SALSALATE tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Acella Pharmaceuticals, LLC

INN (International namn):

SALSALATE

Sammansättning:

SALSALATE 500 mg

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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. CONTRAINDICATIONS SALSALATE TABLETS is 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 is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARN

Produktsammanfattning:

HOW SUPPLIED 500mg Tablets: Supplied in bottles of 100ct (NDC 42192-365-10); white, round-shaped tablets, debossed with “Syntho” on one side, and 112 on the other side. 750mg Tablets: Supplied in bottles of 100ct (NDC 42192-366-10); white, capsule-shaped tablets, debossed with “Syntho” on one side, and 113 on the other. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Bemyndigande status:

unapproved drug other

Produktens egenskaper

SALSALATE- SALSALATE TABLET
ACELLA PHARMACEUTICALS, LLC
_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._
----------
SALSALATE TABLETS
RX ONLY
RX ONLY
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 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 TABLETS contain the active ingredient Salsalate, which 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:
INACTIVE INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide,
Sodium Starch Glycolate, Stearic
Acid, Talc, and Coating (Hypromellose, Polyethylene Glycol,
Polysorbate 80, Titanium Dioxide)
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 compound is absorbed unchanged and undergoes rapid esterase
hydrolysis in the body: its half-
life is about one hour. About 13% is excreted th