Salsalate (Disalcid) is closely related to the class of drugs called salicylates or salicylic acid (Aspirin). It is a non-steroidal anti-inflammatory drug that is used in the symptomatic treatment of patients with joint diseases like osteoarthritis and rheumatoid arthritis.

Salsalate Uses:

• Rheumatic disorders:

  • Used for treating signs and symptoms of osteoarthritis, rheumatoid arthritis, and related rheumatic disorders

Salsalate (Disalcid) dose in Adults

Salsalate (Disalcid) dose in the treatment of Rheumatic disorders:

• Oral: Note: The lowest effective dose for the shortest duration should be used; observe the response to initial therapy and if required, adjust the dose.
• Usual dose: 3 g per day twice or thrice a day

Use in Children:

Not indicated.

Pregnancy Risk Factor C

• Studies on animal reproduction have shown negative effects.
• Salicylates can cause ductus arteriosus closure so avoid use during late pregnancy

Use during breastfeeding:

• Salicylic acid is made from the metabolism salsalate.
• It is also found in breast milk in equal amounts to maternal blood concentrations.
• A baby may consume as much as 80 percent of the mother's body weight.
• The manufacturer suggests caution when giving salsalate to nursing mothers.

Dose in Kidney Disease:

No dosage adjustments have been provided in the manufacturer’s labeling. Not recommended for use advanced renal disease.

Dose in Liver disease:

No dosage adjustments have been provided in the manufacturer’s labeling.

Side effects of Salsalate:

• Cardiovascular:

  • Hypotension

• Central Nervous System:

  • Vertigo

• Dermatologic:

  • Skin Rash
  • Stevens-Johnson Syndrome
  • Toxic Epidermal Necrolysis
  • Urticaria

• Gastrointestinal:

  • Abdominal Pain
  • Diarrhea
  • Gastrointestinal Hemorrhage
  • Gastrointestinal Perforation
  • Gastrointestinal Ulcer
  • Nausea

• Hematologic & Oncologic:

  • Anemia

• Hepatic:

  • Abnormal Hepatic Function Tests
  • Hepatitis

• Hypersensitivity:

  • Anaphylactic Shock
  • Angioedema

• Otic:

  • Auditory Impairment
  • Tinnitus

• Renal:

  • Decreased Creatinine Clearance
  • Nephritis

• Respiratory:

  • Bronchospasm

Contraindications to Salsalate:

• Hypersensitivity (to salsalate or any other component of the formulation).
• Asthma
• Urticaria
• History of an allergic reaction to aspirin and NSAIDs
• Perioperative pain following coronary artery bypass surgery (CABG).

There is limited documentation on allergenic cross-reactivity between salicylates. Cross-sensitivity is possible, however, as there are similarities in chemical structures and/or pharmacologic reactions.

Warnings and precautions

• Anaphylactoid reactions

  • Even if the patient has never been exposed to salsalate, anaphylactoid reactions can occur. Patients with "aspirin triad" (bronchial asthma and aspirin intolerance, rhinitis) may be at greater risk. Patients who have a history of bronchospasm or asthma, rhinitis or urticaria due to NSAID or aspirin therapy should not use salsalate.

• Cardiovascular events: [U.S.Boxed Warning]

  • NSAIDs are associated with an increased chance of adverse cardiovascular thrombotic conditions, such as stroke and MI.
  • The risk of developing a cardiovascular disease or other risk factors may increase if the use is prolonged or for a longer time. 
  • Before prescribing, it is important to carefully assess each patient's cardiovascular risk profile. Patients with fluid retention or heart disease should be treated cautiously.
  • Concurrent administration of salsalate and other nonselective NSAIDs may interfere with Aspirin's cardioprotective effects. 
  • To reduce cardiovascular events, the patient should only take the lowest effective dose and for the shortest time.
  • For patients with high-risk conditions, consider alternative therapies.

