Naloxone-oxyCODONE

Naloxone blocks certain effects of opioid medication, including feelings of well-being that can lead to opioid abuse.

Oxycodone is an opioid pain medication. An opioid is sometimes called a narcotic.

Naloxone and oxycodone is a combination medicine used for around-the-clock treatment of severe pain that is not controlled by other medicines. Naloxone is included in this medicine to prevent the misuse of the narcotic ingredient.

This medicine is not for use on an as-needed basis for pain that is not around-the-clock.

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

You should not use this medicine if you have severe asthma or breathing problems, severe liver disease, or a blockage in your stomach or intestines.

Oxycodone can slow or stop your breathing. Never use this medicine in larger amounts, or for longer than prescribed. Swallow the tablet whole to avoid exposure to a potentially fatal dose. 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. Keep the medication in a place where others cannot get to it.

MISUSE OF NARCOTIC MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH, especially in a child or other person using the medicine without a prescription.

Tell your doctor if you are pregnant. Oxycodone may cause life-threatening withdrawal symptoms in a newborn.

Some drugs can raise or lower your blood levels of oxycodone, which may cause fatal overdose, or make oxycodone less effective. Tell your doctor about all other medicines you start or stop using.

You should not use this medicine if you are allergic to naloxone or oxycodone, or if you have:

• severe asthma or breathing problems;
• severe liver disease; or
• a blockage in your stomach or intestines.

To make sure naloxone and oxycodone is safe for you, tell your doctor if you have:

• any type of breathing problem or lung disease;
• a history of head injury, brain tumor, or seizures;
• a history of drug abuse, alcohol addiction, or mental illness;
• urination problems;
• liver or kidney disease;
• heart disease; or
• problems with your gallbladder, pancreas, or thyroid.

It is not known whether this medicine will harm an unborn baby. If you use oxycodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using naloxone and oxycodone.

Get emergency medical help if you have signs of an allergic reaction: hives; feeling light-headed; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• shallow breathing, slow heartbeat, cold, clammy skin;
• seizure (convulsions);
• confusion, severe drowsiness; or
• a light-headed feeling, like you might pass out.

Naloxone and oxycodone is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

Common side effects may include:

• drowsiness, headache, dizziness;
• stomach pain, nausea, constipation;
• anxiety; or
• sweating.

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.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with naloxone and oxycodone. Check your food and medicine labels to be sure these products do not contain alcohol.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how naloxone and oxycodone will affect you. Dizziness or severe drowsiness can cause falls or other accidents.

Taking this medicine with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking naloxone and oxycodone with a sleeping pill, muscle relaxer, other pain medicine, or medicine for anxiety, depression, or seizures.

Sometimes it is not safe to use certain medications at the same time. Some drugs can raise or lower your blood levels of oxycodone, which may cause side effects or make oxycodone less effective. Oxycodone can also affect blood levels of certain other drugs, making them less effective or increasing side effects.

TELL YOUR DOCTOR ABOUT ALL OTHER MEDICINES YOU START OR STOP USING. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Give a list of all your medicines to any healthcare provider who treats you.

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 take naloxone and oxycodone in larger amounts, or for longer than prescribed. 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 naloxone and oxycodone is against the law.

Do not crush, chew, or break a naloxone and oxycodone extended-release tablet. Swallow it whole to avoid exposure to a potentially fatal dose.

Naloxone and oxycodone is usually taken every 12 hours. Take the medicine at the same time each day.

Do not stop using naloxone and oxycodone suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using naloxone and oxycodone.

Never crush or break a naloxone and oxycodone pill to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of oxycodone and similar prescription drugs.

Store at room temperature, away from heat, moisture, and light.

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 naloxone and oxycodone pills. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush any unused pills down the toilet.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A naloxone and oxycodone overdose can be fatal, especially in a child or other person using the medicine without a prescription.

Overdose symptoms may include extreme drowsiness, weak or limp muscles, cold and clammy skin, pinpoint pupils, loss of consciousness, weak pulse, or slowed breathing (breathing may stop).

Since naloxone and oxycodone is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.