Percodan

DRUG DESCRIPTION

Each PERCODAN (aspirin and oxycodone hydrochloride) Tablet contains:

Oxycodone Hydrochloride, USP...............4.8355 mg*
Aspirin, USP............................................325 mg

PERCODAN (aspirin and oxycodone hydrochloride) Tablets also contain the following inactive ingredients: D&C Yellow 10, FD&C Yellow 6, microcrystalline cellulose and corn starch.

The oxycodone hydrochloride component is Morphinan-6-one, 4,5-epoxy-14-hydroxy-3-methoxy-17-methyl-, hydrochloride, (5a)-., a white to off-white, hygroscopic crystals or powder, odorless, soluble in water; slightly soluble in alcohol and is represented by the following structural formula:

Oxycodone structural formula illustration

C18H21NO4•HCl.........................MW 351.82

The aspirin component is 2-(acetyloxy)-, Benzoic acid, a white crystal, commonly tabular or needle-like, or white, crystalline powder. Is odorless or has a faint odor. Is stable in dry air; in moist air it gradually hydrolyzes to salicylic and acetic acids. Slightly soluble in water; freely soluble in alcohol; soluble in chloroform and in ether; sparingly soluble in absolute ether and is represented by the following structural formula:

Aspirin structural formula illustration

C9H8O4.....................MW 180.16

What are the possible side effects of aspirin and oxycodone (Endodan, Percodan)?

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

Call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
  • shallow breathing, slow heartbeat;
  • fast heart rate;
  • feeling light-headed, fainting;
  • confusion, hallucinations;
  • easy bruising or...

Read All Potential Side Effects and See Pictures of Percodan »

What are the precautions when taking aspirin and oxycodone hydrochloride (Percodan)?

Before taking oxycodone with aspirin, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as codeine, hydrocodone), salicylates (such as salsalate), or nonsteroidal anti-inflammatory drugs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach problems (such as...

Read All Potential Precautions of Percodan »

What are the possible side effects of aspirin and oxycodone (Endodan, Percodan)?

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

Call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
  • shallow breathing, slow heartbeat;
  • fast heart rate;
  • feeling light-headed, fainting;
  • confusion, hallucinations;
  • easy bruising or...

Read All Potential Side Effects and See Pictures of Percodan »

What are the precautions when taking aspirin and oxycodone hydrochloride (Percodan)?

Before taking oxycodone with aspirin, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as codeine, hydrocodone), salicylates (such as salsalate), or nonsteroidal anti-inflammatory drugs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach problems (such as...

Read All Potential Precautions of Percodan »


Percodan Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, upset stomach, constipation, dizziness, drowsiness, headache, increased sweating, dry mouth, lightheadedness, loss of appetite, or weakness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, fainting, slow/fast/irregular heartbeat, mental/mood changes (such as depression, hallucinations), difficult/painful urination, ringing in the ears, decreased hearing, vision changes, easy bruising/bleeding.

Tell your doctor immediately if any of these rare but very serious side effects occur: stomach/abdominal pain, black stools, vomit that looks like coffee grounds, yellowing eyes/skin, dark urine, persistent tiredness, persistent nausea, change in the amount of urine, seizures.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking oxycodone with aspirin, tell your doctor or pharmacist if you are allergic to it; or to other narcotics (such as codeine, hydrocodone), salicylates (such as salsalate), or nonsteroidal anti-inflammatory drugs (such as ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), kidney disease, liver disease, bleeding/blood-clotting disorders (such as hemophilia, vitamin K deficiency, low platelet count), stomach problems (such as ulcers, heartburn, stomach pain), diabetes, gout, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), growths in the nose (nasal polyps), a certain spinal problem (kyphoscoliosis), certain heart problems (such as low blood pressure, irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol/other substances, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease), certain enzyme deficiencies (pyruvate kinase or G6PD deficiency).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Before having surgery, tell your doctor or dentist that you are taking this medication.

Older adults may be more sensitive to the side effects of this drug, especially slow/shallow breathing, drowsiness, or stomach bleeding.

This product contains aspirin. Children and teenagers should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have recently received a vaccine. In these cases, taking aspirin increases the risk of Reye's syndrome, a rare but serious illness.

This medication is not recommended for use during pregnancy. Consult your doctor if you are or think you may be pregnant. Tell your doctor immediately if you become pregnant while taking this medication. Do not use this medication during the last 3 months of pregnancy because of possible harm to the unborn baby or problems during delivery. Infants born to mothers who have used oxycodone for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Percodan Patient Information Including Side Effects

Brand Names: Endodan, Percodan

Generic Name: aspirin and oxycodone (Pronunciation: AS pir in and ox i KOE done)

  • What is aspirin and oxycodone (Percodan)?
  • What are the possible side effects of aspirin and oxycodone (Percodan)?
  • What is the most important information I should know about aspirin and oxycodone (Percodan)?
  • What should I discuss with my healthcare provider before taking aspirin and oxycodone (Percodan)?
  • How should I take aspirin and oxycodone (Percodan)?
  • What happens if I miss a dose (Percodan)?
  • What happens if I overdose (Percodan)?
  • What should I avoid while taking aspirin and oxycodone (Percodan)?
  • What other drugs will affect aspirin and oxycodone (Percodan)?
  • Where can I get more information?

What is aspirin and oxycodone (Percodan)?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Oxycodone is in a group of drugs called narcotic pain relievers.

The combination of aspirin and oxycodone is used to relieve moderate to severe pain.

Aspirin and oxycodone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of aspirin and oxycodone (Percodan)?

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

Call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee ground;
  • shallow breathing, slow heartbeat;
  • fast heart rate;
  • feeling light-headed, fainting;
  • confusion, hallucinations;
  • easy bruising or bleeding; or
  • problems with urination.

Less serious side effects may include:

  • headache, dizziness, drowsiness;
  • heartburn, nausea, vomiting, upset stomach, bloating, gas, constipation, diarrhea;
  • feeling dizzy or drowsy;
  • headache;
  • sweating;
  • ringing in your ears; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about aspirin and oxycodone (Percodan)?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Oxycodone may be habit-forming and should be used only by the person this medicine was prescribed for. Keep the medication in a secure place where others cannot get to it.

Avoid drinking alcohol while taking aspirin and oxycodone. Alcohol may increase your risk of stomach bleeding while taking aspirin.

Tell your doctor if the medicine seems to stop working as well in relieving your pain.

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