SALSALATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

ECI 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, 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 depende

Dettagli prodotto:

500mg Tablets: Supplied in bottles of 100ct (NDC 51293-803-01) 500ct (NDC 51293-803-05) 1000ct (NDC 51293-803-10) Appearance: Yellow colored, round, film-coated tablets debossed “AN” over “512” on one side and plain on the other. 750mg Tablets: Supplied in bottles of 100ct (NDC 51293-804-01) 500ct (NDC 51293-804-05) 1000ct (NDC 51293-804-10) Appearance: Yellow colored, capsule-shaped, scored, film-coated tablets debossed “AN 513” on one side and plain 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
ECI 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, USP
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, 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:
T ABLETS :
INACTIVE INGREDIENTS: Carnauba wax, Colloidal Silicon Dioxide,
Croscarmellose 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
glucuronide