VOLTAREN diclofenac sodium gel

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

REMEDYREPACK INC.

INN（国际名称）:

DICLOFENAC SODIUM

组成:

DICLOFENAC SODIUM 10 mg in 1 g

处方类型:

PRESCRIPTION DRUG

授权状态:

New Drug Application

产品特点

VOLTAREN- DICLOFENAC SODIUM GEL
REMEDYREPACK 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._
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)
RECENT MAJOR CHANGES
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
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)
VOLTAREN
GEL was not evaluated for use on joints of the spine, hip, or
shoulder. (14.1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment goals (2.1)
Lower extremities: Apply the gel (4 g) to the affected area 4 times
daily. Do not apply more than 16 g daily to any one
affected joint of the lower extremities. ( 2.2)