Acetaminophen; Oxycodone Hydrochloride (0072)
[ a-seat-a-min'-oh-fen; ox-ee-koe'-done hye-droe-klor'-ide ]
| Ingredients: |
Acetaminophen; Oxycodone Hydrochloride |
| Indications: |
Pain, moderate to severe |
| Pregnancy Category: |
C |
| FDA Approved: |
1981- 12- 01 |
| Classes: |
Analgesics, narcotic |
| Brand Names: |
Endocet
-
US; Canada
;
Oxycocet
-
Canada
;
Percocet-10/325
-
US
;
Percocet-10/650
-
US
;
Percocet-2.5/325
-
US
;
Percocet-5
-
Canada, Israel
;
Percocet-5/325
-
US
;
Percocet 7.5/325
-
US
;
Percocet-7.5/500
-
US
;
Percocet-Demi
-
Canada
;
Roxicet
-
US
;
Roxilox
-
US
;
Tylox
-
US
;
|
| DEA schedules: |
Schedule II |
DESCRIPTION
|
| |
Acetaminophen, 4′- hydroxyacetanilide, is a non- opiate, nonsalicylate analgesic and antipyretic which occurs as a white,
odorless, crystalline powder, possessing a slightly bitter taste. The molecular formula for acetaminophen is C8 H9 NO2 and the molecular weight is 151.17.
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 C18 H21 NO4 ·HCl and the molecular weight 351.83. It is derived from the opium alkaloid thebaine.
Each tablet, for oral administration, contains acetaminophen and oxycodone HCl in the following strengths (see TABLE 1 ).
| TABLE 1
|
| 7.5/ 325
|
| Acetaminophen |
325 mg |
| Oxycodone HCl |
7.5 mg |
| 7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. |
| 10/ 325
|
| Acetaminophen |
325 mg |
| Oxycodone HCl |
10 mg |
| 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone. |
| 2.5/ 325
|
| Acetaminophen |
325 mg |
| Oxycodone HCl |
2.5 mg |
| 2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone. |
| 5/ 325
|
| Acetaminophen |
325 mg |
| Oxycodone HCl |
5 mg |
| 5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone. |
| 7.5/ 500
|
| Acetaminophen |
500 mg |
| Oxycodone HCl |
7.5 mg |
| 7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone. |
| 10/ 650
|
| Acetaminophen |
650 mg |
| Oxycodone HCl |
10 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 325 mg/ 2.5 mg strength contains FD&C red no. 40 aluminum lake and the 325 mg/ 5 mg strength
contains FD&C blue no. 1 aluminum lake. The 500 mg/ 7.5 mg strength contains FD&C yellow no. 6 aluminum lake and the 650 mg/
10 mg strength contains D&C yellow no. 10 aluminum lake. The 325 mg/ 7.5 mg strength contains FD&C yellow no. 6 aluminum lake
and the 325 mg/ 10 mg strength contains D&C yellow no. 10 aluminum lake.
|
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 acetaminophen; oxycodone HCl 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
|
| |
Acetaminophen; oxycodone HCl is indicated for the relief of moderate to moderately severe pain.
|
CONTRAINDICATIONS
|
| |
Acetaminophen; oxycodone HCl 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 acetaminophen; oxycodone HCl, 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, acetaminophen; oxycodone HCl 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 preexisting 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 acetaminophen; oxycodone HCl or other opioids may obscure the diagnosis or clinical course in patients
with acute abdominal conditions.
|
Special Risk Patients
|
| |
Acetaminophen; oxycodone HCl 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 the Patient
|
| |
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 acetaminophen; oxycodone HCl should be cautioned accordingly.
|
Usage in Pregnancy
|
| |
Teratogenic Effects, Pregnancy Category C
|
| |
Animal reproductive studies have not been conducted with acetaminophen; oxycodone HCl. It is also not known whether acetaminophen;
oxycodone HCl can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Acetaminophen;
oxycodone HCl 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 acetaminophen; oxycodone HCl 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 acetaminophen; oxycodone HCl is excreted in human milk. Because many drugs are excreted in human milk,
caution should be exercised when acetaminophen; oxycodone HCl is administered to a nursing woman.
