Salsalate 750 mg/1
Salsalate · TABLET · Amneal Pharmaceuticals LLC
Salsalate is a tablet containing salsalate at 750 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals LLC.
Key Facts
- Brand Name
- Salsalate
- Generic Name
- Salsalate
- NDC Code (Product)
65162-513- Manufacturer
- Amneal Pharmaceuticals LLC
- Strength
- 750 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Marketing Start
- 09/24/2010
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Salsalate tablets and other treatment options before deciding to use Salsalate tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder.
Dosage & Administration
DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of Salsalate tablets and other treatment options before deciding to use Salsalate tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). After observing the response to initial therapy with Salsalate tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder. Adults: The usual dosage is 3000 mg daily, given in divided doses as follows: 1) two doses of two 750 mg tablets; 2) two doses of three 500 mg tablets; or 3) three doses of two 500 mg tablets. Some patients, e.g., the elderly, may require a lower dosage to achieve therapeutic blood concentrations and to avoid the more common side effects such as auditory. Alleviation of symptoms is gradual, and full benefit may not be evident for 3 to 4 days, when plasma salicylate levels have achieved steady-state. There is no evidence for development of tissue tolerance (tachyphylaxis), but salicylate therapy may induce increased…
Warnings
WARNINGS Reye’s Syndrome may develop in individuals who have chicken pox, influenza, or flu symptoms. Some studies suggest a possible association between the development of Reye’s Syndrome and the use of medicines containing salicylate or aspirin. Salsalate contains a salicylate and therefore is not recommended for use in patients with chicken pox, influenza, or flu symptoms. CARDIOVASCULAR EFFECTS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or symptoms of serious CV events…
Contraindications
CONTRAINDICATIONS Salsalate tablets are contraindicated in patients with known hypersensitivity to salsalate. Salsalate tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS – Anaphylactoid Reactions , and PRECAUTIONS - Preexisting Asthma ). Salsalate tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Adverse Reactions
ADVERSE REACTIONS In two well-controlled clinical trials, the following reversible adverse experiences characteristic of salicylates were most commonly reported with salsalate (n-280 pts; listed in descending order of frequency): tinnitus, nausea, hearing impairment, rash, and vertigo. These common symptoms of salicylates, i.e., tinnitus or reversible hearing impairment, are often used as a guide to therapy. Although cause-and-effect relationships have not been established, spontaneous reports over a ten-year period have included the following additional medically significant adverse experiences: abdominal pain, abnormal hepatic function, anaphylactic shock, angioedema, bronchospasm, decreased creatinine clearance, diarrhea, G.I. bleeding, hepatitis, hypotension, nephritis and urticaria. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Salsalate used for?
Salsalate contains Salsalate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Salsalate a controlled substance?
Salsalate is not classified as a controlled substance by the DEA.
What is the generic name for Salsalate?
The generic name for Salsalate is Salsalate. There are no other listed brand versions of Salsalate.
What is the NDC code for Salsalate 750 mg/1?
The NDC (National Drug Code) for Salsalate 750 mg/1 is 65162-513, listed by Amneal Pharmaceuticals LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)