What is ROXICODONE (Oxycodone Hydrochloride)?
ROXICODONE is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
- An opioid pain medicine that 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
What is the most important information I should know about ROXICODONE?
- Get emergency help 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.
- 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.
ROXICODONE can cause serious side effects. These serious side effects include:
- The possible side effects of ROXICODONE® are: • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
- Get emergency medical help 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, or mental changes such as confusion.
How should I take 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.
- Take your prescribed dose every 4 to 6 hours. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
- 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.
- After you stop taking ROXICODONE®, flush any unused tablets down the toilet.
Important Safety Information
Do not take ROXICODONE if you have:
- Severe asthma, trouble breathing, or other lung problems.
- A bowel blockage or have narrowing of the stomach or intestines.
- Allergy to oxycodone.
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.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking ROXICODONE?
Tell your healthcare provider if you have a history of:
- Head injury, seizures
- Problems urinating
- Liver, kidney, thyroid problems
- Pancreas or gallbladder problems
- Abuse of street or prescription drugs, alcohol addiction, or mental health problems.
- If you are pregnant or planning to become pregnant. Prolonged use of ROXICODONE® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
- If you are breastfeeding. ROXICODONE® passes into breast milk and may harm your baby.
Tell your healthcare provider if you are 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
General information about ROXICODONE
Never give anyone else your ROXICODONE. They could die from taking it. Store ROXICODONE away from children and in a safe place to prevent stealing or abuse. Selling or giving away ROXICODONE is against the law.
What are the ingredients in ROXICODONE?
Active ingredient: Oxycodone Hydrochloride
Other ingredient:
The 5 mg ROXICODONE tablet contains inactive ingredients: microcrystalline cellulose and stearic acid. The 15 mg and 30 mg tablets contain the following inactive ingredients: microcrystalline cellulose; sodium starch glycolate; corn starch; lactose; stearic acid; D&C Yellow No. 10 (15 mg tablet); and FD&C Blue No. 2 (15 mg and 30 mg tablets).