DICLOFENAC SODIUM- diclofenac sodium topical gel

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Alembic Pharmaceuticals Inc.

Administreringssätt:

TOPICAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Diclofenac sodium topical gel is indicated for the topical treatment of actinic keratoses (AK). Diclofenac sodium topical gel is contraindicated in the following patients:  - With known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions (5.1, 5.3, 5.10) and Description (11)]     - With the history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.1, 5.2)] - Application on damaged skin resulting from any etiology, including exudative dermatitis, eczema, infected lesions, burns or wounds [see Warnings and Precautions (5.3)] - In the setting of coronary bypass graft (CABG) surgery [see Warnings and Precautions (5.4)] Risk Summary Use of NSAIDs, including diclofenac sodium topical gel, can cause premature closure of the fetal ductus arteriosu

Produktsammanfattning:

Available in tubes of 100 g (NDC 62332-581-31). Each gram of topical gel contains 30 mg of diclofenac sodium. Storage: Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from heat. Avoid freezing.

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Alembic Pharmaceuticals Inc.
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MEDICATION GUIDE
Diclofenac Sodium Topical Gel, 3%
(dye kloe' fen ak soe' dee um)
What is the most important information I should know about diclofenac
sodium topical gel and medicines called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
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 NSAIDs
○ 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
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 topical gel ?
Diclofenac sodium topical gel is an NSAID that is used on the skin
(topical) to treat a skin condition called actinic keratosis.
Diclofenac
sodium topical gel is not for use in children.
Do not use diclofenac sodium topical gel :
● if you have had an allergic reaction to any of the ingredients in
diclofenac sodium topical gel. See the end of this Medication Guide
for
a complete list of ingredients in diclofenac sodium

Produktens egenskaper

DICLOFENAC SODIUM - DICLOFENAC SODIUM TOPICAL GEL
ALEMBIC PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM
TOPICAL GEL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR DICLOFENAC
SODIUM TOPICAL GEL.
DICLOFENAC SODIUM TOPICAL GEL
INITIAL U.S. APPROVAL: 2000
WARNING: RISK OF SERIOUS CARDIOVASCULAR EVENTS AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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. (5.4)
DICLOFENAC SODIUM TOPICAL GEL IS CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY. (4, 5.4)
NSAIDS CAUSE AN INCREASED RISK OF SERIOUS GASTROINTESTINAL (GI)
ADVERSE EVENTS
INCLUDING BLEEDING, ULCERATION, AND PERFORATION OF THE STOMACH OR
INTESTINES, WHICH
CAN BE FATAL. THESE EVENTS CAN OCCUR AT ANY TIME DURING USE AND
WITHOUT WARNING
SYMPTOMS. ELDERLY PATIENTS AND PATIENTS WITH A PRIOR HISTORY OF PEPTIC
ULCER DISEASE
AND/OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS (5.5)
INDICATIONS AND USAGE
Diclofenac sodium topical gel is a nonsteroidal anti-inflammatory drug
(NSAID) indicated for the topical
treatment of actinic keratoses (AK). (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
the individual patient treatment
goals. (2)
Apply to lesion areas twice daily to adequately cover each lesion. (2)
Use 0.5 g of gel (pea size) on each 5 cm x 5 cm lesion site. (2)
The recommended duration of therapy is from 60 days to 90 days.
Complete healing of the lesion(s) or
optimal therapeutic effect may not be evident for up to 30 days
following cessation of therapy. Lesions
that do not respond to therapy should be re-evaluated and management
reconsidered. (2)
Avoid contact in eyes