Roxicodone

Roxicodone is used to manage pain severe enough to require an opioid pain medicine when other pain medicines do not treat pain well enough or are not tolerated.

Roxicodone can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for opioid analgesics to balance benefits against risks of addiction and misuse. Prescribers must complete REMS-compliant education, counsel patients on safe use and disposal, ensure patients read Medication Guides, and consider patient-prescriber agreements to enhance safety.

Roxicodone is a full mu-opioid receptor agonist providing analgesia with no ceiling effect, meaning doses are limited only by adverse effects like respiratory and CNS depression. Its precise analgesic mechanism is unknown, but CNS opioid receptors throughout the brain and spinal cord are believed to be involved.

Roxicodone first gained FDA approval on October 26, 1998, and is a Schedule II controlled substance.

Get emergency help or call 911 right away if you take too much Roxicodone (overdose). When you first start taking Roxicodone, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.

Taking Roxicodone with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Never give anyone else your Roxicodone. They could die from taking it. Selling or giving away Roxicodone is against the law.

Store Roxicodone securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take Roxicodone if you have:

• Severe asthma
• Trouble breathing or other lung problems
• A bowel blockage or a narrowing of the stomach or intestines
• An allergy to Roxicodone or any of the ingredients in your Roxicodone preparations.

Before taking Roxicodone, tell your healthcare provider if you have a history of:

• Head injury, seizures
• Liver, kidney, thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems.

Tell your healthcare provider if you are:

• Noticing your pain is getting worse. If your pain gets worse after you take Roxicodone, do not take more of Roxicodone without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Roxicodone.
• Pregnant or planning to become pregnant. Using Roxicodone for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• Breastfeeding. Roxicodone passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• Living in a household where there are small children or someone who has abused street or prescription drugs.
• Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Roxicodone with certain other medicines can cause serious side effects that could lead to death.

Common Side Effects

The possible side effects of Roxicodone are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain.

Call your healthcare provider if you have any of these symptoms and they are severe.

Serious Side Effects

Get emergency medical help or call 911 right away if you have:

• Trouble breathing
• Shortness of breath
• Fast heartbeat
• Chest pain
• Swelling of your face, tongue, or throat
• Extreme drowsiness
• Light-headedness when changing positions
• Feeling faint
• Agitation
• High body temperature
• Trouble walking
• Stiff muscles
• Mental changes such as confusion.

These are not all the possible side effects of Roxicodone. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

When taking Roxicodone, do not change your dose. Take Roxicodone exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.

• For acute (short-term) pain, you may only need to take Roxicodone tablets for a few days.
• Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.

You may have some Roxicodone left over that you did not use. See disposal information at the bottom of this section for directions on how to safely throw away (dispose of) your unused Roxicodone.

Comments

• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Roxicodone regularly, do not stop taking Roxicodone without talking to your healthcare provider.

How do I Dispose of Roxicodone?

Dispose of expired, unwanted, or unused Roxicodone tablets by promptly flushing them down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking Roxicodone, DO NOT:

• Drive or operate heavy machinery until you know how Roxicodone affects you. Roxicodone can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Roxicodone may cause you to overdose and die.

Roxicodone can interact dangerously with many medications, potentially causing serious side effects or death. Always inform your doctor of all medications you take, including:

• Other opioids, pain medicines, or prescription cough medicines
• Sedatives, such as Xanax, Valium, Ativan, Klonopin, or Restoril
• Sleeping pills, muscle relaxants, or tranquilizers
• Mental health medications for depression, anxiety, or other conditions
• Neurological medications for Parkinson's disease, migraines, or seizures
• Antibiotics, antifungals, or HIV/hepatitis C treatments
• Heart or blood pressure medications
• Cold, allergy, or asthma medications
• Nausea, motion sickness, or bladder medications

Some medications affect how Roxicodone is processed in the body, potentially raising levels to dangerous concentrations. This list is not complete; always check with your doctor or pharmacist before starting or stopping any medication, including over-the-counter products, vitamins, and herbal supplements.

Ingredients

Active Ingredient: oxycodone hydrochloride

Inactive ingredients (15 mg, green): microcrystalline cellulose, stearic acid, D&C Yellow No. 10, FD&C blue No. 2, sodium starch glycolate type A potato, starch corn, lactose monohydrate, water

Inactive ingredients (30 mg, blue): microcrystalline cellulose, stearic acid, FD&C blue No. 2, sodium starch glycolate type A potato, starch corn, lactose monohydrate, water

Roxicodone is distributed by SpecGx LLC, Webster Groves, MO, 63119 USA.