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Name:Percocet

Generic Name:Oxycodone/Acetaminophen

Shape and Size:Pill with imprint PERCOCET 7.5/325 is orange,
Capsule shape and has been identified as Percocet 325mg/7.5mg

Strength:5mg/325mg, 7.5mg/325mg, 10mg/325mg

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Description

Each tablet, for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:
Oxycodone Hydrochloride, USP
Acetaminophen, USP
*2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.
Oxycodone Hydrochloride, USP
Acetaminophen, USP
*5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
Oxycodone Hydrochloride, USP
Acetaminophen, USP
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP
Acetaminophen, USP
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
Oxycodone Hydrochloride, USP
Acetaminophen, USP
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
Oxycodone Hydrochloride, USP
Acetaminophen, USP
*10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
2.5 mg* 325mg
5mg* 325 mg
7.5 mg* 325 mg
7.5 mg* 500 mg
10 mg* 325 mg
10 mg* 650 mg
All strengths of PERCOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, 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 and the 7.5 mg/500 mg strengths contain FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg and 10 mg/650 mg strengths contain D&C Yellow No. 10 Aluminum Lake.

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.

 

Indication and Usage

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

Contraindications

PERCOCET 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 paralyticileus.

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WARNINGS
Misuse, Abuse and Diversion 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 PERCOCET 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 PERCOCET (Oxycodone and Acetaminophen Tablets, USP) should be closely
monitored for the following potentially serious adverse reactions and complications:
Respiratory Depression

Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in PERCOCET 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), corpulmonale, 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.

Head Injury and Increased Intracranial Pressure

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 pre-existing increase in intracranial pressure. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with head injuries.

Hypotensive 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.

Adverse Reactions

Serious adverse reactions that may be associated with PERCOCET tablet use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock.

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 PERCOCET 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, gastro-intestinal 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.

Pregnancy and Lactation

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
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
PERCOCET 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.

Nursing Mothers
Ordinarily, nursing should not be undertaken while a patient is receiving PERCOCET 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 PERCOCET 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.

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Drug Interactions

Drug/Drug Interactions with Oxycodone
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 PERCOCET 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 (Propanolol): 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 non- hepatic or renal clearance of zidovudine.

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Drug/Laboratory Test Interactions
Depending on the sensitivity/specificity and the test methodology, the individual components of PERCOCET (Oxycodone and Acetaminophen Tablets, USP) 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.

 

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