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 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; Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac Sodium Extended-release Tablets are indicated: Diclofenac Sodium Extended-release Tablets are contraindicated in the following patients:

Product summary:

Diclofenac Sodium Extended-release Tablets are available as follows: 100 mg – unscored, pink, round film coated tablets, engraved with “93” on one side and “1041” on the other side. Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada © 2020 Bausch Health Companies Inc. or its affiliates 9493403 Revised: 11/2020 Repackaged By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
Preferred Pharmaceuticals Inc.
----------
MEDICATION GUIDE FOR NON-
STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
What is the most important information I should know about medicines
called Non-Steroidal 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 (perforations) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
any time 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 surg

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED, EXTENDED
RELEASE
PREFERRED PHARMACEUTICALS INC.
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS,
100 MG
RX ONLY
PRESCRIBING INFORMATION
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
DESCRIPTION
Diclofenac Sodium Extended-release Tablets are a benzeneacetic acid
derivative.
Diclofenac sodium is a white or slightly yellowish crystalline powder
and is sparingly
soluble in water at 25°C. 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:
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 EXTENDED-RELEASE TABLETS ARE CONTRAINDICATED IN
THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY
(_SEE _CONTRAINDICATIONS, WARNINGS).
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).
14
10
2
2
Each extended-release tablet for oral administration contains 100 mg
of diclofenac
sodium, USP. In addition, each tablet contains the following inactive
ingredients:
anhydrous lactose, colloidal silicon dioxide, D & C Red # 27 (phloxine
aluminum lake),
hydroxyethyl cellulose, hypromellose, isopropyl alcohol, lactose
monohydrate,
magnesium stearate, polyethylene glycol, povidone, talc, titanium
dioxide, and triace