RoxyBond

RoxyBond is a pain medication that belongs to the opioid class, used to relieve moderate to severe pain. It is typically prescribed when other treatments have not been effective or have caused side effects.

Extended-release RoxyBond is intended for continuous treatment of severe and chronic pain that needs longer-term management. RoxyBond is not meant to be used on an as-needed basis.

RoxyBond may also be used for other reasons that are not mentioned in this medication guide.

Follow the directions on your prescription label and read all medication guides or instruction sheets. Never use RoxyBond in larger amounts or for longer than prescribed. Tell your doctor if you feel a stronger urge to use more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot access it. Selling or giving away this medicine is against the law.

Never crush a pill or use the liquid to inhale or inject it into your vein. This could lead to death.

Your dose may need to change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using it exactly as directed on the label or as prescribed by your doctor.

Stop taking all other around-the-clock opioid pain medicines when you start taking extended-release RoxyBond.

Swallow the extended-release forms whole to avoid exposure to a potentially fatal overdose. Do not crush, chew, break, open, or dissolve.

Take the extended-release capsules with food. Read and carefully follow the instructions for use on how to prepare and take this medicine if you cannot swallow extended-release capsules whole or if you use a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Measure liquid medicine with the supplied measuring device (not a kitchen spoon).

You may be given other medications to help prevent or treat certain side effects.

You may have withdrawal symptoms if you stop using RoxyBond suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep your medicine in a place where no one can use it improperly.

Do not keep leftover medicine. Just one dose can cause death in someone using it accidentally or improperly. Ask your pharmacist about a drug take-back program, or flush the unused medicine down the toilet.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH.

Fatal side effects may happen if you drink alcohol or use other drugs that make you drowsy or slow your breathing.

Using opioid medicine during pregnancy may lead to life-threatening withdrawal symptoms in the newborn.

You should not use RoxyBond if you are allergic to it, or if you have severe asthma, breathing problems, or a stomach or bowel obstruction (including paralytic ileus).

Tell your doctor if you have ever had:

• other breathing problems, sleep apnea (breathing that stops during sleep);
• a head injury, brain tumor, high pressure inside the skull, or seizures, drug or alcohol addiction, or mental illness;
• if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine;
• urination problems, problems with your gallbladder, pancreas, thyroid, or adrenal gland; or
• liver or kidney disease.

Most forms of oxycodone are not approved for use in people under 18 years old. The extended-release tablets should not be given to a child younger than 11 years old.

Tell your doctor if you also use stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. An interaction with RoxyBond could cause a serious condition called serotonin syndrome.

May harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use RoxyBond during pregnancy, your baby could be born with life-threatening withdrawal symptoms and may need medical treatment for several weeks.

Do not breastfeed. RoxyBond in breast milk can cause life-threatening side effects in a nursing baby.

Long-term RoxyBond may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using RoxyBond.

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

Opioid medicine can slow or stop your breathing, and death may occur, especially if you drink alcohol or use other drugs that cause drowsiness or slow breathing. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.

RoxyBond may cause serious side effects. Call your doctor at once if you have:

• slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
• chest pain, fast or pounding heartbeats;
• a seizure, extreme drowsiness; or
• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

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 of RoxyBond may include:

• sleep problems (insomnia), itching;
• drowsiness, headache, dizziness, tiredness; or
• constipation, stomach pain, nausea, vomiting.

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.

Since RoxyBond is used for pain, it is unlikely that you will miss a dose. If you do miss a dose and it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

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 person using opioid medicine without a prescription.

Your doctor may suggest that you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or do not wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can purchase naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Do not drink alcohol or any products that contain alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activities until you know how RoxyBond will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries. Also avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

You may have a fatal RoxyBond overdose if you start or stop using certain medicines. Tell your doctor about all your medications. Tell your doctor about all your medications, especially if you use medicine to treat HIV, antibiotics, antifungal medication, or seizure medication.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicines, a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• sleep medicine, muscle relaxers, or other drugs that make you drowsy; or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

This list is not complete and many other drugs may affect RoxyBond. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.