DICLOFENAC SODIUM gel

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Asclemed USA, Inc.

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 samenvatting:

Diclofenac Sodium Gel, 3% is available in 100 g (NDC 76420-275-01 relabeled from NDC 51672-1363-7) 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.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Asclemed USA, Inc.
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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 i

Productkenmerken

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
ASCLEMED USA, INC.
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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 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, 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.
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 cm
) of diclofenac was absorbed systemically
in both normal and compromised epidermis after seven days