DICLOFENAC SODIUM gel

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Preferred Pharmaceuticals, Inc.

Stjórnsýsluleið:

TOPICAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium. Diclofenac sodium gel, 3% is contraindicated in the following patients:

Vörulýsing:

Available in tubes of 100 g (NDC 68788-7518-01). Each gram of gel contains 30 mg of diclofenac sodium, USP. 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. †Brands listed are the trademarks of their respective owners. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Revised - September 2017 147I600‐6300 GW7246 Relabeled by Preferred Pharmaceuticals, Inc.

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
Preferred Pharmaceuticals, Inc.
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MEDICATION GUIDE
Diclofenac Sodium (dye kloe' fen ak soe' dee um) 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
○ older age
○ longer use of NSAIDs
○ poor health
○ smoking
○ advanced liver disease
○ drinking alcohol
○ 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 sodi

Vara einkenni

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
•
•
DESCRIPTION
Diclofenac sodium gel, 3%, contains the active ingredient, diclofenac
sodium USP, in a clear,
transparent, colorless to slightly yellow gel base. Diclofenac sodium,
USP 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, USP 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, 3% contains 30 mg of the active
substance, diclofenac sodium, USP.
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, 3% IS CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY BYPASS
GRAFT (CABG) SURGERY_._
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 i