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Roxicet

Generic name: acetaminophen and oxycodone [a-SEET-a-MIN-oh-fen-and-OX-i-KOE-done]
Drug class: narcotic analgesic combinations

What is Roxicet?

Roxicet is a combination of acetaminophen and oxycodone. Oxycodone, an opioid pain medicine, works in the brain to change how your body feels and responds to pain. It changes the way your body responds to and feels pain. Acetaminophen, a less powerful pain reliever, increases the effects of oxycodone. Acetaminophen is also effective in reducing fever. The prescription drug Roxicet relieves moderate-to-severe pain. Roxicet is most effective when taken at the first sign that pain has begun. The medication may not be as effective if you wait until the pain is worse.

Warnings

Roxicet should not be used if you have recently taken alcohol, tranquilizers, or narcotics. Roxicet may slow or stop breathing and can become habit-forming. Use only the prescribed dose and swallow the tablets whole to avoid a potentially deadly dose. Roxicet should never be shared with anyone else. Misuse of opiod medication can cause addiction, overdose, or death. Store the medication where others cannot reach it. Roxicet should not be taken in excess of the recommended dose. Overdosing on acetaminophen may cause liver damage or death. If you experience nausea, upper stomach pain, itching, or loss of appetite, or if your urine is dark or your stools are clay-colored, call your doctor immediately.If the mother took Roxicet while pregnant, oxycodone withdrawal symptoms can be life-threatening for a newborn. Overdoses of acetaminophen may cause liver damage or death. Contact your doctor immediately if you experience pain in the upper stomach, dark urine, or jaundice. If you notice skin redness, a rash, or blistering, stop taking Roxicet immediately and contact your doctor. You can experience fatal side effects if you combine this medication with alcohol or other drugs that make you drowsy or slow down your breathing.

Before you take this drug

Roxicet should not be used if:

  • Severe asthma or breathing problems
  • A blockage of the intestines or stomach

Tell your doctor about any of the following to ensure Roxicet will be safe for you:

  • Sleep apnea, breathing problems;
  • Liver disease
  • Drug or alcohol abuse;
  • Kidney disease
  • A head injury or seizures;
  • Urination problems can be caused by a number of factors.
  • You may have problems with your pancreas or gallbladder, as well as thyroid issues.

Your baby may exhibit withdrawal symptoms post birth if you take opioids while pregnant, making them dependent upon opioids for multiple weeks following their arrival into this world. Any infant that develops dependency on opioids requires medical treatment as soon as they arrive home from hospital. Do not breastfeed. Oxycodone in breast milk can cause breathing problems or death in a nursing infant.

How to take Roxicet?

Follow the directions on your prescription label. Please follow all the instructions on the prescription label. Do not take more or longer than prescribed. An overdose can damage your liver or cause death. If you find yourself wanting to take more medicine, tell your doctor. Roxicet should never be shared with anyone, especially if they have a history of addiction or drug abuse. Misuse can lead to addiction, overdose, or death. Store the medication in a safe place that others can't reach. It is illegal to sell or give Roxicet away. Measure the Roxicet oral solution carefully. Use the provided dosing syringe or a dose-measuring tool (not a spoon). Tell your doctor if you plan to undergo surgery or any medical tests. Roxicet should not be stopped abruptly. You should follow your doctor's advice about reducing your dose. Store away from moisture or heat at room temperature. Track your medication. Be aware of anyone who is misusing your medicine or using it without a valid prescription. Keep leftover Roxicet away from children. One dose of Roxicet can be fatal for someone who uses it incorrectly or accidentally. You should ask your pharmacist about a drug disposal program. If there isn't a take-back program available, flush any unused medication down the toilet.

Details on dosage

Adult dose for pain:

Immediate-release:
Take 1 tablet every 6 hours, as needed.
Maximum dose: 12 tablets in 24 hours
Oral solution: oxycodone acetaminophen, 325mg per 5 mL
Usual dosage: oxycodone/acetaminophen 5 mg/5 mL orally every six hours, as needed.
Maximum dose: oxycodone/acetaminophen 60 mg (60 mL) in 24 hours
Verify the dose in mg and milliliters before administration.
Due to the risk of addiction, abuse, and misuse, it is important to use the lowest dose effective for the shortest time consistent with the individual treatment goals of each patient.
Monitor patients for respiratory depression in the first 24 to 48 hours after initiating treatment and any dose increase.
Use: To manage acute pain severe enough that an opioid analgesic is required and alternative treatments are ineffective.

