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.

给药途径:

TOPICAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

VOLTAREN GEL is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands. - VOLTAREN GEL has not been evaluated for use on the spine, hip, or shoulder. VOLTAREN GEL is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product [see Warnings and Precautions ( 5.7, 5.9)] - 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 ( 5.7, 5.8)] . - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1 ) ] Pregnancy Category C prior to 30 weeks

產品總結:

VOLTAREN GEL (diclofenac sodium topical gel, 1%) is available in tubes containing 100 grams of the topical gel in each tube. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 100 grams tube………………………………NDC 63481-684-47 Storage Store at room temperature 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your VOLTAREN GEL.

授权状态:

New Drug Application

资料单张

REMEDYREPACK INC.
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Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about 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 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 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
•
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 are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat
(inflammation) from medical conditions such
as different types of arthritis, menstrual cramps, and other types of
short-term pain.
Who should not take NSAIDs?
Do not take NSAIDs:
•
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs
•
right before or after heart bypass surgery
Before taking NSAIDS, tell your healthcare provider about all of your
medical

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)
INDICATIONS AND USAGE
VOLTAREN GEL is a nonsteroidal 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 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)
Upper extremities: Apply the gel (2 g) to the affected area 4 times
daily. Do not apply more than 8 g daily to any one
affected joint of the upper extremities. ( 2.3)
Total dose should