Advise both patients and caregivers about the risks of respiratory depression and sedation when Hydrocodone Bitartrate and Ibuprofen Tablets is used with benzodiazepines or other CNS depressants including alcohol and illicit drugs. Advise patients not to drive or operate heavy machinery until the effects of concomitant use of the benzodiazepine or other CNS depressant have been determined.

Drug Interactions, Information for Patients. Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients The use of Hydrocodone Bitartrate and Ibuprofen Tablets in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated. Patients with Chronic Pulmonary Disease: Hydrocodone Bitartrate and Ibuprofen Tablets -treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Hydrocodone Bitartrate and Ibuprofen Tablets see WARNINGS: Elderly, Cachectic, or Debilitated Patients: Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients see WARNINGS: Alternatively, consider the use of non- opioid analgesics in these patients.

Adrenal Insufficiency Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Presentation of adrenal insufficiency may include non-specific symptoms and signs including nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. If adrenal insufficiency is suspected, confirm the diagnosis with diagnostic testing as soon as possible. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off of the opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers.

Other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency. The information available does not identify any particular opioids as being more likely to be associated with adrenal insufficiency.

Severe Hypotension Hydrocodone Bitartrate and Ibuprofen Tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients. There is increased risk in patients whose ability to maintain blood pressure has already been compromised by a reduced blood volume or concurrent administration of certain CNS depressant drugs e. Monitor these patients for signs of hypotension after initiating or titrating the dosage of Hydrocodone Bitartrate and Ibuprofen Tablets.

In patients with circulatory shock, Hydrocodone Bitartrate and Ibuprofen Tablets may cause vasodilation that can further reduce cardiac output and blood pressure. Avoid the use of Hydrocodone Bitartrate and Ibuprofen Tablets in patients with circulatory shock. Monitor such patients for signs of sedation and respiratory depression, particularly when initiating therapy with Hydrocodone Bitartrate and Ibuprofen Tablets.

Opioids may also obscure the clinical course in a patient with a head injury. Avoid the use of Hydrocodone Bitartrate and Ibuprofen Tablets in patients with impaired consciousness or coma. Risks of Use in Patients with Gastrointestinal Conditions Hydrocodone Bitartrate and Ibuprofen Tablets are contraindicated in patients with known or suspected gastrointestinal obstruction, including paralytic ileus.

The hydrocodone in Hydrocodone Bitartrate and Ibuprofen Tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase.

Monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms. Increased Risk of Seizures in Patients with Seizure Disorders The hydrocodone in Hydrocodone Bitartrate and Ibuprofen Tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.

Monitor patients with a history of seizure disorders for worsened seizure control during Hydrocodone Bitartrate and Ibuprofen Tablets therapy.

Risks of Driving and Operating Machinery Hydrocodone Bitartrate and Ibuprofen Tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.

Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. Gastrointestinal Bleeding, Ulceration, and Perforation. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of hydrocodone bitartrate and ibuprofen tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If hydrocodone bitartrate and ibuprofen tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including ibuprofen, cause serious gastrointestinal GI adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with Hydrocodone Bitartrate and Ibuprofen Tablets.

Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors SSRIs ; smoking; use of alcohol; older age; and poor general health status. Most post marketing reports of fatal GI events occurred in elderly or debilitated patients. In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported.

Inform patients of the warning signs and symptoms of hepatotoxicity e. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur e. Hypertension NSAID-containing products, including, can lead to new onset or worsening of pre-existing hypertension, both Hydrocodone Bitartrate and Ibuprofen Tablets of which may contribute to the increased incidence of CV events.

Use of hydrocodone bitartrate and ibuprofen tablets may blunt the CV effects of several therapeutic agents used to treat these medical conditions e. Avoid the use of hydrocodone bitartrate and ibuprofen tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.

If hydrocodone bitartrate and ibuprofen tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.

Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or angiotensin receptor blockers ARBs , and the elderly. No information is available from controlled clinical studies regarding the use of hydrocodone bitartrate and ibuprofen tablets in patients with advanced renal disease.

The renal effects of hydrocodone bitartrate and ibuprofen tablets may hasten the progression of renal dysfunction in patients with pre-existing renal disease. Correct volume status in dehydrated or hypovolemic patients prior to initiating Hydrocodone Bitartrate and Ibuprofen Tablets. Avoid the use of hydrocodone bitartrate and ibuprofen tablets in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function.

If hydrocodone bitartrate and ibuprofen tablets are used in patients with advanced renal disease, monitor patients for signs of worsening renal function. Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, those effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Exacerbation of Asthma Related to Aspirin Sensitivity. Seek emergency help if an anaphylactic reaction occurs. When hydrocodone bitartrate and ibuprofen tablets are used in patients with pre-existing asthma without known aspirin sensitivity , monitor patients for changes in the signs and symptoms of asthma.

