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:

Asclemed USA, Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac Sodium Gel, 3% is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Diclofenac Sodium Gel, 3% is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol and/or polyethylene glycol monomethyl ether 350. Diclofenac Sodium Gel, 3% is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.

Product summary:

Available in tubes of 100 g. Each gram of gel contains 30 mg of diclofenac sodium. 100 g tube – NDC 76420-025-01 (relabeled from NDC 0115-1483-61) 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]. Protect from heat. Avoid freezing. † Voltaren ® is a registered trademark of Novartis. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Asclemed USA, Inc.
----------
MEDICATION GUIDE
DICLOFENAC (DYE KLOE’ FEN AK) SODIUM
GEL, 3%
What is the most important information I should know about Diclofenac
Sodium Gel, 3% and medicines
called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
Diclofenac Sodium Gel, 3% is an NSAID medicine that is used on the
skin only (topical). Do not use
Diclofenac Sodium Gel, 3% 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, 3%?
Diclofenac Sodium Gel, 3% is an NSAID that is used on the skin
(topical) to treat a skin condition called
actinic keratosis. Diclofenac Sodium Gel, 3% is not for use in
children.
Who should not use Diclofenac Sodium Gel, 3%?
Do not use Diclofenac Sodium Gel, 3%:
•
if you have

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
ASCLEMED USA, INC.
----------
DICLOFENAC SODIUM GEL, 3%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
WARNING: RISK OF SERIOUS CARDIOVASCULAR 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.
- DICLOFENAC SODIUM GEL, 3% IS CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY BYPASS
GRAFT (CABG) SURGERY.
DESCRIPTION
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:
Diclofenac Sodium Gel, 3% also contains benzyl alcohol, hydroxyethyl
cellulose,
methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, and
purified water.
1 g of Diclofenac Sodium Gel, 3% contains 30 mg of the active
substance, diclofenac sodium.
CLINICAL PHARMACOLOGY
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, 3% 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 cm
) of
diclofenac was absorbed systemically in both norm