Percocet

Common name: oxycodone hydrochloride and acetaminophen
dosage form: tablets Percocet ? (Oxycodone and acetaminophen tablets, the USP) The CII the RX only

Percocet description

Each tablet for oral administration, comprises oxycodone hydrochloride and acetaminophen in the following advantages:

1. Oxycodone hydrochloride, USP 2.5 mg *
   Acetaminophen, USP 325 mg
   * 2.5 mg oxycodone HCl is equivalent to 2.2409 mg of oxycodone.
2. Oxycodone hydrochloride, USP 5 mg *
   Acetaminophen, USP 325 mg
   * 5 mg oxycodone HCl is equivalent to 4.4815 mg of oxycodone.
3. Oxycodone hydrochloride, USP 7.5 mg *
   Acetaminophen, USP 325 mg
   * 7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
4. Oxycodone hydrochloride, USP 7.5 mg *
   Acetaminophen, USP 500 mg
   * 7.5 mg oxycodone HCl is equivalent to 6.7228 mg of oxycodone.
5. Oxycodone hydrochloride, USP 10 mg *
   Acetaminophen, USP 325 mg
   * 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.
6. Oxycodone hydrochloride, USP 10 mg *
   Acetaminophen, USP 650 mg
   * 10 mg oxycodone HCl is equivalent to 8.9637 mg of oxycodone.

All strong Percocet also contain the following inactive ingredients: colloidal silicon dioxide, sodium croscarmellose, crospovidone, microcrystalline cellulose, povidone, pregelatinized corn starch, and stearic acid. Moreover force of 2.5 mg / 325 mg contains FD & c Red? 40 aluminum lake and the strength of 5 mg / 325 mg and contains FD blue lake. Aluminum? 1 C. 7,5 mg / 325 mg and 7.5 mg / 500 mg strengths contain FD & c yellow? 6 aluminum lake. 10 mg / 325 mg and strengths of 10 mg / 650 mg contain d & c yellow? 10 Aluminum Lake.

Oxycodone, 14-hydroxydihydrocodeinone, a semi-synthetic opioid analgesic that occurs as a white, odorless, crystalline powder with saline, bitter taste. The molecular formula for oxycodone hydrochloride? C18H21NO4? HCl and a molecular weight of 351.83. It is derived from the opium alkaloid thebaine and the following structural formula may be represented by:

Acetaminophen, 4′-hydroxyacetanilide, is-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder, having a bitter taste. Molecular Formula C8H9NO2 for acetaminophen and a molecular weight of 151.17. He following structural formula may be represented by:

Percocet – Clinical Pharmacology

Central Nervous System

Oxycodone is a semi-synthetic opioid agonist purely therapeutic action which the core is analgesia. Other pharmacological effects of oxycodone include anxiolysis, euphoria and feelings of relaxation. These effects are mediated by receptors (? And?) In the central nervous system as the endogenous opioid compounds, such as endorphins and enkephalins. Oxycodone produces respiratory through direct activity on the respiratory centers of the brain stem and depresses the cough reflex by direct effect on the center of the bone marrow.

Acetaminophen? non-opiate, non-salicylate analgesic and antipyretic. Site and mechanism for the analgesic effect of acetaminophen has not been determined. Acetaminophen inflammatory effect through inhibition of endogenous pyrogen acts on hypothalamic heat-regulating center.

Gastrointestinal tract and other smooth muscle

Oxycodone reduces mobility by increasing the tone of smooth muscles of the stomach and duodenum. In the small intestine digestion is delayed decrease in propulsive contractions. Other opioid effects include reduction of the biliary tract smooth muscle spasm of the sphincter of Oddi, increased ureteral and bladder sphincter tone and reducing the tone of the uterus.

Of cardio-vascular system

Oxycodone can cause the release of histamine and may be associated with orthostatic hypotension and other symptoms, such as itching, flushing, red eyes and sweating.

Pharmacokinetics

Absorption and Distribution

The mean absolute oral bioavailability of oxycodone in patients with cancer has been, reported to be about 87%. Oxycodone has been shown in 45% bound to protein in vitro in human plasma. The volume of distribution after intravenous administration of 211.9? 186.6 liters.

Absorption of acetaminophen is rapidly and almost completely from the GI tract after oral administration. Since overdosage absorption over a 4 hour. Acetaminophen is relatively uniformly distributed in most body fluids. Binding of drug to plasma proteins is variable; Only 20% to 50% can be connected at the concentrations encountered during acute intoxication.

