No

Analgesic, Narcotic

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

C-III

C

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

Hypersensitivity to any of the ingredients, aspirin allergy, and 3rd trimester pregnancy

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 hypertrophy, 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.

>10%:

Cardiovascular: Hypotension

Central nervous system: Lightheadedness, dizziness, sedation, drowsiness, fatigue

Dermatologic: Rash, urticaria

Gastrointestinal: Abdominal cramps, heartburn, indigestion, nausea

Neuromuscular & skeletal: Weakness

1% to 10%:

Cardiovascular: Bradycardia

Central nervous system: Headache, nervousness, confusion

Dermatologic: Itching

Endocrine & metabolic: Fluid retention

Gastrointestinal: Dyspepsia, vomiting, abdominal pain, GI ulceration

Genitourinary: Decreased urination

Otic: Tinnitus

Respiratory: Shortness of breath, dyspnea

<1%: Edema, congestive heart failure, arrhythmias, tachycardia, hypertension, confusion, hallucinations, mental depression, insomnia, aseptic meningitis, urticaria, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, polydipsia, hot flashes, gastritis, xerostomia, anorexia, 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, shortness of breath, epistaxis, histamine release, physical and psychological dependence with prolonged use

Treat according to separate ingredient (hydrocodone and ibuprofen) toxicology

Decreased effect: May decrease efficacy of ACE inhibitors and diuretics

Increased toxicity potential: Aspirin, other CNS depressants, alcohol, MAO inhibitors, ACE inhibitors, tricyclic antidepressants, lithium, anticoagulants, anticholinergics, methotrexate

Refer to individual agents

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

No information available to require special precautions

Use with caution in patients taking anticoagulants (due to ibuprofen component)

If self-administered, use exactly as directed (do not increase dose or frequency); 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); constipation (increased exercise, fluids, or dietary fruit and fiber may help - if constipation remains an unresolved problem, consult prescriber about use of stool softeners). Report chest pain or palpitations; persistent dizziness, shortness of breath, or difficulty breathing; 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 be pregnant. Do not breast-feed.

Tablet: Hydrocodone bitartrate 7.5 mg and ibuprofen 200 mg

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.