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|Hydrocodone Bitartrate/Ibuprofen Hydrocodone Bitartrate/Pseudoephedrine Hydrochloride

Hydrocodone Bitartrate/Ibuprofen

Trade Names:
Vicoprofen
- Tablets 7.5 mg hydrocodone bitartrate and 200 mg ibuprofen

Mechanism of Action

Pharmacology

Suppresses cough reflex; stimulates opiate receptors in the CNS and peripherally blocks pain impulse generation.

Decreases inflammation, pain, and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

Indications and Usage

Short-term (generally less than 10 days) management of acute pain. Not indicated for treatment of osteoarthritis or rheumatoid arthritis.

Contraindications

Hypersensitivity to hydrocodone, other opioids, ibuprofen, or other NSAIDs; patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.

Dosage and Administration

PO 1 tablet q 4 to 6 hr (max, 5 tablets/24 hr period).

General Advice

Administer without regard to meals, but administer with food if GI upset occurs.

Storage/Stability

Store at controlled room temperature (59° to 86°F).

Drug Interactions

Antihypertensive effect may be decreased by ibuprofen.

Possible additive CNS depression.

Increased risk of paralytic ileus.

The effect of either the antidepressant or hydrocodone may be increased.

Increased risk of side effects with coadministration of ibuprofen.

Plasma levels may be increased by ibuprofen.

Diuretic effects may be decreased by ibuprofen.

Risk of gastric erosion and bleeding may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Palpitations, vasodilation.

Arrhythmia, hypotension, tachycardia.

CNS

Headache (27%); somnolence (22%); dizziness (14%).

Anxiety, insomnia, nervousness, paresthesia.

Confusion, hypertonia, thinking abnormalities.

Dermatologic

Pruritus, sweating.

EENT

Pharyngitis, rhinitis, tinnitus.

GI

Constipation (22%); nausea (21%); dyspepsia (12%).

Diarrhea, dry mouth, flatulence, vomiting.

Anorexia, gastritis, melena, mouth ulcer, thirst.

Genitourinary

Urinary frequency (less than 3%).

Metabolic

Edema (3 to 9%); liver enzyme elevation (less than 1%).

Musculoskeletal

Arthralgia, myalgia.

Respiratory

Dyspnea, hiccups.

Pulmonary congestion, pneumonia.

Miscellaneous

Abdominal pain, asthenia, infection.

Fever, flu-like symptoms, pain.

Allergic reaction (less than 1%).

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children below 16 yr not established.

Elderly

Use with caution because of possible increased sensitivity to renal and GI effects of ibuprofen, as well as increased respiratory depression with hydrocodone.

Renal Function

Use with caution and monitor kidney function in patients with advanced kidney disease.

Hepatic Function

As with other NSAIDs, ibuprofen has been reported to cause borderline elevations of one or more liver enzymes; this may occur in up to 15% of patients.

Special Risk Patients

Use with caution in elderly or debilitated patients and in those with hepatic or renal dysfunction, hypothyroidism, Addison disease, prostatic hypertrophy, or urethral stricture.

Acute abdominal conditions

Diagnosis may be obscured.

Aseptic meningitis

Aseptic meningitis with fever and coma has been observed on rare occasions in patients on ibuprofen therapy. If signs or symptoms of meningitis develop in a patient on Vicoprofen , the possibility of its being related to ibuprofen should be considered.

Cough reflex

Hydrocodone suppresses the cough reflex; as with opioids, caution should be exercised when Vicoprofen is used postoperatively and in patients with pulmonary disease.

Dependence

Hydrocodone has abuse potential; may be habit forming and cause physical dependence.

Effect on diagnostic signs

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.

Fluid retention and edema

May occur, therefore, use with caution in patients with a history of cardiac decompensation, hypertension, or heart failure.

GI effects

Serious GI toxicity (eg, bleeding, ulceration, perforation) can occur at any time, with or without warning symptoms.

Head injury or increased intracranial pressure

Diagnosis of adverse reactions may be obscured; respiratory depression properties and capacity to elevate CSF pressure of hydrocodone may be markedly exaggerated.

Hematological effects

Ibuprofen, like other NSAIDs, can inhibit platelet aggregation but the effect is quantitatively less and of shorter duration than that seen with aspirin. Because this prolonged bleeding effect may be exaggerated in patients with underlying hemostatic defects, Vicoprofen should be used with caution in persons with intrinsic coagulation defects and those on anticoagulant therapy.

Preexisting asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm, which may be fatal. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Vicoprofen should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma.

Overdosage

Symptoms

Respiratory depression, extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, bradycardia, hypotension, apnea, circulatory collapse, cardiac arrest, death

GI irritation with erosion, hemorrhage or perforation, kidney, liver and heart damage, hemolytic anemia, meningitis, headache, dizziness, tinnitus, confusion, blurred vision, mental disturbances, skin rash, stomatitis, edema, reduced retinal sensitivity, corneal deposits, hyperkalemia

Patient Information

• Explain name, dose, action, and potential side effects of drug.
• Advise patient to take 1 tablet q 4 to 6 hr if needed for pain but to not take more than 5 tablets in 24 hr.
• Advise patient to take without regard to meals but to take with food if GI upset occurs.
• Advise patient that medication is intended to be used for short period of time (less than 10 days) for management of acute pain and is not for long-term use. If pain persists or is not controlled, advise patient to discuss other options for pain management with health care provider.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Advise patient that drug may impair judgment, thinking, or motor skills or cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise patient to stop taking the drug and notify health care provider if any of the following occur: allergic reaction, unusual bleeding or bruising, shortness of breath, black or tarry stools, vomiting of blood or coffee ground material, blurred vision, edema, excessive sedation.
• Advise women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Warn patient not to take any prescription or OTC drugs or dietary supplements without consulting health care provider.
• Advise patient that follow-up visits may be necessary to monitor therapy and to keep appointments.