Metabolism and Elimination

High part n dealkylated noroxycodone oxycodone during the first pass metabolism. Oxymorphone, oxycodone formed o demethylation. The metabolism of oxycodone oxymorphone catalyzes CYP2D6. Free and conjugated noroxycodone, free and conjugated oxycodone and oxymorphone from the human urine following a single oral dose of oxycodone. About 8% to 14% of the dose is excreted as free oxycodone over 24 hours after administration. After a single, oral dose of oxycodone half-life mean? SD-3,51? 1.43 hours.

Acetaminophen is metabolized in liver microsomal cytochrome P450 enzyme system through. Approximately 80-85% of acetaminophen in the body expressed mainly with glucuronic acid and to a lesser extent with sulfuric acid and cysteine. After conjugation liver 90-100% of the drug recovered in the urine with the first day.

About 4% of acetaminophen is metabolized through the cytochrome P450 oxidase for toxic metabolites, which further detoxified conjugation with glutathione present in a fixed amount. It is believed that toxic metabolites NAPQI (N acetyl p-benzoquinoneimine, N-acetylimidoquinone) responsible for hepatic necrosis. High doses of acetaminophen may deplete glutathione stores that decreases the inactivation of toxic metabolites. In larger doses it may exceed capacity of the metabolic pathways for conjugation with glucuronic acid and sulfuric acid, resulting in increased metabolism of acetaminophen alternative ways.

Indications and Usage for Percocet

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 the product.

Oxycodone is contraindicated in any situation where opioids are contraindicated in patients with significant respiratory (in unmonitored settings or the absence of resuscitative equipment), and patients with acute or severe bronchial asthma or hypercarbia. Oxycodone is contraindicated in suspected or known establishment paralytic ileus.

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 abuse, addiction, and diversion should not prevent the proper management of pain.

Healthcare professionals should contact their State Professional Licensing Board for information or State Controlled Substances Authority on how to prevent and detect abuse or diversion of this product.

The administration of Percocet (oxycodone and acetaminophen tablets, USP) tablets should be closely monitored following potentially serious adverse reactions and complications:

breath

Respiratory depression is the danger using oxycodone, one of the active ingredients in Percocet tablets, as with all opioid agonists. Elderly and debilitated patients are particularly at risk for breathing, are not tolerant patients given large initial doses of oxycodone or oxycodone when 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), cor pulmonale, or pre-existing respiratory disorders. In such patients, even usual therapeutic dose of oxycodone may decrease respiratory drive to the point apnea. In these patients alternative non-opioid analgesics and opioids should be considered should be used only under careful medical supervision at the lowest effective dose.

In the event of respiration, can be used reversal agents such as naloxone hydrochloride (see.OVERDOSAGE ).

Head Injury and Increased Intracranial Pressure

Respiratory depressant effects of opioids include carbon dioxide retention and secondary elevation of cerebrospinal fluid pressure and can greatly exaggerated for head injury, other intracranial lesions or increase in intracranial pressure that existed previously. Oxycodone produces effects on pupillary response and consciousness which may obscure neurologic signs of deterioration in patients with head injuries.

hypotensive effect

Oxycodone may cause severe hypotension especially people whose ability to maintain blood pressure has been compromised depleted blood volume, or after concurrent administration with drugs that compromise vasomotor tone such as phenothiazines. Oxycodone as all the opioid analgesics of the morphine type, must be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce blood pressure and cardiac output. Oxycodone may produce orthostatic hypotension in ambulatory patients.

hepatotoxity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most cases of liver injury are associated with the use of acetaminophen in doses that exceed 4000 mg per day, and often involve more than one acetaminophen containing product. Overuse of acetaminophen may be intentional consumption cause harm or unintentional as patients try to get more pain or unconsciously take other acetaminophen-containing products.

The risk of acute liver failure is higher in people with underlying liver disease and those who ingest alcohol while taking acetaminophen.

Allow patients to seek acetaminophen or APAP package labels and do not use more than one product containing acetaminophen. Instruct patients to seek medical care immediately after ingestion of more than 4000 mg of acetaminophen per day, even if they feel well.

Hypersensitivity / anaphylaxis

There have been post-marketing reports of hypersensitivity and anaphylaxis associated with the use of acetaminophen. Clinical signs, swelling of the face, mouth and throat, respiratory distress, urticaria, rash, itching and vomiting. Rarely reported life-threatening anaphylaxis requiring emergency medical care. Instruct patients to immediately stop Percocet and seek medical care if they experience these symptoms. It does not prescribe Percocet for patients with acetaminophen allergy.