|
Pediatric Use
|
| |
Safety and effectiveness in pediatric patients have not been established.
|
|
DRUG INTERACTIONS
|
| |
Patients receiving other opioid analgesics, general anesthetics, phenothiazines, other tranquilizers, sedative- hypnotics
or other CNS depressants (including alcohol) concomitantly with acetaminophen; oxycodone HCl 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.
|
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
|
| |
Acetaminophen; oxycodone HCl 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 g and fatalities with less than
15 g. 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- 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 4 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 HCl 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 HCl (usual initial adult dose 0.4 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. Acetaminophen; oxycodone HCl is given orally.
- Acetaminophen; oxycodone HCl 325 mg/ 7.5 mg and 325 mg/ 10 mg: The usual adult dosage is 1 tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed
4 g.
- Acetaminophen; oxycodone HCl 325 mg/ 2.5 mg: The usual adult dosage is 1 or 2 tablets every 6 hours. The total daily dose of acetaminophen should not exceed 4 g.
- Acetaminophen; oxycodone HCl 325 mg/ 5 mg, 500 mg/ 7.5 mg, and 650 mg/ 10 mg: The usual adult dosage is 1 tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed
4 g.
| TABLE 2
|
| Strength |
Maximal Daily Dose |
| 325 mg/ 7.5 mg |
8 tablets |
| 325 mg/ 10 mg |
6 tablets |
| 325 mg/ 2.5 mg |
12 tablets |
| 325 mg/ 5 mg |
12 tablets |
| 500 mg/ 7.5 mg |
8 tablets |
| 650 mg/ 10 mg |
6 tablets |
|
|
HOW SUPPLIED
|
| |
Percocet is supplied as follows:
- 7.5 mg/ 325 mg: Peach oval- shaped tablet debossed with "PERCOCET" on one side and "7.5/ 325" on the other.
- 10 mg/ 325 mg: Yellow capsule- shaped tablet debossed with "PERCOCET" on one side and "10/ 325" on the other.
- 2.5 mg/ 325 mg: Pink oval tablet embossed with "PERCOCET" on one side and "2.5" on the other.
- 5 mg/ 325 mg: Blue, round, tablet, embossed with "PERCOCET" and "5" on one side and bisect on the other.
- 7.5 mg/ 500 mg: Peach capsule- shaped tablet embossed with "PERCOCET" on one side and "7.5" on the other.
- 10 mg/ 650 mg: Yellow oval tablet embossed with "PERCOCET" on one side and "10" on the other.
Storage
|
| |
Store at controlled room temperature, 15- 30°C (59- 86°F).
Dispense in a tight, light- resistant container with a child- resistant closure (as required).
|
|
PRODUCT IDENTIFICATION
|
| |
Acetaminophen; Oxycodone Hydrochloride ,
tablet ,
325 mg-5 mg
[ Roxane Laboratories Inc
]
Acetaminophen; Oxycodone Hydrochloride ,
tablet ,
325 mg-5 mg
[ Roxane Laboratories Inc
]
Acetaminophen; Oxycodone Hydrochloride ,
tablet ,
500 mg-5 mg
[ Roxane Laboratories Inc
]
Acetaminophen; Oxycodone Hydrochloride ,
