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Pronunciation:

(hye droe KOE done & eye byoo PROE fen)

U.S. Brand Names:

Vicoprofen®

Synonyms:

Ibuprofen and Hydrocodone

Generic Available:

Yes

Canadian Brand Names:

Vicoprofen®

Use:

Short-term (generally <10 days) management of moderate to severe acute pain; is not indicated for treatment of such conditions as osteoarthritis or rheumatoid arthritis

Restrictions:

C-III

Pregnancy Risk Factor:

C/D (3rd trimester)

Pregnancy Implications:

As with other NSAID-containing products, this agent should be avoided in late pregnancy because it may cause premature closure of the ductus arteriosus.

Lactation:

Excretion in breast milk unknown/contraindicated

Contraindications:

Hypersensitivity to hydrocodone, ibuprofen, aspirin, other NSAIDs, or any component of the formulation; pregnancy (3rd trimester)

Warnings/Precautions:

As with any opioid analgesic agent, this agent 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 hyperplasia, or urethral stricture. The usual precautions should be observed and the possibility of respiratory depression should be kept in mind. Patients with head injury, increased intracranial pressure, acute abdomen, active peptic ulcer disease, history of upper GI disease, impaired thyroid function, asthma, hypertension, edema, heart failure, and any bleeding disorder should use this agent cautiously. Hydrocodone suppresses the cough reflex; as with opioids, caution should be exercised when this agent is used postoperatively and in patients with pulmonary disease.

Adverse Reactions:

>10%:

Central nervous system: Headache (27%), dizziness (14%), sedation (22%)

Dermatologic: Rash, urticaria

Gastrointestinal: Constipation (22%), nausea (21%), dyspepsia (12%)

1% to 10%:

Cardiovascular: Bradycardia, palpitation (<3%), vasodilation (<3%), edema (3% to 9%)

Central nervous system: Headache, nervousness, confusion, fever (<3%), pain (3% to 9%), anxiety (3% to 9%), thought abnormalities

Dermatologic: Itching (3% to 9%)

Endocrine & metabolic: Fluid retention

Gastrointestinal: Vomiting (3% to 9%), anorexia, diarrhea (3% to 9%), xerostomia (3% to 9%), flatulence (3% to 9%), gastritis (<3%), melena (<3%), mouth ulcers (<3%)

Genitourinary: Polyuria (<3%)

Neuromuscular & skeletal: Weakness (3% to 9%)

Otic: Tinnitus

Respiratory: Dyspnea, hiccups, pharyngitis, rhinitis

Miscellaneous: Flu syndrome (<3%), infection (3% to 9%)

<1%: CHF, arrhythmia, tachycardia, hypertension, hallucinations, mental depression, insomnia, aseptic meningitis, urticaria, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, polydipsia, hot flashes, biliary tract spasm, cystitis, urinary tract spasm, neutropenia, anemia, agranulocytosis, inhibition of platelet aggregation, hemolytic anemia, bone marrow suppression, leukopenia, thrombocytopenia, hepatitis, peripheral neuropathy, vision changes, blurred vision, conjunctivitis, dry eyes, toxic amblyopia, diplopia, miosis, decreased hearing, acute renal failure, polyuria, allergic rhinitis, epistaxis, histamine release, physical and psychological dependence with prolonged use

Overdosage/Toxicology:

Symptoms of toxicity may include respiratory depression, CNS depression, metabolic acidosis, seizures, hypotension, blood loss, coma, meiosis, and renal failure. Naloxone is the antidote for hydrocodone. Naloxone, 2 mg I.V. with repeat administration as necessary up to a total of 10 mg, can also be used to reverse toxic effects of the opiate. Treatment of NSAID overdose is supportive with symptomatic management as necessary.

Drug Interactions:

Hydrocodone: Substrate of CYP2D6 (major)

Ibuprofen: Substrate (minor) of CYP2C8/9, 2C19; Inhibits CYP2C8/9 (strong)

Also see individual agents.

Ethanol/Nutrition/Herb Interactions:

Based on hydrocodone component: Ethanol: Avoid or limit ethanol (may increase CNS depression). Watch for sedation.

Based on ibuprofen component:

Ethanol: Avoid ethanol (may enhance gastric mucosal irritation).

Food: Ibuprofen peak serum levels may be decreased if taken with food.

Herb/Nutraceutical: Avoid cat's claw, dong quai, evening primrose, feverfew, garlic, ginger, ginkgo, red clover, horse chestnut, green tea, ginseng (all have additional antiplatelet activity).

Mechanism of Action:

Based on hydrocodone component: Binds to opiate receptors in the CNS, altering the perception of and response to pain; suppresses cough in medullary center; produces generalized CNS depression

Based on ibuprofen component: Inhibits prostaglandin synthesis by decreasing the activity of the enzyme, cyclooxygenase, which results in decreased formation of prostaglandin precursors

Pharmacodynamics/Kinetics:

Ibuprofen: See Ibuprofen monograph.

Hydrocodone:

Onset of action: Narcotic analgesic: 10-20 minutes

Duration: 4-8 hours

Distribution: Crosses placenta

Protein binding: 19% to 45%

Metabolism: Hepatic; O-demethylation; N-demethylation and 6-ketosteroid reduction

Half-life elimination: 3.3-4.4 hours

Time to peak: 1.7 hours

Excretion: Urine

Dosage:

Adults: Oral: 1-2 tablets every 4-6 hours as needed for pain; maximum: 5 tablets/day

Patient Education:

If self-administered, use exactly as directed; do not increase dose or frequency. Drug may cause physical and/or psychological dependence. Take with food or milk. While using this medication, do not use alcohol and other prescription or OTC medications (especially sedatives, tranquilizers, antihistamines, or pain medications) without consulting prescriber. Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. May cause dizziness, drowsiness, confusion, nervousness, or anxiety (use caution when driving, climbing stairs, or changing position - rising from sitting or lying to standing, or when engaging in tasks requiring alertness until response to drug is known); nausea, dry mouth, decreased appetite, or gastric distress (frequent mouth care, frequent sips of fluids, chewing gum, or sucking lozenges may help); or constipation (increased exercise, fluids, fruit, or fiber may help; if unresolved, consult prescriber about use of stool softeners). Report chest pain or palpitations; persistent dizziness, shortness of breath, or respiratory difficulty; unusual bleeding (stool, mouth, urine) or bruising; unusual fatigue and weakness; change in elimination patterns; or change in color of urine or stool. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Do not breast-feed.

Additional Information:

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.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation).

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

Sedation, drowsiness, and fatigue are common; may cause nervousness or confusion; may rarely cause hallucinations, depression, or insomnia

Mental Health: Effects on Psychiatric Treatment:

Hypotension is common and may be potentiated by low potency antipsychotics and other psychotropics. May rarely cause agranulocytosis, caution with clozapine and carbamazepine. Sedation may be additive with psychotropics. Ibuprofen may inhibit the clearance of lithium resulting in elevated serum lithium levels; may need to adjust dosage downward.

Dosage Forms:

Tablet: Hydrocodone bitartrate 5 mg and ibuprofen 200 mg; hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg

Vicoprofen®: Hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg

International Brand Names:

Vicoprofen® (CA)

References

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings,"Chest, 2003, 123(3):897-922.

Sunshine A, Olson NZ, O'Neill E, et al, "Analgesic Efficacy of a Hydrocodone With Ibuprofen Combination Compared With Ibuprofen Alone for the Treatment of Acute Postoperative Pain,"J Clin Pharmacol, 1997, 37:908-15.

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