Drugs Details

Drugs Info of Ibudone, Reprexain, Vicoprofen
Drugs Details
  • Drugs Type  : FDA
  • Date : 30th Jun 2015 07:41 am
  • Brand Name : Ibudone, Reprexain, Vicoprofen
  • Generic Name : hydrocodone and ibuprofen (Pronunciation: hye dro KOE done and eye byoo PRO fen)
Descriptions

Each VICOPROFEN (hydrocodone and ibuprofen) tablet contains:

Hydrocodone Bitartrate, USP 7.5 mg

Ibuprofen, USP 200 mg

VICOPROFEN (hydrocodone and ibuprofen) is supplied in a fixed combination tablet form for oral administration. VICOPROFEN (hydrocodone and ibuprofen) combines the opioid analgesic agent, hydrocodone bitartrate, with the nonsteroidal anti-inflammatory (NSAID) agent, ibuprofen.

Hydrocodone bitartrate is a semisynthetic and centrally acting opioid analgesic. Its chemical name is: 4,5 α-epoxy-3-methoxy-17-methylmorphinan-6-one tartrate (1:1) hydrate (2:5). Its chemical formula is: C18H21NO3•C4H6O6•2½H2O, and the molecular weight is 494.50. Its structural formula is:

 

VICOPROFEN® (hydrocodone bitartrate and ibuprofen tablets) Structural Formula Illustration

 

Ibuprofen is a nonsteroidal anti-inflammatory agent [non-selective COX inhibitor] with analgesic and antipyretic properties. Its chemical name is: (±)-2-(p-isobutylphenyl) propionic acid. Its chemical formula is: C13H18O2, and the molecular weight is: 206.29. Its structural formula is:

 

VICOPROFEN® (hydrocodone bitartrate and ibuprofen tablets) Structural Formula Illustration

 

Inactive ingredients in VICOPROFEN (hydrocodone and ibuprofen) tablets include: colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, and titanium dioxide.

 

What are the possible side effects of hydrocodone and ibuprofen (Ibudone, Reprexain, Vicoprofen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using hydrocodone and ibuprofen and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • bloody or tarry...

Read All Potential Side Effects and See Pictures of Vicoprofen »

What are the precautions when taking hydrocodone and ibuprofen (Vicoprofen)?

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...

Read All Potential Precautions of Vicoprofen »

Indications

Carefully consider the potential benefits and risks of VICOPROFEN (hydrocodone and ibuprofen) and other treatment options before deciding to use VICOPROFEN (hydrocodone and ibuprofen) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

VICOPROFEN (hydrocodone and ibuprofen) tablets are indicated for the short-term (generally less than 10 days) management of acute pain. VICOPROFEN (hydrocodone and ibuprofen) is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis.

Dosage Administration

Carefully consider the potential benefits and risks of VICOPROFEN (hydrocodone and ibuprofen) and other treatment options before deciding to use VICOPROFEN (hydrocodone and ibuprofen) . Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

After observing the response to initial therapy with VICOPROFEN (hydrocodone and ibuprofen) , the dose and frequency should be adjusted to suit an individual patient's needs.

For the short-term (generally less than 10 days) management of acute pain, the recommended dose of VICOPROFEN (hydrocodone and ibuprofen) is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. It should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.

The lowest effective dose or the longest dosing interval should be sought for each patient (see WARNINGS), especially in the elderly. After observing the initial response to therapy with VICOPROFEN (hydrocodone and ibuprofen) , the dose and frequency of dosing should be adjusted to suit the individual patient's need, without exceeding the total daily dose recommended.

How Supplied

VICOPROFEN (hydrocodone and ibuprofen) tablets are available as:

White film-coated round convex tablets, engraved with "VP" over Abbott "A" logo on one side and plain on the other side.

Bottles of 100-NDC 0074-2277-14

Bottles of 500-NDC 0074-2277-54

Hospital Unit Dosage Package-100 tablets

(4 x 25 tablets)-NDC 0074-2277-12

Storage

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container. 
A Schedule CS-III Controlled Substance.

Abbott Laboratories, North Chicago, IL 60064, U.S.A. FDA rev date: 7/25/2008

Side Effects

VICOPROFEN (hydrocodone and ibuprofen) was administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see DOSAGE AND ADMINISTRATION). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of VICOPROFEN (hydrocodone and ibuprofen) an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg.

The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of VICOPROFEN (hydrocodone and ibuprofen) , without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows:

name of adverse event = less than 3%

adverse events marked with an asterisk * = 3% to 9%

adverse event rates over 9% are in parentheses.

