DICLOFENAC SODIUM tablet, delayed release

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

American Health Packaging

INN (Jina la Kimataifa):

DICLOFENAC SODIUM

Tungo:

DICLOFENAC SODIUM 75 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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

Bidhaa muhtasari:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 50 mg: round, light brown, enteric-coated tablets “ P ” over “ 50 ” imprinted on one side in black ink and plain on the reverse side are supplied as: Unit dose packages of 100 (10 x 10) NDC 60687-606-01 Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
American Health Packaging
----------
MEDICATION GUIDE
8233301/0322F
Diclofenac Sodium (dye kloe' fen ak soe' dee um) Delayed-release
Tablets, USP
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:
•
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
•
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 r

Tabia za bidhaa

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
AMERICAN HEALTH PACKAGING
----------
DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
8233301/0322F
RX ONLY
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:
C
H
Cl
NNaO
                M.W. 318.14
Diclofenac sodium is a white to off-white, hygroscopic crystalline
powder. It is freely
14
10
2
2
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 25 mg, 50
mg, or 75 mg of
diclofenac sodium. In addition, each tablet contains the following
inactive ingredients.
Inactive ingredients: lactose (monohydrate), microcrystalline
ce