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|Roxanol Concentrate

Roxanol Concentrate

Roxanol Concentrate is used for:

Treating moderate to severe pain.

Roxanol Concentrate is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use Roxanol Concentrate if:

• you are allergic to any ingredient in Roxanol Concentrate
• you have known or suspected paralysis of the intestines or antibiotic-associated colitis
• you have diarrhea due to poisoning
• you are taking cimetidine, sodium oxybate (GHB), or a tricyclic antidepressant (eg, amitriptyline), or you drink alcohol
• you have slowed breathing or severe asthma or are having an asthma attack

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

Before using Roxanol Concentrate:

Some medical conditions may interact with Roxanol Concentrate. 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 asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems, or you have a history of drug abuse or dependence
• if you have increased pressure in the head, a recent head injury, or lesions in the head
• if you have difficulty urinating; heart, liver, or thyroid disease; hypercapnia (abnormally increased carbon dioxide tension in your arteries); curvature of the spine; seizures; or a history of suicidal thoughts or behaviors
• if you have low blood volume, a stomach blockage or inflammatory bowel disease, have had stomach tract surgery, or are in shock

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

• Fluoxetine, naltrexone, narcotic agonists/antagonists (eg, pentazocine), rifampin, or risperidone because they may decrease Roxanol Concentrate"s effectiveness
• Barbiturate anesthetics (eg, thiopental), cimetidine, ethanol, ketorolac, sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because side effects (eg, disorientation, respiratory depression, seizures) may occur
• Barbiturate anesthetics (eg, thiopental) or sodium oxybate (GHB) because the risk of their side effects may be increased by Roxanol Concentrate
• Mexiletine or trovafloxacin because their effectiveness may be decreased by Roxanol Concentrate

This may not be a complete list of all interactions that may occur. Ask your health care provider if Roxanol Concentrate 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 Roxanol Concentrate:

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

• Take Roxanol Concentrate by mouth with or without food.
• Use the dropper that comes with Roxanol Concentrate to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• Take Roxanol Concentrate on a regular schedule to get the most benefit from it. It is more effective in preventing pain than in treating pain after it occurs.
• If you also take trovafloxacin, do not take it within 4 hours before or after taking Roxanol Concentrate. Check with your doctor if you have questions.
• If you miss a dose of Roxanol Concentrate, 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 Roxanol Concentrate.

Important safety information:

• Roxanol Concentrate may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Roxanol Concentrate with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Roxanol Concentrate; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Roxanol Concentrate may cause constipation. Constipation may be avoided by using a stool softener or fiber laxative.
• The risk of Roxanol Concentrate becoming habit-forming may be greater if you take it in high doses or for a long time. Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Tell your doctor or dentist that you take Roxanol Concentrate before you receive any medical or dental care, emergency care, or surgery.
• Do not take Roxanol Concentrate if you have had a severe allergic reaction to morphine or hydromorphone (eg, MS Contin, Roxanol, Dilaudid). If you have a question about whether you are allergic to Roxanol Concentrate or if a certain medicine contains morphine or hydromorphone, contact your doctor or pharmacist.
• Lab tests, including liver function, kidney function, lung function, and complete blood cell counts, may be performed while you use Roxanol Concentrate. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Roxanol Concentrate with caution in the ELDERLY; they may be more sensitive to its effects.
• Roxanol Concentrate should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Roxanol Concentrate while you are pregnant. Roxanol Concentrate is found in breast milk. Do not breast-feed while taking Roxanol Concentrate.

When used for long periods of time or at high doses, Roxanol Concentrate may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Roxanol Concentrate stops working well. Do not take more than prescribed.

Some people who use Roxanol Concentrate for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Roxanol Concentrate suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Roxanol Concentrate:

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; exaggerated sense of well-being; headache; lightheadedness; nausea; restless mood; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue); excessive drowsiness; hallucinations; pounding in the chest; seizures; shock; shortness of breath; sudden chest pain; sweating.

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 and clammy skin; convulsions; deep sleep; dizziness; drowsiness; lightheadedness; loss of consciousness; low body temperature; slowed breathing; slowed heartbeat.

Store Roxanol Concentrate between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Roxanol Concentrate out of the reach of children and away from pets.

General information:

• If you have any questions about Roxanol Concentrate, please talk with your doctor, pharmacist, or other health care provider.
• Roxanol Concentrate 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 Roxanol Concentrate. 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.