DICLOFENAC SODIUM tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

BluePoint Laboratories

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

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 patients (see WARNINGS; Anaphylactic Reactions, PRECAUTIONS; Exacerbation of Asthma Related to Aspirin Sensitivity). - In the setting of coronary artery bypass graft (CABG) surgery (see  WARNINGS; Cardiovascular Thrombotic Events).

Bidhaa muhtasari:

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 68001-612-00 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 by: Ingenus Pharmaceuticals, LLC Fairfield, NJ 07004 For BluePoint Laboratories 555200 Revised: 10/2023 Dispense with Medication Guide available at: www.ingenus.com/medguide/bp/diclofenac-sodium-er-tablets.pdf

Idhini hali ya:

Abbreviated New Drug Application

Taarifa za kipeperushi

BluePoint Laboratories
----------
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 provider a

Tabia za bidhaa

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, FILM COATED
BLUEPOINT LABORATORIES
----------
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
14
10
2
2
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.
FDA approved dissolution test specifications differ fr