Body as a Whole

Abdominal pain*; Asthenia*; Fever; Flu syndrome; Headache (27%); Infection*; Pain.

Cardiovascular

Palpitations; Vasodilation.

Central Nervous System

Anxiety*; Confusion; Dizziness (14%); Hypertonia; Insomnia*; Nervousness*;Paresthesia; Somnolence (22%); Thinking abnormalities.

Digestive

Anorexia; Constipation (22%); Diarrhea*; Dry mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea (21%); Thirst; Vomiting*.

Metabolic and Nutritional Disorders

Edema*.

Respiratory

Dyspnea; Hiccups; Pharyngitis; Rhinitis.

Skin and Appendages

Pruritus*; Sweating*.

Special Senses

Tinnitus.

Urogenital

Urinary frequency.

Incidence less than 1%

Body as a Whole Allergic reaction.

Cardiovascular

Arrhythmia; Hypotension; Tachycardia.

Central Nervous System

Agitation; Abnormal dreams; Decreased libido; Depression; Euphoria; Mood changes; Neuralgia; Slurred speech; Tremor, Vertigo.

Digestive

Chalky stool; “Clenching teeth”; Dysphagia; Esophageal spasm; Esophagitis;Gastroenteritis; Glossitis; Liver enzyme elevation.

Metabolic and Nutritional

Weight decrease.

Musculoskeletal

Arthralgia; Myalgia.

Respiratory

Asthma; Bronchitis; Hoarseness; Increased cough; Pulmonary congestion;Pneumonia; Shallow breathing; Sinusitis.

Skin and Appendages

Rash; Urticaria.

Special Senses

Altered vision; Bad taste; Dry eyes.

Urogenital

Cystitis; Glycosuria; Impotence; Urinary incontinence; Urinary retention.

Drug Abuse and Dependence

Misuse Abuse and Diversion of Opioids

VICOPROFEN (hydrocodone and ibuprofen) contains hydrocodone, anopioid agonist, and is a Schedule III controlled substance. VICOPROFEN (hydrocodone and ibuprofen) , and other opioids used in analgesia can be abused and are subject to criminal diversion.

Addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease utilizing a multidisciplinary approach, but relapse is common.

“Drug seeking” behavior is very common in addicts and drug abusers. Drug-seeking tactics include emergency calls or visits near the end of office hours, refusal to undergo appropriate examination, testing or referral, repeated “loss” of prescriptions, tampering with prescriptions and reluctance to provide prior medical records or contact information for other treating physician(s). “Doctor shopping” to obtain additional prescriptions is common among drug abusers and people suffering from untreated addiction.

Abuse and addiction are separate and distinct from physical dependence and tolerance. Physical dependence usually assumes clinically significant dimensions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. Physicians should be aware that abuse of opioids can occur in the absence of true addiction and is characterized by misuse for non-medical purposes, often in combination with other psychoactive substances. VICOPROFEN (hydrocodone and ibuprofen) , like other opioids, may be diverted for non-medical use. Record-keeping of prescribing information, including quantity, frequency, and renewal requests is strongly advised.

Proper assessment of the patient, proper prescribing practices, periodic re-evaluation of therapy, and proper dispensing and storage are appropriate measures that help to limit abuse of opioid drugs.

Interactions

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking VICOPROFEN (hydrocodone and ibuprofen) concomitantly with ACE-inhibitors.

Anticholinergics

The concurrent use of anticholinergics with hydrocodone preparations may produce paralytic ileus.

Antidepressants

The use of Monoamine Oxidase Inhibitors (MAOIs) or tricyclic antidepressants with VICOPROFEN (hydrocodone and ibuprofen) may increase the effect of either the antidepressant or hydrocodone.

MAOIs have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant depression of respiration or coma. The use of hydrocodone is not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

Aspirin

When VICOPROFEN (hydrocodone and ibuprofen) is administered with aspirin, the protein binding of aspirin is reduced, although the clearance of free VICOPROFEN (hydrocodone and ibuprofen) is not altered. The clinical significance of this interaction is not known; however, as with other NSAID-containing products, concomitant administration of VICOPROFEN (hydrocodone and ibuprofen) and aspirin is not generally recommended because of the potential of increased adverse effects.

