DICLOFENAC SODIUM gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

GLENMARK PHARMACEUTICALS INC., USA

INN (International Name):

diclofenac sodium

Composition:

diclofenac sodium 30 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac sodium gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium gel is contraindicated in the following patients: Risk Summary Use of NSAIDs, including diclofenac sodium gel, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of diclofenac sodium gel use between about 20 and 30 weeks of gestation and avoid diclofenac sodium gel use at about 30 weeks of gestation and later in pregnancy. Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including diclofenac sodium gel, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal d

Product summary:

Each gram of Diclofenac Sodium Topical Gel, 3% contains 30 mg of diclofenac sodium, USP. Diclofenac Sodium Gel, 3% is available as follows: Storage: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

GLENMARK PHARMACEUTICALS INC., USA
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MEDICATION GUIDE
Dispense with Medication Guide available at:
www.glenmarkpharma-us.com/medguides
Diclofenac Sodium (dye-KLOE-fen-ak SOE-dee-um)
Gel
What is the most important information I should know about diclofenac
sodium gel and 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 or use 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 or use
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:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What is diclofenac sodium gel?
Diclofenac sodium gel is an NSAID that is used on the skin (topical)
to treat a skin condition called actinic
keratosis. Diclofenac sodium gel is not for use in children.
Do not use diclofenac sodium gel:
•
if you have had an allergic reaction to any of the ingredients in
diclofenac sodium gel. See the end of
this Medication Guide fo

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM GEL
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DICLOFENAC SODIUM GEL.
DICLOFENAC SODIUM TOPICAL GEL
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS AND GASTROINTESTINAL
EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Diclofenac sodium gel is a nonsteroidal anti-inflammatory drug (NSAID)
indicated for the topical treatment
of actinic keratoses (AK). (1)
DOSAGE AND ADMINISTRATION
•
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Topical gel, 3% (3)
CONTRAINDICATIONS
•
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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. (5.4)
Diclofenac sodium gel is contraindicated in the setting of coronary
artery bypass graft (CABG)
surgery. (4, 5.4)
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 (5.5)
Use the lowest effective dosage for shortest duration consistent with
the individual patient treatment
goals. (2)
Apply to lesion areas twice daily to adequately cover each lesion. (2)
Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. (2)
The recommended duration of therapy is from 60 days to 90 days.
Complete healing of the lesion(s)
or optimal therapeutic effect may not be evident for up to 30 days
following cessation of therap