Best Brand Name Oxycodone 10325 for Pain Relief Reviews

What is Percocet and how is it used?

Percocet is a prescription medicine used to care for the symptoms of acute hurting and moderate-to-severe pain. Percocet may be used alone or with other medications.

• Percocet belongs to a class of drugs chosen Analgesics, Opioid Combos.

What are the possible side effects of Percocet?

Percocet may cause serious side effects including:

• noisy breathing,
• sighing,
• shallowing animate,
• lightheadedness,
• weakness,
• tiredness,
• fever,
• unusual bruising or bleeding,
• confusion,
• unusual thoughts or behavior,
• problems with urination,
• nausea,
• upper breadbasket pain,
• tiredness,
• loss of appetite,
• dark urine,
• clay-colored stools,
• yellowing of skin or optics (jaundice),
• vomiting,
• dizziness,
• worsening tiredness, and
• weakness

Get medical aid right away, if you lot accept whatsoever of the symptoms listed above.

The virtually common side furnishings of Percocet include:

• dizziness,
• drowsiness,
• feeling tired,
• feelings of extreme happiness or sadness,
• nausea,
• vomiting,
• stomach hurting,
• constipation, and
• headache

Tell the physician if you have any side issue that bothers you or that does not go abroad.

These are not all the possible side effects of Percocet. For more information, inquire your physician or pharmacist.

Call your dr. for medical advice about side effects. You lot may study side effects to FDA at 1-800-FDA-1088.

WARNING

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the utilize of acetaminophen at doses that exceed 4000 milligrams per mean solar day and often involve more than than one acetaminophen-containing product.

Description

Each tablet, for oral assistants, contains oxycodone hydrochloride and acetaminophen in the post-obit strengths:

Oxycodone Hydrochloride, USP two.v mg*
Acetaminophen, USP 325 mg
*ii.v mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.

Oxycodone Hydrochloride, USP five mg*
Acetaminophen, USP 325 mg
*five mg oxycodone HCl is equivalent to four.4815 mg of oxycodone.

Oxycodone Hydrochloride, USP seven.5 mg*
Acetaminophen, USP 325 mg
*7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.

Oxycodone Hydrochloride, USP 10 mg*
Acetaminophen, USP 325 mg
*x mg oxycodone HCl is equivalent to eight.9637 mg of oxycodone.

All strengths of PERCOCET as well contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. In improver, the 2.5 mg/325 mg strength contains FD&C Carmine No. forty Aluminum Lake and the 5 mg/325 mg strength contains FD&C Blue No. i Aluminum Lake. The 7.v mg/325 mg force contains FD&C Yellow No. half dozen Aluminum Lake. The 10 mg/325 mg forcefulness contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg and ten mg/325 mg strengths may besides contain corn starch.

Oxycodone, xiv-hydroxydihydrocodeinone, is a semisynthetic opioid analgesic that 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 351.82. It is derived from the opium alkaloid thebaine, and may be represented by the post-obit 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_viiiH_ixNO_two and the molecular weight is 151.17. It may be represented by the following structural formula:

3 pharmacies well-nigh 11430 accept coupons for Endocet 10/325 (Make Names:Percocet for v-325MG)

INDICATIONS

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

DOSAGE AND Assistants

Dosage should be adapted according to the severity of the hurting and the response of the patient. It may occasionally exist 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. PERCOCET tablets are given orally.

PERCOCET 2.v mg/325 mg

The usual developed dosage is 2 tablets every half dozen hours as needed for hurting. The full daily dose of acetaminophen should not exceed 4 grams.

PERCOCET 5 mg/325 mg; PERCOCET 7.five mg/325 mg; PERCOCET 10 mg/325 mg

The usual adult dosage is one tablet every vi hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Strength	Maximal Daily Dose
PERCOCET ii.5 mg/325 mg	12 Tablets
PERCOCET 5 mg/325 mg	12 Tablets
PERCOCET 7.5 mg/325 mg	8 Tablets
PERCOCET 10 mg/325 mg	half-dozen Tablets

Cessation of Therapy

In patients treated with PERCOCET tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to preclude signs and symptoms of withdrawal in the physically dependent patient.

HOW SUPPLIED

PERCOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied equally follows:

2.five mg/325 mg

Pink, oval, tablet, debossed with "PERCOCET" on one side and "ii.five" on the other.

Bottles of 100NDC 63481-627-70

5 mg/325 mg

Blueish, round, tablet, debossed with "PERCOCET" and "5" on one side and bisect on the other.