CNS Depressants

Patients receiving other opioids, antihistamines, antipsychotics, antianxiety agents, or other CNS depressants (including alcohol) concomitantly with VICOPROFEN (hydrocodone and ibuprofen) may exhibit an additive CNS depression. When combined therapy is contemplated, the dose of one or both agents should be reduced.

Diuretics

Ibuprofen has been shown to reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition ofrenal prostaglandin synthesis. During concomitant therapy with VICOPROFEN (hydrocodone and ibuprofen) the patient should be observed closely for signs of renal failure (see WARNINGS - Renal Effects), as well as diuretic efficacy.

Lithium

Ibuprofen has been shown to elevate plasma lithium concentration and reduce renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when VICOPROFEN (hydrocodone and ibuprofen) and lithium are administered concurrently, patients should be observed for signs of lithium toxicity.

Methotrexate

Ibuprofen, as well as other NSAIDs, has been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that ibuprofen could enhance the toxicity of methotrexate. Caution should be used when VICOPROFEN (hydrocodone and ibuprofen) is administered concomitantly with methotrexate.

Mixed Agonist/Antagonist Opioid Analgesics

Agonist/antagonist analgesics (i.e., pentazocine, nalbuphine, butorphanol and buprenorphine) should be administered with caution to patients who have received or are receiving a course of therapy with a pure opioid agonist analgesic such as hydrocodone. In this situation, mixed agonist/antagonist analgesics may reduce the analgesic effect of hydrocodone and/or may precipitate withdrawal symptoms in these patients.

Neuromuscular Blocking Agents

Hydrocodone, as well as other opioid analgesics, may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.

Warnings

Cardiovascular Effects

Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or 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. The concurrent use of aspirin and an NSAID does increase the risk of serious GI events (see GI WARNINGS).

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (seeCONTRAINDICATIONS).

Hypertension

NSAID-containing products, including VICOPROFEN (hydrocodone and ibuprofen) , can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAID-containing products, including VICOPROFEN (hydrocodone and ibuprofen) , should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy.

Congestive Heart Failure and Edema

Fluid retention and edema have been observed in some patients taking NSAIDs. VICOPROFEN (hydrocodone and ibuprofen) should be used with caution in patients with fluid retention or heart failure.

Misuse Abuse and Diversion of Opioids

VICOPROFEN (hydrocodone and ibuprofen) contains hydrocodone an opioidagonist, and is a Schedule III controlled substance. Opioid agonists have the potential for being abused and are sought by abusers and people with addiction disorders, and are subject to diversion.

VICOPROFEN (hydrocodone and ibuprofen) can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing VICOPROFEN (hydrocodone and ibuprofen) in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion (see Drug Abuse and Dependence).

Respiratory Depression

At high doses or in opioid-sensitive patients, hydrocodone may produce dose-related respiratory depression by acting directly on the brain stem respiratory centers. Hydrocodone also affects the center that controls respiratory rhythm, and may produce irregular and periodic breathing.

Head Injury and Increased Intracranial Pressure

The respiratory depressant effects of opioids and their capacity to elevatecerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury, intracranial lesions or a pre-existing increase in intracranial pressure. Furthermore, opioids produce adverse reactions, which may obscure the clinical course of patients with head injuries.

Acute Abdominal Conditions

The administration of opioids may obscure the diagnosis or clinical course of patients with acute abdominal conditions.

Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding and Perforation

NSAIDs, including VICOPROFEN (hydrocodone and ibuprofen) , can cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the 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 NSAIDs. Only one in five patients who develops a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occur in approximately 1% of patients treated for 3-6 months, and in about 2-4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleedingwho use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and therefore, special care should be taken in treating this population.

To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of the NSAID until a serious GI adverse event is ruled out. For high-risk patients, alternate therapies that do not involve NSAIDs should be considered.

Renal Effects

Long-term administration of NSAIDs has resulted in renal papillary necrosisand other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renalperfusion. In these patients, administration of a nonsteroidal anti-inflammatory drug may cause a dose-dependent reduction in prostaglandinformation 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, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

Advanced Renal Disease

No information is available from controlled clinical studies regarding the use of VICOPROFEN (hydrocodone and ibuprofen) in patients with advanced renal disease. Therefore, treatment with VICOPROFEN (hydrocodone and ibuprofen) is not recommended in patients with advanced renal disease. If VICOPROFEN (hydrocodone and ibuprofen) therapy must be initiated, close monitoring of the patient's renal function is advisable.

