SALSALATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Carilion Materials Management

INN (Nome Internazionale):

SALSALATE

Composizione:

SALSALATE 750 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 ). Salsalate is indicated for relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis and related rheumatic disorder. WARNINGS 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 , and ). WARNINGS – Anaphylactoid Reactions PRECAUTIONS - Preexisting Asthma Salsalate tablet, USP is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graf

Dettagli prodotto:

NDC:68151-1924-1 in a PACKAGE of 1 TABLETS

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SALSALATE - SALSALATE TABLET
CARILION MATERIALS MANAGEMENT
_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, USP
Rx Only
• 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 and ).• Salsalate tablets, USP
is contraindicated for
the treatment of perioperative pain in the setting of coronary artery
bypass graft (CABG)
surgery (see ). • 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 ).
CARDIOVASCULAR RISKWARNINGSCLINICAL
TRIALSWARNINGSGASTROINTESTINAL RISKWARNINGS
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:
T ABLETS :
Carnauba wax, Colloidal Silicon Dioxide, Croscarmellose INACTIVE
INGREDIENTS:
Sodium, D&C Yellow #10, Hypromellose, Microcrystalline Cellulose,
Polyethylene Glycol, Stearic
Acid, 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 through the kidneys as a
glucu