Precautionary measures

Are common

Opioid analgesics should be used with caution in combination 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 Abdominal Conditions

Management 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 debilitated patients, in patients with severe liver damage, pulmonary or renal function, hypothyroidism, Addison’s disease, prostatic hypertrophy, urethral stricture, acute alcoholism, delirium, kyphoscoliosis with respiratory depression, myxedema and toxic psychosis.

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

Following administration of Percocet tablets anaphylactic reactions in patients with known hypersensitivity to codeine were recorded, with a compound of structure similar to that of morphine and oxycodone. The frequency of possible cross sensitivity is unknown.

Interactions with other CNS depressants

Patients receiving other opioid analgesics, general anesthetics, phenothiazines, tranquilizers, anti-emetics centralized action, sedative-hypnotics, or other CNS depressants (including alcohol) concomitantly with Percocet tablets may exhibit an additive CNS depression. When such combined therapy, the dose should be reduced to one or both agents.

Interaction with mixed agonist / antagonist opioids

Agonist / antagonist analgesics (ie, pentazocine, nalbuphine, and butorphanol) should be administered with caution to a patient who has received or is receiving a course of therapy with a pure opioid agonist analgesic such as oxycodone. In this situation, mixed agonist / antagonist analgesics may reduce the analgesic effect of oxycodone and / or may precipitate withdrawal symptoms in these patients.

Outpatient surgery and post-operative use

Oxycodone and other opioids morphine as a decrease in intestinal motility has been shown. Ileus is a common postoperative complication, particularly after intra-abdominal surgery with opioid analgesia. Care should be taken to monitor the reduction of intestinal motility in postoperative patients receiving opioids. Standard supportive therapy should be implemented.

Use in Pancreatic / biliary tract

Oxycodone may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. Opioids such as oxycodone can lead to increased serum levels of amylase.

Tolerance and physical dependence

Tolerance is the need to increase doses of opioid to maintain certain effects, such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of the drug or after administration of the antagonist. Physical dependence and tolerance are not unusual during chronic opioid therapy.

The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, sweating, chills, myalgia, and mydriasis. Other symptoms may also develop, including :, irritability, anxiety, back pain, joint pains, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, or diarrhea, high blood pressure, respiratory rate or heart rhythm.

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

Information for Patients / Caregivers

The following information should be provided to patients receiving tablets Percocet their doctor, nurse, pharmacist or caregiver:

1. Do not take Percocet , if you are allergic to any of its ingredients.
2. If you develop signs of allergy rash or difficulty breathing stop taking Percocet and call your healthcare provider.
3. Do not take more than 4000 mg of acetaminophen per day. Call your doctor if you took more than the recommended dose.
4. Patients should be aware that Percocet tablets contain oxycodone, which is a morphine-like substance.
5. Patients should be instructed to keep Percocet tablets in a safe place out of the reach of children. Among the random ingestions emergency medical care should be sought immediately.
6. When Percocet pills is no longer needed, the unused tablets should be destroyed by flushing down the toilet.
7. Patients should be advised not to adjust the medication dose themselves. Instead, they should consult with their prescribing physician.
8. Patients should be advised Percocet pills can adversely affect the mental or physical abilities required for the performance of potentially dangerous tasks (eg, traffic, heavy machinery operation).
9. Patients should not combine Percocet pills with alcohol, opioid analgesics, tranquilizers, sedatives, or other CNS depressants if, according to the recommendations and advice of a doctor. When the mode with other CNS depressants, Percocet tablets can cause dangerous additive central nervous system or respiratory depression which can result in serious injury or death.
10. Safe use of tablets Percocet during pregnancy has not been established; Thus, women who plan to become pregnant or are pregnant should consult their doctor before taking the tablets Percocet .
11. Nursing mothers should consult with their physicians about whether to discontinue nursing or to discontinue Percocet tablets because of the potential for serious adverse reactions on infants.
12. Patients who were treated with tablets Percocet more than a few weeks should be advised not to abruptly discontinue the drug. Patients should consult with their doctor to schedule phasing taper the dose of medication.
13. Patients should be advised Percocet tablets are potential drug. They should be protected from theft, and it will never be given to anyone other than the person for whom it is prescribed.

laboratory tests

Although oxycodone may cross-react with certain drugs urine, available studies have not been found, which is determined by the duration of detectability of oxycodone in urine drug screens. However, based on pharmacokinetic data, the approximate duration of detectability for a single oxycodone estimates about one to two days after exposure to the drug.

