SALSALATE tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

PD-Rx Pharmaceuticals, Inc.

INN (Nome Internazionale):

SALSALATE

Composizione:

SALSALATE 750 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of SALSALATE TABLETS and other treatment options before deciding to use SALSALATE TABLETS. 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. CONTRAINDICATIONS SALSALATE TABLETS is contraindicated in patients with known hypersensitivity to salsalate. SALSALATE TABLETS 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 is contraindicated for the treatment of peri-operative pain in the setting of coronary artery b

Dettagli prodotto:

HOW SUPPLIED 750mg Tablets: Supplied in bottles of 30ct (NDC 43063-577-30); white, capsule-shaped tablets, debossed with “Syntho” on one side, and 113 on the other. Dispense contents with a child-resistant closure (as required) and in a tight container as defined in the USP.

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

SALSALATE- SALSALATE TABLET
PD-RX 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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SALSALATE TABLETS
RX ONLY
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 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 TABLETS contain the active ingredient Salsalate, which 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:
INACTIVE INGREDIENTS: Microcrystalline Cellulose, Silicon Dioxide,
Sodium Starch
Glycolate, Stearic Acid, Talc, and Coating (Hypromellose, Polyethylene
Glycol, Polysorbate
80, 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
t