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:

Marlex Pharmaceuticals Inc

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 dependence

Dettagli prodotto:

500mg Tablets: Supplied in bottles of 100ct       (NDC 10135-0492-01) 500ct       (NDC 10135-0492-05) 1000ct       (NDC 10135-0492-10) 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 10135-0493-01) 500ct       (NDC 10135-0493-05) 1000ct       (NDC 10135-0493-10) 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 (68-77°F): excursions permitted to 15-30°C (59-86°F). [See USP Controlled Room Temperature]. Rx Only

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SALSALATE- SALSALATE TABLET, FILM COATED
MARLEX PHARMACEUTICALS INC
_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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SALS ALATE
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, and
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 conjugate