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|Reprexain

Reprexain

Reprexain is used for:

Short-term treatment of pain.

Reprexain is an opioid analgesic and NSAID combination. Exactly how it works is not known. Ibuprofen may block certain substances in the body that cause inflammation. Hydrocodone may affect opiate receptors in the brain to decrease pain.

Do NOT use Reprexain if:

• you are allergic to any ingredient in Reprexain or any other codeine- or morphine-related medicine (eg, codeine)
• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
• you have severe kidney problems or you have severe diarrhea or other bowel problems caused by antibiotics or food poisoning
• you have recently had or will be having bypass heart surgery
• you are in the last 3 months of pregnancy
• you take sodium oxybate (GHB) or you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days

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

Before using Reprexain :

Some medical conditions may interact with Reprexain . 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 or a family member has a history of mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse, or if you drink alcohol
• if you have a history of kidney, liver, or lung problems, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers)
• if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth inflammation
• if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel problems, or if you are at risk for any of these problems
• if you have Addison disease, thyroid problems, an enlarged prostate, or trouble urinating
• if you have asthma or breathing problems, seizures, growths in the brain, a recent head injury, or if you have had recent surgery
• if you have poor health, dehydration or low fluid volume, or low blood sodium levels

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

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), heparin, salicylates (eg, aspirin), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of bleeding, including stomach bleeding, may be increased
• Antihistamines (eg, diphenhydramine), barbiturates (eg, phenobarbital), cimetidine, narcotic pain medicine (eg, codeine), or sodium oxybate (GHB) because the risk of excessive drowsiness or severe breathing problems may be increased
• Anticholinergics (eg, benztropine), MAOIs (eg, phenelzine), probenecid, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Reprexain "s side effects
• Naltrexone or rifampin because they may decrease Reprexain "s effectiveness
• Cyclosporine, lithium, methotrexate, or quinolones (eg, ciprofloxacin) because the risk of their side effects may be increased by Reprexain
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Reprexain

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

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

• Reprexain comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Reprexain refilled.
• Take Reprexain by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you miss a dose of Reprexain and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

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

Important safety information:

• Reprexain may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Reprexain 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 Reprexain ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Serious stomach ulcers or bleeding can occur with the use of Reprexain . Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Reprexain with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Reprexain has ibuprofen in it. Before you start any new medicine, check the label to see if it has ibuprofen in it too. If it does or you are not sure, check with your doctor or pharmacist.
• Do not take aspirin while you take Reprexain unless your doctor tells you to. If you already take aspirin for a heart or other condition, talk with your doctor about whether or not you should continue to take it with Reprexain .
• Lab tests, including liver function, kidney function, complete blood cell counts, and blood pressure, may be performed while you use Reprexain . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Reprexain with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding.
• Reprexain should be used with extreme caution in CHILDREN younger than 16 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Reprexain may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Reprexain while you are pregnant. It is not known if Reprexain is found in breast milk. Do not breast-feed while taking Reprexain .

When used for long periods of time or at high doses, Reprexain 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 Reprexain stops working well. Do not take more than prescribed.

Some people who use Reprexain 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 suddenly stop taking Reprexain , you may experience WITHDRAWAL symptoms, including 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 Reprexain :

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:

Anxiety; constipation; diarrhea; dizziness; dry mouth; gas; headache; heartburn; increased sweating; loss of appetite; nausea; nervousness; stomach pain or upset; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; blurred vision; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slow or shallow breathing; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; 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 blurred vision; cold and clammy skin; coma; confusion; decreased urination; loss of consciousness; ringing in the ears; severe dizziness or drowsiness; severe muscle weakness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Store Reprexain at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Reprexain out of the reach of children and away from pets.

General information:

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