    NDC 63481-628-70
    Peach oval-shaped
    tablet embossed with
    Unit dose package
       of 100 tablets
    NDC 63481-628-75
    "PERCOCET" on one
    side and "7.5/325" on the other.
    7.5 mg/500 mg
    Bottles of 100
    NDC 63481-621-70
    Peach capsule-shaped
    tablet embossed with
    "PERCOCET" on one
    side and "7.5" on the other.
    10 mg/325 mg
    Bottles of 100
    NDC 63481-629-70
    Yellow capsule-shaped
    tablet embossed with
    Unit dose package
       of 100 tablets
    NDC 63481-629-85
    "PERCOCET" on
    one side and "10/325" on the other.
    10 mg/650 mg
    Bottles of 100
    NDC 63481-622-70
    Yellow oval tablet
    embossed with
    "PERCOCET" on one
    side and "10" on the other.

    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.

    Manufactured for:

    Endo Pharmaceuticals Inc.

    Chadds Ford, Pennsylvania 19317

    PERCOCET® is a Registered Trademark of Endo Pharmaceuticals Inc.

    Copyright © Endo Pharmaceuticals Inc. 2004

    Printed in U.S.A.         415042/March, 2004

                                                            415242













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