- Therapy may increase risk of serious and potentially fatal cardiovascular thrombotic events, MI, and stroke. Risk further increases with duration of use, presence of cardiovascular disease/risk factors for CV disease [US Black Box Warning]
- Salsalate is contraindicated in the treatment of peri-operative pain in the setting of CABG surgery [US Black Box Warning]
- NSAIDs may increase risk of serious GI events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events occur at any time and without warning symptoms. Elderly patients are at greater risk for serious GI events [US Black Box Warning]
- Use the lowest effective dose for the shortest duration possible in patients with known CV disease or risk factors for CV disease as it causes serious cardiovascular thrombotic events, myocardial infarction, and stroke
- Salsalate causes inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine. Restrict use in patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding
- If a serious GI adverse event is suspected, discontinue the therapy and promptly institute an alternative therapy
- Avoid long term therapy with the drug, concomitant use of oral corticosteroids or anticoagulants, smoking, use of alcohol
- Severe hepatotoxicity can occur any time during treatment, closely monitor (ALT and AST) levels periodically in patients receiving continued therapy. Use the lowest effective dose for the shortest duration possible to minimize the potential risk of hepatotoxicity
- Avoid concomitant use of drugs known to be potentially hepatotoxic
- May lead to onset of hypertension or worsening of pre-existing hypertension, closely monitor blood pressure before initiating and during treatment
- Use with caution in patients taking thiazides or loop diuretics as it may hamper the therapeutic response of thiazides or loop diuretics. Closely monitor BP during therapy
- Use cautiously in patients with fluid retention or heart failure, as it causes fluid retention and edema
- Monitor for renal toxicity in long term treatment, including renal papillary necrosis and other renal injury. Avoid use in advanced renal disease
- Restrict administration in patients with aspirin triad
- Discontinue the treatment at the first appearance of skin rash or any other sign of hypersensitivity like anaphylactoid reactions
- Check hematologic profile including hemoglobin or hematocrit at regular intervals in patients on long-term treatment with NSAIDs as it may cause anemia due to fluid retention, occult or gross GI blood loss
- Therapy inhibits platelet aggregation and prolongs bleeding time in some patients, closely monitor patients with coagulation disorders or receiving anticoagulants
- Cautiously administer in patients with pre-existing asthma/aspirin-sensitive asthma as it may cause an exacerbation of symptoms
- Monitor for signs of GI bleeding. Perform CBC and other blood chemistries, liver function tests and renal function tests periodically
- Use with caution in older age, poor general health status, debilitated patients
- Concomitant use of ACEI, thiazides, and loop diuretics increase risk of renal toxicity
- Use in third trimester use may cause premature closure of the ductus arteriosus
Cautions: Use cautiously in
- Hepatic impairment
- Renal impairment
- Cardiovascular disease
- Presence of cardiac risk factors
- Hypertension
- CHF
- Fluid retention
- Hx of PUD/GI bleed
- Hematological disorders
- Dehydration
- Long term use
- Diuretic use
- ACE inhibitor/ARB use
- Anticoagulant use
- Elderly/debilitated patients
Pregnancy Category:C
Breastfeeding: It is not known if salsalate is excreted in breastmilk. The active metabolite, salicylic acid is excreted in breastmilk in concentrations similar to that of maternal blood levels. Manufacturer advises caution.
Pricing data from www.DrugStore.com in U.S.A.
- Salsalate 750 MG TABS [Bottle] (AMNEAL PHARMACEUTICALS)
60 mg = $47.99
120 mg = $71.97 - Salsalate 500 MG TABS [Bottle] (AMNEAL PHARMACEUTICALS)
100 mg = $39.99
300 mg = $99.97
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
Drug Name: SALSALATE 500 mg
Ingredient(s): N/A
Imprint: 103;Caraco
Color(s): Blue
Shape: Round
Size (mm): 11.00
Score: 2
Inactive Ingredient(s): cellulose, microcrystalline / sodium starch glycolate type a potato / povidone / stearic acid / hypromellose / polydextrose / titanium dioxide / triacetin / fd&c blue no. 1 / fd&c blue no. 2 / polyethylene glycol
Drug Label Author:
Caraco Pharmaceutical Laboratories, Ltd.
DEA Schedule:
Non-Scheduled
Drug Name: SALSALATE 750 mg
Ingredient(s): N/A
Imprint: 105;C
Color(s): Blue
Shape: Capsule
Size (mm): 19.00
Score: 2
Inactive Ingredient(s): cellulose, microcrystalline / sodium starch glycolate type a potato / povidone / stearic acid / hypromellose / polydextrose / titanium dioxide / triacetin / fd&c blue no. 1 / fd&c blue no. 2 / polyethylene glycol
Drug Label Author:
Caraco Pharmaceutical Laboratories, Ltd.
DEA Schedule:
Non-Scheduled