Anaphylactoid Reactions

As with other NSAID-containing products, anaphylactoid reactions may occur in patients without known prior exposure to VICOPROFEN (hydrocodone and ibuprofen) . VICOPROFEN (hydrocodone and ibuprofen) should not be given to patients with the aspirin triad. This symptom complex typically occurs in asthmatic patients who experience rhinitis with or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after taking aspirin or other NSAIDs. Fatal reactions to NSAIDs have been reported in such patients (seeCONTRAINDICATIONS and PRECAUTIONS - Pre-existing Asthma). Emergency help should be sought in cases where an anaphylactoid reaction occurs.

Skin Reactions

Products containing NSAIDs, including VICOPROFEN (hydrocodone and ibuprofen) , can cause serious skin adverse events such as exfoliativedermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

Pregnancy

As with other NSAID-containing products, VICOPROFEN (hydrocodone and ibuprofen) should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.

Precautions

General

VICOPROFEN (hydrocodone and ibuprofen) cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of VICOPROFEN (hydrocodone and ibuprofen) in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Special Risk Patients

As with any opioid analgesic agent, VICOPROFEN (hydrocodone and ibuprofen) tablets should be used with caution in elderly or debilitated patients, and those with severe impairment of hepatic or renal function,hypothyroidism, Addison's disease, prostatic hypertrophy or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind.

Cough Reflex

Hydrocodone suppresses the cough reflex; as with opioids, caution should be exercised when VICOPROFEN (hydrocodone and ibuprofen) is used postoperatively and in patients with pulmonary disease.

Hepatic Effects

Borderline elevations of one or more liver enzymes may occur in up to 15% of patients taking NSAIDs including ibuprofen as found in VICOPROFEN (hydrocodone and ibuprofen) . These laboratory abnormalities may progress, may remain essentially unchanged, or may be transient with continued therapy. Notable elevations of SGPT (ALT) or SGOT (AST) (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDS. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminanthepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of more severe hepatic reactions while on VICOPROFEN (hydrocodone and ibuprofen) therapy. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g.eosinophilia, rash, etc.), VICOPROFEN (hydrocodone and ibuprofen) should be discontinued.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs including ibuprofen as found in VICOPROFEN (hydrocodone and ibuprofen) . This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs including ibuprofen, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving VICOPROFEN (hydrocodone and ibuprofen) who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Pre-existing Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which may be fatal. Since cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, VICOPROFEN (hydrocodone and ibuprofen) should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with pre-existing asthma.

Aseptic Meningitis

Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy as found in VICOPROFEN (hydrocodone and ibuprofen) . Although it is probably more likely to occur in patients withsystemic 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 VICOPROFEN (hydrocodone and ibuprofen) , the possibility of its being related to ibuprofen should be considered.

Information for Patients

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the VICOPROFEN Medication Guide that accompanies each prescription dispensed.

  1. VICOPROFEN® (hydrocodone and ibuprofen) (hydrocodone bitartrate 7.5 mg and ibuprofen 200mg), like other opioid-containing analgesics, may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery; patients should be cautioned accordingly.
  2. Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.
  3. VICOPROFEN (hydrocodone and ibuprofen) can be abused in a manner similar to other opioid agonists, legal or illicit. VICOPROFEN (hydrocodone and ibuprofen) may be habit-forming Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.
  4. VICOPROFEN (hydrocodone and ibuprofen) , like other NSAID-containing products, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (see WARNINGS, Cardiovascular Effects).
  5. VICOPROFEN (hydrocodone and ibuprofen) , like other NSAID-containing products, can cause GI discomfort and serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain,dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS, Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation).
  6. VICOPROFEN (hydrocodone and ibuprofen) , like other NSAID-containing products, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
  7. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
  8. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.
  9. Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (seeWARNINGS).
  10. In late pregnancy, as with other NSAIDs, VICOPROFEN (hydrocodone and ibuprofen) should be avoided because it may cause premature closure of the ductus arteriosus.
  11. Patients should be instructed to report any signs of blurred vision or other eye symptoms.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, VICOPROFEN (hydrocodone and ibuprofen) should be discontinued.

Carcinogenicity, Mutagenicity, and Impairment of Fertility

The carcinogenic and mutagenic potential of VICOPROFEN (hydrocodone and ibuprofen) has not been investigated. The ability of VICOPROFEN (hydrocodone and ibuprofen) to impair fertility has not been assessed.

Pregnancy

Pregnancy Category C.

