DICLOFENAC SODIUM gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Advanced Rx Pharmacy of Tennessee, LLC

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 and/or polyethylene glycol monomethyl ether 350. Diclofenac Sodium Gel, 3% is contraindicated in the following patients: - In the setting of coronary artery bypass graft (CABG) surgery.

Produkt oppsummering:

Available in tubes of 100 g. Each gram of gel contains 30 mg of diclofenac sodium. 100g tube NDC: 80425-0234-01 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. To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. †Voltaren® is a registered trademark of Novartis. Manufactured by: Tolmar, Inc. Fort Collins, CO 80526 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 04006125 Rev. 0 04/19

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

Advanced Rx Pharmacy of Tennessee, LLC
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MEDGUIDE DICLOFENAC (DYE KLOE’
FEN AK) SODIUM 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 NSAIDswith
longer use of
NSAIDsIncreased 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
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
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%?
Do not use Diclofenac Sodium Gel, 3%:
•
if you have had an allergic reaction to any of the ingredients in
Diclofenac Sodium Gel, 3%. See
the end of this Medication Guide for a complete list of ingredients in
Diclofenac Sodium Gel, 3%.
•
right before or after heart bypass surgery.
Before using Diclofenac Sodium Gel, 3%, tell your healthcare provider
about all of you

Preparatomtale

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
DICLOFENAC SODIUM 3% GEL
SPL UNCLASSIFIED SECTION
Rx only
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
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, 3% also contains benzyl alcohol, hydroxyethyl
cellulose,
methoxypolyethylene glycol 350, PEG-60 hydrogenated castor oil, 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, 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
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 after seven days, with four
times daily
applications.
After topical application of 2 g diclofenac sodium gel, 3% three times
daily for six days to
the calf of the leg in healthy subjects, diclofenac could be detected
in plasma. Mean
bioavailability parameters were AUC0-t 9±19 ng/hr/mL (mean±SD