REPREXAIN

Physicians prescribe REPREXAIN to relieve short-term acute pain lasting ten days or less.

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Other, off label uses for REPREXAIN

Ingredients in REPREXAIN soothe cough as well as reduce fever and inflammation.

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Administration/Dosage

REPREXAIN contains hydrocodone and ibuprofen. Hawthorn Pharmaceuticals, Inc., offers REPREXAIN in three strengths in tablet form intended for oral use. Each REPREXAIN contains 200 mg of ibuprofen and either 2.5 mg, 5 mg or 10 mg of hydrocodone bitartrate.

Physicians should prescribe the lowest effective dose REPREXAIN for the shortest duration possible. REPREXAIN should be used for 10 days or less and only in cases of acute pain.

Physicians should prescribe the lowest possible dose and discontinue therapy at the earliest possible time.

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Action

Hydrocodone acts with the central nervous system, or CNS, to change the way the brain perceives pain. Other CNS actions include drowsiness, mental clouding and changes in mood.

The hydrocodone in REPREXAIN acts on smooth muscle groups, including those in the digestive tract.

Ibuprofen is a non-steroidal anti-inflammatory drug, or NSAID. Researchers are still working to establish exactly how NSAIDs work but think these drugs inhibit the production of chemicals associated with pain, fever and inflammation.

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Warnings

Cardiovascular Events

Using NSAIDs like the ibuprofen in REPREXAIN increases the risk for serious heart and blood conditions, like bleeding disorders, heart attack and stroke. Individuals with a history of heart disease may be at greater risk. To minimize this risk, physicians should start these patients at a low dose and discontinue use as soon as possible.

Using an NSAID like ibuprofen to treat pain in the 10 to 14 days after the heart surgery known as CABG increases the risk for heart attack and stroke.

Products containing NSAIDs, like REPREXAIN, can lead to the onset of new high blood pressure or it can worsen pre-existing cases of hypertension; these may contribute to an increased incidence of cardiovascular events. Patients with hypertension should use caution when taking REPREXAIN and have their blood pressure checked frequently.

Taking REPREXAIN may cause fluid retention and edema. Patients battling pre-existing fluid retention or heart failure should use care when consuming REPREXAIN.

Misuse, Abuse and Diversion of Opioids

To use a Because of the euphoria hydrocodone provides, recreational users target REPREXAIN. REPREXAIN can be diverted from therapeutic use to non-medical use. To use a drug non-medically means to take it to get high or to treat a condition other than the one for which it was prescribed.

Respiratory Depression

Hydrocodone acts on breathing centers in the brain to depress respiration. At high doses and in some consumers, the hydrocodone in REPREXAIN may cause the dangerous breathing condition, respiratory depression. Hydrocodone also affects the brain areas responsible for respiratory rhythm, producing irregular and periodic breathing.

Symptoms of respiratory depression include slow or shallow breathing, irregular breathing patterns and a bluish color around the eyes, lips and fingertips.

Head Injury and Increased Intracranial Pressure

Hydrocodone can elevate cerebrospinal fluid pressure surrounding the brain and spinal cord. Head injury, brain tumor or a pre-existing increase in pressure inside the skull may enhance this effect as well as increase the respiratory depressant effects of hydrocodone. Additionally, hydrocodone can produce side effects that can obscure the condition of patients suffering from head injuries.

Acute Abdominal Conditions

The hydrocodone in REPREXAIN may obscure the diagnosis or progression of acute abdominal conditions.

Gastrointestinal (GI) Effects
NSAIDs, including the ibuprofen in REPREXAIN can cause serious GI events, such as inflammation, bleeding, ulcers and perforation of the stomach, small intestine, or large intestine. These events can be fatal and can occur at any time, with or without warning symptoms in people taking NSAIDs. Only one in five NSAID consumers who develops a serious upper gastrointestinal problem has symptoms. While the risk for ulcers, bleeding and perforations increase with long-term NSAID use, even short-term NSAID use poses a risk.

Thos with a history of ulcers or gastrointestinal bleeding should use REPREXAIN with care as these individuals face a 10-fold risk for developing gastrointestinal bleeding as compared to consumers without these risk factors. Other risk factors for GI bleeding include using oral corticosteroids or anticoagulants, long-term NSAID use, smoking, alcohol use, older age and poor overall health. Most reports of fatal GI events are in elderly or debilitated patient. Using the lowest effective dose of REPREXAIN for the shortest time possible reduces the risk for GI events.

