DICLOFENAC SODIUM- 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:

BluePoint Laboratories

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 25 mg: round, yellow, enteric-coated tablets imprinted GG 737 on one side in black ink and plain on the reverse side are supplied as: NDC 68001-202-00 bottles of 100 tablets 50 mg: round, brown, enteric-coated tablets imprinted GG 738 on one side in black ink and plain on the reverse side are supplied as: NDC 68001-201-06 bottles of 60 tablets NDC 68001-201-00 bottles of 100 tablets NDC 68001-201-08 bottles of 1000 tablets 75 mg: round, pink, enteric-coated tablets imprinted GG 739 on one side in black ink and plain on the reverse side are supplied as: NDC 68001-200-06 bottles of 60 tablets NDC 68001-200-00 bottles of 100 tablets NDC 68001-200-03 bottles of 500 tablets NDC 68001-200-08 bottles of 1000 tablets 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
BluePoint Laboratories
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MEDICATION GUIDE
FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
What is the most important information I should know about medicines
called Nonsteroidal 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:
•
anytime 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 surgery.
Before taking NSAIDs,

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM TABLET, DELAYED RELEASE
BLUEPOINT LABORATORIES
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DICLOFENAC SODIUM DELAYED-RELEASE TABLETS, USP
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Diclofenac sodium is a benzeneacetic acid derivative, designated
chemically as 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The
structural formula is:
Diclofenac sodium is a faintly yellowish white to light beige,
virtually odorless, slightly hygroscopic
crystalline powder. It is freely soluble in methanol, soluble in
ethanol, sparingly soluble in water and
practically insoluble in chloroform and in dilute acid. The
n-octanol/water partition coefficient is 13.4
at pH 7.4 and 1545 at pH 5.2. Diclofenac sodium has a dissociation
constant (pKa) of 4.0 ± 0.2 at 25°C
in water.
Each enteric-coated tablet for oral administration contains 25 mg, 50
mg, or 75 mg of diclofenac
sodium. In addition, each tablet contains the following inactive
ingredients. Inactive ingredients: Black
iron oxide, croscarmellose sodium, hydroxypropyl cellulose,
hypromellose, lactose (monohydrate),
magnesium stearate, methacrylic acid copolymer, microcrystalline
cellulose, polyethylene glycol,
povidone, red iron oxide, shellac, and titanium dioxide. The 25 MG
also contains: D & C Yellow #10
Aluminum Lake. The 50 MG also contains: yellow iron oxide. The 75 MG
also contains: carnauba wax,
glycerol monostearate, and yellow iron oxide.
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 AND PRECAUTIONS).
Diclofenac sodium delayed-release tablets are contraindicated in the
setting of coronary
artery bypass graft (CABG) surgery (see CONTRAINDICATIONS AND
WARNINGS).
NSAIDs cause an increased risk of serious gastrointestinal adverse
events including
inflammation, bleeding, ulceration, and perforati