What happens if I miss the dose?

You are unlikely to miss a Roxicet dose, as it is prescribed for pain. If it's almost time to take your next dose, skip any missed doses. Never take two doses in one go.

What happens if I overdose?

Call the Poison Help Line at 1-800-222-1222 or seek emergency medical care. A fatal overdose of acetaminophen or oxycodone is possible. The first signs of an overdose are loss of appetite, sickness, nausea, and vomiting. Other symptoms include confusion, weakness, or sweating. Other symptoms include dark urine and yellowing skin or whites of the eyes. Overdose may also result in severe muscle weakness, pinpoint pupillary, extremely slow breathing, extreme sleepiness, or coma.

What should be avoided?

Roxicet can cause you to become dizzy or drowsy. Do not drive or operate machinery until you are sure of how it will affect you. Drowsiness can lead to accidents or serious injuries. Don't drink alcohol. Side effects and death can occur. Before using any other medication that contains acetaminophen (also known as APAP), consult your doctor or pharmacist. Combining certain medications can cause a fatal overdose.

Side effects of Roxicet

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of your lips, face, tongue, or throat, contact emergency medical assistance.

If you take opioid medicine, it can cause your breathing to slow down or stop. Death may result. If you are having slow breathing with long pauses or blue lips, someone caring for you needs to seek immediate medical attention. Acetaminophen can cause severe skin reactions that are fatal. This may happen even if you've taken it before and never had a reaction. If you experience skin redness, a rash, blisters, or peeling, stop taking the medicine immediately and contact your doctor.

If you experience:

  • Sighing, noisy breathing, shallow breathing, or breathing that stops while sleeping
  • Feeling dizzy as though they might pass out.
  • Weakness, tiredness, fever, unusual bruising, or bleeding;
  • Confuse yourself with unusual thoughts or behaviors.
  • Problems with Urination
  • Liver disease: nausea (upper stomach pain), fatigue, loss of appetite, dark urine or clay-colored stool, or jaundice.
  • Low levels of cortisol—nause and vomiting, loss of appetite, dizziness, or worsening fatigue.

If you experience symptoms of serotonin disorder, including agitation, hallucinations, fever, sweating, or shivering, rapid heart rate, muscle stiffness, and twitching, You may also experience nausea, vomiting, or diarrhea.The risk of serious side effects is higher in older adults, especially those who are obese or malnourished. Men or women may be affected by long-term opioid use. The effects of opioids on fertility may not be permanent.

Common Roxicet side effects include:

  • Feeling tired, dizziness, or drowsiness;
  • Feelings of extreme happiness or sorrow;
  • Nausea, vomiting, and stomach pain;
  • Constipation
  • Headache.

There may be other side effects. Call your doctor immediately if experiencing side effects; call the FDA's Information Hotline on Side Effects (1-800FDA-1088) for reporting purposes.

Interaction with other drug

If you stop or start taking certain medicines, you may experience breathing problems or withdrawal. You should tell your doctor if other medicines are being used, such as antifungal, blood pressure or heart medication, seizure medications, or medication to treat HIV and Hepatitis C.

Opioid medications can interact with other drugs, causing dangerous side effects and even death. Tell your doctor if you use:

  • Cold or allergy medicine, bronchodilator asthma or COPD medications, or diuretic (water pill);
  • Medicines for motion sickness or irritable intestinal syndrome
  • Other narcotic medication—opioid prescription cough medicine or pain medications;
  • A sedative such as Valium, diazepam (alprazolam), lorazepam (lorazepam), Xanax (Klonopin), Versed, and others.
  • A drug that makes you sleepy or slows your breathing. A sleeping tablet, a muscle relaxer, or medicine for mood disorders or mental illnesses.
  • Drugs that increase serotonin in the body, such as stimulants, medicines for depression, Parkinson’s disease, migraine headaches, or serious infections

This list is incomplete. Other drugs, such as vitamins and herbal products, may interact with acetaminophen or oxycodone. This list does not encompass every potential interaction.

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Prescription only

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