Teratogenic Effects

Reproductive studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities. VICOPROFEN (hydrocodone and ibuprofen) , administered to rabbits at 95 mg/kg (5.72 and 1.9 times the maximum clinical dose based on body weight and surface area, respectively), a maternally toxic dose, resulted in an increase in the percentage of litters and fetuses with any major abnormality and an increase in the number of litters and fetuses with one or more nonossified metacarpals (a minor abnormality). VICOPROFEN (hydrocodone and ibuprofen) , administered to rats at 166 mg/kg (10.0 and 1.66 times the maximum clinical dose based on body weight and surface area, respectively), a maternally toxic dose, did not result in any reproductive toxicity. However, animal reproduction studies are not always predictive of human response. There are no adequate and well-controlled studies in pregnant women. VICOPROFEN (hydrocodone and ibuprofen) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of the ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal.

Labor and Delivery

As with other drugs known to inhibit prostaglandin synthesis, an increased incidence of dystocia and delayed parturition occurred in rats. Administration of VICOPROFEN (hydrocodone and ibuprofen) is not recommended during labor and delivery. The effects of VICOPROFEN (hydrocodone and ibuprofen) on labor and delivery in pregnant women are unknown.

Nursing Mothers

It is not known whether hydrocodone is excreted in human milk. In limited studies, an assay capable of detecting 1 mcg/mL did not demonstrate ibuprofen in the milk of lactating mothers. However, because of the limited nature of the studies, and because of the potential for serious adverse reactions in nursing infants from VICOPROFEN (hydrocodone and ibuprofen) , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of VICOPROFEN (hydrocodone and ibuprofen) in pediatric patients below the age of 16 have not been established.

Geriatric Use

In controlled clinical trials there was no difference in tolerability between patients < 65 years of age and those ≥ 65, apart from an increased tendency of the elderly to develop constipation. However, because the elderly may be more sensitive to the renal and gastrointestinal effects of nonsteroidal anti-inflammatory agents as well as possible increased risk of respiratory depression with opioids, extra caution and reduced dosages should be used when treating the elderly with VICOPROFEN (hydrocodone and ibuprofen) .

OverDose

Following an acute overdosage, toxicity may result from hydrocodone and/oribuprofen.

Signs and Symptoms

Hydrocodone Component

Serious overdose with hydrocodone is characterized by respiratory depression (a decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis) extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, and sometimesbradycardia and hypotension. In severe overdosage, apnea, circulatory collapse, cardiac arrest and death may occur.

Ibuprofen Component

Symptoms include gastrointestinal irritation with erosion and hemorrhage or perforation, kidney damage, liver damage, heart damage, hemolytic anemia,agranulocytosis, thrombocytopenia, aplastic anemia, and meningitis. Other symptoms may include headache, dizziness, tinnitus, confusion, blurred vision, mental disturbances, skin rash, stomatitis, edema, reduced retinalsensitivity, corneal deposits, and hyperkalemia.

Treatment

Primary attention should be given to the re-establishment of adequate respiratory exchange through provision of a patent airway and the institution of assisted or controlled ventilation. Naloxone, a narcotic antagonist, can reverse respiratory depression and coma associated with opioid overdose or unusual sensitivity to opioids, including hydrocodone. Therefore, an appropriate dose of naloxone hydrochloride should be administered intravenously with simultaneous efforts at respiratory resuscitation. Since the duration of action of hydrocodone may exceed that of the naloxone, the patient should be kept under continuous surveillance and repeated doses of the antagonist should be administered as needed to maintain adequate respiration. Supportive measures should be employed as indicated. Gastric emptying may be useful in removing unabsorbed drug. In cases where consciousness is impaired it may be inadvisable to perform gastric lavage. If gastric lavage is performed, little drug will likely be recovered if more than an hour has elapsed since ingestion. Ibuprofen is acidic and is excreted in the urine; therefore, it may be beneficial to administer alkali and induce diuresis. In addition to supportive measures the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen. Dialysis is not likely to be effective for removal of ibuprofen because it is very highly bound to plasma proteins.

ContrainDications

VICOPROFEN (hydrocodone and ibuprofen) is contraindicated in patients with known hypersensitivity to hydrocodone or ibuprofen. Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone.

VICOPROFEN (hydrocodone and ibuprofen) should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS - Anaphylactoid Reactions, and PRECAUTIONS - Preexisting Asthma).

VICOPROFEN (hydrocodone and ibuprofen) is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft(CABG) surgery (see WARNINGS).

