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:

Direct_Rx

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac Sodium Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Diclofenac Sodium Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium. Diclofenac Sodium Gel is contraindicated in the following patients: In the setting of coronary artery bypass graft (CABG) surgery.

Product summary:

Diclofenac Sodium Gel, 3% is available in 50 g and 100 g tubes. Each gram of gel contains 30 mg of diclofenac sodium. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
Direct_Rx
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Medication Guide
Diclofenac (dye-KLOE-fen-ak) Sodium Gel, 3%
What is the most important information I should know about Diclofenac
Sodium Gel and medicines
called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
Diclofenac Sodium Gel is an NSAID medicine that is used on the skin
only (topical). Do not use
Diclofenac Sodium Gel in or on the eyes.
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 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:
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 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.
Who should not use Diclofenac Sodium Gel?
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 Medica

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
DIRECT_RX
----------
DICLOFENAC SODIUM GEL
Rx Only
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada
L6T 1C1
Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532
TARO is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.
Revised: July, 2016
PK-7347-1
27
Diclofenac Sodium Gel, 3%, contains the active ingredient, diclofenac
sodium, in a clear, transparent,
colorless to slightly yellow gel base. Diclofenac sodium is a white to
slightly yellow crystalline
powder. It is freely soluble in methanol, soluble in ethanol,
sparingly soluble in water, slightly soluble
in acetone, and partially insoluble in ether. The chemical name for
diclofenac sodium is:
Sodium [o-(2,6-dichloranilino) phenyl] acetate
Diclofenac sodium has a molecular weight of 318.13.
The CAS number is CAS-15307-79-6. The structural formula is
represented below:
[Chemical Structure]
Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hyaluronate
sodium, polyethylene glycol
monomethyl ether, and purified water.
1 g of Diclofenac Sodium Gel contains 30 mg of the active substance,
diclofenac sodium.
The mechanism of action of diclofenac sodium in the treatment of
actinic keratoses (AK) is unknown.
The contribution to efficacy of individual components of the vehicle
has not been established.
Pharmacokinetics
Absorption
When diclofenac sodium gel is applied topically, diclofenac is
absorbed into the epidermis. In a study
in patients with compromised skin (mainly atopic dermatitis and other
dermatitic conditions) of the hands,
arms or face, approximately 10% of the applied dose (2 grams of 3% gel
over 100 cm2) of diclofenac
was absorbed systemically in both normal and compromised epidermis
after seven days, with four times
daily applications.
After topical application of 2 g diclofenac sodium gel three times
daily for six days to the calf of the
leg in healthy subjects, diclofenac could be detected in plasma. Mean
bioavai