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:

Lake Erie Medical DBA Quality Care Products LLC

INN (Международно Name):

diclofenac sodium

Композиция:

diclofenac sodium 30 mg in 1 g

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:

Статус Оторизация:

Abbreviated New Drug Application

Листовка

Lake Erie Medical DBA Quality Care Products LLC
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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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
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

Данни за продукта

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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, 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.
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
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 systemi