Urine testing for opiates may be conducted to determine the illegal use of drugs and for medical reasons, such as the evaluation of patients with altered consciousness or monitoring the effectiveness of recovery efforts. Preliminary determination of opiates in urine screening involves the use of immunoassay and thin layer chromatography (TLC). Gas chromatography / mass spectrometry (GC / MS) can be used as the third stage of the identification step in medical research in this sequence for testing after opiate immunoassay and TLC. Further identities Keto 6 opiates (e.g., oxycodone) can be distinguished by analysis of their trimethylsilyl derivative methoxime (MO-TMS).

Drug / interactions with oxycodone

Opioid analgesics may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Patients receiving CNS depressants like other opioid analgesics, general anesthetics, phenothiazines, 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, the dose should be reduced to one or both agents. Joint use of anticholinergics with opioids may produce paralytic ileus.

Agonist / antagonist analgesics (ie, pentazocine, nalbuphine, naltrexone and butorphanol) should be administered with caution to a patient who has received or receives pure opioid agonist, such as oxycodone. These agonist / antagonist analgesics may reduce the analgesic effect of oxycodone or may precipitate withdrawal symptoms.

Drug / interactions with acetaminophen

Alcohol, ethyl: in chronic alcoholics after different dose levels (moderate to extreme) acetaminophen hepatotoxicity has occurred.

Anticholinergics: Start acetaminophen effect may be delayed or dropped slightly, but the final pharmacological effect is not affected anticholinergics.

Oral contraceptives: Increase glucuronidation, resulting in increased and decreased plasma clearance half-life of acetaminophen.

Charcoal (activated): reduces the absorption of acetaminophen when as soon as possible after the overdose.

Beta blockers (Propanolol): Propanolol, appears to inhibit the enzyme systems responsible for the oxidation and glucuronidation of acetaminophen. Thus it can be increased pharmacologic effects of acetaminophen.

loop diuretics: loop diuretic effects can be reduced because acetaminophen may reduce renal excretion and prostaglandin decrease in plasma renin activity.

Lamotrigine: lamotrigine serum concentrations may be reduced, reducing produce a therapeutic effect.

Probenecid: probenecid may increase the therapeutic efficacy of acetaminophen slightly.

Zidovudine: Pharmacological effects of zidovudine can be reduced due to expansion of hepatic or renal clearance of zidovudine.

Drug / Laboratory Test Interactions

Depending on the specificity and sensitivity of the test methodology individual components Percocet (oxycodone and acetaminophen tablets, USP) may cross-react with the definitions used in the preliminary detection of cocaine (primary urinary metabolite, benzilekgoin) or marijuana (cannabis) in human urine. More specific alternative chemical method must be used to obtain a confirmed analytical result. Confirmatory preferred method is gas chromatography / mass spectrometry (GC / MS). Further clinical considerations and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.

Acetaminophen may interfere with home blood glucose measuring systems; reduced by> 20% in the mean glucose values ​​should be noted. It appears that this effect drug concentrations and depends on the system.

Carcinogenesis, mutagenesis, impairment of fertility

carcinogenesis

Studies in animals to evaluate the carcinogenic potential of oxycodone and acetaminophen have not been performed.

mutagenesis

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

fertility

Animal studies to evaluate the effects of oxycodone on fertility have not been performed.

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 if the opinion of the physician, the potential benefits outweigh the possible hazards

Nonteratogenic effects

Opioids can cross the placental barrier and can cause breathing infants. Opioid use during pregnancy can cause fetal physically addicts. After the birth of the newborn 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 because of its potential impact on neonatal respiratory function.

nursing mothers

Usually the nurses were not carried out while the 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 rare reports of somnolence and lethargy children lactating mothers taking 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 precautions should be made when determining the dosage level and frequency of Percocet tablets for elderly patients after clearing Oxycodone may be slightly reduced in this patient population compared to younger patients.

hepatic impairment

In Oxycodone Pharmacokinetic studies in patients with end-stage liver disease, oxycodone decreased plasma clearance and half-life increased. Care should be taken when oxycodone is used in patients with hepatic impairment.

renal impairment

In a study of patients with end-stage renal impairment average half-life and clearance are disabled has been extended in uremic patients by increasing the proliferation capacity. Oxycodone should be used with caution in patients with renal impairment.

Adverse reactions

Serious adverse reactions that could be associated with the use of tablet Percocet include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension and shock (see.OVERDOSAGE ).

