Endocet

ENDOCET (Oxycodone and Acetaminophen Tablets, USP) is supplied as follows:

5 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

Unit dose package of 100 tablets NDC 60951-602-75

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

7.5 mg/500 mg

Peach, capsule-shaped, tablet debossed with "E796" on one side and "7.5" on the other.

Bottles of 100                                  NDC 60951-796-70

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

10 mg/650 mg

Yellow, oval, tablet debossed with "E797" on one side and "10" on the other.

Bottles of 100                                  NDC 60951-797-70

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

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

DEA Order Form Required.

Manufactured for: Endo Pharmaceuticals Inc. Chadds Ford, Pennsylvania 19317. February, 2007. FDA rev date: n/a

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 ENDOCET (oxycodone and acetaminophen tablets) tablets in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion. Concerns about misuse, addiction, and diversion 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 diversion of this product.

Administration of ENDOCET (Oxycodone and Acetaminophen Tablets, USP) tablets should be closely monitored for the following potentially serious adverse reactions and complications:

Respiratory Depression

Respiratory depression is a hazard with the use of oxycodone, one of the active ingredients in ENDOCET (oxycodone and acetaminophen tablets) tablets, as with all opioid agonists. Elderly and debilitated patients are at particular risk for respiratory depression 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 acute asthma, chronic obstructive pulmonary disorder (COPD), cor pulmonale, or preexisting respiratory impairment. In such patients, even usual therapeutic doses of oxycodone may decrease respiratory drive to the point of apnea. In these patients alternative non-opioid analgesics should be considered, and opioids should be employed only under careful medical supervision at the lowest effective dose.

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

Head Injury and Increased Intracranial Pressure

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

Hypotensive Effect

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

Precaution should be taken in patients with liver disease. Hepatotoxicity and severe hepatic failure occurred in chronic alcoholics following therapeutic doses.

Endocet is part of the drug class:

• Anilides

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how acetaminophen and oxycodone will affect you.

Ask a doctor or pharmacist before using any other cold, allergy, pain, or sleep medication. Acetaminophen (sometimes abbreviated as APAP) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen which can lead to a fatal overdose. Check the label to see if a medicine contains acetaminophen or APAP.

Avoid drinking alcohol. It may increase your risk of liver damage while taking acetaminophen.

Follow all directions on your prescription label. Oxycodone can slow or stop your breathing, especially when you start using this medicine or whenever your dose is changed. Never use this medicine in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Oxycodone may be habit-forming, even at regular doses. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription. Selling or giving away acetaminophen and oxycodone is against the law.

Measure liquid medicine with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

If you need surgery, tell the surgeon ahead of time that you are using this medicine. You may need to stop using the medicine for a short time.

Do not stop using this medicine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using the medicine.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Oxycodone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Do not keep leftover acetaminophen and oxycodone pills or liquid. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills or liquid medicine down the toilet.

Never crush or break an acetaminophen and oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or other person using this medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat;

• a light-headed feeling, like you might pass out;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• problems with urination;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low cortisol levels--nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common side effects include:

• headache, drowsiness, tiredness;

• nausea, vomiting, stomach pain, constipation;

• blurred vision; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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 60951-701-70

5 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

Storage

Store 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:
Par Pharmaceutical
Chestnut Ridge, NY 10977

Endocet® is a registered trademark of Endo Pharmaceuticals Inc.

© 2017 Endo Pharmaceuticals Inc. All rights reserved.

Printed in U.S.A.

8183403 R8
Revised: 3/17

Endocet contains a combination of acetaminophen and oxycodone. Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic. Acetaminophen is a less potent pain reliever that increases the effects of oxycodone.

Endocet is used to relieve moderate to severe pain.

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

Get emergency medical help if you have signs of an allergic reaction to Endocet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking Endocet and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat;

• a light-headed feeling, like you might pass out;

• confusion, unusual thoughts or behavior;

• seizure (convulsions);

• problems with urination;

• infertility, missed menstrual periods;

• impotence, sexual problems, loss of interest in sex;

• liver problems - nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Endocet side effects include:

• headache, drowsiness, tiredness;

• nausea, vomiting, stomach pain, constipation;

• blurred vision; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.