SALSALATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SALSALATE (UNII: V9MO595C9I) (SALSALATE - UNII:V9MO595C9I)

Available from:

Caraco Pharmaceutical Laboratories, Ltd.

INN (International Name):

SALSALATE

Composition:

SALSALATE 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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, osteoarthritis and related rheumatic disorder. Salsalate tablet, USP is contraindicated in patients with known hypersensitivity to salsalate. Salsalate tablet, USP 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 tablet, USP is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Drug abuse and depen

Product summary:

Salsalate Tablets, USP, 500 mg are circular, blue colored film coated tablet, scored, debossed "103/103" on one side, and "Caraco Logo" debossed on other side. Bottles of 100                              NDC 57664-103-08 Bottles of 500                              NDC 57664-103-13 Bottles of 1000                            NDC 57664-103-18 Salsalate Tablets, USP, 750 mg are capsule shaped, blue colored film coated tablet, debossed "105" on one side, and "C/C" scored on other side. Bottles of 100                              NDC 57664-105-08 Bottles of 500                              NDC 57664-105-13 Bottles of 1000                            NDC 57664-105-18 Store at controlled room temperature 15-30°C (59-86°F). Rx only

Authorization status:

unapproved drug other

Summary of Product characteristics

SALSALATE - SALSALATE TABLET
CARACO PHARMACEUTICAL LABORATORIES, LTD.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events,
myocardial infarction, and stroke, which can be fatal. This risk may
increase with duration of
use. Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at
greater risk. (See WARNINGS and CLINICAL TRIALS)
Salsalate tablets, USP is contraindicated for the treatment of
perioperative pain in the setting
of coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
bleeding, ulceration, and perforation of the stomach or intestines,
which can be fatal. These
events can occur at any time during use and without warning symptoms.
Elderly patients are at
greater risk for serious gastrointestinal events. (See WARNINGS)
DESCRIPTION
Salsalate, is a nonsteroidal anti-inflammatory agent for oral
administration. Chemically, salsalate
(salicylsalicylic acid or 2-hydroxy-benzoic acid, 2- carboxyphenyl
ester) is a dimer of salicylic acid;
its structural formula is shown below.
CHEMICAL STRUCTURE:
Each tablet, for oral administration contains 500 mg or 750 mg of
salsalate, USP. In addition each tablet
contains the following inactive ingredients: Microcrystalline
Cellulose, Sodium Starch Glycolate,
Povidone, and Stearic Acid. Also contains: Hydroxypropyl
Methylcellulose, Polydextrose, Titanium
Dioxide, Triacetin, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2
Aluminum Lake and
Polyethylene Glycol.
CLINICAL PHARMACOLOGY
Salsalate is insoluble in acid gastric fluids (<0.1 mg/ml at pH 1.0),
but readily soluble in the small
intestine where it is partially hydrolyzed to two molecules of
salicylic acid. A significant portion of the
parent c