Frequently observed no serious adverse reactions include lightheadedness, dizziness, drowsiness or sedation, nausea and vomiting. These effects appear to be more prominent in ambulatory than nonambulatory patients, and some of these adverse reactions may be alleviated if the patient lies. Other adverse reactions include euphoria, dysphoria, constipation and itching.

Hypersensitivity reactions may include: skin eruption, urticarial, erythematous skin reactions. Hematologic reactions may include: anemia, neutropenia, pancytopenia, hemolytic anemia. Rare cases of agranulocytosis has also been associated with the use of acetaminophen. In high doses, the most serious adverse effect is dose-dependent, potentially fatal hepatic necrosis. Renal tubular necrosis and hypoglycemic coma may occur.

Other adverse reactions resulting from postmarketing experience with Percocet tablets organ system listed 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, not accidental overdose

Of cardio-vascular system

Hypotension, hypertension, tachycardia, orthostatic hypotension, bradycardia, heart rate, dysrhythmias

Central and peripheral nervous system

Stupor, tremor, paraesthesia, hypoaesthesia, lethargy, convulsions, anxiety, mental disabilities, agitation, cerebral edema, confusion, dizziness,

Fluids and electrolytes

Dehydration, of hyperkalemia, metabolic acidosis, respiratory alkalosis

Gastrointestinal

Indigestion, taste disturbance, stomach pain, bloating, sweating increased, diarrhea, dry mouth, flatulence, gastrointestinal disorders, nausea, vomiting, pancreatitis, intestinal obstruction, ileus

liver

Transient elevation of liver enzymes, increased bilirubin, hepatitis, liver failure, jaundice, hepatotoxicity, liver disorders

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

Eyepiece

Cramps, visual disturbances, red-eye reduction

Mental health

Drug dependence, drug abuse, insomnia, confusion, anxiety, agitation, depressed level of consciousness, nervousness, hallucinations, drowsiness, 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

Drug Abuse and Dependence

Percocet tablets are regulated substance in list II. Oxycodone is an opioid mu-agonist with an abuse liability similar to morphine. Oxycodone, morphine and other opioids used in anesthesia, can be abused and subject to criminal diversion.

Addiction is defined as abnormal, compulsive use, use for non-medical purposes substance despite physical, psychological, occupational, or interpersonal difficulties arising from such use, and continued use despite harm or risk of harm. Addiction? is a treatable disease, using a multi-disciplinary approach, but relapse is common. Opioid dependence is relatively rare in patients with chronic pain, but it may be more common in people who have a past history of alcohol or abuse or dependence. Pseudoaddiction refers to pain in the search behavior of patients whose pain mismanagement. This is considered an iatrogenic effect of ineffective pain management. Your doctor needs to assess continually the psychological and clinical status of the patient’s pain, in order to distinguish dependency pseudoaddiction and thus be able to adequately treat pain.

Physical dependence on prescribed medication does not mean dependence. Physical dependence involves the appearance of a withdrawal syndrome in the case of a sudden reduction or cessation of drug use or if administered opiate antagonist. Physical dependence can be detected after a few days of opioid therapy. However, clinically significant physical dependence is only considered after several weeks of therapy, a relatively high dosage. In this case, abrupt discontinuation of opioid may lead to a withdrawal syndrome. If the cessation of opioids therapeutically indicated, gradually form of the drug for 2 weeks allows withdrawal. The severity of the withdrawal syndrome depends primarily on the daily dose of opioids, duration of therapy and medical status of the person.

Oxycodone Withdrawal syndrome is similar to that of morphine. This syndrome is characterized by yawning, anxiety, increased heart rate and blood pressure, anxiety, nervousness, muscle pain, tremors, irritability, chills, alternating with hot flashes, salivation, anorexia, severe sneezing, lacrimation, rhinorrhea, dilated pupils, diaphoresis, piloerection, nausea, vomiting, abdominal cramps, diarrhea, and insomnia and pronounced weakness and depression.

“Drug-seeking ‘behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated? Loss? prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician (s). ? Commercial Doctor? to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and independent of physical dependence and tolerance. Physicians should be aware that addiction may not be accompanied by concurrent tolerance and symptoms of physical dependence in all addicts. In addition, abuse of opioids can occur in the absence of true addiction and is characterized by the use for non-medical purposes, often in combination with other drugs. Oxycodone, like other opioids, used for non-medical use. Careful management of prescribing information, including the number of requests, frequency, and renewal is strongly recommended.