tablet ,
325 mg-5 mg
[ Barr Laboratories Inc
]
Acetaminophen; Oxycodone Hydrochloride ,
capsule ,
500 mg-5 mg
[ Barr Laboratories Inc
]
Acetaminophen; Oxycodone Hydrochloride ,
tablet ,
325 mg-5 mg
[ Endo Laboratories LLC
]
Acetaminophen; Oxycodone Hydrochloride ,
capsule ,
500 mg-5 mg
[ Mallinckrodt Medical Inc
]
Acetaminophen; Oxycodone Hydrochloride ,
tablet ,
325 mg-5 mg
[ Endo Laboratories LLC
]
Acetaminophen; Oxycodone Hydrochloride ,
capsule ,
500 mg-5 mg
[ Janssen Pharmaceuticals
]
|
PRODUCT LISTING - RATED THERAPEUTICALLY EQUIVALENT
|
| |
| capsule - oral - 500 mg- 5 mg -
|
| 100.0 |
$26.72 |
GENERIC
Qualitest Pharmaceuticals Inc
|
00603499721 |
| 100.0 |
$26.72 |
GENERIC
Mallinckrodt Medical Inc
|
00406053201 |
| 100.0 |
$34.86 |
GENERIC
Barr Laboratories Inc
|
00555065802 |
| 100.0 |
$41.67 |
GENERIC
Vintage Pharmaceuticals Inc
|
00254483228 |
| 100.0 |
$46.50 |
GENERIC
Major Pharmaceuticals Inc
|
00904197360 |
| 100.0 |
$49.50 |
GENERIC
Barr Laboratories Inc
|
51285065802 |
| 100.0 |
$57.00 |
GENERIC
Barr Laboratories Inc
|
00555065102 |
| 100.0 |
$57.72 |
Roxilox
Roxane Laboratories Inc
|
00054279525 |
| 100.0 |
$59.00 |
GENERIC
Amide Pharmaceutical Inc
|
52152004102 |
| 100.0 |
$79.39 |
GENERIC
Watson Pharmaceuticals
|
00591073701 |
| 100.0 |
$81.30 |
GENERIC
Endo Laboratories LLC
|
60951066070 |
| 100.0 |
$129.71 |
Tylox
Janssen Pharmaceuticals
|
00045052660 |
| 100.0 |
$170.58 |
Tylox
Janssen Pharmaceuticals
|
00045052679 |
| 500.0 |
$181.13 |
GENERIC
Mallinckrodt Medical Inc
|
00406053205 |
| 500.0 |
$249.00 |
GENERIC
Amide Pharmaceutical Inc
|
52152004104 |
| 500.0 |
$386.18 |
GENERIC
Endo Laboratories LLC
|
60951066085 |
| tablet - oral - 650 mg- 10 mg -
|
| 100.0's |
$148.10 |
Endocet
Endo Laboratories LLC
|
60951079770 |
| 100.0's |
$211.13 |
Percocet- 10/ 650
Endo Laboratories LLC
|
63481062270 |
| 500.0's |
$703.52 |
Endocet
Endo Laboratories LLC
|
60951079785 |
| tablet - oral - 325 mg- 5 mg -
|
| 10.0's |
$4.88 |
GENERIC
Physicians Total Care
|
54868170002 |
| 10.0's |
$32.91 |
GENERIC
Mallinckrodt Medical Inc
|
00406051262 |
| 20.0's |
$6.42 |
GENERIC
Physicians Total Care
|
54868170004 |
| 24.0's |
$8.96 |
GENERIC
Physicians Total Care
|
54868170003 |
| 25.0's x 4.0 |
$83.75 |
Percocet- 5/ 325
Endo Laboratories LLC
|
63481012775 |
| 25.0's x 4.0 |
$139.94 |
Percocet- 5/ 325
Endo Laboratories LLC
|
63481062375 |
| 30.0's |
$7.98 |
GENERIC
Physicians Total Care
|
54868170001 |
| 100.0's |
$7.89 |
GENERIC
Qualitest Pharmaceuticals Inc
|
00603499821 |
| 100.0's |
$11.06 |
GENERIC
Mallinckrodt Medical Inc
|
00406051201 |
| 100.0's |
$11.44 |
GENERIC
Watson Pharmaceuticals
|
00591074901 |
| 100.0's |
$19.55 |
GENERIC
Major Pharmaceuticals Inc
|
00904046560 |
| 100.0's |
$30.14 |
Endocet
Endo Laboratories LLC
|
60951060275 |
| 100.0's |
$32.00 |
GENERIC
