SALSALATE tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

3T Federal Solutions LLC

INN (Algemene Internationale Benaming):

SALSALATE

Samenstelling:

SALSALATE 500 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 depend

Product samenvatting:

Salsalate Tablets, USP, 500 mg are round, yellow colored, film-coated tablet, debossed "BP 507" on one side, and plain on the other. Bottles of 100 NDC 50682-507-01 Bottles of 500 NDC 50682-507-05 Bottles of 1000 NDC 50682-507-10 Salsalate Tablets, USP, 750 mg are capsule-shaped, yellow colored film-coated tablet, bisected, debossed "BP 508" on one side, and plain on the other. Bottles of 100 NDC 50682-508-01 Bottles of 500 NDC 50682-508-05 Bottles of 1000 NDC 50682-508-10 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°C - 30°C (59°F - 86°F). (See USP Controlled Room Temperature) Rx only REFERENCES Manufactured for: 3T Federal Solutions LLC 6013 Techni Center Drive Suite B Austin, TX 78721 Rev. 04/12 Made in the USA

Autorisatie-status:

unapproved drug other

Productkenmerken

SALSALATE - SALSALATE TABLET, FILM COATED
3T FEDERAL SOLUTIONS 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
500 AND 750 MG
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 are 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. It has a molecular formula of C
H O and molecular weight of
258.23.
CHEMICAL STRUCTURE:
EACH TABLET, for oral administration contains 500 mg or 750 mg of
salsalate, USP.
INACTIVE INGREDIENTS: colloidal silicon dioxide, croscarmellose
sodium, D&C yellow # 10 Lake,
hypromellose, microcrystalline cellulose, mineral oil, polyethylene
glycol, stearic acid, talc 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