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Drugs & Medications

Reprexain

GENERIC NAME(S): HYDROCODONE/IBUPROFEN

WARNINGS:

The ibuprofen in this combination medication may rarely increase the risk for a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This can occur without warning symptoms and at any time during treatment. Older adults have an increased risk of bleeding.

Stop taking this medication and get medical help right away if you notice any of the following rare but very serious side effects: chest pain, severe dizziness, weakness on one side of the body, vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)

Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.

Who should not take Reprexain?
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Uses

This combination medication is used for a short time (usually less than 10 days) to help relieve moderate to severe pain. It contains a narcotic pain reliever (hydrocodone) and a nonsteroidal anti-inflammatory drug-NSAID (ibuprofen). Hydrocodone works in the brain to change how your body feels and responds to pain. Ibuprofen reduces pain and fever.

This medication is not intended to treat long-term conditions (such as arthritis).

How to use Reprexain

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually every 4 to 6 hours as needed. Take it with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for 10 minutes after taking this drug. You may take this drug with or without food. If you have nausea, it may help to take this drug with food. Ask your doctor or pharmacist about other ways to decrease nausea (such as lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take the medication more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. The manufacturer recommends you take no more than 5 tablets in a 24-hour period.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well. Also follow your doctor's or pharmacist's directions for the safe use of other non-narcotic pain relievers (such as acetaminophen).

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as restlessness, watering eyes, runny nose, nausea, sweating, muscle aches) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Ask your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

Side Effects

See also Warning section.

Upset stomach, nausea, vomiting, constipation, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, fast/pounding heartbeat, difficult/painful swallowing, mental/mood changes, difficulty urinating, swelling of hands/feet, sudden/unexplained weight gain, unusual weakness, unusual tiredness.

Stop taking this medication and get medical help right away if any of these rare but serious side effects occur: fainting, slow/irregular/shallow breathing, change in amount of urine, unusual drowsiness/difficulty waking up, unexplained fever, persistent/severe headache, unexplained stiff neck.

This drug may rarely cause serious, possibly fatal, liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this medication, tell your doctor or pharmacist if you are allergic to ibuprofen or hydrocodone; or to aspirin or other NSAIDs (such as naproxen, celecoxib); or to narcotic pain medications (such as codeine, morphine, hydromorphone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), low red blood cell count (anemia), bleeding or clotting problem, brain disorders (such as head injury, tumor, seizures, stroke), breathing problems (such as asthma, sleep apnea, chronic obstructive pulmonary disease-COPD), growths in the nose (nasal polyps), high blood pressure, heart problems (such as irregular heartbeat, recent heart attack), liver disease, mental/mood disorders (such as confusion, depression, thoughts of suicide), personal or family history of regular use/abuse of drugs/alcohol, stomach/intestinal problems (such as ulcer, blockage, constipation, diarrhea due to infection, paralytic ileus), fluid retention/swelling of the ankles/feet/hands, difficulty urinating (such as due to enlarged prostate), gallbladder disease, disease of the pancreas (pancreatitis).

Kidney problems can sometimes occur with the use of NSAID medications, including ibuprofen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.

Older adults may be more sensitive to the side effects of this drug, especially dizziness, drowsiness, confusion, stomach bleeding, kidney problems and slow/shallow breathing.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

Babies born to mothers who have used this medication in high doses or for an extended time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice any of these symptoms in your newborn, tell the doctor promptly.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aliskiren, ACE Inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (such as prednisone), lithium, pemetrexed, probenecid, certain pain medications (mixed narcotic agonist-antagonists such as pentazocine, nalbuphine, butorphanol).

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Other medications can affect the removal of hydrocodone from your body, which may affect how this medication works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and other narcotic pain relievers (such as codeine, hydromorphone).

Check all prescription and nonprescription medicine labels carefully for ibuprofen or other pain/fever drugs (aspirin, NSAIDs such as celecoxib, ketorolac, or naproxen). These drugs are similar to ibuprofen, so taking one of these drugs while also taking ibuprofen may increase your risk of side effects. However, if your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise.

Daily use of ibuprofen may decrease aspirin's ability to prevent heart attack/stroke. Talk to your doctor about using a different medication (such as acetaminophen) to treat pain. If you must take ibuprofen, talk to your doctor about possibly taking immediate-release aspirin (not enteric-coated/EC) while taking ibuprofen. Take this product at least 8 hours before or at least 30 minutes after your aspirin dose. Do not increase your daily dose of aspirin or change the way you take aspirin/other medications without your doctor's approval.

This medication may interfere with certain laboratory tests (including amylase/lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: slow breathing, fast/slow/irregular heartbeat, loss of consciousness.

Notes

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (such as kidney function tests) may be performed to check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case.

Missed Dose

If you are taking this product on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Different brands of this medication may have different storage requirements. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised April 2014. Copyright(c) 2014 First Databank, Inc.

Images

REPREXAIN 5-200 MG TABLET
REPREXAIN 5-200 MG TABLET
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IP 146
REPREXAIN 10-200 MG TABLET
REPREXAIN 10-200 MG TABLET
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IP 117
REPREXAIN 2.5-200 MG TABLET
REPREXAIN 2.5-200 MG TABLET
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oblong
imprint
IP 116
REPREXAIN 5-200 MG TABLET
REPREXAIN 5-200 MG TABLET

Identification

color
white
shape
oval
imprint
IP 146
This medicine is a white, oval, scored, film-coated tablet imprinted with "IP 146".
REPREXAIN 10-200 MG TABLET
REPREXAIN 10-200 MG TABLET

Identification

color
yellow
shape
round
imprint
IP 117
This medicine is a yellow, round, film-coated tablet imprinted with "IP 117".
REPREXAIN 2.5-200 MG TABLET
REPREXAIN 2.5-200 MG TABLET

Identification

color
white
shape
oblong
imprint
IP 116
This medicine is a white, oblong, film-coated tablet imprinted with "IP 116".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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