DICLOFENAC SODIUM tablet, delayed release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Mylan Institutional Inc.

INN (Algemene Internationale Benaming):

DICLOFENAC SODIUM

Samenstelling:

DICLOFENAC SODIUM 50 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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,

Product samenvatting:

Diclofenac Sodium Delayed-Release Tablets, USP are available containing 50 mg or 75 mg of diclofenac sodium, USP. The 50 mg tablets are a light brown, enteric coated, round, unscored tablets imprinted with G-DS-50 in black ink. They are available as follows: NDC 51079-466-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). The 75 mg tablets are a light pink, enteric coated, round, unscored tablets imprinted with G-DS-75 in black ink. They are available as follows: NDC 51079-224-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from light and moisture. PHARMACIST: Dispense a Medication Guide with each prescription.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Mylan Institutional Inc.
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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:
•
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:
•
any time 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
•
older 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 not take NSAIDs?
Do not take NSAIDs:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other
NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthcare provider about all of your
medical co

Productkenmerken

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
MYLAN INSTITUTIONAL INC.
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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, 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 delayed-release tablets, USP are a benzene-acetic
acid derivative. Diclofenac
sodium delayed-release tablets are available as enteric-coated tablets
of 50 mg (light brown) or 75 mg
(light pink) for oral administration. Diclofenac sodium, USP is a
faintly yellowish white to light beige
crystalline powder and is sparingly soluble in water at 25°C. The
chemical name is Sodium [ _o_-(2,6-
dichloroanilino)phenyl]acetate. The molecular weight is 318.13. Its
molecular formula is C
H
Cl
NNaO
and it has the following structural formula:
The inactive ingredients in diclofenac sodium delayed-release tablets
include: crospovidone, FD&C
Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate,
magnesium stearate, methacrylic
acid copolymer, microcrystalline cellulose, polyethylene glycol,
povidone, simethicone, sodium
hydroxide, talc and titanium dioxide. The 50 mg tablets also contain
FD&C Blue No. 2 Aluminum Lake
and yel