SOLARAZE- diclofenac sodium gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

diclofenac sodium (UNII: QTG126297Q) (diclofenac - UNII:144O8QL0L1)

Tilgjengelig fra:

PharmaDerm a division of Fougera Pharmaceuticals Inc.

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Solaraze® (diclofenac sodium) Gel is indicated for the topical treatment of actinic keratoses (AK). Sun avoidance is indicated during therapy. Solaraze® (diclofenac sodium) Gel is contraindicated in patients with a known hypersensitivity to diclofenac, benzyl alcohol, polyethylene glycol monomethyl ether 350 and/or hyaluronate sodium. Solaraze® (diclofenac sodium) Gel is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.

Produkt oppsummering:

Available in tubes of 100 g (NDC 10337-803-01). 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: Almirall Hermal GmbH D-21465 Reinbek, Germany Made in Germany Manufactured for: IL312D R04/16

Autorisasjon status:

New Drug Application

Informasjon til brukeren

SOLARAZE- DICLOFENAC SODIUM GEL
PharmaDerm a division of Fougera Pharmaceuticals Inc.
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Medication Guide
Solaraze (sol-ar-aze)
(diclofenac sodium) Gel, 3%
What is the most important information I should know about Solaraze
Gel and medicines called
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?
Solaraze Gel is an NSAID medicine that is used on the skin only
(topical). Do not use Solaraze 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 Solaraze Gel?
Solaraze Gel is an NSAID that is used on the skin (topical) to treat a
skin condition called actinic
keratosis.
Solaraze Gel is not for use in children.
Who should not use Solaraze Gel?
Do not use Solaraze Gel:
• if you have had an allergic reaction to any of the ingredients in
Solara

Preparatomtale

SOLARAZE- DICLOFENAC SODIUM GEL
PHARMADERM A DIVISION OF FOUGERA PHARMACEUTICALS INC.
----------
SOLARAZE GEL
DICLOFENAC SODIUM-3%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
DESCRIPTION
Solaraze
(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:
Solaraze
Gel also contains benzyl alcohol, hyaluronate sodium, polyethylene
glycol monomethyl
ether, and purified water.
1 g of Solaraze
(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.
®
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.
SOLARAZE IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG)
S URGERY.
®
®
®
PHARMACOKINETICS
_ABSORPTION_
When Solaraze
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 an