DICLOFENAC SODIUM- diclofenac sodium tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of Diclofenac Sodium Extended-Release Tablets, USP and other treatment options before deciding to use Diclofenac Sodium Extended-Release Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac Sodium Extended-Release Tablets, USP are indicated: Diclofenac sodium extended-release tablets, USP is contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium extended-release tablets, USP 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, Anaphylactic Reactions, and PRECAUTIONS, Preexisting Asthma). Diclofenac sodium extended-release tablets, USP are contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft

Product summary:

Diclofenac Sodium Extended-Release Tablets, USP 100 mg - round, light pink, biconvex film-coated tablet with beveled edges, with “GG” and “904” printed in black ink on one side and the other side is blank. Bottle of 30 - 68788-9389-3 Bottle of 60 - 68788-9389-6 Bottle of 90 - 68788-9389-9 Bottle of 100 - 68788-9389-1 Bottle of 120 - 68788-9389-8 Do not store above 30ºC (86ºF). Protect from moisture. Dispense in tight container (USP).

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
Preferred Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death.
This chance increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a "coronary artery bypass
graft (CABG)."
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during treatment.
Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called "corticosteroids" and "anticoagulants"
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each other
and cause serious side effects. Keep a list of your medicines to show
to your healthca

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
PREFERRED PHARMACEUTICALS, INC.
----------
DICLOFENAC SODIUM
EXTENDED-RELEASE TABLETS, USP
TABLETS OF 100 MG
RX ONLY
PRESCRIBING INFORMATION
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac Sodium Extended-Release Tablets, USP is a benzeneacetic
acid derivative. Diclofenac
sodium extended-release is available as extended-release tablets of
100 mg (light pink) 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
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.)
Diclofenac sodium extended-release tablets, USP are contraindicated
for the treatment of
perioperative pain in the setting of coronary artery bypass graft
(CABG) surgery (see
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.)
14
10
2
2
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium extended-release tablets, USP is a non-steroidal
anti-inflammatory drug (NSAID)
that exhibits anti-inflammatory, analgesic, and antipyretic activities
in animal models. The mechanism of
action of diclofenac sodium extended-release tablets, USP, like that
of other NSAIDs, is not completely
understood but may be related to prostaglandin synthetase inhibition.
PHARMACOKINETICS
_ABSORPTION_
Diclofenac is 100% absorbed after oral administration compar