Renal Effects

Using ibuprofen for a long time can result in serious kidney problems including renal papillary necrosis, a condition where kidney cells die. Ibuprofen may prevent adequate blood flow to the kidneys. Some people are at greater risk for this interaction between their kidneys and the ibuprofen in REPREXAIN, especially elderly consumer and individuals who suffer kidney disease, heart failure or liver disease. The medications ACE inhibitors and diuretics, sometimes referred to as "water pills," also increase the risk for renal effects.

Anaphylactoid Reactions

NSAIDs may cause anaphylactoid reactions, a dangerous and potentially fatal form of an allergic reaction. An anaphylactoid reaction can occur in patients without known prior exposure to REPREXAIN; normally a person can have an allergic reaction only to something he has been in contact with before. An anaphylactoid reaction typically happens in asthmatic patients who experience a runny or stuffy nose with or without nasal polyps. Individuals who experience the serious breathing problem, bronchospasms, after taking aspirins or other NSAIDs are also at risk for anaphylactoid reactions.

Skin Reactions

REPREXAIN and other products containing ibuprofen may cause serious, potentially fatal skin reactions including exfoliative dermatitis, Stevens-Johnson Syndrome and toxic epidermal necrolysis. These skin reactions may occur without warning. Consumers should discontinue REPREXAIN at the first sign of skin sensitivity.

Pregnancy

Using REPREXAIN in late pregnancy may cause an important blood vessel in the unborn baby to close prematurely.

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Precautions

REPREXAIN may cause dizziness, drowsiness or impair physical and mental performance. Consumers should avoid operating motor vehicles or other heavy machinery while taking REPREXAIN. Alcohol and other CNS depressants add to this effect.

The ibuprofen in REPREXAIN may cause bleeding problems, including some types of anemia and prolonged bleeding times.

Special Risk Patients

Elderly and debilitated patients should use REPREXAIN with caution, as should those with severe liver or kidney dysfunction, Addison's disease or certain types of thyroid, prostate or urinary problems. The hydrocodone in REPREXAIN suppresses the cough reflex, therefore surgical patients and individuals with breathing problems should use REPREXIAN with care.

REPREXAIN may raise laboratory test results monitoring liver function in up to 15 percent of consumers. Rarely, consumers have suffered severe liver reactions including yellowing of the skin and eyes, liver dysfunction and even liver failure; some of these cases had fatal outcomes.

People with asthma may have aspirin-sensitive asthma; these individuals are at higher risk for the serious and sometimes fatal breathing problem, bronchospasm. Cross-reactions between aspirin and other NSAIDs have been reported, so individuals with this type of asthma should not take REPREXAIN.

Contraindications

REPREXAIN is not for use in relieving pain from osteoarthritis or rheumatoid arthritis.
People with known hypersensitivity to hydrocodone or ibuprofen should not use REPREXAIN. Individuals hypersensitive to other opioids, such as codeine or morphine, may experience cross-sensitivity to the hydrocodone in REPREXAIN.

Individuals with asthma, itching or rash after taking aspirin or other NSAIDs should not take REPREXAIN. Severe, rarely fatal, reactions may occur.

Sudden Cessation

Using REPREXAIN continuously for more than a few weeks may be habit-forming and cause physical dependence resulting in flulike withdrawal symptoms when the consumer stops using this drug abruptly. The individual may be able to avoid these withdrawal symptoms by taking successively smaller doses increasingly further apart.

Pregnancy and Breastfeeding

REPREXAIN is Pregnancy Category C, meaning scientists have not yet determined whether taking REPREXAIN affects a woman's ability to get pregnant or have established the potential harm to her unborn baby.

Babies born to mothers who took REPREXAIN continuously late in pregnancy may be born dependent on hydrocodone and suffer withdrawal symptoms in the first few days of life. These babies are more irritable and cry, sneeze and yawn excessively. Other neonatal withdrawal symptoms include tremors, hyperactive reflexes, rapid breathing, increased stools, vomiting and fever.

Research has not yet established whether hydrocodone passes into breast milk and what harm it might do to a nursing child. Mothers should weigh the benefits to her health against the potential harm to her child.

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Drug Interactions

REPREXAIN can interact with other medications in unsafe or unfavorable ways.
ACE-inhibitors
REPREXAIN may prevent ACE-inhibitors from effectively reducing blood pressure.

Anticholinergics

Using REPREXAIN with the class of drugs known as anticholinergics may cause the dangerous digestive problem, paralytic ileus.

Antidepressants
Using REPREXAIN with the antidepressant drugs, MAOIs and tricyclic antidepressants, can increase the effects of either hydrocodone or the antidepressant. People who have used MAOIs in the previous 14 days should not use REPREXAIN.

Aspirin
Using REPREXAIN with aspirin may increase the risk for side effects.

