DICLOFENAC SODIUM- diclofenac sodium gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 30 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Available in tubes of 100 g and 50 g. Each gram of gel contains 30 mg of diclofenac sodium. 100 g tube – NDC 0115-1483-61 50 g tube – NDC 0115-1483-56 Storage: Store at 20º - 25ºC (68º - 77ºF); excursions permitted to 15º - 30ºC (59º - 86ºF) [see USP Controlled Room Temperature]. Protect from heat. Avoid freezing. †Voltaren® is a registered trademark of Novartis. Manufactured by: TOLMAR Inc., Fort Collins, CO 80526 Distributed by: Impax Generics, Hayward, CA 94544 44488 Rev. 3 06/16

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
REMEDYREPACK INC.
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MEDICATION GUIDE
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:
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:
• 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 º older age
•
longer use of NSAIDs º poor health
•
smoking º advanced liver disease
•
drinking alcohol 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, 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 Diclofe

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
REMEDYREPACK INC.
----------
DICLOFENAC SODIUM GEL, 3%
RX ONLY
FOR DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC USE.
BOXED WARNING SECTION
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, 3% 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, 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 applied dose (2 grams of
3% gel over 100 cm
) of
diclofenac was absorbed syste