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|Oxycodone Concentrate

Oxycodone Concentrate

Oxycodone Concentrate is used for:

Treating moderate to severe pain. It may be used before surgery to sedate the patient and reduce fear. It may also be used for other conditions as determined by your doctor.

Oxycodone Concentrate is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use Oxycodone Concentrate if:

• you are allergic to any ingredient in Oxycodone Concentrate or any other oxycodone- or morphine-related medicine (eg, codeine)
• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you have severe bowel motility problems (eg, paralytic ileus) or severe diarrhea associated with antibiotic use (pseudomembranous colitis)
• you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using Oxycodone Concentrate:

Some medical conditions may interact with Oxycodone Concentrate. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
• if you have a history of recent head injury, increased pressure in the brain, growths in the brain (eg, tumors), or seizures
• if you have a history of heart problems, low blood pressure, liver or kidney problems, an underactive thyroid, adrenal gland problems (eg, Addison disease), stomach or bowel problems, gallbladder problems, inflammation of the pancreas, a blockage of the bladder or bowel, an enlarged prostate, or the blood disease porphyria
• if you have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with Oxycodone Concentrate. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cimetidine, furazolidone, MAO inhibitors (eg, phenelzine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of side effects such as severe drowsiness, slow or difficult breathing, confusion, and seizures may be increased
• Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because the effectiveness of Oxycodone Concentrate may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Oxycodone Concentrate may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Oxycodone Concentrate:

Use Oxycodone Concentrate as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Oxycodone Concentrate by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use the dropper that comes with Oxycodone Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If you miss a dose of Oxycodone Concentrate and you are using it regularly, use it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Oxycodone Concentrate.

Important safety information:

• Oxycodone Concentrate may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Oxycodone Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Oxycodone Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Oxycodone Concentrate may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Tell your doctor or dentist that you take Oxycodone Concentrate before you receive any medical or dental care, emergency care, or surgery.
• Use Oxycodone Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.
• Oxycodone Concentrate should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Oxycodone Concentrate while you are pregnant. Oxycodone Concentrate is found in breast milk. Do not breast-feed while taking this medicine.

When used for long periods of time or at high doses, Oxycodone Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Oxycodone Concentrate stops working well. Do not take more than prescribed.

Some people who use Oxycodone Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Oxycodone Concentrate, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Oxycodone Concentrate:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; nausea; sleeplessness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fast or slow heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold and clammy skin; confusion; loss of consciousness; seizures; severe drowsiness, dizziness, or lightheadedness; slow breathing; slow heartbeat.

Store Oxycodone Concentrate at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from light, heat, and moisture. Do not store in the bathroom. Keep Oxycodone Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Oxycodone Concentrate, please talk with your doctor, pharmacist, or other health care provider.
• Oxycodone Concentrate is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Oxycodone Concentrate. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.