hydrocodone/ibuprofen (Rx)

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Brand and Other Names:Ibudone, Reprexain, more...Vicoprofen

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

hydrocodone/ibuprofen

tablet: Schedule II

  • 2.5mg/200mg
  • 5mg/200mg
  • 7.5mg/200mg
  • 10mg/200mg
more...

Analgesia

Short-term (generally less than 10 days) management of acute pain

Lowest effective dose for the shortest duration consistent with individual patient treatment goals

Usual dose: 5-7.5 mg/200 mg PO q4-6 hr PRN; not to exceed 5 tabs/24hr

Renal Impairment

Not recommended in patients with advanced renal disease

Renal disease or impairment; increased risk of renal toxicity and injury may occur

Administration

Not indicated for the treatment of chronic conditions such as osteoarthritis or rheumatoid arthritis

Extra caution and reduced dosages should be used when treating the elderly

Elderly or debilitated patients may experience increased risk of gastrointestinal injury, including fatal events; increased risk of renal toxicity and injury; respiratory depression

Dosage Forms & Strengths

hydrocodone/ibuprofen

tablet: Schedule II

  • 2.5mg/200mg
  • 5mg/200mg
  • 7.5mg/200mg
  • 10mg/200mg
more...

Analgesia

<16 years: Safety and efficacy not established

≥16 years

  • Short-term (generally <10 days) management of acute pain
  • Lowest effective dose for the shortest duration consistent with individual patient treatment goals
  • Usual dose: 5-7.5 mg/200 mg PO q4-6 hr PRN; not to exceed 5 tabs/24hr
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Interactions

Interaction Checker

and hydrocodone/ibuprofen

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Dizziness

            Drowsiness

            Constipation

            Nausea

            Vomiting

            Diarrhea

            Dyspepsia

            Flatulence

            Hypotension

            1-10%

            Syncope

            Agitation, depression, dizziness, dysphoria, euphoria

            Faintness, mental clouding, restlessness, sedation, weakness

            Cholinergic effects

            Flushing, sweating, urticaria

            Respiratory depression

            Headache, fatigue, lightheadedness, tinnitus

            Erythematous macular rashes

            Erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis,  photosensitivity

            GI bleeding, GI ulceration

            Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia

            Jaundice

            Acute renal failure, decreased creatinine clearance, elevations in BUN

            <1%

            Bronchitis

            Asthma

            Cystitis

            Cough

            Dysphagia

            Abnormal dreams

            Decreased libido

            Myalgia

            Neuralgia

            Pulmonary congestion

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            Warnings

            Black Box Warnings

            Cardiovascular Risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), and stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

            Gastrointestinal Risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use and without warning symptoms
            • Elderly patients are at greater risk for serious GI events

            Contraindications

            Coronary artery bypass graft (CABG) surgery, treatment of peri-operative pain; increased incidence of myocardial infarction and stroke

            Hypersensitivity to ibuprofen, hydrocodone

            Hypersensitivity to other opioids; cross-sensitivity reaction possible

            ASA allergy

            Relative: bleeding disorder, duodenal/gastric/peptic ulcer, stomatitis, SLE, ulcerative colitis, upper GI disease, late pregnancy (may cause premature closure of ductus), asthma, urticaria, or allergic-type reactions following aspirin or other nonsteroidal anti-inflammatory agents; severe, even fatal, anaphylactic-like reactions

            Cautions

            Cardiovascular event risk may increase w/ duration of use

            Gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal may occur

            Abuse, misuse, diversion, and dependence potential

            Addison's disease; respiratory depression may occur

            Alcohol use or smoking; increased risk of gastrointestinal injury

            Asthma, especially with history of aspirin-sensitive asthma; severe bronchospasm and fatalities may occur

            Coagulation disorder; bleeding time may be prolonged

            Long-term use; increased risk of gastrointestinal or renal injury; anemia may occur

            Pregnancy, third trimester use; premature close of ductus arteriosus may occur

            Skin reactions; serious adverse events including exfoliative dermatitis, Stevens Johnson syndrome, toxic epidermal necrolysis

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            Pregnancy & Lactation

            Pregnancy Category: C; D in 3rd trimester

            Lactation: Excreted in breast milk; not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Hydrocodone: Binds to opiate receptors in the CNS, which in turn produces generalized CNS depression and alters perception and response to pain

            Ibuprofen: Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2); has antipyretic, anti-inflammatory, and analgesic properties  

            Metabolism

            Hydrocodone: by liver (O-demethylation, N-demethylation, 6-keto reduction); hepatic P450 enzyme CYP2D6

            Ibuprofen: rapid hepatic oxidation to inactive metabolites: (+)-2-[4'-(2-hydroxy-2-methylpropyl) phenyl] propionic acid (metabolite A), (+)-2-[4'-(2-carboxypropyl) phenyl] propionic acid (metabolite B)

            Elimination

            Excretion

            • Hydrocodone: Mainly urine
            • Ibuprofen: Urine 50-60% (<10% unchanged)

            Half-Life

            • Hydrocodone: 3.3-4.4 hr
            • Ibuprofen: 2-4 hr

            Absorption

            Onset: 0.5 hr (ibuprofen)

            Bioavailability 80-90% (ibuprofen)

            Vd: 0.12 L/kg (ibuprofen)

            Protein Bound: 90-99% (ibuprofen)

            Peak Plasma Time

            • Hydrocodone: 1.3 hr
            • Ibuprofen: 2 hr

            Duration

            • Hydrocodone: 4-8 hr
            • Ibuprofen: 4-6 hr

            Pharmacogenomics

            Hydrocodone is metabolized to Hydromorphone via CYP2D6; CYP2D6 poor metabolizers may not achieve adequate analgesia

            Ultra-rapid metabolizers (up to 7% of Caucasians and up to 30% of Asian and African populations) may have increased toxicity due to rapid conversion

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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