DICLOFENAC SODIUM tablet, delayed release

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Proficient Rx LP

INN (International Nazwa):

DICLOFENAC SODIUM

Skład:

DICLOFENAC SODIUM 50 mg

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

INDICATIONS AND USAGE 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). Diclofenac Sodium Delayed-Release Tablets, USP, are indicated: CONTRAINDICATIONS Diclofenac Sodium Delayed-Release Tablets are contraindicated in patients with known hypersensitivity to Diclofenac. Diclofenac Sodium Delayed-Release Tablets should not be given to patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see Error! Hyperlink reference not valid. , and Error! Hyperlink reference not valid. ). Diclofenac Sodium Delayed-Release Tablets, USP are contraindicated in the setting of coronary artery bypass graft

Podsumowanie produktu:

HOW SUPPLIED Diclofenac Sodium Delayed-Release Tablets, USP, for oral administration, are available as: 50 mg: round, Light brown, enteric-coated tablets P 50 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 15.....................................NDC 63187-714-15 Bottles of 30.....................................NDC 63187-714-30 Bottles of 60.....................................NDC 63187-714-60 Bottles of 90.....................................NDC 63187-714-90 Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container. Manufactured by: UNIQUE PHARMACEUTICAL LABORATORIES. (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India. Manufactured for: Rising® Rising Pharmaceuticals, Inc. Allendale, NJ 07401 1-800-521-5340 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 118063 July 2015

Status autoryzacji:

Abbreviated New Drug Application

Ulotka dla pacjenta

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
Proficient Rx LP
----------
Diclofenac Sodium Delayed-Release Tablets, USP
MEDICATION GUIDE for Non-Steroidal 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 reaction with
aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.

Charakterystyka produktu

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
PROFICIENT RX LP
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP 25 MG, 50 MG AND 75 MG
Rx only
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
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 and Precautions_].
Diclofenac sodium delayed-release tablets is contraindicated in the
setting of
coronary artery bypass graft (CABG) surgery [see ERROR! HYPERLINK
REFERENCE NOT VALID. and _Warnings_].
NSAIDs cause an increased risk of serious gastrointestinal adverse
events
including inflammation, 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
Diclofenac Sodium Delayed-Release Tablets, USP are a benzene-acetic
acid
derivative. Diclofenac Sodium Delayed-Release Tablets are available as
delayed-
release (delayed-release) tablets of 25 mg, 50 mg and 75mg for oral
administration.
The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid,
monosodium salt. The molecular weight is 318.14. Its molecular formula
is
C
H
Cl
NNaO , and it has the following structural formula
14
10
2
2
The inactive ingredients in Diclofenac Sodium Delayed-Release Tablets
include:
lactose (monohydrate), microcrystalline cellulose, croscarmellose
sodium,
povidone, talc, magnesium stearate, methacrylic acid copolymer,
polyethylene
glycol, opadry brown (Titanium dioxide, hypromellose, polyethylene
glycol, iron
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac Sodium Delayed-Release Tablets, are a nonsteroidal
anti-inflammatory drug
(NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic
activities in animal
mod