DICLOFENAC SODIUM tablet, delayed release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

זמין מ:

Cambridge Therapeutics Technologies, LLC

INN (שם בינלאומי):

DICLOFENAC SODIUM

הרכב:

DICLOFENAC SODIUM 75 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac sodium delayed-release tablets are indicated: - •For relief of the signs and symptoms of osteoarthritis - •For relief of the signs and symptoms of rheumatoid arthritis - •For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis Diclofenac sodium delayed-release tablets are contraindicated in the following patients. - •Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS: Anaphylactic Reactions , Serious Skin Reactions ). - •History of asthma, urticaria, or other allergic-type reactions after taking aspirin or o

leaflet_short:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 75 mg: round, pink, enteric-coated tablets imprinted GG 739 on one side in black ink and plain on the reverse side are supplied as: NDC 70882-115-30, Adherence Packages of 30 Tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Cambridge Therapeutics Technologies, LLC
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
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:
•
owith increasing doses of NSAIDs
•
owith 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:
•
oany time during use
•
owithout warning symptoms
•
othat may cause death
•
The risk of getting an ulcer or bleeding increases with:
•
opast history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
•
otaking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
oincreasing doses of NSAIDs
•
olonger use of NSAIDs
•
osmoking
•
odrinking alcohol
•
oolder age
•
opoor health
•
oadvanced liver disease
•
obleeding problems
NSAIDs should only be used:
•
•
oexactly as prescribed
•
oat the lowest dose possible for your treatment
•
ofor 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 not take NSAIDs?
Do not take NSAIDs:
•
•if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
•r

מאפייני מוצר

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
CAMBRIDGE THERAPEUTICS TECHNOLOGIES, LLC
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) CAUSE AN INCREASED
RISK OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, INCLUDING MYOCARDIAL INFARCTION AND
STROKE, WHICH CAN
BE FATAL. THIS RISK MAY OCCUR EARLY IN TREATMENT AND MAY INCREASE WITH
DURATION OF USE
(SEE WARNINGS).
•DICLOFENAC SODIUM DELAYED-RELEASE TABLETS ARE CONTRAINDICATED IN
THE SETTING OF CORONARY
ARTERY BYPASS GRAFT (CABG) SURGERY (SEE CONTRAINDICATIONS AND
WARNINGS).
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
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 AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC ULCER
DISEASE AND/OR GI
BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (SEE WARNINGS).
DESCRIPTION
Diclofenac sodium is a benzeneacetic acid derivative, designated
chemically as 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
structural formula is:
Diclofenac sodium is a faintly yellowish white to light beige,
virtually odorless, slightly hygroscopic
crystalline powder. It is freely soluble in methanol, soluble in
ethanol, sparingly soluble in water and
practically insoluble in chloroform and in dilute acid. The
n-octanol/water partition coefficient is 13.4
at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation
constant (pKa) of 4.0 ± 0.2 at 25°C
in water.
Each enteric-coated tablet for oral administration contains 75 mg of
diclofenac sodium. In addition, each
tablet contains the following inactive ingredients. Inactive
ingredients: Black iron oxide,
croscarmellose sodium, hydroxypropyl cellulose, hypromellose, lactose