Hydrocodone/Ibuprofen

DEA Class; Rx

Common Brand Names; Ibudone, Reprexain, Vicoprofen

Analgesics, NSAID/Opioid Combos

Semisynthetic opioid analgesic-NSAID combination
For acute, moderate pain
NSAIDs may increase risk of serious CV or GI events; use lowest effective dose for the shortest possible duration

For the short-term (generally less than 10 days) treatment of acute severe pain requiring an opioid analgesic and for which alternative treatments are inadequate.

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

Dizziness

Drowsiness

Constipation

Nausea

Vomiting

Diarrhea

Dyspepsia

Flatulence

Hypotension

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

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

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

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

5 tablets/day PO.

5 tablets/day PO.

16 to 17 years: 5 tablets/day PO.
13 to 16 years: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

hydrocodone/ibuprofen

Tablet: Schedule II

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