DICLOFENAC POTASSIUM tablet, film coated
Country: United States
Language: English
Source: NLM (National Library of Medicine)
Patient Information leaflet
(PIL)
15-06-2021
Summary of Product characteristics
(SPC)
15-06-2021
Active ingredient:
DICLOFENAC POTASSIUM (UNII: L4D5UA6CB4) (DICLOFENAC - UNII:144O8QL0L1)
Available from:
A-S Medication Solutions
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, anaphylactic reactions to NSAIDs have been reported in
Product summary:
Product: 50090-0646 NDC: 50090-0646-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-0646-1 21 TABLET, FILM COATED in a BOTTLE NDC: 50090-0646-3 45 TABLET, FILM COATED in a BOTTLE NDC: 50090-0646-4 90 TABLET, FILM COATED in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Patient Information leaflet
A-S Medication Solutions
----------
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 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 healthcare
provider about all of your
medical condit
Read the complete document
Summary of Product characteristics
DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
DICLOFENAC POTASSIUM TABLETS USP, 50 MG
RX ONLY
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:
C
H
Cl
KNO M.W. 334.24
Diclofenac potassium, USP 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
silicon dioxide,
Read the complete document
