DICLOFENAC SODIUM DELAYED RELEASE- diclofenac sodium tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)

Available from:

Blenheim Pharmacal, Inc.

INN (International Name):

Diclofenac Sodium

Composition:

Diclofenac Sodium 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential bene ts and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Diclofenac is indicated: Diclofenac sodium delayed-release tablets is contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac 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 WARNINGS, Anaphylactoid Reactions, and PRECAUTIONS, Preexisting Asthma). Diclofenac is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

Product summary:

Diclofenac sodium delayed-release tablets 50 mg – white to off-white, biconvex, round-shaped, unscored (imprinted on one side), supplied in: Bottles of 21 (NDC 10544-188-21) Bottles of 30 (NDC 10544-188-30) Bottles of 60 (NDC 10544-188-60) Bottles of 90 (NDC 10544-188-90) 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 as defined in the USP. Manufactured and Distributed by: Carlsbad Technology, Inc. Carlsbad, CA 92008 USA Packaged by: Blenheim Pharmacal, Inc. North Blenheim, NY 12131 USA Revised: February 2010 CTI-11 Rev. C Printed in USA

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
Blenheim Pharmacal, 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 healthcare pr

Summary of Product characteristics

DICLOFENAC SODIUM DELAYED RELEASE- DICLOFENAC SODIUM TABLET, DELAYED
RELEASE
BLENHEIM PHARMACAL, INC.
----------
DICLOFENAC SODIUM
DELAYED-RELEASE TABLETS USP
RX ONLY
PRESCRIBING INFORMATION
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac, as the sodium salt, is a benzene-acetic acid derivative.
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
NaO , 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 delayed-release tablets is 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
Each enteric-coated tablet for oral administration contains 50 mg or
75 mg of diclofenac sodium. In
addition, each tablet contains the following inactive ingredients;
black iron oxide, hypromellose, lactose
monohydrate, magnesium stearate, methacrylic acid copolymer,
microcrystalline cellulose,
pharmaceutical glaze, polyethylene glycol, povidone, sodium starch
glycolate, talc, titanium dioxide,
triethyl citrate.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Diclofenac sodium delayed-release tablets is a nonsteroidal
anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic, and antipyretic activities in
animal models. The mechanism of
action of diclofenac, lik