Bottles of 100NDC 63481-623-70
Bottles of 500NDC 63481-623-85

7.v mg/325 mg

Peach, oval-shaped, tablet, debossed with "PERCOCET" on one side and "vii.v/325" on the other.

Bottles of 100NDC 63481-628-70

10 mg/325 mg

Yellowish, capsule-shaped, tablet, debossed with "PERCOCET" on one side and "10/325" on the other.

Bottles of 100NDC 63481-629-70

Shop at xx° to 25°C (68° to 77°F). [Meet USP Controlled Room Temperature].

Dispense in a tight, lite-resistant container as divers in the USP, with a child-resistant closure (as required).

DEA Society Form Required.

Manufactured for: Endo Pharmaceuticals Inc. Malvern, PA 19355. Revised: August 2014

QUESTION

Medically speaking, the term "myalgia" refers to what blazon of hurting? Encounter Respond

SIDE Furnishings

Serious adverse reactions that may be associated with PERCOCET tablet employ include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock (encounter OVERDOSAGE).

The most frequently observed not-serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea, and vomiting. These furnishings seem to be more prominent in ambulatory than in nonambulatory patients, and some of these agin reactions may be alleviated if the patient lies down. Other agin 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 also been associated with acetaminophen use. In loftier doses, the most serious adverse effect is a dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic blackout 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:

Trunk as a Whole

Anaphylactoid reaction, allergic reaction, malaise, asthenia, fatigue, chest pain, fever, hypothermia, thirst, headache, increased sweating, adventitious overdose, non-accidental overdose

Cardiovascular

Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, palpitations, dysrhythmias

Fundamental and Peripheral Nervous System

Stupor, tremor, paraesthesia, hypoaesthesia, languor, seizures, anxiety, mental impairment, agitation, cognitive edema, confusion, dizziness

Fluid and Electrolyte

Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis Gastrointestinal

Dyspepsia, gustatory modality disturbances, abdominal pain, abdominal distention, sweating increased, diarrhea, dry out 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

Thrombocytop enia

Hypersensitivity

Astute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria, anaphylactoid reaction

Metabolic and Nutritional

Hypoglycemia, hyperglycemia, acidosis, alkalosis

Musculoskeletal

Myalgia, rhabdomyolysis

Ocular

Miosis, visual disturbances, red middle

Psychiatric

Drug dependence, drug abuse, indisposition, confusion, feet, agitation, depressed level of consciousness, nervousness, hallucination, somnolence, low, 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 memory

Drug Corruption And Dependence

PERCOCET tablets are a Schedule II controlled substance. Oxycodone is a mu-agonist opioid with an abuse liability similar to morphine. Oxycodone, similar morphine and other opioids used in analgesia, tin be abused and is subject to criminal diversion.

Drug addiction is defined as an aberrant, 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 impairment or hazard of harm. Drug addiction is a treatable affliction, utilizing a multi-disciplinary approach, but relapse is common. Opioid addiction is relatively rare in patients with chronic pain merely may be more common in individuals who have a past history of alcohol or substance corruption or dependence. Pseudoaddiction refers to pain relief seeking behavior of patients whose pain is poorly managed. It is considered an iatrogenic effect of ineffective hurting management. The wellness care provider must assess continuously the psychological and clinical condition of a pain patient in order to distinguish addiction from pseudoaddiction and thus, exist able to care for the pain fairly.

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. Yet, clinically pregnant physical dependence is only seen after several weeks of relatively high dosage therapy. In this case, sharp discontinuation of the opioid may event in a withdrawal syndrome. If the discontinuation of opioids is therapeutically indicated, gradual tapering of the drug over a 2-week catamenia will forestall withdrawal symptoms. The severity of the withdrawal syndrome depends primarily on the daily dosage of the opioid, the elapsing of therapy and medical condition of the private.

The withdrawal syndrome of oxycodone is similar to that of morphine. This syndrome is characterized past yawning, anxiety, increased centre rate and blood pressure, restlessness, nervousness, muscle aches, tremor, irritability, chills alternate with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea and insomnia, and pronounced weakness and low.

"Drug-seeking" beliefs is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits nearly the end of part 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 dr.(southward). "Doctor Shopping" to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physicians should exist aware that addiction may non be accompanied by concurrent tolerance and symptoms of concrete dependence in all addicts. In addition, corruption of opioids tin 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 not-medical use. Conscientious record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper cess of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit corruption of opioid drugs.

