DICLOFENAC POTASSIUM tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC POTASSIUM (UNII: L4D5UA6CB4) (DICLOFENAC - UNII:144O8QL0L1)

Available from:

RedPharm Drug, Inc.

INN (International Name):

DICLOFENAC POTASSIUM

Composition:

DICLOFENAC POTASSIUM 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Diclofenac potassium tablets are indicated: • For treatment of primary dysmenorrhea • For relief of mild to moderate pain • For relief of the signs and symptoms of osteoarthritis • For relief of the signs and symptoms of rheumatoid arthritis Diclofenac is 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, anaphylact

Product summary:

Diclofenac potassium tablets USP, 50 mg are available as orange, round, unscored, biconvex, film-coated tablets debossed with the numbers “93” and “948” on one face of the tablet and plain on the other. Bottles of 100 (NDC 0093-0948-01) Bottles of 500 (NDC 0093-0948-05) 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 as defined in the USP, with a child-resistant closure (as required). Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. L 5/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC POTASSIUM- diclofenac potassium tablet, film coated
RedPharm Drug, Inc.
----------
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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
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:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 have 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 he

Summary of Product characteristics

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
REDPHARM DRUG, INC.
----------
BOXED WARNING
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 potassium 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 potassium tablets USP are a benzeneacetic acid derivative.
Diclofenac
potassium tablets USP, 50 mg are available as orange, film-coated
tablets for oral
administration. The chemical name is 2-[(2,6-dichlorophenyl)amino]
benzeneacetic acid,
monopotassium salt. The structural formula is:
[diclofenac potassium structural formula]
C14H10Cl2KNO2 M.W. 334.24
Diclofenac potassium is a faintly yellowish white to light beige,
virtually odorless, slightly
hygroscopic crystalline powder. It is freely soluble in methanol,
soluble in ethanol and
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. It has a
single dissociation
constant (pKa) of 4.0 ± 0.2 at 25°C in water.
Each tablet, for oral administration, contains 50 mg of diclofenac
potassium. In addition,
each tablet contains the following inactive ingredients: colloidal
silic