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:

Blenheim Pharmacal, 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. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diclofenac sodium extended-release tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis Diclofenac sodium extended-release tablets, USP are contraindicated in patients with known hypersensitivity to diclofenac. Diclofenac sodium extended-release tablets 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, Anaphylactoid Reactions , and PR

Product summary:

Diclofenac Sodium Extended-release Tablets, USP 100 mg - Pink round convex film coated tablet debossed with DX 41 on one side. Bottle of 100 Watson NDC 0591-0676-01. Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in tight container (USP). Manufactured for: Watson Laboratories Inc. Corona, CA 92880 USA Manufactured by: Dexcel ® Ltd. 1 Dexcel Street Or-Akiva 30600, Israel

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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 of 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 provider and pharmacist.
•
if you are pregnant. NSAID medicin

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
BLENHEIM PHARMACAL, INC.
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS,
USP, TABLETS OF 100 MG
_PRESCRIBING INFORMATION RX ONLY_
CARDIOVASCULAR RISK
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
peri-operative pain in the setting of coronary artery bypass graft
(CABG) surgery (see
WARNINGS).
GASTROINTESTINAL RISK
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 extended-release tablets, USP are benzeneacetic acid
derivative. Diclofenac sodium
extended-release tablets of 100 mg (pink) are available 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 extended-release tablets
include: carnauba wax,
cetostearyl alcohol, colloidal silicon dioxide, compressible sugar,
copovidone, gum acacia,
hydroxypropyl methylcellulose, iron oxide red, magnesium stearate,
polyethylene glycol, povidone,
sugar, talc, titanium dioxide.
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Diclofenac sodium extended-release tablets, USP are a non-steroidal
anti-inflammatory drug (NSAID)
that exhibits anti-infl