Oxecta

Name: Oxecta

Oxecta Overview

Oxycodone is a prescription medication used to treat moderate to severe pain. This medication belongs to a group of drugs called opioids which work by stopping pain signals made in the brain.

Oxycodone comes in several forms including tablets, capsules, oral solution (liquid) and extended-release tablets. It is also found in combination with other medications such as acetaminophen, ibuprofen, and aspirin.

Common side effects of oxycodone include constipation, nausea, drowsiness, and dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Oxecta Drug Class

Oxecta is part of the drug class:

  • Natural opium alkaloids

Oxecta Interactions

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Be especially careful about taking other medicines that make you sleepy such as:

  • pain medicines
  • sleeping pills
  • anxiety medicines
  • antihistamines
  • anti-depressants
  • tranquilizers
  • anti-nausea medicine
  • alcohol

This is not a complete list of oxycodone drug interactions. Ask your doctor or pharmacist for more information.

Oxecta and Lactation

Oxycodone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from oxycodone, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

 

Warnings and Precautions

Respiratory Depression

Respiratory depression is the primary risk of Oxecta. Respiratory depression occurs more frequently in elderly or debilitated patients, in those suffering from conditions accompanied by hypoxia, hypercapnia, or upper airway obstruction, or following large initial doses of opioids given to non-tolerant patients, or when opioids are given in conjunction with other agents that depress respiration (e.g., benzodiazepines, tricyclic antidepressants, and sedative-hypnotics).

Oxecta must be used with extreme caution in patients with chronic obstructive pulmonary disease or cor pulmonale, and in patients having substantially decreased respiratory reserve (e.g., severe kyphoscoliosis), hypoxia, hypercapnia, or pre-existing respiratory depression. In such patients, even usual therapeutic doses of Oxecta may decrease respiratory drive to the point of apnea. In these patients, alternative non-opioid analgesics should be considered, and opioids must be employed only under careful medical supervision at the lowest effective dose.

Misuse and Abuse of Opioids 

Oxecta contains oxycodone HCl, an opioid agonist and a Schedule II controlled substance. Such drugs are sought by drug abusers and people with addiction disorders.

Oxecta can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing oxycodone HCl in situations where the physician or pharmacist is concerned about an increased risk of misuse or abuse.

Oxecta may be abused by crushing, chewing, snorting or injecting the product. These practices pose a significant risk to the abuser that could result in overdose and death [see DRUG ABUSE AND DEPENDENCE (9)].

Concerns about abuse and addiction should not prevent the proper management of pain. Healthcare professionals should contact their State Professional Licensing Board or State Controlled Substances Authority for information on how to prevent and detect abuse or misuse of this product.

Central Nervous System Depressants

Patients receiving narcotic analgesics, general anesthetics, phenothiazines, benzodiazepines, other tranquilizers, sedative-hypnotics, or other central nervous system depressants concomitantly with Oxecta may exhibit an additive central nervous system depression. Interactive effects resulting in respiratory depression, hypotension, profound sedation, or coma may result if these drugs are taken in combination with the usual dosage of Oxecta. When such combined therapy is contemplated, the dose of one or both agents should be reduced.

Patients should not consume alcoholic beverages, or any medications containing alcohol while taking Oxecta.

Head Injury and Increased Intracranial Pressure

In the presence of head injury, intracranial lesions or a preexisting increase in intracranial pressure, the possible respiratory depressant effects of Oxecta and its potential to elevate cerebrospinal fluid pressure (resulting from vasodilation following CO2 retention) may be markedly exaggerated. Furthermore, Oxecta can produce effects on pupillary response and consciousness, which may obscure neurologic signs of further increases in intracranial pressure in patients with head injuries.

Hypotensive Effect

Oxecta may cause severe hypotension in patients whose ability to maintain blood pressure has been compromised by a depleted intravascular volume, or after concurrent administration with drugs such as phenothiazines, general anesthetics or other agents which compromise vasomotor tone. Oxecta may produce orthostatic hypotension in ambulatory patients. Oxecta must be administered with caution to patients in circulatory shock, since vasodilation produced by the drug may further reduce cardiac output and blood pressure.

Gastrointestinal Effects

Do not administer Oxecta to patients with gastrointestinal obstruction, especially paralytic ileus because oxycodone HCl diminishes propulsive peristaltic waves in the gastrointestinal tract and may prolong the obstruction.

The administration of Oxecta may obscure the diagnosis or clinical course in patients with acute abdominal condition.

Use in Pancreatic/Biliary Tract Disease

Use Oxecta with caution in patients with biliary tract disease, including acute pancreatitis, as oxycodone HCl may cause spasm of the sphincter of Oddi and diminish biliary and pancreatic secretions.

Special Risk Groups

Use Oxecta with caution and in reduced dosages in patients with severe renal or hepatic impairment, Addison's disease, hypothyroidism, prostatic hypertrophy, or urethral stricture, and in elderly or debilitated patients [see USE IN SPECIFIC POPULATIONS (8)].

Exercise caution in the administration of Oxecta to patients with CNS depression, toxic psychosis, acute alcoholism and delirium tremens. All opioids may aggravate convulsions in patients with convulsive disorders, and all opioids may induce or aggravate seizures in some clinical settings.

Keep Oxecta out of the reach of children. In case of accidental ingestion, seek emergency medical help immediately.

Driving and Operating Machinery

Oxecta may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating heavy machinery. The patient using Oxecta must be cautioned accordingly [see DRUG INTERACTIONS (7)].

