Roxicodone

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects include:

• nausea
• constipation
• vomiting
• headache
• itching

This is not a complete list of oxycodone side effects. Ask your doctor or pharmacist for more information.

Grapefruit and grapefruit juice may interact with oxycodone and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.
 

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Oxycodone falls into category B. There are no well-done studies that have been done in humans with oxycodone. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

If you take more oxycodone than prescribed, or overdose, call your local emergency number (such as 911) or your local Poison Control Center right away, or get emergency help.

You should not use oxycodone if you are allergic to it, or if you have:

• severe asthma or breathing problems; or

• a blockage in your stomach or intestines.

You should not use oxycodone unless you are already using a similar opioid medicine and are tolerant to it.

Most brands of oxycodone are not approved for use in people under 18. OxyContin should not be given to a child younger than 11 years old.

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

• 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;

• problems with your gallbladder, pancreas, or thyroid; or

• if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

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.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Do not breast-feed. Oxycodone can pass into breast milk and may cause drowsiness or breathing problems in a nursing baby.

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

Like other narcotic medicines, oxycodone can slow your breathing. Death may occur if breathing becomes too weak. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, pinpoint pupils, or if you are hard to wake up.

Call your doctor at once if you have:

• shallow breathing, slow heartbeats;

• confusion, severe drowsiness, seizure (convulsions);

• severe constipation;

• missed menstrual periods;

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

• a light-headed feeling, like you might pass out; 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, confusion, fever, sweating, fast heart rate, chest pain, feeling short of breath, muscle stiffness, trouble walking, or feeling faint.

Serious side effects may be more likely in older adults and those who are malnourished or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common side effects may include:

• drowsiness, headache, dizziness, tired feeling; or

• constipation, stomach pain, nausea, vomiting, loss of appetite.

• dry mouth; or

• mild itching.

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.

In the U.S.

• Dazidox
• Eth-Oxydose
• Oxaydo
• OxyCONTIN
• OxyCONTIN CR
• Oxydose
• Oxyfast
• Oxy IR
• Roxicodone
• Roxicodone Intensol
• Roxybond
• Xtampza ER

Available Dosage Forms:

• Capsule, Extended Release
• Tablet, Extended Release
• Tablet
• Capsule
• Solution

Therapeutic Class: Analgesic

Chemical Class: Opioid

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine will add to the effects of alcohol and other CNS depressants. CNS depressants are medicines that slow down the nervous system, which may cause drowsiness or make you less alert. Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics (numbing medicines), including some dental anesthetics. This effect may last for a few days after you stop using this medicine. Check with your doctor before taking any of these medicines while you are using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as abdominal or stomach cramps, anxiety, fever, nausea, runny nose, sweating, tremors, or trouble sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Roxicodone (oxycodone hydrochloride tablets USP):

5 mg tablets, scored and embossed with 54 582 on one side.
15 mg green tablets, scored and embossed with 54 710 on one side.
30 mg blue tablets, scored and embossed with 54 199 on one side.

NDC 23635-581-10

100 Tablets

Roxicodone®
Oxycodone Hydrochloride Tablets USP
CII

Rx Only

15 mg

PHARMACIST: Dispense the Medication Guide provided separately to each patient.

Distributed by:
Mallinckrodt Brand Pharmaceuticals, Inc.
Hazelwood, MO 63042 USA

Mallinckrodt™

960B10
Rev 12/2016