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ENDOCET
Overview
What is ENDOCET?
Oxycodone Hydrochloride and Acetaminophen is available in tablets for oral administration.
Each tablet for oral administration, contains oxycodone hydrochloride and acetaminophen in the following strengths:
Oxycodone Hydrochloride, USP 2.5 mg* (*2.5 mg oxycodone hydrochloride is equivalent to 2.2409 mg of oxycodone.) Acetaminophen, USP 325 mg
Oxycodone Hydrochloride, USP 5 mg* (*5 mg oxycodone hydrochloride is equivalent to 4.4815 mg of oxycodone.) Acetaminophen, USP 325 mg
Oxycodone Hydrochloride, USP 7.5 mg* (*7.5 mg oxycodone hydrochloride is equivalent to 6.7228 mg of oxycodone.) Acetaminophen, USP 325 mg
Oxycodone Hydrochloride, USP 10 mg* (*10 mg oxycodone hydrochloride is equivalent to 8.9637 mg of oxycodone.) Acetaminophen, USP 325 mg
All strengths of ENDOCET also contain the following inactive ingredients: Colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, povidone, pregelatinized cornstarch, and stearic acid. May also contain crospovidone. In addition, the 2.5 mg/325 mg strength contains FD&C Red No. 40 Aluminum Lake. The 7.5 mg/325 mg strength contains FD&C Yellow No. 6 Aluminum Lake. The 10 mg/325 mg strength contains D&C Yellow No. 10 Aluminum Lake. The 7.5 mg/325 mg strength and the 10 mg/325 mg strength may also contain corn starch.
Oxycodone Hydrochloride and Acetaminophen Tablets contain oxycodone, 14- hydroxydihydrocodeinone, a semisynthetic opioid analgesic which occurs as a white to off-white fine crystalline powder. The molecular formula for oxycodone hydrochloride is CHNO∙ HCl and the molecular weight is 351.82. It is derived from the opium alkaloid, thebaine, and may be represented by the following structural formula:
Oxycodone Hydrochloride and Acetaminophen Tablets contain acetaminophen, 4'-hydroxyacetanilide, is a non-opiate, non-salicylate analgesic and antipyretic which occurs as a white, odorless, crystalline powder. The molecular formula for acetaminophen is CHNO and the molecular weight is 151.16. It may be represented by the following structural formula:
What does ENDOCET look like?
What are the available doses of ENDOCET?
Sorry No records found.
What should I talk to my health care provider before I take ENDOCET?
Sorry No records found
How should I use ENDOCET?
ENDOCET is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Limitations of Use
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see ].
Initiate the dosing regimen for each patient individually, taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see ].
Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy and following dosage increases with ENDOCET and adjust the dosage accordingly [see ].
What interacts with ENDOCET?
Sorry No Records found
What are the warnings of ENDOCET?
Sorry No Records found
What are the precautions of ENDOCET?
Sorry No Records found
What are the side effects of ENDOCET?
Sorry No records found
What should I look out for while using ENDOCET?
ENDOCET is contraindicated in patients with:
What might happen if I take too much ENDOCET?
Following an acute overdosage, toxicity may result from the oxycodone or the acetaminophen.
Clinical Presentation
Acute overdosage with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations.
Acetaminophen
Dose-dependent potentially fatal hepatic necrosis is the most serious adverse effect of acetaminophen overdosage. 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 not be apparent until 48 to 72 hours post-ingestion.
Treatment of Overdose
Oxycodone
In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support techniques.
The opioid antagonists, naloxone or nalmefene, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to oxycodone overdose, administer an opioid antagonist. Opioid antagonists should not be administered in the absence of clinically significant respiratory or circulatory depression secondary to oxycodone overdose.
Because the duration of opioid reversal is expected to be less than the duration of action of oxycodone in ENDOCET, carefully monitor the patient until spontaneous respiration is reliably reestablished. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information.
In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be initiated with care and by titration with smaller than usual doses of the antagonist.
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 be obtained immediately if the patient presents 4 hours or more after ingestion to assess potential risk of hepatotoxicity; acetaminophen levels drawn less than 4 hours post-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 be readily performed since the hepatic injury is dose dependent and occurs early in the course of intoxication
How should I store and handle ENDOCET?
