SALSALATE RX- 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:

ANDAPharm 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 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 dependence have not been r

Dettagli prodotto:

Appearance: Yellow Colored, round, film-coated tablets debossed '809' on one side and plain on the other. Appearance: Yellow colored, capsule-shaped, film-coated 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].

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SALSALATE RX- SALSALATE TABLET, FILM COATED
ANDAPHARM 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
CARDIOVASCULAR RISK
NSAIDs may cause an increase 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-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.
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 through the kidneys as a
glucuronide