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|Roxicet Solution

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Roxicet Solution

Generic Name: Acetaminophen/Oxycodone Oral Solution (a-seet-a-MIHN-oh-fen/OX-ee-KOE-dohn)
Brand Name: Roxicet

Roxicet Solution is used for:

Relieving moderate to moderately severe pain. Roxicet Solution may also be used to treat other conditions as determined by your doctor.

Roxicet Solution is a combination of a narcotic and an analgesic/antipyretic. The narcotic works by binding to opioid receptors in the brain and spinal cord, while the analgesic/antipyretic decreases the formation of certain chemicals (eg, prostaglandins), which reduces pain.

Do NOT use Roxicet Solution if:

you are allergic to any ingredient in Roxicet Solution
you have severe diarrhea due to taking an antibiotic
you are taking naltrexone or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Roxicet Solution:

Some medical conditions may interact with Roxicet Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have liver or kidney disease, heart problems, lung disease, seizure disorders, serious head injury or brain disease, spinal problems, an underactive thyroid, adrenal gland problems, or breathing problems
prostate problems, difficulty urinating, abdominal/stomach problems, gallbladder problems, severe diarrhea, inflammatory bowel disease, or hepatitis
if you have or have a history of substance abuse or dependence, psychiatric problems, or if you have tried or had thoughts of suicide

Some MEDICINES MAY INTERACT with Roxicet Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:

Naltrexonebecause the effectiveness of Roxicet Solution may be decreased
Barbiturate anesthetics (eg, thiopental), cimetidine, isoniazid, sodium oxybate (GHB), or sulfinpyrazone because side effects such as difficulty breathing and sedation may occur
Anticoagulants (eg, warfarin), barbiturate anesthetics (eg, thiopental), or sodium oxybate (GHB) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Roxicet Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Roxicet Solution:

Use Roxicet Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Roxicet Solution may be taken with food if it upsets your stomach, although doing so may decrease its effectiveness. Consult your doctor or pharmacist about alternatives for decreasing nausea (such as taking antihistamines or lying down for 1 to 2 hours with minimal head movement).
Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.
If you miss a dose of Roxicet Solution and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Roxicet Solution.

Important safety information:

Roxicet Solution may cause dizziness, lightheadedness, blurred vision, or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Roxicet Solution. Using Roxicet Solution alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
To minimize dizziness or lightheadedness, get up slowly when rising from a seated or lying position.
Avoid alcohol or other mental depressant medicines (eg, tranquilizers, sleeping pills) while taking Roxicet Solution.
Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Roxicet Solution.
To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you become constipated while using Roxicet Solution, talk with your doctor or pharmacist; a stool softener or bulk laxative may help.
Roxicet Solution contains acetaminophen. Adults should not take more than a total of 4 grams (4,000 mg) of acetaminophen in a 24 hour period (3 grams [3,000 mg] per day if you have liver disease). Check with your doctor before taking other pain relievers, cough-and-cold medicines, or allergy medicines as they may also contain acetaminophen. Acetaminophen may cause liver damage. If you drink alcohol on a daily basis, do not take Roxicet Solution without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage (symptoms include yellowing of skin or eyes, stomach pain, dark urine).
Caution is advised when using Roxicet Solution in the ELDERLY because they may be more sensitive to its side effects, especially decreased breathing and drowsiness effects.
Use Roxicet Solution with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Roxicet Solution during pregnancy. Roxicet Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Roxicet Solution, check with your doctor to discuss the risks to your baby.

Roxicet Solution may be habit-forming and lead to DEPENDENCE if used in high doses or for a long period of time. If you are on long-term or high-dosage therapy, you may have WITHDRAWAL symptoms (eg, convulsions, tremor, stomach and muscle cramps, vomiting, sweating) if you suddenly stop taking Roxicet Solution. Do not stop therapy abruptly or change dosage without asking your pharmacist or doctor. Discuss overuse with your doctor or pharmacist.

Possible side effects of Roxicet Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; flushing; lightheadedness; mental/mood changes; nausea; vision changes; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in amount of urine; dark urine; slow or irregular heartbeat; slow or irregular breathing; stomach pain; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch .

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold/clammy skin; extreme drowsiness; fatigue; loss of consciousness; persistent nausea/vomiting; slow heartbeat; slow, shallow, or abnormal breathing; stomach pain; unusual sweating; weakness; yellowing of the skin or eyes.

Proper storage of Roxicet Solution:

Store Roxicet Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Roxicet Solution out of the reach of children and away from pets.

General information:

If you have any questions about Roxicet Solution, please talk with your doctor, pharmacist, or other health care provider.
Roxicet Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Roxicet Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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