Like other opioid medications, PERCOCET tablets are bailiwick to the Federal Controlled Substances Act. After chronic use, PERCOCET tablets should not be discontinued abruptly when it is thought that the patient has become physically dependent on oxycodone.

Interactions with Alcohol and Drugs of Abuse

Oxycodone may be expected to take additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous organisation depression.

DRUG INTERACTIONS

Drug/Drug Interactions with Oxycodone

Opioid analgesics may enhance the neuromuscular-blocking action of skeletal musculus relaxants and produce an increment in the caste of respiratory depression.

Patients receiving CNS depressants such every bit 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 low. When such combined therapy is contemplated, the dose of one or both agents should exist reduced. The concurrent apply of anticholinergics with opioids may produce paralytic ileus.

Agonist/antagonist analgesics (i.due east., pentazocine, nalbuphine, naltrexone, and butorphanol) should be administered with caution to a patient who has received or is receiving a pure opioid agonist such every bit oxycodone. These agonist/antagonist analgesics may reduce the analgesic upshot 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 upshot is not significantly affected by anticholinergics.

Oral Contraceptives : Increase in glucuronidation resulting in increased plasma clearance and a decreased one-half-life of acetaminophen.

Charcoal (activated) : Reduces acetaminophen assimilation when administered every bit soon as possible afterward overdose.

Beta Blockers (Propanolol) : Propanolol 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 furnishings of the loop diuretic may be decreased because acetaminophen may decrease renal prostaglandin excretion and decrease plasma renin activeness.

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 furnishings of zidovudine may exist decreased considering of enhanced non-hepatic or renal clearance of zidovudine.

Drug/Laboratory Examination 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 gild to obtain a confirmed analytical result. The preferred confirmatory method is gas chromatography/mass spectrometry (GC/MS). Moreover, clinical considerations and professional judgment should exist applied to any drug-of-corruption examination result, particularly when preliminary positive results are used.

Acetaminophen may interfere with home blood glucose measurement systems; decreases of >xx% in hateful glucose values may be noted. This effect appears to be drug, concentration and system dependent.

WARNINGS

Misuse, Corruption 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 tin can exist 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 take chances of misuse, abuse, or diversion. Concerns near misuse, addiction, and diversion should non prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Say-so for data on how to prevent and detect corruption or diversion of this product.

Administration of PERCOCET (Oxycodone and Acetaminophen Tablets, USP) should be closely monitored for the post-obit potentially serious adverse reactions and complications:

Respiratory Depression

Respiratory depression is a take a chance with the use of oxycodone, i of the active ingredients in PERCOCET tablets, equally with all opioid agonists. Elderly and debilitated patients are at detail risk for respiratory low 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 astute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, fifty-fifty usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative not-opioid analgesics should exist considered, and opioids should be employed but under careful medical supervision at the lowest effective dose.

In case of respiratory depression, a reversal agent such as naloxone hydrochloride may exist utilized (see OVERDOSAGE).

Head Injury and Increased Intracranial Pressure

The respiratory depressant furnishings of opioids include carbon dioxide retention and secondary pinnacle 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 level. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of worsening in patients with caput injuries.

Hypotensive Effect

Oxycodone may cause severe hypotension particularly in individuals whose ability to maintain blood pressure has been compromised by a depleted claret volume, or afterwards concurrent assistants 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

Acetaminophen has been associated with cases of astute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and oftentimes involve more than one acetaminophen containing production. The excessive intake of acetaminophen may be intentional to cause self-impairment or unintentional equally patients attempt to obtain more hurting relief or unknowingly take other acetaminophen-containing products.

The risk of astute liver failure is higher in individuals with underlying liver disease and in individuals who ingest booze while taking acetaminophen.

Instruct patients to look for acetaminophen or APAP on bundle labels and not to utilise more ane product that contains acetaminophen. Instruct patients to seek medical attention immediately upon ingestion of more 4000 milligrams of acetaminophen per day, even if they feel well.

Serious skin reactions

Rarely, acetaminophen may cause serious skin reactions such as astute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (10), which can be fatal. Patients should be informed near the signs of serious skin reactions, and use of the drug should be discontinued at the first appearance of skin rash or whatever other sign of hypersensitivity.

