DICLOFENAC SODIUM gel

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Asclemed USA, Inc.

Администрация маршрут:

TOPICAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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:       - In the setting of coronary artery bypass graft (CABG) surgery.

Обзор продуктов:

Available in tubes of 100 g (NDC 76420-261-01 relabeled from NDC 0472-1783-10). 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. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
Asclemed USA, 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 sodium gel, 3%

Характеристики продукта

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 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.
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 normal and co