SALSALATE tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Amneal Pharmaceuticals LLC

INN (International ime):

SALSALATE

Sastav:

SALSALATE 500 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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. Salsalate tablets are 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 are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Drug abuse and dependence have not been reported with salsalate.

Proizvod sažetak:

Salsalate tablets, USP 500 mg  are available as yellow colored, round, film-coated tablets debossed “AN” over “512” on one side and plain on the other. They are supplied as follows: Bottles of 100             NDC 65162-512-10 Bottles of 500             NDC 65162-512-50 Bottles of 1,000ct       NDC 65162-512-11 Salsalate tablets, USP 750 mg  are available as yellow colored, capsule-shaped, scored, film-coated tablets debossed “AN 513” on one side and plain on the other. They are supplied as follows: Bottles of100              NDC 65162-513-10 Bottles of 500             NDC 65162-513-50 Bottles of 1,000          NDC 65162-513-11 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 between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Rx only

Status autorizacije:

unapproved drug other

Uputa o lijeku

Amneal 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.
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
Dispense with Medication Guide available at:
documents.amneal.com/mg/salsalate.pdf
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft
(CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
oolder age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions
such as different types of arthritis, menstrual cramps, and other
types of short-term pain.
Who should

Svojstava lijeka

SALSALATE- SALSALATE TABLET
AMNEAL 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
500 MG 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 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 USP, is a nonsteroidal anti-inflammatory agent for oral
administration.
Chemically, salsalate, USP (salicylsalicylic acid or 2-hydroxy-benzoic
acid, 2-
carboxyphenyl ester) is a dimer of salicylic acid; its structural
formula is shown below.
CHEMICAL STRUCTURE:
TABLETS:
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