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Generic Name
Oxycodone / Paracetamol

Dosage Form


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• A strong prescription pain medicine that contains an opioid (narcotic) that is used to
manage pain, severe enough to require an opioid analgesic and for which alternative
treatments are inadequate and when other pain treatments such as non-opioid pain
medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take
your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse
that can lead to death.

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ENDOCET (oxycodone hydrochloride and acetaminophen) is indicated for relief of moderate
to moderately severe pain, including conditions accompanied by fever.
ENDOCET is not indicated as an as-needed (prn) analgesic.
Geriatrics (> 65 years of age)
In general, dose selection for an elderly patient should be cautious, usually starting at the low end
of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac
function, concomitant disease or other drug therapy (see ACTION AND CLINICAL
PHARMACOLOGY, Special Populations and Conditions, Geriatrics).
Pediatrics (< 18 years of age)
The safety and efficacy of ENDOCET has not been studied in the pediatric population. Therefore
the use of ENDOCET is not recommended in patients under 18 years of age.

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How To Take

When taking ENDOCET:
• Do not change your dose. Take ENDOCET exactly as prescribed by your healthcare
provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 6 hours as needed for pain. Do not take more than your
prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking ENDOCET regularly, do not stop taking ENDOCET without
talking to your healthcare provider.
• After you stop taking ENDOCET, dispose of unused tablets by flushing them down the
While taking ENDOCET DO NOT:
• Drive or operate heavy machinery, until you know how ENDOCET affects you.
ENDOCET can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using
products containing alcohol during treatment with ENDOCET may cause you to overdose
and die.

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Side Effects

Adverse effects of ENDOCET (oxycodone hydrochloride and acetaminophen) tablets are similar
to those of other opioid analgesics, and represent an extension of pharmacological effects of the
drug class. The major hazards of opioids include respiratory and central nervous system
depression and to a lesser degree, circulatory depression, respiratory arrest, shock and cardiac
The most frequently observed adverse effects of ENDOCET are light-headedness, dizziness,
sedation, nausea and vomiting. These effects seem to be more prominent in ambulatory than in
non-ambulatory patients, and some of these adverse reactions may be alleviated if the patient lies
Other adverse reactions include euphoria, dysphoria, constipation and pruritus.
Sedation is a common side effect of opioid analgesics, especially in opioid naïve individuals.
Sedation may also occur partly because patients often recuperate from prolonged fatigue after the
relief of persistent pain. Most patients develop tolerance to the sedative effects of opioids within
three to five days and, if the sedation is not severe, will not require any treatment except
reassurance. If excessive sedation persists beyond a few days, the dose of the opioid should be
reduced and alternate causes investigated. Some of these are: concurrent CNS depressant medication, hepatic or renal dysfunction, brain metastases, hypercalcemia and respiratory failure.
If it is necessary to reduce the dose, it can be carefully increased again after three or four days if
it is obvious that the pain is not being well controlled. Dizziness and unsteadiness may be
caused by postural hypotension, particularly in elderly or debilitated patients, and may be
alleviated if the patient lies down.
Nausea and Vomiting:
Nausea is a common side effect on initiation of therapy with opioid analgesics and is thought to
occur by activation of the chemoreceptor trigger zone, stimulation of the vestibular apparatus and
through delayed gastric emptying. The prevalence of nausea declines following continued
treatment with opioid analgesics. When instituting therapy with an opioid for chronic pain, the
routine prescription of an antiemetic should be considered. In the cancer patient, investigation of
nausea should include such causes as constipation, bowel obstruction, uremia, hypercalcemia,
hepatomegaly, tumor invasion of celiac plexus and concurrent use of drugs with emetogenic
properties. Persistent nausea which does not respond to dosage reduction may be caused by
opioid-induced gastric stasis and may be accompanied by other symptoms including anorexia,
early satiety, vomiting and abdominal fullness. These symptoms respond to chronic treatment
with gastrointestinal prokinetic agents.
Practically all patients become constipated while taking opioids on a persistent basis. In some
patients, particularly the elderly or bedridden, fecal impaction may result. It is essential to
caution the patients in this regard and to institute an appropriate regimen of bowel management
at the start of prolonged opioid therapy. Stimulant laxatives, stool softeners, and other
appropriate measures should be used as required. As fecal impaction may present as overflow
diarrhea, the presence of constipation should be excluded in patients on opioid therapy prior to
initiating treatment for diarrhea.

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• Patients who are hypersensitive to the active substances oxycodone hydrochloride and
acetaminophen, or other opioid analgesics or to any ingredient in the formulation. For a
section of the Product Monograph.
• Patients with severe hepatic insufficiency or active liver disease.
In patients with known or suspected mechanical gastrointestinal obstruction (e.g., bowel
obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any
• Patients with suspected surgical abdomen (e.g., acute appendicitis or pancreatitis).
• Patients with mild pain that can be managed with other pain medications.
• Patients with acute or severe bronchial asthma, chronic obstructive airway, or status
• Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and
cor pulmonale.
• Patients with acute alcoholism, delirium tremens, and convulsive disorders.
• Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and
head injury.
• Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy).

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