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:

Amneal Pharmaceuticals of New York LLC

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, 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 and 50 g. Each gram of gel contains 30 mg of diclofenac sodium. 100 g tube – NDC 0115-1483-61 50 g tube – NDC 0115-1483-56 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. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. † Voltaren® is a registered trademark of Novartis. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006125 Rev. 0 04/19

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Amneal Pharmaceuticals of New York LLC
----------
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

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
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 syste