VOLTAREN- diclofenac sodium gel

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

A-S Medication Solutions

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 is contraindicated in the following patients: Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation Risk Summary Use of NSAIDs, including VOLTAREN® GEL, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including VOLTAREN® GEL, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of VOLTAREN® GEL in pregnant women. Human and animal studies indicate that diclofenac crosses the placenta. Data from observational studies regarding potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In the general U.S. population, all clinically recognized pregnancies, regardless of drug exposure, have a background

Produkt oversigt:

Product: 50090-1099 NDC: 50090-1099-0 100 g in a TUBE

Autorisation status:

New Drug Application

Indlægsseddel

VOLTAREN- DICLOFENAC SODIUM GEL
A-S Medication Solutions
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MEDICATION GUIDE
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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs
o
increasing doses of NSAIDs
o
older age
o
longer use of NSAID
o
poor health
o
smoking
o
advanced liver problems
o
drinking alcohol
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 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
med

Produktets egenskaber

VOLTAREN- DICLOFENAC SODIUM GEL
A-S MEDICATION SOLUTIONS
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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._
•
•
•
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)
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
®
®
®
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)
®
VOLTAREN GEL was not evaluated for use on joints of the spine, hip, or
shoulder. (14.1)
®
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment goals (2.1)
Lower extremities: App