Hypersensitivity / anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with use of acetaminophen. Clinical signs including swelling of the face, oral fissure, and pharynx, respiratory distress, urticaria, rash, pruritus, and vomiting. There were infrequent reports of life-threatening anaphylaxis requiring emergency medical attention. Instruct patients to discontinue PERCOCET immediately and seek medical care if they experience these symptoms. Do non prescribe PERCOCET for patients with acetaminophen allergy.

PRECAUTIONS

Full general

Opioid analgesics should be used with caution when combined with CNS depressant drugs, and should be reserved for cases where the benefits of opioid analgesia outweigh the known risks of respiratory depression, altered mental state, and postural hypotension.

Acute Intestinal Conditions

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

PERCOCET tablets should be given with caution to patients with CNS depression, elderly or devitalized patients, patients with severe impairment of hepatic, pulmonary, or renal role, hypothyroidism, Addison's affliction, prostatic hypertrophy, urethral stricture, astute alcoholism, delirium tremens, kyphoscoliosis with respiratory low, myxedema, and toxic psychosis.

PERCOCET tablets may obscure the diagnosis or clinical course in patients with acute intestinal conditions. Oxycodone may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Post-obit administration of PERCOCET tablets, anaphylactic reactions have been reported in patients with a known hypersensitivity to codeine, a compound with a structure similar to morphine and oxycodone. The frequency of this possible cross-sensitivity is unknown.

Interactions with Other CNS Depressants

Patients receiving other opioid analgesics, full 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 low. When such combined therapy is contemplated, the dose of i or both agents should be reduced.

Interactions with Mixed Agonist/Adversary Opioid Analgesics

Agonist/antagonist analgesics (i.due east., pentazocine, nalbuphine, and butorphanol) should exist administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such equally oxycodone. In this state of affairs, mixed agonist/antagonist analgesics may reduce the analgesic result of oxycodone and/or may precipitate withdrawal symptoms in these patients.

Ambulatory Surgery and Postoperative Use

Oxycodone and other morphine-like opioids have been shown to decrease bowel movement. Ileus is a common postoperative complication, peculiarly after intra-abdominal surgery with use of opioid analgesia. Caution should exist taken to monitor for decreased bowel motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.

Use in Pancreatic/Biliary Tract Disease

Oxycodone may cause spasm of the Sphincter of Oddi and should be used with caution in patients with biliary tract affliction, including acute pancreatitis. Opioids like oxycodone may cause increases in the serum amylase level.

Tolerance and Physical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such every bit analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms later precipitous discontinuation of a drug or upon administration of an antagonist. Concrete dependence and tolerance are non unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized past some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including: irritability, feet, backache, joint pain, weakness, abdominal cramps, indisposition, nausea, anorexia, vomiting, diarrhea, or increased claret pressure, respiratory rate, or heart rate.

In full general, opioids should not be abruptly discontinued (run into DOSAGE AND ADMINISTRATION: Cessation of Therapy).

Laboratory Tests

Although oxycodone may cross-react with some drug urine tests, no available studies were establish which determined the duration of detectability of oxycodone in urine drug screens. Yet, based on pharmacokinetic data, the approximate duration of detectability for a single dose of oxycodone is roughly estimated to exist one to two days following drug exposure.

Urine testing for opiates may be performed to determine illicit drug employ and for medical reasons such as evaluation of patients with contradistinct states of consciousness or monitoring efficacy of drug rehabilitation efforts. The preliminary identification of opiates in urine involves the use of an immunoassay screening and thin-layer chromatography (TLC). Gas chromatography/mass spectrometry (GC/MS) may be utilized every bit a 3rd-stage identification step in the medical investigational sequence for opiate testing later immunoassay and TLC. The identities of half dozen-keto opiates (e.g., oxycodone) tin can further exist differentiated past the analysis of their methoxime-trimethylsilyl (MO-TMS) derivative.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis

Animal studies to evaluate the carcinogenic potential of oxycodone and acetaminophen have non been performed.

Mutagenesis

The combination of oxycodone and acetaminophen has not been evaluated for mutagenicity. Oxycodone alone was negative in a bacterial reverse mutation assay (Ames), an in vitro chromosome aberration analysis with human lymphocytes without metabolic activation and an in vivo mouse micronucleus assay. Oxycodone was clastogenic in the homo lymphocyte chromosomal analysis in the presence of metabolic activation and in the mouse lymphoma assay with or without metabolic activation.

Fertility

Animal studies to evaluate the effects of oxycodone on fertility have non been performed.

