DICLOFENAC POTASSIUM- 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:

Sandoz 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: Diclofenac potassium tablets are contraindicated in the following patients:

Product summary:

Diclofenac potassium tablets, USP 50 mg are white, round, film-coated, debossed GG977 on one side and plain on the reverse side are supplied as follows: NDC 0781-5017-01 in bottles of 100 tablets NDC 0781-5017-10 in bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Protect from moisture.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
Sandoz Inc
----------
MEDICATION GUIDE
FOR NONSTEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
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:
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
any time during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
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 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 yo

Summary of Product characteristics

DICLOFENAC POTASSIUM- DICLOFENAC POTASSIUM TABLET, FILM COATED
SANDOZ INC
----------
DICLOFENAC POTASSIUM TABLETS, USP 50 MG
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
DESCRIPTION
Diclofenac potassium is a benzeneacetic acid derivative, designated
chemically as 2-[(2,6-
dichlorophenyl) amino] benzeneacetic acid, monopotassium salt. The
molecular weight is 334.25. Its
molecular formula is C
H Cl
NKO . The structural formula is:
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, 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 potassium
has a dissociation constant (pKa)
of 4.0 ± 0.2 at 25°C in water.
Each diclofenac potassium tablet, USP intended for oral administration
contains 50 mg of diclofenac
potassium, USP. In addition, each tablet contains the following
inactive ingredients: hydroxypropyl
methylcellulose, lactose monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, polysorbate 80, pregelatinized starch and titanium dioxide.
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).
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