Clinical Pharamacology

Hydrocodone Component

Hydrocodone is a semisynthetic opioid analgesic and antitussive with multiple actions qualitatively similar to those of codeine. Most of these involve thecentral nervous system and smooth muscle. The precise mechanism of action of hydrocodone and other opioids is not known, although it is believed to relate to the existence of opiate receptors in the central nervous system. In addition to analgesia, opioids may produce drowsiness, changes in mood, and mental clouding.

Ibuprofen Component

Ibuprofen is a non-steroidal anti-inflammatory agent that possesses analgesic and antipyretic activities. Its mode action, like that of other NSAIDs, is not completely understood, but may be related to inhibition ofcyclooxygenase activity and prostaglandin synthesis. Ibuprofen is a peripherally acting analgesic. Ibuprofen does not have any known effects on opiate receptors.

Pharmacokinetics

Absorption

After oral dosing with the VICOPROFEN (hydrocodone and ibuprofen) tablet, a peak hydrocodone plasma level of 27 ng/mL is achieved at 1.7 hours, and a peak ibuprofen plasma level of 30 mcg/mL is achieved at 1.8 hours. The effect of food on the absorption of either component from the VICOPROFEN (hydrocodone and ibuprofen) tablet has not been established.

Distribution

Ibuprofen is highly protein-bound (99%) like most other non-steroidal anti-inflammatory agents. Although the extent of protein binding of hydrocodone in human plasma has not been definitely determined, structural similarities to related opioid analgesics suggest that hydrocodone is not extensively protein bound. As most agents in the 5-ring morphinan group of semi-synthetic opioids bind plasma protein to a similar degree (range 19% [hydromorphone] to 45% [oxycodone]), hydrocodone is expected to fall within this range.

Metabolism

Hydrocodone exhibits a complex pattern of metabolism, including O-demethylation, N-demethylation, and 6-keto reduction to the corresponding 6-α-and 6-β-hydroxy metabolites. Hydromorphone, a potent opioid, is formed from the O-demethylation of hydrocodone and contributes to the total analgesic effect of hydrocodone. The O- and -demethylation processes are mediated by separate P-450 isoenzymes: CYP2D6 and CYP3A4, respectively.

Ibuprofen is present in this product as a racemate, and following absorption it undergoes interconversion in the plasma from the R-isomer to the S-isomer. Both the R- and S- isomers are metabolized to two primary metabolites: (+)-2-4'-(2hydroxy-2-methyl-propyl) phenyl propionic acid and (+)-2-4'-(2carboxypropyl) phenyl propionic acid, both of which circulate in the plasma at low levels relative to the parent.

Elimination

Hydrocodone and its metabolites are eliminated primarily in the kidneys, with a mean plasma half-life of 4.5 hours. Ibuprofen is excreted in the urine, 50% to 60% as metabolites and approximately 15% as unchanged drug and conjugate. The plasma half-life is 2.2 hours.

Special Populations

No significant pharmacokinetic differences based on age or gender have been demonstrated. The pharmacokinetics of hydrocodone and ibuprofen from VICOPROFEN (hydrocodone and ibuprofen) has not been evaluated in children.

Renal Impairment

The effect of renal insufficiency on the pharmacokinetics of the VICOPROFEN (hydrocodone and ibuprofen) dosage form has not been determined.

Clinical Studies

In single-dose studies of post surgical pain (abdominal, gynecological, orthopedic), 940 patients were studied at doses of one or two tablets. VICOPROFEN (hydrocodone and ibuprofen) produced greater efficacy than placebo and each of its individual components given at the same dose. No advantage was demonstrated for the two-tablet dose.

Patient Information

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) 
(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

  • with longer use of NSAID medicines
  • in people who have heart disease

NSAID medicines should never be used right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

    The chance of a person getting an ulcer or bleeding increases with

    • taking medicines called “corticosteroids” and “anticoagulants”
    • longer use
    • smoking
    • drinking alcohol
    • older age
    • having poor health

NSAID medicines should only be used:

  • exactly as prescribed
  • at the lowest dose possible for your treatment
  • for the shortest time needed

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

  • different types of arthritis
  • menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

  • if you had an asthma attack, hives, or other allergic reaction with aspirinor any other NSAID medicine
  • for pain right before or after heart bypass surgery

Tell your healthcare provider:

  • about all your medical conditions.
  • about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
  • if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
  • if you are breastfeeding. Talk to your doctor.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

 

