Ibudone

Uses

Doctors prescribe Ibudone to relieve acute pain lasting less than ten days. Ibudone is not appropriate for treatment of chronic pain, like that associated with arthritis.
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Other, off label uses for this medicine

Ingredients in Ibudone soothe a nagging cough, reduce a fever and ease inflammation.

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Administration/Dosage

Ibudone is available in tablet form for oral administration. ProEthic Pharmaceuticals produces Ibudone in two strengths. Each tablet contains 200 mg of ibuprofen and 5 mg or 10 mg of hydrocodone bitartrate.

Physicians should start with the lowest dose possible and discontinue Ibudone as soon as possible to minimize the risk for cardiovascular problems, especially in older patients. The usual dose is one tablet every four to six hours as needed for pain, not to exceed five tablets in a 24-hour period. Physicians will monitor the patient's condition and response to treatment, modifying Ibudone dosage accordingly.

Medical research has not yet established whether Ibudone is safe and effective for children under the age of 16.

Since patients take Ibudone only when needed for pain and not on a regular schedule, consumers do not need to worry about missed doses.

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Action

Hydrocodone works by binding to opioid receptors in the nervous system to change the way the brain perceives pain. Interaction with the central nervous system, or CNS, causes analgesia, sedation, relief from anxiety and a pleasant euphoria.

Hydrocodone acts on smooth muscle groups, like the intestinal muscles that keep food moving through the digestive tract. Hydrocodone works on the breathing center in the brain, the medulla, to depress the cough reflex. Consequently, hydrocodone may cause digestive issues and breathing problems.

Ibuprofen is a non-steroidal anti-inflammatory drug, or NSAID, that works differently than hydrocodone to produce a more effective analgesia than either medicine could alone. Scientists have not yet determined exactly how ibuprofen works, but they think it reduces pain by interfering with the production of prostaglandin, a natural compound that delivers pain messages to the brain.
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Warnings

Cardiovascular Effects

Clinical trials show using ibuprofen and other NSAIDs increases the risk for potentially fatal heart and vein problems, including blood clotting issues, heart attack and stroke. Using Ibudone or other drugs containing NSAIDs 10 to 15 days after some types of coronary bypass surgery increases the risk for heart attack and stroke.

Hypertension

Ibudone and other NSAID products may lead to the onset of new hypertension or worsen existing cases of high blood pressure in a way that increases the risk for cardiovascular events. Prescribing physicians should monitor the consumer's blood pressure closely.

Congestive Heart Failure and Edema

Some Ibudone consumers experience fluid retention and edema, which is fluid accumulation in body tissues. Fluid in the heart is known as pulmonary edema, a serious cardiovascular condition. Congestive heart failure is condition where the heart cannot effectively pump blood to the entire body. Patients with edema or congestive heart failure should use Ibudone with caution.

Respiratory Depression

Because of the way the hydrocodone acts on respiratory centers in the brain, Ibudone may cause respiratory depression, a dangerous breathing problem. In cases of respiratory depression, the lungs cannot adequately exchange oxygen for carbon dioxide and other gases, causing suffocation and a buildup of toxic gases in body tissues. Symptoms of respiratory depression include slow or shallow breathing, irregular respiratory patterns and a bluish tinge around the victim's eyes, mouth and fingertips.

Respiratory depression occurs after high doses of Ibudone or in consumers who are hypersensitive to the effects of hydrocodone.

Head Injury and Intracranial Pressure

Along with causing respiratory depression, the hydrocodone in Ibudone may increase fluid pressure surrounding the brain. Head injuries, intracranial lesions and pre-existing elevated intracranial pressure may enhance these opioid effects. Additionally, using Ibudone may obscure the presence of a head injury or make it difficult for a physician to gauge how well a head injury is healing.

Acute Abdominal Conditions

Using Ibudone may obscure diagnosis and progress of patients suffering from acute abdominal conditions.

Gastrointestinal Effects

The ibuprofen in Ibudone may cause serious gastrointestinal effects suddenly and without warning; some gastrointestinal effects can be fatal. Most spontaneous, fatal gastrointestinal effects occur in older or debilitated patients.

Gastrointestinal effects include inflammation, bleeding, ulceration and perforation of the stomach, small intestine or large intestine. Only one in five people who develop a serious ibuprofen-related gastrointestinal effect have symptoms. Using a short course of the lowest Ibudone dose possible reduces the risk for these gastrointestinal effects.

Patients with a history of ulcers or gastrointestinal bleeding are ten times more likely to develop gastrointestinal bleeding than other consumers are. Other factors that increase the risk for gastrointestinal bleeding include the use of oral corticosteroids or anticoagulants, using NSAIDs for a long time, smoking, alcohol consumption, older age and poor overall health.

Renal Disease

Using ibuprofen for a long time may cause serious kidney problems including renal papillary necrosis, a condition involving the death of certain cells in the kidneys. Ibuprofen may affect the blood flow to the kidneys. Some individuals are at greater risk for this interaction between ibuprofen and the kidneys, especially those who suffer kidney disease, heart failure, liver disease and the elderly. The medications ACE inhibitors and diuretics, commonly known as "water pills," also increase the risk for renal effects.