Cytochrome P450 3A4 Inhibitors and Inducers

Since the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone, drugs that alter CYP3A4 activity may cause changes in clearance of oxycodone which could lead to changes in oxycodone plasma concentrations. The expected clinical results with CYP3A4 inhibitors would be an increase in oxycodone plasma concentrations and possibly increased or prolonged opioid effects. The expected clinical results with CYP3A4 inducers would be a decrease in oxycodone plasma concentrations, lack of efficacy or, possibly, development of an abstinence syndrome in a patient who had developed physical dependence to oxycodone.

If co-administration is necessary, caution is advised when initiating oxycodone treatment in patients currently taking, or discontinuing, CYP3A4 inhibitors or inducers. Evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved [see DRUG INTERACTIONS (7.5) and CLINICAL PHARMACOLOGY (12.3)].

How Supplied/Storage and Handling

Oxecta (oxycodone HCl, USP) is supplied as round, convex, white tablets as follows:

5 mg tablets debossed with the strength "5" on one side and the King Logo on the other side.

NDC 60793-525-01 Bottles of 100 tablets

7.5 mg tablets debossed with the strength "7.5" on one side and the King Logo on the other side.

NDC 60793-526-01 Bottles of 100 tablets

Dispense in tight container as defined in the USP, with a child-resistant closure.

Store at 25ºC (77ºF); with excursions permitted to 15º-30ºC (59º-86ºF) [See USP Controlled Room Temperature].

Protect from moisture.

Handling

All opioids, including Oxecta, are liable to diversion and misuse both by the general public and healthcare workers and must be handled accordingly.

DEA Schedule II Order Form Required

Prescribing Information as of January 2014

Patient Counseling Information

Provide the following information to patients receiving Oxecta or their caregivers:

  • Advise patients that Oxecta is a narcotic pain reliever and must be taken only as directed.
  • Advise patients to take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth. Advise patients that Oxecta tablets must be swallowed whole. Do not crush or dissolve. Do not use Oxecta for administration via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes.
  • Advise patients not to pre-soak, lick or otherwise wet the tablet prior to placing in the mouth.
  • Advise patients to take Oxecta only as directed.
  • Advise patients not to adjust the dose of Oxecta without consulting with a physician or other healthcare professional.
  • Advise patients that Oxecta may cause drowsiness, dizziness, or lightheadedness and may impair mental and/or physical ability required for the performance of potentially hazardous tasks (e.g., driving, operating heavy machinery). Advise patients started on Oxecta or patients whose dose has been adjusted to refrain from any potentially dangerous activity until it is established that they are not adversely affected.
  • Instruct patients not to combine Oxecta with central nervous system depressants (sleep aids, tranquilizers) except by the orders of the prescribing physician, and not to combine with alcohol because dangerous additive effects may occur, resulting in serious injury or death.
  • Instruct women of childbearing potential who become or are planning to become pregnant to consult a physician prior to initiating or continuing therapy with Oxecta. Advise patients that safe use in pregnancy has not been established and that prolonged use of opioid analgesics, including Oxecta, during pregnancy may cause fetal-neonatal physical dependence, and neonatal withdrawal may occur.
  • If patients have been receiving treatment with Oxecta for more than a few weeks and cessation of therapy is indicated, counsel them on the importance of safely tapering the dose and that abruptly discontinuing the medication could precipitate withdrawal symptoms. Provide a dose schedule to help patients gradually discontinue the medication.
  • Advise patients that sharing this Oxecta can result in fatal overdose and death.
  • Advise patients that Oxecta is a potential drug of abuse. They must protect it from theft. Patients should keep Oxecta in a locked cabinet, drawer, or medicine safe. It must never be given to anyone other than the individual for whom it was prescribed.
  • Instruct patients to keep Oxecta in a secure place out of the reach of children. When Oxecta is no longer needed, the unused tablets should be destroyed by flushing them down the toilet.
  • Advise patients taking Oxecta of the potential for severe constipation; appropriate laxatives and/or stool softeners as well as other appropriate treatments should be initiated from the onset of opioid therapy.
  • Advise patients of the most common adverse reactions that may occur while taking Oxecta: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
  • Advise patients to call 911 or the local Poison Control center and get emergency help immediately if they take more Oxecta than prescribed.
  • Advise patients that if they miss a dose to take it as soon as possible. If it is almost time for the next dose, skip the missed dose and take the next dose at the regularly scheduled time. Do not take 2 doses at once unless instructed by their healthcare provider. If they are not sure about their dosing, call their healthcare provider.

Under license from:

Acura Pharmaceuticals, Inc.

Palatine, Illinois 60067

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0648-2.0
1/2014

LabelGraphics1

LabelGraphics2

Oxecta 
oxycodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60793-525
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 5 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND (convex) Size 11mm
Flavor Imprint Code 5;K
Contains     
Packaging
# Item Code Package Description
1 NDC:60793-525-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202080 06/17/2011
Oxecta 
oxycodone hydrochloride tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60793-526
Route of Administration ORAL DEA Schedule CII    
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE HYDROCHLORIDE (OXYCODONE) OXYCODONE HYDROCHLORIDE 7.5 mg
Product Characteristics
Color WHITE Score no score
Shape ROUND (convex) Size 11mm
Flavor Imprint Code 7;5;K
Contains     
Packaging
# Item Code Package Description
1 NDC:60793-526-01 100 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202080 06/17/2011
Labeler - Pfizer Laboratories Div Pfizer Inc (134489525)
Establishment
Name Address ID/FEI Operations
Noramco, Inc. 057234486 API MANUFACTURE(60793-526, 60793-525)
Revised: 01/2014   Pfizer Laboratories Div Pfizer Inc

What is Oxecta?

Oxecta (oxycodone) is an opioid pain medication. An opioid is sometimes called a narcotic.

Oxecta is an immediate release tablet used to treat moderate to severe pain.

Oxecta may also be used for purposes not listed in this medication guide.

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