• Gastrointestinal events [U.S.-Boxed Warning]

  • NSAIDs may increase the risk of gastrointestinal irritation, inflammation and ulceration as well as bleeding and perforation.
  • These events can occur without warning and at any time during therapy. 
  • Patients with a history or ulcers and bleeding (GI disease) should be cautious.AspirinAnticoagulants and/or Corticosteroids, smoking, alcohol use, the elderly, or patients with disabilities. 
  • To reduce the risk of GI adverse reactions, the lowest effective dose should be administered for the shortest time. This is consistent with the individual patient's goals.
  • Patients at high risk should consider alternative therapies. 
  • Concomitant use of aspirin with doses greater than 325 mg can significantly increase the risk of gastrointestinal problems (eg, ulcers). It is recommended to combine gastroprotective therapy and proton pump inhibitors.

• Hematologic effects

  • This may lead to a decrease of platelet adhesion or aggregation.
  • Patients with coagulation disorders and those on anticoagulants should be closely monitored for prolonged bleeding.
  • Anemia can occur when NSAID therapy is continued for a long time. Patients who are on long-term NSAID therapy must be closely monitored for anemia.

• Hepatic effects

  • NSAIDs can cause severe hepatic reactions, such as liver failure, fulminant hepatitis or liver failure, but they are rarely fatal.
  • This medication may cause an elevation of ALT and AST. If you have any signs or symptoms, stop using it.

• Sensitivity to salicylates:

  • Patients with sensitive to tartrazine dyes or nasal polyps may be at greater risk for salicylate sensitivity. Past nonreaction does not guarantee safe future use of medication.

• Reactions to skin:

  • SNSAIDs can cause severe skin reactions, such as exfoliative dermatitis (SJS), Stevens-Johnson syndrome, and toxic epidermal necrolysis. These could be fatal. Stop using NSAIDs immediately if you notice skin rash or hypersensitivity.

• Asthma

  • Aspirin-sensitive asthma patients should not be given as it can cause severe bronchospasm.
  • Be careful.

• Coronary bypass surgery for coronary artery bypass: [U.S.Boxed Warning]

  • Perioperative pain treatment in the context of coronary bypass graft (CABG), surgery is contraindicated.
  • Following CABG surgery, use of the device may increase your risk of MI or stroke.

• Hepatic impairment

  • Be careful.
  • Pay attention.

• Hypertension:

  • Be cautious. It may cause hypertension to worsen or new-onset. Use of NSAIDs concurrently can also affect the response to ACE inhibitors and thiazides or loop diuretics.

• Renal impairment

  • NSAIDs can cause impairment of renal function. A decrease in prostaglandin synthesis could be caused by NSAIDs being used in a dose-dependent manner. This reduces renal blood flow, which could lead to renal decompensation.
  • Patients with impaired renal function, heart failure, liver dysfunction, diuretics and ACE inhibitors are at greater risk for renal toxicity.
  • Before starting treatment, patients should be properly hydrated. Also, it is important to monitor their renal function.
  • Advanced renal disease is not a good candidate for NSAID use. Long-term NSAID treatment may cause renal papillary necrosis.

Salsalate: Drug Interaction

Monitoring parameters:

• Signs and symptoms of GI bleeding
• Blood Pressure
• Kidney function
• Urinary pH
• Plasma salicylate levels
• Blood CP and chemistry profile (periodically during long-term therapy).

How to administer Salsalate?

Should be administered with food to reduce GI distress.

Mechanism of action of Salsalate:

• Prostaglandin synthesis inhibition is caused by salsalate.
• It also has anti-inflammatory effects that are less severe than aspirin.

The beginning of action After continuous dosing, it takes between 3 and 4 days for the therapeutic effects to kick in

Absorption: Complete absorption from the small intestine. Food causes slower absorption

Metabolism: The intestine partially hydrolyzes salicylic acid (active) into 2 moles and metabolites. Further metabolism occurs in the liver.

Half-life elimination Salsalate takes almost one hour. Salicylic acid takes 3.5 to 16 hours due to biotransformation with limited capacity.

Excretion: Urine is the primary excretory organ.

International Brand Names of Salsalate:

• Disalcid
• Disal
• Mono-Getic
• Sala
• Salate

Salsalate Brand Names in Pakistan:

No Brands Available in Pakistan.