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:

Preferred Pharmaceuticals, Inc.

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:

Product summary:

Diclofenac Sodium Gel, 3% is available in 100 g (NDC 68788-7546-01) 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

Preferred Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: 12/2016
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:
1.
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
1.
with increasing doses of NSAIDs
2.
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.
2.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
3.
anytime during use
4.
without warning symptoms
5.
that may cause death
The risk of getting an ulcer or bleeding increases with:
6.
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
7.
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
•
older age
•
poor health
•
smoking
•
drinking alcohol
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
1.
exactly as prescribed
2.
at the lowest dose possible for your treatment
3.
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

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
PREFERRED PHARMACEUTICALS, INC.
----------
DICLOFENAC SODIUM
GEL, 3%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
1.
2.
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, hyaluronate
sodium, polyethylene glycol
monomethyl ether, and purified water.
1 g of Diclofenac Sodium Gel 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.
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
US E.
DICLOFENAC SODIUM GEL IS CONTRAINDICATED IN THE SETTING OF CORONARY
ARTERY BYPASS GRAFT
(CABG) SURGERY.
PHARMACOKINETICS
ABS ORPTION
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 cm ) of diclofenac
was absorbed systemically in both normal and compromised epider