CNS Depressants
Using REPREXAIN with other opioids, antihistamines, antipsychotics, anti-anxiety drugs or other CNS depressants, including alcohol, may add to CNS depression.

Diuretics
REPREXAIN may interfere with the way diuretics, or "water pills," work.

Lithium
In those who take Lithium, REPREXAIN may elevate blood lithium levels and interfere with the way the kidneys clear lithium from the body.

Methotrexate
REPREXAIN may enhance the toxicity of methotrexate.

Mixed Agonist/Antagonist Opioid Analgesics

Some drugs can interfere with the way REPREXAIN works, preventing analgesia and producing withdrawal symptoms in consumers who have become physically dependent on hydrocodone. These drugs include pentazocine, nalbuphine, butorphanol and buprenorphine.

Neuromuscular Blocking Agents
The hydrocodone in REPREXAIN may enhance the way muscle relaxants work. Using REPREXAIN with neuromuscular blocking agents increases the risk for and degree of respiratory depression.

Warfarin
The ibuprofen in REPREXAIN works together with warfarin to increase the risk for serious GI bleeding.

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Side effects

REPREXAIN may cause side effects. General side effects include abdominal pain, weakness, fever, headache, infection and pain. This product may cause palpitations, loss of appetite, nausea, constipation or diarrhea and dry mouth. REPREXAIN may cause upset stomach, itching, sweating and ringing in the ears.

Because of the way the hydrocodone interacts with the central nervous system, REPREXAIN may cause CNS side effects including anxiety, confusion, dizziness, stiff muscles, insomnia, nervousness, sleepiness and thinking abnormalities.

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Overdose

It is possible to overdose on either the hydrocodone or the ibuprofen in REPREXAIN, or both. Prescription painkiller overdose kill nearly 15,000 people every year in the United States while NSAID overdose claims 7,600 lives. REPREXAIN overdose requires emergency care.

Hydrocodone overdose and ibuprofen overdose have different effects and produce different symptoms. Hydrocodone overdose causes respiratory depression, extreme sleepiness that worsens to stupor or coma, weak muscles and cold, clammy skin. Sometimes the victim will have a slow heartbeat and low blood pressure. In severe overdoses, the individual will suffer a stopped heartbeat, circulatory collapse or death.

Ibuprofen overdose may result in irritation, erosion or perforation of the gastrointestinal tract, damage to the kidneys, liver or heart, or meningitis, bleeding disorders or various types of anemia. Symptoms include headache, dizziness, confusion, ringing in the ears and blurred vision. Other symptoms include skin rash, swelling, mental disturbances, high blood potassium levels and inflammation in the mouth and eye problems.

Emergency room personnel will establish an airway or put the victim on a ventilator to help him breathe. Physicians will administer naloxone to counter the effects of respiratory depression and coma associated with hydrocodone toxicity. Nurses may introduce charcoal to absorb excess REPREXAIN from the victim's stomach. If less than one hour has elapsed since the victim consumed REPREXAIN, nurses will pump excess medication from the patient's stomach.

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Abuse

Hydrocodone causes a pleasant euphoria that makes REPREXAIN a target for recreational abuse. The DEA classifies REPREXAIN as a category III narcotic, meaning it poses a moderate risk for abuse. To reduce this risk, REPREXAIN is available only with a prescription.
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Withdrawal

Using REPREXAIN for more than a few weeks increases the risk for developing physical dependence resulting in uncomfortable withdrawal symptoms when the individual stops using this drug. Experiencing withdrawal symptoms does not necessarily indicate criminal behavior - it is possible to become physically dependent on hydrocodone after using therapeutic doses of REPREXAIN as directed by a physician. Flulike physical symptoms and demoralizing psychological symptoms prevent many individuals from discontinuing REPREXAIN.
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Detox

Some hospitals now offer detoxification services, where physicians administer drugs to lower opioid levels plus a variety of medications to ease the ensuing withdrawal symptoms. While inpatient detoxification reduces the severity of withdrawal, they do not reduce the length of detoxification or deal with the demoralizing aspects of drug dependence.

Rapid detox is the most humane and efficient form of detoxification available. During rapid detox, board-certified anesthesiologists administer the standard detoxification and anti-withdrawal drugs along with sedatives and anesthesia. The rapid detox patient dozes in a comfortable "twilight sleep" during detoxification, unaware of the physical and psychological aspects of withdrawal when he awakens a few hours later.

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Storage

Keep REPREXAIN at temperatures between 68 degrees Fahrenheit and 77 degrees Fahrenheit, in a light-resistant container.

Facts

  • REPREXAIN