hydrocodone/ibuprofen (Rx)

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

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    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

            Addiction, abuse, and misuse

            • Long-acting hydrocodone exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death
            • Assess each patient’s risk prior to prescribing, and monitor all patients regularly for the development of these behaviors or conditions

            Life-threatening respiratory depression

            • Serious, life-threatening, or fatal respiratory depression may occur
            • Monitor for respiratory depression, especially during initiation or following a dose increase
            • Instruct patients to swallow capsules/tablets whole; crushing, chewing, or dissolving the extended-release dosage forms can cause rapid release and absorption of a potentially fatal dose of hydrocodone

            Accidental exposure

            • Accidental consumption of even 1 dose of hydrocodone, especially by children, can result in a fatal overdose of hydrocodone

            Neonatal opioid withdrawal syndrome

            • For patients who require opioid therapy while pregnant, be aware that infants may require treatment for neonatal opioid withdrawal syndrome
            • Prolonged maternal use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening and requires management according to protocols developed by neonatology experts

            Interaction with CNS depressants

            • Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death
            • Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate
            • Limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation
            • Coingestion of with alcohol may increase hydrocodone plasma levels and result in a potentially fatal overdose (alters release of drug from capsule)

            Interaction with CYP3A4 inhibitors

            • Initiation of CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of hydrocodone

            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

            ASA allergy

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

            Significant respiratory depression

            Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment

            Known or suspected gastrointestinal obstruction, including paralytic ileus

            Known hypersensitivity (e.g., anaphylactic reactions, serious skin reactions) to hydrocodone, ibuprofen, or any components of the drug product.

            Patients known to be hypersensitive to other opioids may exhibit cross-sensitivity

            History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs

            Cautions

            Do not prescribe for acute pain or as needed (prn) pain relief; only for severe chronic pain requiring continuous, around-the-clock opioid analgesia

            Hydrocodone is an opioid agonist and a Schedule II controlled substance with a high potential for abuse similar to fentanyl, methadone, morphine, oxycodone, and oxymorphone

            Coadministration with other CNS depressants may cause profound sedation, respiratory depression, and death; if coadministration is required, consider dose reduction of 1 or both drugs

            Monitor carefully in elderly, cachectic, debilitated patients, and those with chronic pulmonary disease because of increased risk for life-threatening respiratory depression

            Monitor patients with head injury or increased ICP for sedation and respiratory depression; avoid use in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention

            May cause severe hypotension, including orthostatic hypotension and syncope; added risk to individuals whose ability to maintain blood pressure has been compromised by a depleted blood volume, or after concurrent administration with drugs such as phenothiazines or other agents which compromise vasomotor tone

            Coadministration with CYP3A4 inhibitors may increase hydrocodone systemic exposure and result in toxicity; if co-administration with CYP3A4 necessary, monitor patients closely who are currently taking, or discontinuing, CYP3A4 inhibitors or inducers; evaluate these patients at frequent intervals and consider dose adjustments until stable drug effects are achieved

            Caution must be used with potentially hazardous activities

            Avoid use of mixed agonist/antagonist analgesics (ie, pentazocine, nalbuphine, butorphanol) when taking full opioid agonist analgesics

            Profound sedation, respiratory depression, coma, and death may result from concomitant administration with benzodiazepines or other CNS depressants (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, other opioids, alcohol); because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate

            Cases of adrenal insufficiency reported with opioid use, more often following greater than one month of use; symptoms may include nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure; if adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids; wean patient off of opioid to allow adrenal function to recover and continue corticosteroid treatment until adrenal function recovers; other opioids may be tried as some cases reported use of a different opioid without recurrence of adrenal insufficiency

            May cause spasm of sphincter of Oddi; opioids may cause increases in serum amylase; monitor patients with biliary tract disease, including acute pancreatitis, for worsening symptoms

            Cases of serotonin syndrome, a potentially life-threatening condition, reported with concomitant use of serotonergic drugs; this may occur within the recommended dosage range; the onset of symptoms generally occur within several hours to a few days of concomitant use, but may occur later than that; discontinue therapy immediately if serotonin syndrome is suspected

            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

            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

            Prolonged use of opioid analgesics during pregnancy can cause neonatal opioid withdrawal syndrome; there are no available data in pregnant women to inform a drug associated risk for major birth defects and miscarriage; published studies with morphine use during pregnancy have not reported a clear association with opioids and major birth defects

            Prolonged use of opioid analgesics during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth; the onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of drug by newborn; observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly

            Lactation

            Drug is present in breast milk; published lactation studies report variable concentrations of drug in breast milk with administration of immediate-release formulation to nursing mothers in early postpartum period

            The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy; capsules and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

            Monitor infants exposed to drug through breast milk for excess sedation and respiratory depression; withdrawal symptoms can occur in breastfed infants when maternal administration of an opioid analgesic is stopped, or when breast- feeding is stopped

            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.

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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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            • Compare formulary status to other drugs in the same class.
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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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