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:

Asclemed USA, 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 sodium hyaluronate. Diclofenac sodium gel is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.

Каталог на резюме:

Each gram of Diclofenac Sodium Gel, 3% contains 30 mg of diclofenac sodium. Diclofenac Sodium Gel, 3% is available as follows: NDC 76420-132-01 100 g tube (relabeled from NDC 68462-355-94) Storage: Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Protect from heat. Avoid freezing. † Voltaren® is a registered trademark of Novartis. Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Asclemed USA, Inc.
----------
MEDICATION GUIDE
Medication Guide
Diclofenac Sodium Gel, 3%
(dye-KLOE-fen-ak SOE-dee-um)
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:
o with increasing doses of NSAIDs
o 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:oanytime during useowithout
warning symptomsothat may cause
death
The risk of getting an ulcer or bleeding increases with:
opast history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDsotaking medicines
called “corticosteroids”, “anticoagulants”, “SSRIs”, or
“SNRIs”oincreasing doses of NSAIDsolonger use
of NSAIDsosmokingodrinking alcoholoolder ageopoor healthoadvanced
liver diseaseobleeding 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 in
diclofenac

Данни за 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 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
off white, hygroscopic
crystalline powder, and melts at about 284°C. It is freely soluble in
methanol, soluble in ethanol,
sparingly soluble in water, and practically insoluble in chloroform
and 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, sodium
hyaluronate, polyethylene glycol
monomethyl ether, and purified water.
1 g of Diclofenac Sodium Gel, 3% 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