DICLOFENAC SODIUM gel

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

NuCare Pharmaceuticals,Inc.

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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.

Каталог на резюме:

Available in tubes of 100 g (NDC 68071-4859-1). Each gram of gel contains 30 mg of diclofenac sodium. Storage: Store at controlled room temperature 20-25°C (68-77°F); excursions permitted between 15-30°C (59-86°F). Protect from heat. Avoid freezing. †Voltaren® is a registered trademark of Novartis. Manufactured by Perrigo Yeruham, Israel For Gage Development Company, LLC Distributed By Perrigo® Allegan, MI 49010 ● www.perrigo.com Rev 08-17 7B400 RC J1

Статус Оторизация:

Abbreviated New Drug Application

Листовка

NuCare 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 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
•
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?
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 alle

Данни за продукта

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
NUCARE 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
- 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 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 cm²) of diclofenac was
absorbed systemically
in both normal and compromised epidermis afte