Oxycodone / Acetaminophen

Trade Names:
Percocet
- Tablets 5 mg oxycodone hydrochloride/325 mg acetaminophen
- Tablets 7.5 mg oxycodone hydrochloride/500 mg acetaminophen
- Tablets 10 mg oxycodone hydrochloride/650 mg acetaminophen

Trade Names:
Roxicet
- Tablets 5 mg oxycodone hydrochloride/325 mg acetaminophen
- Solution, oral 5 mg oxycodone hydrochloride/325 mg acetaminophen

Trade Names:
Roxicet 5/500
- Caplets 5 mg oxycodone/500 mg acetaminophen

Trade Names:
Roxilox
- Capsules 5 mg oxycodone hydrochloride/500 mg acetaminophen

Trade Names:
Tylox
- Capsules 5 mg oxycodone hydrochloride/500 mg acetaminophen

Pharmacology

Acetaminophen inhibits synthesis of prostaglandins and peripherally blocks pain impulse generation, whereas, oxycodone binds to opiate receptors in CNS. Combination has synergistic effect on alleviating pain.

Indications and Usage

Relief of moderate to moderately severe pain.

Contraindications

Hypersensitivity to acetaminophen, oxycodone, or similar compounds.

Dosage and Administration

PO 5 mg (1 tablet, caplet, or teaspoonful) every 6 h as needed.

Storage/Stability

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

Drug Interactions

Additive CNS depression.

Increased risk of hepatotoxicity.

Additive CNS depression.

Laboratory Test Interactions

With Chemstrip bG , Dextrostix , and Visidex II home blood glucose systems, may cause false decrease in mean glucose values.

Adverse Reactions

Cardiovascular

Hypotension; bradycardia; tachycardia.

CNS

Lightheadedness; dizziness; weakness; fatigue; sedation; euphoria; dysphoria; nervousness; headache; confusion.

Dermatologic

Pruritus; rash.

GI

Nausea; vomiting; constipation; abdominal pain; anorexia; biliary spasm; dry mouth.

Genitourinary

Urinary retention or hesitancy.

Respiratory

Dyspnea; respiratory depression.

Miscellaneous

Malaise; tolerance; psychological and physical dependence with chronic use.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Hepatic Function

Chronic alcoholics should limit acetaminophen intake to less than 2 g/day.

Special Risk Patients

Use with caution in elderly, debilitated patients and those with hepatic or kidney failure or conditions accompanied by hypoxia or hypercapnia; monitor carefully to avoid decrease in pulmonary ventilation. Also use cautiously in patients sensitive to CNS depressants, postoperatively and in patients with pulmonary disease.

Sulfite Sensitivity

Use with caution in patients known to be sensitive, as some products contain bisulfites.

Acute abdominal conditions

Diagnosis may be obscured; use with caution.

Dependence

Can produce drug dependence; has abuse potential.

Head injury

Respiratory depression and elevation of CSF pressure may be exacerbated.

Overdosage

Symptoms

Miosis, respiratory depression, CNS depression (somnolence progressing to stupor or coma), hepatic damage, circulatory collapse, cardiopulmonary arrest, death.

Patient Information

• Instruct patient to take medication before pain becomes severe for greatest effectiveness.
• Teach patient methods to prevent constipation.
• Instruct patient to make position changes slowly if lightheadedness or sedation occurs.
• Advise patient to avoid intake of alcoholic beverages or products containing alcohol while using this medication.
• Advise patient that drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.
• Caution patient that physical dependency and withdrawal symptoms may occur following discontinuation of long-term therapy.

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