SALSALATE tablet, film coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Westminster Pharmaceuticals, LLC

INN (Nome Internazionale):

Salsalate

Composizione:

Salsalate 500 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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. Salsalate Tablets, USP is contraindicated in patients with known hypersensitivity to salsalate. Salsalate Tablets, 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 Tablets, 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 dependence have not been reported with salsalate.

Dettagli prodotto:

500 mg Tablets in bottles of 100 ct (NDC 69367-160-04) 500 mg Tablets in bottles of 500 ct (NDC 69367-160-06) Appearance, 500 mg: Yellow Colored, round, film-coated tablets debossed '809' on one side and plain on the other. 750 mg Tablets in bottles of 100 ct (NDC 69367-161-04) 750 mg Tablets in bottles of 500 ct (NDC 69367-161-06) Appearance, 750 mg: Yellow colored, capsule-shaped, filmcoated tablets debossed '810' on one side and bisect on the other. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP. Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Rx only

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SALSALATE- SALSALATE TABLET, FILM COATED
WESTMINSTER 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._
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SALSALATE TABLETS, USP
500 MG AND 750 MG
RX ONLY
SALSALATE - SALSALATE TABLET, FILM COATED
WESTMINSTER 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, visit http://www.fda.gov/.
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. Theseevents 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, USP 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: D&C Yellow No. 10 Aluminum Lake, Hypromellose,
Magnesium
Stearate, Microcrystalline Cellulose, Pregelatinized Starch,
Polyethylene Glycol,
Polysorbate 80, Polyvinyl Alcohol, Silicon Dioxide, Talc.
CLINICAL PHARMACOLOGY
Salsalate is insoluble in acid gastric fluids (<0.1 mg/mL at pH 1.0),
but rea