Serious side effects include:
• heart attack
• stroke
• high blood pressure
• heart failure from body swelling (fluid retention)
• kidney problems including kidney failure
• bleeding and ulcers in the stomach and intestine
• low red blood cells (anemia)
• life-threatening skin reactions
• life-threatening allergic reactions
• liver problems including liver failure
• asthma attacks in people who have asthma
Other side effects include:
• stomach pain
• constipation
• diarrhea
• gas
• heartburn
• nausea
• vomiting
• dizziness

 

Get emergency help right away if you have any of the following symptoms:

 

• shortness of breath or trouble breathing
• chest pain
• weakness in one part or side of your body
• slurred speech
• swelling of the face or throat

 

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

 

• nausea
• more tired or weaker than usual
• itching
• your skin or eyes look yellow
• stomach pain
• flu-like symptoms
• vomit blood
• there is blood in your bowel
movement or it is black and sticky
like tar
• unusual weight gain
• skin rash or blisters with fever
• swelling of the arms and legs, hands
and feet

 

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

 

GENERIC NAME TRADENAME
Celecoxib Celebrex
Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
Diflunisal Dolobid
Etodolac Lodine, Lodine XL
Fenoprofen Nalfon, Nalfon 200
Flurbirofen Ansaid
Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen Oruvail
Ketorolac Toradol
Mefenamic Acid Ponstel
Meloxicam Mobic
Nabumetone Relafen
Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, Naprelan, Naprapac (copackaged with lansoprazole)
Oxaprozin Daypro
Piroxicam Feldene
Sulindac Clinoril
Tolmetin Tolectin, Tolectin DS, Tolectin 600
* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

 

 

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

HYDROCODONE/IBUPROFEN - ORAL

 

(HYE-droe-KOE-done/EYE-bue-proe-fen)

 

COMMON BRAND NAME(S): Vicoprofen

 

WARNING: 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.

 

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: 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.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Upset stomach, nausea, vomiting, constipation, dizziness, lightheadedness, 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 (such as agitation, confusion, hallucinations), 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, seizure.

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.

 

Read the Vicoprofen (hydrocodone and ibuprofen) Side Effects Center for a complete guide to possible side effects

Learn More »
 

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. Avoid 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, trouble getting pregnant). 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 drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor immediately if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG 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, narcotic antagonists (such as naltrexone, naloxone), 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.

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 2015. Copyright(c) 2015 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Ibudone, Reprexain, Vicoprofen

Generic Name: hydrocodone and ibuprofen (Pronunciation: hye dro KOE done and eye byoo PRO fen)

  • What is hydrocodone and ibuprofen (Vicoprofen)?
  • What are the possible side effects of hydrocodone and ibuprofen (Vicoprofen)?
  • What is the most important information I should know about hydrocodone and ibuprofen (Vicoprofen)?
  • What should I discuss with my healthcare provider before taking hydrocodone and ibuprofen (Vicoprofen)?
  • How should I take hydrocodone and ibuprofen (Vicoprofen)?
  • What happens if I miss a dose (Vicoprofen)?
  • What happens if I overdose (Vicoprofen)?
  • What should I avoid while taking hydrocodone and ibuprofen (Vicoprofen)?
  • What other drugs will affect hydrocodone and ibuprofen (Vicoprofen)?
  • Where can I get more information?

What is hydrocodone and ibuprofen (Vicoprofen)?

 

Hydrocodone is an opioid pain medication. An opioid is sometimes called a narcotic.

Ibuprofen is a non steroidal anti inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain, fever, and inflammation.

The combination of hydrocodone and ibuprofen is used short-term to relieve severe pain. This medication is not for treating arthritis pain.

Hydrocodone and ibuprofen may also be used for purposes not listed in this medication guide.

Hydrocodone-Ibuprofen 7.5 mg-200 mg-AMN

round, white, imprinted with IP 145

What are the possible side effects of hydrocodone and ibuprofen (Vicoprofen)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using hydrocodone and ibuprofen and call your doctor at once if you have a serious side effect such as:

  • sudden numbness or weakness, sudden severe headache, confusion, problems with vision or speech;
  • chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
  • pain, swelling, warmth, or redness in one or both legs;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain;
  • shallow breathing, slow heartbeat;
  • easy bruising or bleeding, feeling like you might pass out;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, headache, neck stiffness, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • headache, dizziness, drowsiness;
  • mild nausea, vomiting, upset stomach, constipation, diarrhea;
  • blurred vision; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Vicoprofen (hydrocodone and ibuprofen) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about hydrocodone and ibuprofen (Vicoprofen)?