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed (protect from moisture). Protect from light.ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:2.5 mg/325 mg Pink, oval, tablet, debossed with “E701” on one side and “2.5” on the other. Bottles of 100 NDC 60951-701-705 mg/325 mg White, round, tablet, with one face scored and the other inscribed "Endo" and "602". Bottles of 100 NDC 60951-602-70 Bottles of 500 NDC 60951-602-85 7.5 mg/325 mg Peach, oval-shaped, tablet, debossed with “ E700” on one side and “7.5/325” on the other. Bottles of 100 NDC 60951-700-70 10 mg/325 mg Yellow, capsule-shaped, tablet, debossed with “E712” on one side and “10/325” on the other. Bottles of 100 NDC 60951-712-70 StorageStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP.DEA Order Form Required.Distributed by: Chestnut Ridge, NY 10977ENDOCET is a registered trademark of Endo Pharmaceuticals Inc.© 2017 Endo Pharmaceuticals Inc. All rights reserved.Printed in U.S.A.8183403 R8Revised: 3/17
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Oxycodone is a full opioid agonist with relative selectivity for the mu-opioid receptor, although it can interact with other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with oxycodone. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions, including respiratory and CNS depression.
The precise mechanism of the analgesic action is unknown. However, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.
The precise mechanism of the analgesic properties of acetaminophen is not established but is thought to involve central actions.
Non-Clinical Toxicology
ENDOCET is contraindicated in patients with:After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see ], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to ENDOCET.
If concomitant use is necessary, consider dosage reduction of ENDOCET until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider increasing the ENDOCET dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal.
After stopping a CYP3A4 inducer, as the effects of the inducer decline, the oxycodone plasma concentration will increase [see ], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression.
If concomitant use is necessary, consider increasing the ENDOCET dosage until stable drug effects are achieved. Monitor for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider ENDOCET dosage reduction and monitor for signs of respiratory depression.
Benzodiazepines and Other CNS Depressants
Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation [see ].
If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue ENDOCET if serotonin syndrome is suspected.
The use of ENDOCET is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.
If urgent use of an opioid is necessary, use test doses and frequent titration of small doses to treat pain while closely monitoring blood pressure and signs and symptoms of CNS and respiratory depression.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics
Advise patient to avoid concomitant use of these drugs.
Muscle Relaxants
If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of ENDOCET and/or the muscle relaxant as necessary.
Diuretics
If concomitant use is warranted, monitor patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
Anticholinergic Drugs
If concomitant use is warranted, monitor patients for signs of urinary retention or reduced gastric motility when ENDOCET is used concomitantly with anticholinergic drugs.
Alcohol, ethyl
Oral Contraceptives
Charcoal (activated)
Beta Blockers (Propranolol)
Loop Diuretics
Lamotrigine
Probenecid
Zidovudine
Advise the patient to read the FDA-approved patient labeling ().
Addiction, Abuse, and Misuse
Life-Threatening Respiratory Depression
Accidental Ingestion
Interactions with Benzodiazepines and Other CNS Depressants
,
Serotonin Syndrome
Monoamine Oxidase Inhibitor (MAOI) Interaction
Adrenal Insufficiency
Important Administration Instructions
,
Advise patients not to adjust the medication dose themselves and to consult with their healthcare provider prior to any dosage adjustment.
Advise patients who are treated with ENDOCET for more than a few weeks not to abruptly discontinue the medication. Advise patients to consult with their physician for a gradual discontinuation dose schedule to taper off the medication.
Maximum Daily Dose of Acetaminophen
Hypotension
Anaphylaxis
,
.
Pregnancy
Neonatal Opioid Withdrawal Syndrome
,
Embryo-Fetal Toxicity
Lactation
Infertility
.
Driving or Operating Heavy Machinery
Constipation
,
Disposal of Unused ENDOCET
The following adverse reactions have been identified during post approval use of ENDOCET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Serious adverse reactions that may be associated with oxycodone and acetaminophen use include respiratory depression, apnea, respiratory arrest, circulatory depression, hypotension, and shock [see ].
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 oxycodone and acetaminophen are listed by organ system and in decreasing order of severity and/or frequency as follows:
Body as a Whole:
Cardiovascular:
Central and Peripheral Nervous System:
Fluid and Electrolyte:
Gastrointestinal:
Hepatic:
Hearing and Vestibular:
Hematologic:
Hypersensitivity:
Metabolic and Nutritional:
Musculoskeletal:
Ocular:
Psychiatric:
Respiratory System:
Skin and Appendages:
Urogenital:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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