Salsalate

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Salsalate may be taken up to 3 times per day. Follow your doctor's instructions.

Take the medicine with a full glass of water.

Take salsalate with food, milk, or an antacid if it upsets your stomach. To prevent stomach upset, do not lie down for at least 30 minutes after taking salsalate.

It may take up to 2 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 weeks of treatment.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using salsalate.

If you need surgery, tell the surgeon ahead of time that you are using salsalate. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include ringing in your ears, severe dizziness or drowsiness, sweating, fast breathing, severe vomiting or diarrhea, confusion, or seizure (convulsions).

Since salsalate is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Dosage Forms & Strengths

tablet

• 500mg
• 750mg

Osteoarthritis

3 g PO divided q8-12hr

Use lowest effective dose for shortest possible duration

Rheumatoid Arthritis

3 g PO divided q8-12hr

Use lowest effective dose for shortest possible duration

Safety & efficacy not established

Osteoarthritis

3 g PO divided q8-12hr

Use lowest effective dose for shortest possible duration

Rheumatoid arthritis

3 g PO divided q8-12hr

Use lowest effective dose for shortest possible duration

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ANISINDIONE/SALSALATE
• DICUMAROL/SALSALATE
• HEPARIN/SALSALATE
• KETOROLAC/SALSALATE
• PHENPROCOUMON/SALSALATE
• SALSALATE/WARFARIN

This is not a complete list of Salsalatedrug interactions. Ask your doctor or pharmacist for more information.

Salsalate may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Ask a doctor or pharmacist before using any other over-the-counter medicine. Salicylates and NSAIDs are contained in many combination medicines. Taking certain products together can cause you to get too much of a certain drug. Check the label to see if a medicine contains aspirin, ibuprofen, naproxen, ketoprofen, magnesium salicylate, or similar medicines.

If you are also taking low-dose aspirin because your doctor has prescribed it to prevent heart attack or stroke, do not stop taking it or change your dose without your doctor's advice. Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid smoking, since it can also increase your risk of stomach bleeding.

• It is used to treat arthritis.
• It is used to treat rheumatoid arthritis.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Salsalate, is a nonsteroidal anti-inflammatory agent for oral administration. Chemically, Salsalate (salicylsalicylic acid or 2-hydroxybenzoic acid, 2-carboxyphenyl ester) is a dimer of salicylic acid; its structural formula is shown below.

Chemical Structure:

Inactive Ingredients: Colloidal Silicon Dioxide, D&C Yellow #10 Aluminum Lake, Hypromellose, Microcrystalline Cellulose, Sodium Starch Glycolate, Stearic Acid, Talc, Titanium Dioxide, Triacetin.

Carefully consider the potential benefits and risks of Salsalate tablets, USP and other treatment options before deciding to use Salsalate tablets, USP. 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, and related rheumatic disorder.

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, ie., 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.

• Salicylate

Salsalate inhibits prostaglandin synthesis providing, anti-inflammatory effects with less inhibition of platelet aggregation than aspirin

Absorption

Complete, from small intestine; food slows absorption

Metabolism

Salsalate is partially hydrolyzed in the intestine to two moles of salicylic acid (active) and metabolites; salicylates are further metabolized in the liver

Excretion

Primarily urine

Store at 15°C to 30°C (59°F to 86°F).

False results for plasma T4; salsalate is metabolized to salicylic acid; consider test interactions for salicylic acid.

Applies to salsalate: oral tablets

Side effects include:

Tinnitus, nausea, hearing impairment, rash, vertigo.

Applies to salsalate: oral capsule, oral tablet

General

The most frequently reported side effects were usually reversible and included tinnitus, nausea, hearing impairment, rash, and vertigo.[Ref]

Gastrointestinal

Frequency not reported: Nausea, abdominal pain, diarrhea, gastrointestinal bleeding[Ref]

Cardiovascular

Frequency not reported: Hypotension[Ref]

Dermatologic

Frequency not reported: Rash, angioedema, urticaria[Ref]

Hepatic

Frequency not reported: Hepatic function abnormal, hepatitis[Ref]

Renal

Frequency not reported: Nephritis[Ref]

Respiratory

Frequency not reported: Bronchospasm[Ref]

Other

Frequency not reported: Tinnitus, hearing impaired, vertigo, creatinine clearance decreased[Ref]

Immunologic

Frequency not reported: Anaphylactic shock[Ref]

Some side effects of salsalate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.