Oxycodone Hydrochloride / Aspirin

Trade Names:
Percodan
- Tablets 4.5 mg oxycodone hydrochloride/ 0.38 mg oxycodone terephthalate/325 mg aspirin

Pharmacology

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Relieves pain by stimulating opiate receptors in CNS

Inhibits prostaglandin synthesis, resulting in analgesia, anti-inflammatory activity, and inhibition of platelet aggregation.

Indications and Usage

For the relief of moderate to moderately severe pain.

Contraindications

Hypersensitivity to any component of the product.

Dosage and Administration

PO Usual dose is 1 tablet every 6 h as needed for pain (max, 12 tablets [4 g aspirin] every 24 h).

Storage/Stability

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

Drug Interactions

Effects of anticoagulants may be enhanced by aspirin, increasing the risk of bleeding.

Effects may be additive.

Effects may be inhibited by aspirin.

Laboratory Test Interactions

None well documented.

Adverse Reactions

CNS

Lightheadedness; dizziness; sedation; euphoria; dysphoria.

Dermatologic

Pruritus.

GI

Nausea; vomiting; constipation.

Precautions

Pregnancy

Safety of use has not been established.

Children

Safety and efficacy not established. Reye syndrome has been associated with aspirin administration to children (including teenagers) with acute febrile illness.

Special Risk Patients

Use with caution in the elderly or debilitated and patients with severe hepatic or renal function impairment, peptic ulcers, hypothyroidism, Addison disease, and prostatic hypertrophy or urethral stricture.

Acute abdominal conditions

Diagnosis or clinical course may be obscured.

Ambulatory patients

Mental and physical abilities may be impaired.

Dependency

Oxycodone has abuse potential.

Head injury and increased intracranial pressure

Cerebrospinal fluid pressure may be markedly exaggerated in the presence of head injury.

Peptic ulcers

Use with caution in the presence of peptic ulcer.

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.

Patient Information

• Advise patient to take 1 tablet every 6 h or as prescribed if needed for pain but to not take more than 12 tablets in 24 h.
• Advise patient to take without regard to meals but to take with food if GI upset occurs.
• 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-like material, excessive sedation.

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