Anaphylaxis

Anaphylaxis is a serious form of allergic reaction. Anyone can suffer an anaphylactic reaction from Ibudone, even in those who have never taken medicine containing hydrocodone and ibuprofen; normally, someone can only suffer an allergic reaction to substances with which he has had previous contact.

Individuals with the "aspirin triad" should not take Ibudone. The aspirin triad is asthma, nasal polyps and rhinitis. Anaphylaxis may be fatal in these individuals.

Skin Reactions

Ibudone and other products containing NSAIDs can cause serious skin reactions without warning. Skin reactions include exfoliative dermatitis, Stevens-Johnson Syndrome and toxic epidermal necrolysis, which can be fatal.

More Warnings about Using Ibudone

Precautions

General

Ibudone reduces pain and fever in a way that can obscure the diagnosis of some medical conditions.

Respiratory

The hydrocodone in Ibudone suppresses the cough reflex. Consequently, physicians should prescribe Ibudone with caution after surgery and to those with breathing problems.

Some people with asthma have aspirin-sensitive asthma, associated with the potentially fatal breathing problem, bronchospasm. It is possible for someone with aspirin-sensitive asthma to have a cross-over sensitivity to ibuprofen. Those with aspirin-sensitive asthma and other types of pre-existing asthma should use Ibudone with care.

Hepatic

Ibudone elevates liver enzyme blood test results in about 15 percent of consumers. Rarely, Ibudone consumers suffer rare hepatic reactions like yellowing of the skin and eyes, hepatitis, death of liver cells and liver failure. These effects are sometimes fatal. Physicians should evaluate Ibudone consumers presenting symptoms or clinical signs of liver problems and consider discontinuing Ibudone therapy.

Hematological Effects

The NSAID in Ibudone may cause anemia in some consumers and prolonged bleeding times in others.

Aseptic Meningitis

Rarely, ibuprofen and hydrocodone tablets are associated with cases of aseptic meningitis with fever and coma. Although it is probably more likely to occur in patients with the autoimmune disorder, systemic lupus erythematosus, aseptic meningitis has been reported in consumers without an underlying chronic disease.

Contraindications

Individuals who are hypersensitive to the effects of hydrocodone or ibuprofen should not use Ibudone. Those who are sensitive to other opioids, such as morphine or codeine, may experience cross-sensitivity to hydrocodone.

Ibudone is not appropriate for treating pain after surgery or coronary artery bypass graft, sometimes called CABG.

People who have experienced asthma, hives or other types of allergic reaction to aspirin should not take Ibudone. Rarely, severe or fatal anaphylactic reactions have occurred in these consumers.

Pregnancy and Breastfeeding

The FDA categorizes drugs according to the risk posed to a pregnant woman or her unborn baby. The FDA rates Ibudone as a pregnancy category C, meaning research has not yet determined the risk hydrocodone poses but that Ibudone should be used only when the benefits outweigh the risks.

NSAIDs like the ibuprofen in Ibudone may affect the cardiovascular system of the unborn child, especially when used late in pregnancy.

Using Ibudone late in the pregnancy may cause the baby to become physically dependent on hydrocodone and suffer withdrawal symptoms after birth, such as irritability and excessive crying, tremors, hyperactive reflexes, rapid breathing, increased stools, sneezing, yawning, vomiting and fever. The intensity of these symptoms does not always correlate with the dose of Ibudone or the duration of drug use.

Researchers have not yet established whether the hydrocodone in Ibudone passes into breast milk and onto a nursing child. Mothers should weigh the benefits and risks of taking Ibudone while breastfeeding a baby.

Sudden cessation

Discontinuing Ibudone abruptly may cause unpleasant withdrawal symptoms, especially if the consumer has taken large doses or used Ibudone continually for more than a few weeks. It may be helpful to taper Ibudone use by taking smaller doses further apart.

Medical History

Ibudone may not be appropriate for individuals with a history of certain medical conditions, including those with liver or kidney problems, hypothyroidism, Addison's disease, prostate problems or urinary trouble.

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Drug Interactions

Some medications may interfere with the way Ibudone works; Ibudone may interact with other drugs in an unsafe or undesirable ways. Patients should supply to the prescribing physician a complete list of all prescription, over-the-counter drugs, vitamins, supplements and herbal remedies. An Ibudone consumer should not begin, stop or change the way he takes any substance, including non-prescription products, without first consulting his doctor.

Patients who have taken an antidepressant known as an MAO inhibitor within the previous two weeks should not take Ibudone. Using hydrocodone while an MAO inhibitor is still in the body may cause serious, potentially fatal side effects including anxiety, confusion, significant respiratory depression and coma.

Drugs known as mixed agonist/antagonist opioids may interfere with the way Ibudone works; these drugs may cause unpleasant withdrawal symptoms in opioid-dependent individuals. Examples of mixed agonist/antagonist opioids include pentazocine, nalbuphine, butorphanol and buprenorphine.

