DICLOFENAC SODIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ingenus Pharmaceuticals, LLC

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: - for relief of the signs and symptoms of osteoarthritis - for relief of the signs and symptoms of rheumatoid arthritis Diclofenac sodium extended-release tablets are contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS; Anaphylactic Reactions, Serious Skin Reactions). - History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such pat

Product summary:

Diclofenac sodium extended-release tablets, USP 100 mg – Pink, round, convex film coated tablets debossed with ING on one side and 278 on the other side. Bottles of 100: NDC 50742-278-01 Preserve in well-closed containers. Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32811 554902 Revised: 10/2023 Dispense with Medication Guide available at: www.ingenus.com/medguide/diclofenac-sodium-er-tablets.pdf ingenus Dispense with Medication Guide available at: www.ingenus.com/medguide/diclofenac-sodium-er-tablets.pdf

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Ingenus Pharmaceuticals, LLC
----------
MEDICATION GUIDE
Diclofenac Sodium (dye-KLOE-fen-ak SOE-dee-um) Extended-Release
Tablets, USP
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 (perforation) 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
•
older age
•
longer use
of
NSAIDs
•
poor health
•
smoking
•
advanced liver disease
•
drinking
alcohol
•
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.
Before taking NSAIDs, tell your healthcare provi

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED
INGENUS PHARMACEUTICALS, LLC
----------
DICLOFENAC SODIUM EXTENDED-RELEASE TABLETS USP, 100 MG
RX ONLY
PRESCRIBING INFORMATION
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND
GASTROINTESTINAL EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
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).
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
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).
DESCRIPTION
Diclofenac sodium extended-release tablets, USP is a benzeneacetic
acid derivative.
Diclofenac sodium extended-release tablets are available as
extended-release tablets of
100 mg (pink) for oral administration. Diclofenac sodium is a white to
off-white,
hygroscopic, 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 g/mol. Its molecular formula is C
H
Cl
NNaO , and it has
the following structural formula
The inactive ingredients in diclofenac sodium extended-release tablets
include:
anhydrous lactose, hydroxyethyl cellulose, povidone, colloidal silicon
dioxide, talc,
magnesium stearate, hypromellose, titanium dioxide, macrogol, iron
oxide red,
polysorbate 80.
14
10
2
2
polysorbate 80.
FDA approved dissolution test sp