These serious events may occur without warning. Premature Closure of Fetal Ductus Arteriosus Ibuprofen may cause premature closure of the fetal ductus arteriosus. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with hydrocodone bitartrate and ibuprofen tablets has any signs or symptoms of anemia, monitor hemoglobin or hematocrit. Co-morbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents e.

Aseptic Meningitis Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy as found in Hydrocodone Bitartrate and Ibuprofen Tablets. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.

If signs or symptoms of meningitis develop in a patient on Hydrocodone Bitartrate and Ibuprofen Tablets, the possibility of its being related to ibuprofen should be considered. Precautions Masking of Inflammation and Fever The pharmacological activity of hydrocodone bitartrate and ibuprofen tablets in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections.

Ophthalmological Effects Blurred or diminished vision, scotomata, and changes in color vision have been reported with oral ibuprofen. Discontinue ibuprofen if a patient develops such complaints, and refer the patient for an ophthalmologic examination that includes central visual fields and color vision testing. Information for Patients Advise the patient to read the FDA-approved patient labeling Medication Guide that accompanies each prescription dispensed.

Patients, families, or their caregivers should be informed of the following information before initiating therapy with hydrocodone bitartrate and ibuprofen tablets and periodically during the course of ongoing therapy.

Addiction, Abuse, and Misuse. Instruct patients not to share hydrocodone bitartrate and ibuprofen tablets with others and to take steps to protect hydrocodone bitartrate and ibuprofen tablets from theft or misuse. Life-Threatening Respiratory Depression Inform patients of the risk of life-threatening respiratory depression, including information that the risk is greatest when starting hydrocodone bitartrate and ibuprofen tablets or when the dosage is increased, and that it can occur even at recommended dosages see WARNINGS: Advise patients how to recognize respiratory depression and to seek medical attention if breathing difficulties develop.

Instruct patients to take steps to store hydrocodone bitartrate and ibuprofen tablets securely and to dispose of unused hydrocodone bitartrate and ibuprofen tablets appropriately as described below. Interactions with Benzodiazepines and Other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if hydrocodone bitartrate and ibuprofen tablets are used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider see WARNINGS: Serotonin Syndrome Inform patients that opioids could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.

Warn patients of the symptoms of serotonin syndrome and to seek medical attention right away if symptoms develop. MAOI Interaction Inform patients to avoid taking hydrocodone bitartrate and ibuprofen tablets while using any drugs that inhibit monoamine oxidase. Adrenal Insufficiency Inform patients that opioids could cause adrenal insufficiency, a potentially life-threatening condition. Adrenal insufficiency may present with non-specific symptoms and signs such as nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.

For the short-term generally less than 10 days management of acute pain, the recommended dose of hydrocodone bitartrate and ibuprofen tablets are one tablet every 4 to 6 hours, as necessary. Hypotension Inform patients that hydrocodone bitartrate and ibuprofen tablets may cause orthostatic hypotension and syncope. Instruct patients how to recognize symptoms of low blood pressure and how to reduce the risk of serious consequences should hypotension occur e. Anaphylaxis Inform patients that anaphylaxis has been reported with ingredients contained in Hydrocodone Bitartrate and Ibuprofen Tablets.

Pregnancy Neonatal Opioid Withdrawal Syndrome Inform female patients of reproductive potential that prolonged use of hydrocodone bitartrate and ibuprofen tablets during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated see Boxed Warning , WARNINGS: Embryo-Fetal Toxicity Inform female patients of reproductive potential that hydrocodone bitartrate and ibuprofen tablets can cause fetal harm and to inform the prescriber of a known or suspected pregnancy.

Lactation Advise nursing mothers to monitor infants for increased sleepiness more than usual , breathing difficulties, or limpness. Infertility Inform patients that chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.

Carcinogenicity, Mutagenicity, Impairment of Fertility. Driving or Operating Heavy Machinery Inform patients that hydrocodone bitartrate and ibuprofen tablets may impair the ability to perform potentially hazardous activities such as driving a car or operating heavy machinery.

Risks of Driving and Operating Machinery. Cardiovascular Thrombotic Events Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their healthcare provider immediately see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation Advise patients to report symptoms of ulcerations and bleeding, including epigastric pain, dyspepsia, melena, and hematemesis to their healthcare provider.

Hepatotoxicity Inform patients of the warning signs and symptoms of hepatotoxicity e. Heart Failure and Edema Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur see WARNINGS: Heart Failure and Edema. Serious Skin Reactions Advise patients to stop hydrocodone bitartrate and ibuprofen tablets immediately if they develop any type of rash and to contact their healthcare provider as soon as possible see WARNINGS: Disposal of Unused Hydrocodone Bitartrate and Ibuprofen Tablets Advise patients to flush the unused tablets down the toilet when hydrocodone bitartrate and ibuprofen tablets are no longer needed or to contact the Drug Enforcement Agency DEA to find the location of an authorized collector Pharmacokinetics , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to Hydrocodone Bitartrate and Ibuprofen Tablets.

