VOLTAREN diclofenac sodium gel

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Preferred Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

DICLOFENAC SODIUM

Σύνθεση:

DICLOFENAC SODIUM 10 mg in 1 g

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

VOLTAREN- DICLOFENAC SODIUM GEL
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VOLTAREN GEL SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR VOLTAREN GEL.
VOLTAREN GEL (DICLOFENAC SODIUM TOPICAL GEL), 1%, FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
VOLTAREN GEL is a non-steroidal anti-inflammatory drug indicated for
the relief of the pain of osteoarthritis of joints
amenable to topical treatment, such as the knees and those of the
hands. (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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. (5.1).
VOLTAREN GEL IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY.
(4, 5.1)
®
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. (5.2)
Boxed Warning 04/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
04/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 04/2016
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VOLTAREN GEL was not evaluated for use on joints of the spine, hip, or
shoulder. (14.1)
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Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment goals (2.1)
Lower extremities: