Trade Names:Ibudone- Tablets 5 mg hydrocodone bitartrate and 200 mg ibuprofen- Tablets 10 mg hydrocodone bitartrate and 200 mg ibuprofen
Trade Names:Reprexain- Tablets 2.5 mg hydrocodone bitartrate and 200 mg ibuprofen- Tablets 5 mg hydrocodone bitartrate and 200 mg ibuprofen- Tablets 10 mg hydrocodone bitartrate and 200 mg ibuprofen
Trade Names:Vicoprofen- Tablets 7.5 mg hydrocodone bitartrate and 200 mg ibuprofenIbucodone (Canada)
Suppresses cough reflex; stimulates opiate receptors in the CNS and peripherally blocks pain impulse generation.Ibuprofen
Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.
Short-term (generally less than 10 days) management of acute pain. Not indicated for treatment of osteoarthritis or rheumatoid arthritis.
Hypersensitivity to hydrocodone, other opioids, ibuprofen, or other NSAIDs; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
PO 1 tablet every 4 to 6 h (max, 5 tablets/24-h period).
Administer without regard to meals, but administer with food if GI upset occurs.
Store at controlled room temperature (59° to 86°F).
Antihypertensive effect may be decreased by ibuprofen.Antianxiety agents, antihistamines, antipsychotic, CNS depressants (including alcohol), opioids
Possible additive CNS depression.Anticholinergics
Increased risk of paralytic ileus.Antidepressants (eg, MAOIs, tricyclic antidepressants)
The effect of either the antidepressant or hydrocodone may be increased.Aspirin
Increased risk of adverse reactions with coadministration of ibuprofen.Lithium, methotrexate
Plasma levels may be increased by ibuprofen.Loop diuretics (eg, furosemide), thiazide diuretics (eg, chlorothiazide)
Diuretic effects may be decreased by ibuprofen.Warfarin
Risk of gastric erosion and bleeding may be increased.
None well documented.
Palpitations, vasodilation.Less than 1%
Arrhythmia, hypotension, tachycardia.
Headache (27%); somnolence (22%); dizziness (14%).3% to 9%
Anxiety, insomnia, nervousness, paresthesia.Less than 3%
Confusion, hypertonia, thinking abnormalities.
Pharyngitis, rhinitis, tinnitus.
Constipation (22%); nausea (21%); dyspepsia (12%).3% to 9%
Diarrhea, dry mouth, flatulence, vomiting.Less than 3%
Anorexia, gastritis, melena, mouth ulcer, thirst.
Urinary frequency (less than 3%).
Edema (3% to 9%); liver enzyme elevation (less than 1%).
Dyspnea, hiccups.Less than 1%
Pulmonary congestion, pneumonia.
Abdominal pain, asthenia, infection.Less than 3%
Fever, flu-like symptoms, pain.
Allergic reaction (less than 1%).
Category C .
Safety and efficacy in children younger than 16 yr of age not established.
Use with caution because of possible increased sensitivity to renal and GI effects of ibuprofen, as well as increased respiratory depression with hydrocodone.
Use with caution and monitor kidney function in patients with advanced kidney disease.
As with other NSAIDs, ibuprofen has been reported to cause borderline elevations of one or more liver enzymes; this may occur in up to 15% of patients.
Use with caution in elderly or debilitated patients and in those with hepatic or renal function impairment, hypothyroidism, Addison disease, prostatic hypertrophy, or urethral stricture.
Diagnosis may be obscured.
Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy. If signs or symptoms of meningitis develop in a patient on Vicoprofen , the possibility of its being related to ibuprofen should be considered.
Hydrocodone suppresses the cough reflex; as with opioids, caution should be exercised when Vicoprofen is used postoperatively and in patients with pulmonary disease.
Hydrocodone has abuse potential; may be habit forming and cause physical dependence.
The antipyretic and anti-inflammatory activity of ibuprofen may reduce fever and inflammation, thus diminishing their utility as diagnostic signs in detecting complications of presumed noninfectious, noninflammatory painful conditions.
May occur, therefore, use with caution in patients with a history of cardiac decompensation, hypertension, or heart failure.
Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.
Diagnosis of adverse reactions may be obscured; respiratory depression properties and capacity to elevate CSF pressure of hydrocodone may be markedly exaggerated.
Ibuprofen, like other NSAIDs, can inhibit platelet aggregation but the effect is quantitatively less and of shorter duration than that seen with aspirin. Because this prolonged bleeding effect may be exaggerated in patients with underlying hemostatic defects, Vicoprofen should be used with caution in persons with intrinsic coagulation defects and those on anticoagulant therapy.
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. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Vicoprofen should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.
Respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, bradycardia, hypotension, apnea, circulatory collapse, cardiac arrest, deathIbuprofen
GI irritation with erosion, hemorrhage or perforation, kidney, liver and heart damage, hemolytic anemia, meningitis, headache, dizziness, tinnitus, confusion, blurred vision, mental disturbances, skin rash, stomatitis, edema, reduced retinal sensitivity, corneal deposits, hyperkalemia
Copyright © 2009 Wolters Kluwer Health.