If concomitant use is necessary, consider dosage reduction of hydrocodone bitartrate and ibuprofen tablets until stable drug effects are achieved. Monitor patients for respiratory depression and sedation at frequent intervals. If a CYP3A4 inhibitor is discontinued, consider a dosage increase of hydrocodone bitartrate and ibuprofen tablets until stable drug effects are achieved.

Monitor for signs of opioid withdrawal. Pharmacokinetics , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone see WARNINGS: Pharmacokinetics , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. If concomitant use is necessary, consider a dosage increase of hydrocodone bitartrate and ibuprofen tablets until stable drug effects are achieved.

If a CYP3A4 inducer is discontinued, consider hydrocodone bitartrate and ibuprofen tablets dosage reduction and monitor for signs of respiratory depression. Which drugs or supplements interact with hydrocodone and ibuprofen? Hydrocodone, like other narcotic pain-relievers, interacts with medications and drugs that slow the brain's processes, such as alcohol , barbiturates , skeletal muscle relaxants including carisoprodol Soma , cyclobenzaprine Flexeril , and benzodiazepines for example, lorazepam [ Ativan ], and clonazepam [ Klonopin ].

Opioids such as hydrocodone can slow bowel motility. When combined with medications that possess anticholinergic activity, this effect on the bowel may be accentuated, leading to marked constipation. Such drugs include dicyclomine Bentyl , some antihistamines for example, carbinoxamine [Rondec], clemastine [ Tavist ], diphenhydramine [ Benadryl ], promethazine [Phenergan] ; some phenothiazines for example, thioridazine [Mellaril], triflupromazine [Stelazine] ; some tricyclic antidepressants for example, amitriptyline [ Elavil , Endep ] amoxapine [Asendin], clomipramine [ Anafranil ], protriptyline [Vivactil] ; clozapine Clozaril , cyclobenzaprine Flexeril , and disopyramide Norpace.

The use of antidiarrheals for example, diphenoxylate [ Lomotil ], loperamide [ Imodium ] in persons taking opioid analgesics such as hydrocodone can lead to severe constipation and possibly greater sedation. Cimetidine Tagamet , when used with opiate analgesics such as hydrocodone, can cause confusion , disorientation, seizures or respiratory depression by increasing blood concentrations of the opiate.

Ibuprofen, which has blood thinning anticoagulant properties, is used with caution in patients taking other blood thinning anticoagulants such as warfarin Coumadin , because of an increased risk of bleeding. Concurrent use of ibuprofen and clopidogrel Plavix can also lead to increased risk of bleeding. Patients taking lithium Eskalith, Lithobid can develop toxic blood lithium levels if ibuprofen is taken at the same time.

Ibuprofen may increase methotrexate Rheumatrex , Trexall toxicity when used together.

Can I take another Hydrocodon-Acetaminophen after 600 mg of Ibuprofen?

An opioid antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate. In animal studies, NSAIDs, including ibuprofen, inhibit prostaglandin synthesis, cause and parturition, and increase the incidence of stillbirth. Pharmacokineticsresulting in decreased efficacy or onset of a withdrawal syndrome in motrin who have developed physical dependence to hydrocodone see WARNINGS: Digoxin The concomitant use of ibuprofen with digoxin has been reported to estradiol norethindrone acetate tablets 1.0mg 0.5mg the serum concentration and prolong the half-life of digoxin. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. Concomitant use of hydrocodone bitartrate and ibuprofen tablets and and doses of aspirin is not generally recommended because of the increased risk of bleeding see WARNINGS: Which drugs or supplements interact with hydrocodone and ibuprofen? Monitor such patients for signs of sedation and respiratory depression, motrin 600mg and vicodin, particularly when initiating therapy with Hydrocodone Bitartrate and Motrin Tablets. If the decision is made to prescribe a benzodiazepine or other CNS depressant concomitantly with an 600mg analgesic, prescribe vicodin lowest effective dosages and minimum durations of concomitant use. The use of hydrocodone bitartrate and ibuprofen tablets are not recommended for patients taking MAOIs or within 14 days of stopping such treatment. Limited published literature reports that, following oral administration, ibuprofen is present in human milk at relative infant doses of 0. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high-pitched cry, tremor, 600mg, diarrhea, and failure to gain weight. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, motrin 600mg and vicodin, vicodin selective serotonin reuptake inhibitors SSRIs ; smoking; use of alcohol; older age; and poor general health status.

Your Brain on Drugs - Hydrocodone (College Health Guru)

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