Pregnancy

Teratogenic Effects: Pregnancy Category C

Animal reproductive studies have not been conducted with PERCOCET. Information technology is also not known whether PERCOCET can cause fetal impairment when administered to a meaning woman or tin 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 tin 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 nativity, 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 office in the newborn.

Nursing Mothers

Ordinarily, nursing should non be undertaken while a patient is receiving PERCOCET tablets considering of the possibility of sedation and/or respiratory low in the infant. Oxycodone is excreted in breast milk in low concentrations, and in that location have been rare reports of somnolence and lethargy in babies of nursing mothers taking an oxycodone/acetaminophen product. Acetaminophen is too excreted in chest milk in low concentrations.

Pediatric Use

Safety and effectiveness in pediatric patients have non 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 exist slightly reduced in this patient population when compared to younger patients.

Hepatic Impairment

In a pharmacokinetic written report of oxycodone in patients with terminate-stage liver disease, oxycodone plasma clearance decreased and the elimination half-life increased. Care should exist exercised when oxycodone is used in patients with hepatic impairment.

Renal Impairment

In a report of patients with terminate stage renal impairment, mean elimination one-half-life was prolonged in uremic patients due to increased volume of distribution and reduced clearance. Oxycodone should exist used with caution in patients with renal impairment.

Overdosage & Contraindications

OVERDOSE

Following an acute overdosage, toxicity may effect from the oxycodone or the acetaminophen.

Signs and Symptoms

Toxicity from oxycodone poisoning includes the opioid triad of: pinpoint pupils, depression of respiration, and loss of consciousness. Serious overdosage with oxycodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal book, Cheyne-Stokes respiration, cyanosis), extreme somnolence progressing to stupor or blackout, skeletal muscle flaccidity, cold and clammy pare, and sometimes bradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest, and death may occur.

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

Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may non be credible until 48 to 72 hours post-ingestion.

Treatment

A unmarried or multiple drug overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison command center is recommended. Immediate handling includes support of cardiorespiratory role and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, and other supportive measures should be employed every bit indicated. Assisted or controlled ventilation should also be considered.

Oxycodone

Master 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 confronting respiratory depression which may consequence from overdosage or unusual sensitivity to opioids, including oxycodone. Since the duration of activity of oxycodone may exceed that of the antagonist, the patient should be kept under continued surveillance, and repeated doses of the adversary should exist administered as needed to maintain adequate respiration. An opioid antagonist should non exist administered in the absenteeism of clinically significant respiratory or cardiovascular depression.

Acetaminophen

Gastric decontamination with activated charcoal should be administered just prior to N-acetylcysteine (NAC) to decrease systemic absorption if acetaminophen ingestion is known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should exist obtained immediately if the patient presents iv hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours mail-ingestion may be misleading. To obtain the best possible outcome, NAC should be administered as soon as possible where impending or evolving liver injury is suspected. Intravenous NAC may be administered when circumstances preclude oral administration.

Vigorous supportive therapy is required in severe intoxication. Procedures to limit the continuing absorption of the drug must exist readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication.

CONTRAINDICATIONS

PERCOCET tablets should not be administered to patients with known hypersensitivity to oxycodone, acetaminophen, or whatsoever other component of this product.

Oxycodone is contraindicated in any state of affairs 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.

CLINICAL PHARMACOLOGY

Key Nervous System

Oxycodone is a semisynthetic pure opioid agonist whose principal therapeutic action is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (notably ^ and chiliad) in the central nervous system for endogenous opioid-like compounds such as endorphins and enkephalins. Oxycodone produces respiratory depression through direct action at respiratory centers in the brain stem and depresses the cough reflex by direct consequence on the center of the medulla.

Acetaminophen is a not-opiate, not-salicylate analgesic and antipyretic. The site and mechanism for the analgesic effect of acetaminophen has not been determined. The antipyretic effect of acetaminophen is accomplished through the inhibition of endogenous pyrogen action on the hypothalamic heat-regulating centers.

Gastrointestinal Tract and Other Polish Musculus

Oxycodone reduces movement by increasing smooth muscle tone in the tummy and duodenum. In the pocket-sized intestine, digestion of nutrient is delayed by decreases in propulsive contractions. Other opioid effects include contraction of biliary tract smooth musculus, spasm of the Sphincter of Oddi, increased ureteral and float sphincter tone, and a reduction in uterine tone.

Cardiovascular Organization

Oxycodone may produce a release of histamine and may be associated with orthostatic hypotension, and other symptoms, such every bit pruritus, flushing, cherry-red optics, and sweating.

