Generic
Sulindac
9 brands available in the market
At a glance
Sulindac is an NSAID used for rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gouty arthritis, and acute painful shoulder.
Description
Sulindac is a prodrug that is metabolized to its active sulfide metabolite. It inhibits cyclooxygenase (COX) enzymes, reducing prostaglandin synthesis and exhibiting anti-inflammatory, analgesic, and antipyretic effects.
Indications
- Rheumatoid arthritis
- Osteoarthritis
- Ankylosing spondylitis
- Periarticular inflammatory disorders
- Acute painful shoulder
- Acute gouty arthritis
- Diabetic neuropathy
- Diabetic retinopathy
Therapeutic class
Drugs for Osteoarthritis, Rheumatoid Arthritis & Gout
Pharmacological class
NSAID (Non-Steroidal Anti-Inflammatory Drug)
Pharmacology
Sulindac is a prodrug that is metabolized in the liver to its active sulfide metabolite. This active metabolite inhibits cyclooxygenase (COX-1 and COX-2), reducing prostaglandin synthesis and decreasing inflammation, pain, and fever.
Mechanism of action
Reduces inflammation and pain by inhibiting prostaglandin synthesis.
Dosage
Adult Dose (Oral):
- Osteoarthritis/RA/Ankylosing spondylitis: 150 mg twice daily; max 400 mg/day
- Acute painful shoulder/Acute gouty arthritis: 200 mg twice daily (7-14 days); max 400 mg/day
Administration
- Take with food
- Swallow tablet whole; do not chew, crush, or break
- Take at the same time each day
Missed dose
If you miss a dose, take it as soon as you remember; if almost time for the next dose, skip it; do not double the dose.
Side effects
Common Side Effects (1-10%):
- Abdominal pain (10%), constipation (3-9%)
- Diarrhea (3-9%), dizziness (3-9%)
- Dyspepsia (3-9%), headache (3-9%)
- Nausea (3-9%), rash (3-9%)
Serious (<1%):
- Hypersensitivity reactions, thrombocytopenia
- Leukopenia, agranulocytosis
- Hematuria, renal impairment
- Hepatitis, jaundice, liver necrosis
Precautions & warnings
- Use at lowest effective dose for the shortest duration possible
- Risk of serious cardiovascular thrombotic events, MI, and stroke
- May cause hypertension, fluid retention, and edema; caution in heart failure
- Serious GI adverse events (ulceration, bleeding, perforation) may occur
- Severe hepatotoxicity (jaundice, fulminant hepatitis) is rare
- May cause renal impairment; higher risk in pre-existing renal disease, heart failure, elderly
Contraindications
- Hypersensitivity to sulindac or NSAIDs
- Pregnancy (3rd trimester)
- Treatment of peri-operative pain in CABG surgery
Drug interactions
- Dimethyl sulfoxide: Peripheral neuropathy
- Cyclosporine: Increased nephrotoxicity
- Methotrexate: Increased toxicity risk
- Other NSAIDs, warfarin, thrombolytic agents: Increased bleeding risk
- Antihypertensives: Antagonistic effect
- Lithium: Unpredictable interactions
Food interactions
Caution is advised when consuming alcohol with Sulindac (increased GI bleeding risk); consult your doctor.
Use in pregnancy
Use in Pregnancy: First two trimesters (Category C): use only if clearly needed; 3rd trimester (Category D): do not use; consult your doctor.
Pregnancy Category: D — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Unknown if excreted in human milk; decide whether to discontinue nursing or the drug; consult your doctor.
Pediatric use
Safety and efficacy not established in children
Geriatric use
Caution required in elderly patients; dose adjustment may be needed
Renal / hepatic impairment
Renal Impairment: Dose reduction may be needed; not recommended in severe renal impairment; consult your doctor.
Hepatic Impairment: Acute and chronic hepatic disease may require dose reduction; consult your doctor.
Overdose effects
Overdose may cause GI, renal, and CNS toxicity; provide symptomatic and supportive treatment.
Storage conditions
Store below 25°C, away from light and moisture; keep out of reach of children.
Chemical structure
Sulindac