 

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term. Do not use hydrocodone and ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking hydrocodone and ibuprofen, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to hydrocodone and ibuprofen (such as ibuprofen, ketoprofen, or naproxen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains naproxen, aspirin, ibuprofen, ketoprofen, or naproxen.

Hydrocodone may be habit-forming and should be used only by the person for whom it was prescribed. Keep the medication in a secure place where others cannot get to it.

Avoid drinking alcohol. It may increase your risk of stomach bleeding while taking ibuprofen.

Patient Detailed How Take

What should I discuss with my healthcare provider before taking hydrocodone and ibuprofen (Vicoprofen)?

 

You should not use this medication if you are allergic to hydrocodone or ibuprofen (Advil, Motrin), or other NSAIDs such as Aleve, Naprosyn, Celebrex, Arthrotec, Cataflam, Voltaren, Indocin, Mobic, and others.

Do not use hydrocodone and ibuprofen just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

This medicine may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

This medicine may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are taking hydrocodone and ibuprofen, especially in older adults.

To make sure you can safely take hydrocodone and ibuprofen, tell your doctor if you have any of these other conditions:

  • heart disease, congestive heart failure, high blood pressure, or a history of heart attack, stroke, or blood clot;
  • asthma or other breathing disorders;
  • liver or kidney disease;
  • a history of head injury or brain tumor;
  • stomach or intestinal disorder, history of stomach ulcer or bleeding;
  • underactive thyroid, Addison's disease or other adrenal gland disorder;
  • curvature of the spine;
  • an enlarged prostate or problems with urination; or
  • mental illness or a history of drug or alcohol addiction.

Hydrocodone may be habit forming and should be used only by the person for whom it was prescribed. Never share hydrocodone and ibuprofen with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

FDA pregnancy category C. Hydrocodone may cause breathing problems or addiction/withdrawal symptoms in a newborn. Taking ibuprofen during the last 3 months of pregnancy may harm the unborn baby. Do not take hydrocodone and ibuprofen during pregnancy unless your doctor has told you to.

It is not known whether hydrocodone and ibuprofen passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using hydrocodone and ibuprofen.

Older adults may be more likely to have side effects from this medicine.

How should I take hydrocodone and ibuprofen (Vicoprofen)?

 

Take exactly as prescribed. Never take hydrocodone and ibuprofen in larger amounts, or for longer than recommended by your doctor.Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

If you need surgery, tell the surgeon ahead of time that you are using hydrocodone and ibuprofen. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Hydrocodone and ibuprofen is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Patient Detailed Avoid Taking

What happens if I miss a dose (Vicoprofen)?

 

Since hydrocodone and ibuprofen is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Vicoprofen)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of hydrocodone and ibuprofen can be fatal.

Overdose symptoms may include extreme drowsiness, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), black or bloody stools, coughing up blood, urinating less than usual or not at all, confusion, ringing in your ears, pinpoint pupils, weak pulse, slow heart rate, blue lips, shallow breathing, or fainting.

What should I avoid while taking hydrocodone and ibuprofen (Vicoprofen)?

 

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how hydrocodone and ibuprofen will affect you.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to ibuprofen (such as ketoprofen or naproxen). Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains naproxen, aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding while taking ibuprofen.

What other drugs will affect hydrocodone and ibuprofen (Vicoprofen)?

 

Before using hydrocodone and ibuprofen, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by hydrocodone and ibuprofen.

Tell your doctor about all other medicines you use, especially:

  • lithium (Eskalith, Lithobid);
  • methotrexate (Rheumatrex, Trexall);
  • antidepressants such as amitriptyline (Elavil, Vanatrip) or imipramine (Tofranil);
  • an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate);
  • aspirin or other NSAIDs, such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch), indomethacin (Indocin), meloxicam (Mobic), and others;
  • heart or blood pressure medication such as benazepril (Lotensin), enalapril (Vasotec), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace), and others;
  • a bronchodilator (such as Atrovent, Spiriva), diuretics (water pills), steroid medicines, or blood thinners;
  • an injected narcotic medication such as pentazocine (Talwin), butorphanol (Stadol), or nalbuphine Nubain);
  • atropine (Atreza, Sal-Tropine), belladonna (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), or scopolamine (Transderm Scop); or
  • bowel or bladder medicines such as darifenacin (Enablex), solifenacin (Vesicare), dicyclomine (Bentyl), and others.

This list is not complete and other drugs may interact with hydrocodone and ibuprofen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about hydrocodone and ibuprofen.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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