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|Oxycodone and Acetaminophen Oxycodone and Acetaminophen capsules |
| Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Oxycodone and AcetaminophenGeneric Name: oxycodone hydrochloride and acetaminophen Dosage Form: Tablets Code 991Z00 Rev. 01/05 Oxycodone and Acetaminophen DescriptionEach tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths: Oxycodone Hydrochloride 2.5mg Acetaminophen, USP 300 mg 2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone. Oxycodone Hydrochloride 5mg Acetaminophen, USP 300 mg 5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. Oxycodone Hydrochloride 7.5 mg Acetaminophen, USP 300 mg 7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. Oxycodone Hydrochloride 10 mg Acetaminophen, USP 300 mg 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. All strengths of Oxycodone and Acetaminophen tablets 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/300 mg strength contains FD&C Blue #1 Aluminum Lake HT 28%-31% pure dye and the 5 mg/300 mg strength contains D&C Yellow No. 10. The 7.5 mg/ 300 mg strength contains FD&C Red #40 Aluminum Lake HT 38-42% pure dye and the 10 mg/ 300 mg strength contains FD&C Yellow #6 Aluminum Lake HT 38-42% pure dye. 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 C8H9NO2 and the molecular weight is 151.16. 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 C18H21NO4·HCL and the molecular weight is 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the following structural formula:  Oxycodone and Acetaminophen - Clinical PharmacologyThe 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 principle actions of therapeutic value of the oxycodone in Oxycodone and Acetaminophen tablets 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 for Oxycodone and AcetaminophenOxycodone and Acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. ContraindicationsOxycodone and Acetaminophen tablets should not be administered to patients who are hypersensitive to oxycodone, acetaminophen, or any other component of this product. WarningsDrug DependenceOxycodone 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 Oxycodone and Acetaminophen tablets, 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, Oxycodone and Acetaminophen tablets are subject to the Federal Controlled Substances Act (Schedule II). PrecautionsGeneralHead 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 Oxycodone and Acetaminophen tablets or other opioids may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Special Risk Patients: Oxycodone and Acetaminophen tablets 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 patientsOxycodone 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 Oxycodone and Acetaminophen tablets should be cautioned accordingly. Drug InteractionsPatients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, 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. Usage in PregnancyTeratogenic Effects: Pregnancy Category C Animal reproductive studies have not been conducted with Oxycodone and Acetaminophen tablets. It is also not known whether Oxycodone and Acetaminophen tablets can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Oxycodone and Acetaminophen tablets 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 DeliveryAs with all opioids, administration of Oxycodone and Acetaminophen tablets 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 Oxycodone and Acetaminophen tablets are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Oxycodone and Acetaminophen tablets are administered to a nursing woman. Pediatric UseSafety and effectiveness in pediatric patients have not been established. Adverse ReactionsThe 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 DependenceOxycodone and Acetaminophen Tablets, USP are a Schedule II controlled substance. Oxycodone can produce drug dependence and has the potential for being abused (See WARNINGS). OverdosageAcetaminophenSigns 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-Strokes 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. Oxycodone and Acetaminophen Dosage and AdministrationDosage 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. Oxycodone and Acetaminophen Tablets, USP are given orally. The total daily dose of acetaminophen should not exceed 4 grams. Oxycodone and Acetaminophen Tablets, USP 2.5 mg/300 mgThe usual adult dosage is one or two tablets every six hours (maximal daily dose of Oxycodone and Acetaminophen Tablets, USP 2.5 mg/300 mg is 12 tablets). Oxycodone and Acetaminophen Tablets, USP 5 mg/300 mgThe usual adult dosage is one tablet every 6 hours as needed for pain (maximal daily dose of Oxycodone and Acetaminophen Tablets, USP 5 mg/300 mg is 12 tablets). Oxycodone and Acetaminophen Tablets, USP 7.5 mg/300 mgThe usual adult dosage is one tablet every 6 hours as needed for pain (maximal daily dose of Oxycodone and Acetaminophen Tablets, USP 7.5 mg/300 mg is 8 tablets). Oxycodone and Acetaminophen Tablets, USP 10 mg/300 mgThe usual adult dosage is one tablet every 6 hours as needed for pain (maximal daily dose of Oxycodone and Acetaminophen Tablets, USP 10 mg/300 mg is 6 tablets). How is Oxycodone and Acetaminophen SuppliedOxycodone and Acetaminophen Tablets, USP are supplied as follows:
2.5 mg/300 mg Light blue, round-shaped, convex face tablet debossed "MIA" on one side and "250" on the other side. Bottles of 30 NDC# 46672-193-03 Bottles of 100 NDC# 46672-193-10 Bottles of 500 NDC# 46672-193-50 5 mg/300 mg Yellow, capsule-shaped, convex face tablet debossed "MIA" score on one side and "500” on the other side. Bottles of 30 NDC# 46672-194-03 Bottles of 100 NDC# 46672-194-10 Bottles of 500 NDC# 46672-194-50 7.5 mg/300 mg Red, capsule-shaped, flat face, beveled edge tablet debossed "MIA" on one side and "750" on the other side. Bottles of 30 NDC# 46672-195-03 Bottles of 100 NDC# 46672-195-10 Bottles of 500 NDC# 46672-195-50 10 mg/300 mg Orange, oval-shaped, convex face tablet debossed "MIA" on one side and "1000" on the other side. Bottles of 30 NDC# 46672-196-03 Bottles of 100 NDC# 46672-196-10 Bottles of 500 NDC# 46672-196-50 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. Manufactured by: MIKART, INC. Atlanta, Georgia 30318 Code 991Z00 Rev. 01/05
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