VOLTAREN- diclofenac sodium gel

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Endo Pharmaceuticals Inc.

INN:

DICLOFENAC SODIUM

composition:

DICLOFENAC SODIUM 10 mg in 1 g

administration_route:

TOPICAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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 rate of 2

leaflet_short:

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.

authorization_status:

New Drug Application

PIL

Endo Pharmaceuticals 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

SPC

VOLTAREN- DICLOFENAC SODIUM GEL
ENDO 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._
•
•
•
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)
•
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 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