Pharmacokinetics

Absorption and Distribution

The mean absolute oral bioavailability of oxycodone in cancer patients was reported to be about 87%. Oxycodone has been shown to be 45% spring to man plasma proteins in vitro. The volume of distribution subsequently intravenous administration is 211.9 ±186.6 L.

Absorption of acetaminophen is rapid and almost consummate from the GI tract after oral administration. With overdosage, absorption is consummate in four hours. Acetaminophen is relatively uniformly distributed throughout most body fluids. Binding of the drug to plasma proteins is variable; only twenty% to 50% may be bound at the concentrations encountered during astute intoxication.

Metabolism and Elimination

A loftier portion of oxycodone is North-dealkylated to noroxycodone during commencement-pass metabolism. Oxymorphone, is formed by the O-demethylation of oxycodone. The metabolism of oxycodone to oxymorphone is catalyzed past CYP2D6. Free and conjugated noroxycodone, free and conjugated oxycodone, and oxymorphone are excreted in human urine following a single oral dose of oxycodone. Approximately viii% to fourteen% of the dose is excreted as complimentary oxycodone over 24 hours afterwards administration. Following a single, oral dose of oxycodone, the hateful ± SD elimination half-life is 3.51 ± 1.43 hours.

Acetaminophen is metabolized in the liver via cytochrome P450 microsomal enzyme. About 8085% of the acetaminophen in the body is conjugated principally with glucuronic acid and to a lesser extent with sulfuric acid and cysteine. Later hepatic conjugation, 90 to 100% of the drug is recovered in the urine with in the first day.

About 4% of acetaminophen is metabolized via cytochrome P450 oxidase to a toxic metabolite which is further detoxified past conjugation with glutathione, present in a fixed amount. It is believed that the toxic metabolite NAPQI (N acetyl-p-benzoquinoneimine, Northward-acetylimidoquinone) is responsible for liver necrosis. High doses of acetaminophen may deplete the glutathione stores so that inactivation of the toxic metabolite is decreased. At high doses, the capacity of metabolic pathways for conjugation with glucuronic acid and sulfuric acrid may be exceeded, resulting in increased metabolism of acetaminophen past alternate pathways.

PATIENT INFORMATION

The post-obit information should be provided to patients receiving PERCOCET tablets by their physician, nurse, pharmacist, or caregiver:

1. Do non take PERCOCET if you are allergic to any of its ingredients.
2. If you develop signs of allergy such every bit a rash or difficulty breathing stop taking PERCOCET and contact your healthcare provider immediately.
3. Practice not have more than than 4000 milligrams of acetaminophen per day. Call your doctor if you took more than the recommended dose.
4. Patients should be enlightened that PERCOCET tablets contain oxycodone, which is a morphinelike substance.
5. Patients should be instructed to keep PERCOCET tablets in a secure place out of the reach of children. In the case of adventitious ingestions, emergency medical care should be sought immediately.
6. When PERCOCET tablets are no longer needed, the unused tablets should be destroyed by flushing down the toilet.
7. Patients should be brash not to adjust the medication dose themselves. Instead, they must consult with their prescribing physician.
8. Patients should be advised that PERCOCET tablets may impair mental and/or concrete power required for the performance of potentially hazardous tasks (e.one thousand., driving, operating heavy machinery).
9. Patients should not combine PERCOCET tablets with booze, opioid analgesics, tranquilizers, sedatives, or other CNS depressants unless nether the recommendation and guidance of a medico. When co-administered with another CNS depressant, PERCOCET tablets can cause dangerous condiment central nervous system or respiratory depression, which can result in serious injury or decease.
10. The rubber utilise of PERCOCET tablets during pregnancy has non been established; thus, women who are planning to become pregnant or are pregnant should consult with their dr. earlier taking PERCOCET tablets.
11. Nursing mothers should consult with their physicians virtually whether to discontinue nursing or discontinue PERCOCET tablets because of the potential for serious adverse reactions to nursing infants.
12. Patients who are treated with PERCOCET tablets for more than a few weeks should be advised non to abruptly discontinue the medication. Patients should consult with their medico for a gradual discontinuation dose schedule to taper off the medication.
13. Patients should exist advised that PERCOCET tablets are a potential drug of corruption. They should protect it from theft, and it should never be given to anyone other than the private for whom it was prescribed.

From

Report Problems to the Nutrient and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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Source: https://www.rxlist.com/percocet-drug.htm

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