Ibudone may interact in unfavorable ways with:

  • ACE-inhibitors
  • Anticholinergics
  • Antidepressants, especially MAOIs
  • Aspirin
  • CNS depressants, especially other opioids, alcohol, antihistamines, antipsychotics and anti-anxiety drugs
  • Diuretics
  • Lithium
  • Methotrexate
  • Neuromuscular blocking agents, including muscle relaxants
  • Warfarin

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Side effects

Ibudone, like all medications, may cause side effects in some consumers. The severity of these side effects generally increased with higher daily doses of Ibudone.

Commonly reported side effects include loss of appetite, constipation or diarrhea, dry mouth, upset stomach, gas, thirst, nausea and vomiting. Consumers may experience upset stomach, hiccups, runny or stuffy nose, throat inflammation, itching, sweating, ringing in the ears or urinary frequency. Other side effects include palpitations, abdominal pain, fever, headache, infection and pain.

Central nervous system side effects include anxiety, confusion, dizziness, insomnia, nervousness, sleepiness and abnormal thoughts.
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Overdose

It is possible to overdose on either the hydrocodone or the ibuprofen in Ibudone; both types of overdose are serious and potentially fatal. Overdoses of prescription painkillers including kill nearly 15,000 Americans each year, while NSAID overdose claims another 7,600 lives.

Symptoms of hydrocodone overdose include respiratory depression, extreme sleepiness that worsens into a coma, weak muscles and cold, clammy skin. The victim may have a slow heartbeat or very low blood pressure. In a severe hydrocodone overdose, the individual may stop breathing and suffer a collapse of the circulatory system; his heart may stop and he may die.

Ibuprofen causes different signs and symptoms, including gastrointestinal irritation resulting in hemorrhage or perforation, kidney damage, liver damage, heart damage, various types of anemia, low white blood cell counts, low platelet counts that cause bleeding disorders and meningitis. The patient may show signs of high blood potassium levels, corneal deposits, edema and reduced sensitivity to darkness and light. Symptoms of ibuprofen overdose include headache, dizziness, tinnitus, confusion, blurred vision, mental disturbances and inflammation in the mouth.

Transport all suspected victims of Ibudone overdose to the nearest hospital or contact poison control at 1-800-222-1222. Emergency department doctors will administer naloxone to counteract the effects of hydrocodone. Nurses will establish an airway and provide other supportive respiratory care. Nurses may pump excess Ibudone from the stomach, start an IV to administer fluids and stabilize electrolyte balance.

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Abuse

Doctors in the United States prescribe more products containing hydrocodone than any other type of drug. In 2010, American pharmacists filled more than 139 million prescriptions for products containing hydrocodone. The hydrocodone in Ibudone produces a pleasant euphoric feeling; consequently, hydrocodone is the most widely abused drugs in the U.S.

In 2010, 7 million people took psychotherapeutic drugs like Ibudone for non-medical reasons. 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.

The U.S. Drug Enforcement Agency, or DEA, classifies a substance according to its risk for abuse relative to other drugs. For example, heroin is a schedule I narcotic because it gets consumers high quite easily when compared to the schedule V over-the-counter cough suppressant, Robitussin AC, which would probably cause the individual to vomit before he got high. Ibudone is a schedule III narcotic, posing the same risk for abuse as anabolic steroids. To reduce this risk for abuse, Ibudone is available only with a doctor's prescription.

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Withdrawal

Taking Ibudone for a long time or abusing Ibudone for non-medical reasons increases the risk the body will grow dependent on a certain level of hydrocodone to feel "normal." When hydrocodone levels fall abruptly in an opioid-dependent person, his body struggles to maintain chemical stability. Doctors refer to this as the detoxification process. Detoxification causes unpleasant flulike withdrawal symptoms.

Withdrawal symptoms are not necessarily an indication of criminal drug abuse - it is possible to become physically dependent after using therapeutic doses of Ibudone as prescribed by a physician.

Ibudone withdrawal produces physical and psychological withdrawal symptoms that can last five or more days. Physical withdrawal symptoms include muscle aches, watery eyes, insomnia, runny nose, sweating, goose bumps and yawning. Other physical symptoms include stomach cramps, diarrhea, nausea and vomiting.

Psychological symptoms may interfere with recovery efforts, especially when left untreated or poorly treated. Psychological symptoms include anxiety and agitation.

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Detox

Many institutions now offer inpatient detoxification services to help individuals overcome dependence on Ibudone. During detoxification, doctors administer drugs to counteract hydrocodone and give the patient medication to reduce physical withdrawal symptoms; the individual must still endure the psychological aspects of Ibudone withdrawal.

Rapid detox is the most humane and efficient form of detoxification available today. During rapid detox procedures, board-certified anesthesiologists give the patient sedatives and anesthesia alongside the standard detoxification and anti-withdrawal drugs. The rapid detox patient sleeps comfortably through the detoxification process, unaware of the grueling and demoralizing symptoms of withdrawal.
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Storage

Keep Ibudone at temperatures between 68 degrees Fahrenheit and 77 degrees Fahrenheit, away from light.

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Facts

  • Ibudone