Drug Guide
Sulindac
Classification
Therapeutic: Nonsteroidal Anti-Inflammatory Drug (NSAID)
Pharmacological: NSAID, Non-selective COX inhibitor
FDA Approved Indications
- Relief of pain, swelling, and inflammation in various musculoskeletal disorders such as rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, and tender, benign prostatic hyperplasia (BPH).
Mechanism of Action
Sulindac inhibits cyclooxygenase (COX-1 and COX-2 enzymes), thereby decreasing prostaglandin synthesis, which mediates inflammation, pain, and fever.
Dosage and Administration
Adult: Typically, 150 mg twice daily or divided doses; dose may vary based on condition and response.
Pediatric: Not commonly used in children; safety and efficacy not established.
Geriatric: Start at lower end of dosing range due to increased risk of adverse effects; monitor renal and hepatic function.
Renal Impairment: Adjust dose based on renal function; caution in severe impairment.
Hepatic Impairment: Use with caution; start at lower doses; monitor hepatic function.
Pharmacokinetics
Absorption: Well absorbed orally, with peak plasma levels in 1-2 hours.
Distribution: Extensively bound to plasma proteins (~97%).
Metabolism: Metabolized in the liver to active and inactive metabolites.
Excretion: Primarily via renal excretion of metabolites.
Half Life: Approximately 8-17 hours, allowing for twice daily dosing.
Contraindications
- Hypersensitivity to sulindac, other NSAIDs, or components of the formulation.
- History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs.
Precautions
- History of gastrointestinal bleeding or ulceration, renal impairment, hepatic impairment, heart failure, hypertension.
- Use with caution during pregnancy, especially after 30 weeks gestation.
Adverse Reactions - Common
- Gastrointestinal upset, dyspepsia (Common)
- Dizziness (Common)
- Headache (Common)
Adverse Reactions - Serious
- Gastrointestinal bleeding or ulceration (Uncommon to rare)
- Cardiovascular events, such as hypertension, edema, or increased risk of thrombotic events (Uncommon)
- Allergic reactions, including anaphylaxis (Rare)
Drug-Drug Interactions
- Other NSAIDs, corticosteroids, anticoagulants (e.g., warfarin), antihypertensives (e.g., ACE inhibitors, diuretics)
Drug-Food Interactions
- Alcohol may increase gastrointestinal bleeding risk.
Drug-Herb Interactions
N/ANursing Implications
Assessment: Monitor for signs of gastrointestinal bleeding, renal function, and hepatic function before and during therapy. Assess for allergy history.
Diagnoses:
- Risk for bleeding related to NSAID use.
- Risk for impaired renal perfusion.
Implementation: Administer with food or milk to decrease gastrointestinal upset. Monitor vital signs and laboratory tests as indicated.
Evaluation: Assess for relief of symptoms and monitor for adverse effects, adjusting dosage as needed.
Patient/Family Teaching
- Take medication with food or milk to reduce gastrointestinal upset.
- Report signs of gastrointestinal bleeding (black stools, abdominal pain), allergic reactions, or signs of kidney problems.
- Avoid alcohol and concurrent use of other NSAIDs unless directed.
- Use the medication exactly as prescribed, and do not alter dose without healthcare provider consultation.
Special Considerations
Black Box Warnings:
- Cardiovascular risk: NSAIDs may increase the risk of heart attack and stroke, especially with long-term use or high doses.
Genetic Factors: N/A
Lab Test Interference: NSAIDs can affect renal function tests and may interfere with some urinalysis results.
Overdose Management
Signs/Symptoms: Nausea, vomiting, dizziness, gastrointestinal bleeding, renal failure.
Treatment: Supportive care; activated charcoal if ingestion was recent; manage symptoms; ensure adequate hydration; dialysis in severe cases.
Storage and Handling
Storage: Store at room temperature away from moisture, heat, and light.
Stability: Stable for the duration of the shelf life as indicated on the package.