DICLOFENAC SODIUM- diclofenac gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac sodium topical gel, 1% is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - Diclofenac sodium topical gel, 1% has not been evaluated for use on the spine, hip, or shoulder. Diclofenac sodium topical gel 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 and Precautions ( 5.7, 5.9)] - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7, 5.8)] - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1)] Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, inc

Product summary:

Diclofenac sodium topical gel, 1% is available in tubes containing 100 g of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 g tube NDC 42291-256-11 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your diclofenac sodium topical gel.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM- diclofenac gel
AvKARE
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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
•
oolder 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 health care provider about all

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC GEL
AVKARE
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HIGHLIGHTS OF PRESCRIBING INFORMATION
DICLOFENAC SODIUM TOPICAL GEL, 1%
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM
TOPICAL GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DICLOFENAC
SODIUM TOPICAL GEL.
DICLOFENAC SODIUM TOPICAL GEL, 1%, FOR TOPICAL USE ONLY INITIAL U.S.
APPROVAL: 1988
WARNING: RISK OF SERIOUSCARDIOVASCULAR AND GASTROINTESTINALEVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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. ( 5.1)
DICLOFENAC SODIUM TOPICAL GEL IS CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY. ( 4, 5.1)
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. ( 5.2)
INDICATIONS AND USAGE
Diclofenac sodium topical gel, 1% is a non-steroidal anti-inflammatory
drug indicated for the relief of the
pain of osteoarthritis of joints amenable to topical treatment, such
as the knees and those of the hands. (
1)
Diclofenac sodium topical gel, 1% was not evaluated for use on joints
of the spine, hip, or shoulder. (
14.1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
( 2.1)
Lower extremities: Apply the gel (4 g) to the affected area 4 times
daily. Do not apply more than 16 g
daily to any one affected joint of the lower extremities. ( 2.2)
Upper extremities: Apply the gel (2 g) to the affected area 4 times
daily. Do not a