Amide Pharmaceutical Inc
|
52152007502 |
| 100.0's |
$44.36 |
Endocet
Endo Laboratories LLC
|
60951060270 |
| 100.0's |
$51.46 |
Roxicet
Roxane Laboratories Inc
|
00054465025 |
| 100.0's |
$60.28 |
Roxicet
Roxane Laboratories Inc
|
00054865024 |
| 100.0's |
$90.44 |
Percocet- 5/ 325
Endo Laboratories LLC
|
63481012770 |
| 100.0's |
$139.94 |
Percocet- 5/ 325
Endo Laboratories LLC
|
63481062370 |
| 500.0's |
$79.45 |
GENERIC
Major Pharmaceuticals Inc
|
00904046540 |
| 500.0's |
$107.90 |
GENERIC
Barr Laboratories Inc
|
00555027804 |
| 500.0's |
$108.55 |
GENERIC
Mallinckrodt Medical Inc
|
00406051205 |
| 500.0's |
$139.99 |
GENERIC
Amide Pharmaceutical Inc
|
52152007504 |
| 500.0's |
$217.08 |
Roxicet
Roxane Laboratories Inc
|
00054465029 |
| 500.0's |
$221.80 |
Endocet
Endo Laboratories LLC
|
60951060285 |
| 500.0's |
$230.98 |
GENERIC
Watson Pharmaceuticals
|
00591074905 |
| 500.0's |
$230.98 |
GENERIC
Qualitest Pharmaceuticals Inc
|
00603499828 |
| 500.0's |
$429.56 |
Percocet- 5/ 325
Endo Laboratories LLC
|
63481012785 |
| 500.0's |
$664.69 |
Percocet- 5/ 325
Endo Laboratories LLC
|
63481062385 |
| tablet - oral - 500 mg- 7.5 mg -
|
| 100.0's |
$113.25 |
Endocet
Endo Laboratories LLC
|
60951079670 |
| 100.0's |
$161.44 |
Percocet- 7.5/ 500
Endo Laboratories LLC
|
63481062170 |
| 500.0's |
$429.46 |
Endocet
Endo Laboratories LLC
|
60951079685 |
|
PRODUCT LISTING - EQUIVALENTS NOT AVAILABLE
|
| |
| solution - oral - 325 mg- 5 mg/ 5 ml -
|
| 5.0 ml x 40.0 |
$44.55 |
Roxicet
Roxane Laboratories Inc
|
00054864816 |
| 500.0 ml |
$46.19 |
Roxicet
Roxane Laboratories Inc
|
00054368663 |
| tablet - oral - 325 mg- 2.5 mg -
|
| 100.0's |
$55.56 |
Percocet- 2.5/ 325
Endo Laboratories LLC
|
63481062775 |
| 100.0's |
$100.00 |
Percocet- 2.5/ 325
Endo Laboratories LLC
|
63481062770 |
| tablet - oral - 500 mg- 5 mg -
|
| 100.0's |
$63.42 |
Roxicet
Roxane Laboratories Inc
|
00054878424 |
| 100.0's |
$115.20 |
Roxicet
Roxane Laboratories Inc
|
00054478425 |
| tablet - oral - 325 mg- 10 mg -
|
| 100.0's |
$177.72 |
GENERIC
Watson Pharmaceuticals
|
00591093201 |
| 100.0's |
$177.92 |
Endocet
Endo Laboratories LLC
|
60951071270 |
| 100.0's |
$197.69 |
Percocet- 10/ 325
Endo Laboratories LLC
|
63481062970 |
| tablet - oral - 650 mg- 10 mg -
|
| 100.0's |
$137.68 |
GENERIC
Watson Pharmaceuticals
|
52544082501 |
| 100.0's |
$137.68 |
GENERIC
Watson Pharmaceuticals
|
00591082501 |
| tablet - oral - 325 mg- 7.5 mg -
|
| 100.0's |
$135.92 |
GENERIC
Watson Pharmaceuticals
|
00591093301 |
| 100.0's |
$136.07 |
Endocet
Endo Laboratories LLC
|
60951070070 |
| 100.0's |
$151.19 |
Percocet 7.5/ 325
Endo Laboratories LLC
|
63481062870 |
| tablet - oral - 500 mg- 7.5 mg -
|
| 100.0's |
$105.30 |
GENERIC
Watson Pharmaceuticals
|
52544082401 |
| 100.0's |
$105.30 |
GENERIC
Watson Pharmaceuticals
|
00591082401 |
|
|