Salsalate

Generic name:

Salsalate

Drug class:

Nonsteroidal anti-inflammatory drug (NSAID), Salicylate derivative

Dosage form:

• Tablet (oral)
• Extended-release tablet (oral)

Root of administration:

Oral

Dose:

• Adults: Typically 500 mg to 1,000 mg two to three times daily
• Maximum daily dose: Up to 3,000 to 4,000 mg per day, depending on indication and clinical response
• Dose adjustments may be required in elderly or patients with renal/hepatic impairment
• Varies by indication; consult label

Mechanism of action:

Salsalate is a non-acetylated salicylate that exerts anti-inflammatory, analgesic, and antipyretic effects primarily through the inhibition of cyclooxygenase (COX-1 and COX-2) enzymes, leading to decreased formation of prostaglandins. Unlike acetylsalicylic acid, salsalate has minimal irreversible platelet inhibition.

Drug usage cases:

• Rheumatoid arthritis (mild to moderate symptoms)
• Osteoarthritis
• Inflammatory conditions responsive to NSAIDs
• Musculoskeletal pain and inflammatory disorders
• Off-label: Potential anti-inflammatory use in certain metabolic syndrome or type 2 diabetes-related inflammatory processes (clinical studies ongoing)

Drug contra indications:

• Hypersensitivity to salsalate, salicylates, or other NSAIDs
• History of asthma, urticaria, or allergic-type reactions to aspirin or other NSAIDs
• Active peptic ulcer disease or gastrointestinal bleeding
• Severe renal impairment
• Coagulation disorders or bleeding diathesis
• Known aspirin-induced asthma or anaphylaxis
• Varies by indication; consult label

Side effects:

• Gastrointestinal: nausea, vomiting, dyspepsia, abdominal pain, gastrointestinal ulceration, bleeding, or perforation
• Central nervous system: headache, dizziness, tinnitus
• Hypersensitivity reactions: rash, pruritus, angioedema, bronchospasm (aspirin-sensitive asthmatics)
• Renal: fluid retention, renal impairment
• Hematologic: bleeding tendencies, prolonged bleeding time (less than aspirin)
• Hepatic: elevated liver enzymes, hepatotoxicity (rare)
• Reye’s syndrome (children and adolescents with viral infections; rare but serious)
• Rare: aplastic anemia, thrombocytopenia

Warnings:

• Risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation, which may be fatal
• Use with caution in patients with renal or hepatic impairment
• May cause fluid retention and edema; monitor in patients with hypertension or heart failure
• Hypersensitivity reactions including bronchospasm and anaphylaxis may occur, especially in patients with known aspirin or NSAID allergy
• Avoid use in children and adolescents with viral infections due to risk of Reye’s syndrome
• May interfere with platelet function and prolong bleeding time—caution in patients undergoing surgery or with bleeding disorders
• Potential risk in pregnancy (third trimester) including premature closure of the fetal ductus arteriosus
• Varies by indication; consult label

Use during pregnancy or breastfeeding:

Salsalate is classified as pregnancy category C (first and second trimesters) and category D (third trimester) due to risk of premature closure of the fetal ductus arteriosus, oligohydramnios, and possible fetal renal impairment when used in late pregnancy. Use during the third trimester is generally contraindicated. Use during pregnancy only if potential benefits outweigh risks.

Breastfeeding: Salsalate is excreted in breast milk in small amounts. Use with caution in nursing mothers, monitoring infants for adverse effects such as bleeding or hypersensitivity. Alternative agents preferred if possible during lactation.