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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
Central Nervous System
Metabolic and Nutritional Disorders
Skin and Appendages
Incidence less than 1%
Body as a Whole Allergic reaction.
Central Nervous System
Metabolic and Nutritional
Skin and Appendages
Altered vision; Bad taste; Dry eyes.
Drug Abuse and Dependence
Misuse Abuse and Diversion of Opioids
VICOPROFEN (hydrocodone and ibuprofen) contains hydrocodone, an opioid 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.
Read the Vicoprofen (hydrocodone and ibuprofen) Side Effects Center for a complete guide to possible side effects
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.
The concurrent use of anticholinergics with hydrocodone preparations may produce paralytic ileus.
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.
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.
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.
Ibuprofen has been shown to reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal 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.
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.
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.
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.
Read the Vicoprofen Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/3/2008
This monograph has been modified to include the generic and brand name in many instances.
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