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

Like other opioids Percocet tablets may be the federal Controlled Substances Act. After chronic use of Percocet tablets should not be discontinued suddenly, when they thought that the patient is physically dependent on oxycodone.

Interaction with alcohol and drug abuse

That is expected to oxycodone may have additive effects when used in conjunction with alcohol, other opioids, or illicit drugs that cause central nervous system depression.

Overdosage

After acute overdosage toxicity may result oxycodone or acetaminophen.

Signs and symptoms

Toxicity from oxycodone poisoning includes the opioid triad: identify students, respiratory depression, and loss of consciousness. 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, skin cold and clammy, and sometimes bradycardia and hypotension. In severe overdosage may occur apnea, circulatory collapse, cardiac arrest and death.

In acetaminophen overdosage: dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect. Also there is renal tubular necrosis, hypoglycemic coma and coagulation defects.

After potentially hepatotoxic overdose symptoms 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

One or more of overdose with oxycodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support for measures to reduce drug absorption and cardiorespiratory function. Oxygen, intravenous fluids, vasopressors and other supportive measures should be employed as indicated. Consideration should also be assisted or controlled ventilation.

oxycodone

Primary attention should be given to the reestablishment of adequate respiratory exchange through provision of a patent airway and institution of assisted or controlled ventilation. Naloxone hydrochloride opioid antagonist is a specific antidote against respiratory depression which may result from overdosage or unusual sensitivity to opioids, including oxycodone. Since the duration of action of oxycodone may exceed the antagonist, the patient must be under constant observation and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Opioid antagonists should not be administered in the absence of clinically significant respiratory or cardiovascular depression.

Acetaminophen

Gastric decontamination with activated carbon should be limited to N-acetylcysteine ​​(NAC) reduce systemic absorption if acetaminophen ingestion known or suspected to have occurred within a few hours of presentation. Serum acetaminophen levels should be obtained immediately if the patient is 4 hours or more after ingestion to evaluate the potential risk of hepatotoxicity; acetaminophen levels drawn at least 4 hours post-ingestion which may be misleading. To obtain the best possible results, NAC should be administered as soon as possible imminent or developing liver injury is suspected. Intravenous NAC may be administered when circumstances do not allow oral administration.

Active support of therapy is required in severe intoxication. The procedures limit the continued absorption of the drug is easily performed since the liver injury is dose dependent and occurs early in the course of intoxication.

Dosage Percocet and management

The dosage should be adjusted according to the severity of the pain and the patient’s response. Sometimes it may be necessary to go beyond the usual dosage recommended below in the case of more severe pain or in those patients who have become tolerant of the analgesic effect of opioids. If the pain is constant, an opioid analgesic should be done on a regular basis around the clock schedule. Percocet tablets given orally.

Percocet 2.5 mg / 325 mg
usual adult dose? One or two tablets every 6 hours. The total daily dose of acetaminophen should not exceed 4 grams.

Percocet 5 mg / 325 mg; Percocet 7.5 mg / 500 mg; Percocet 10 mg / 650 mg
usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Percocet 7.5 mg / 325 mg; Percocet 10 mg / 325 mg
usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.

Force	The maximum 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

Discontinuation of therapy

In patients treated with Percocet tablets more than a few weeks longer in need of therapy should be tapered gradually doses to prevent signs and symptoms of withdrawal in physically dependent patients.

How it Percocet comes

Percocet (oxycodone and acetaminophen tablets, USP) is supplied as follows:

2.5 mg / 325 mg
Pink, oval tablet debossed with? Percocet ? on the one hand and? 2.5? with another.
Bottles of 100 NDC 63481-627-70

5 mg / 325 mg
Blue round tablet, debossed with? Percocet ? and? 5? on one side and the other regional.
100 NDC 63481-623-70 Bottles
Bottles 500 NDC 63481-623-85
Unit dose package of 100 tablets NDC 63481-623-75

7.5 mg / 325 mg
Peach, oval tablet debossed with? Percocet ? on the one hand and? 7.5 / 325? with another.
Bottles of 100 NDC 63481-628-70

7.5 mg / 500 mg
tablet is capsule-shaped, peach, debossed with? Percocet ? on the one hand and? 7.5? with another.
Bottles of 100 NDC 63481-621-70

10 mg / 325 mg of
yellow, capsule-shaped, debossed tablet? Percocet ? on the one hand and? 10/325? with another.
Bottles of 100 NDC 63481-629-70

10 mg / 650 mg
Yellow, oval tablet debossed with? Percocet ? on the one hand and? 10? with another.
Bottles of 100 NDC 63481-622-70