VOLTAREN- diclofenac sodium gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. The use of Voltaren® Gel is contraindicated in patients with a known hypersensitivity to diclofenac. Voltaren® Gel should not be administered in patients who have experienced asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.1)]. Voltaren® Gel is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see   Warnings and Precautions (5.1 )] . The safety of Voltaren® Gel has not been established during pregnancy. There are no well-controlled studies of diclofenac in pregnant women. Human and animal studies indicate that diclofenac crosses the placenta. In late pregnancy, as with other NSAIDs,

Product summary:

Voltaren® Gel is available in tubes containing 100 g of the topical gel in each tube. Physician samples are packaged in 20 g tubes. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%).       100 gram tube                     NDC 21695-791-00            Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]  Keep from freezing.

Authorization status:

New Drug Application

Patient Information leaflet

Rebel Distributors Corp
----------
18 MEDICAL GUIDE
Medication GuideforNon-steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time
during treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other
NSAID medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines to
show to your healthcare
provider and pharmacist.
•
if you are pregnant.

Summary of Product characteristics

VOLTAREN- DICLOFENAC SODIUM GEL
REBEL DISTRIBUTORS CORP
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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.
INITIAL U.S. APPROVAL: 1988
DOSAGE AND ADMINISTRATION
Total dose should not exceed 32 g per day, over all affected joints.
(2.3) Voltaren Gel should be measured onto the
enclosed dosing card to the appropriate 2 g or 4 g designation. (2)
(2)
CONTRAINDICATIONS
Use during the peri-operative period in the setting of coronary artery
bypass graft (CABG) surgery. (4)
WARNINGS AND PRECAUTIONS
Elevations of one or more liver tests may occur during therapy with
diclofenac sodium. These laboratory abnormalities
may progress, may remain unchanged, or may be transient with continued
therapy. Borderline elevations (i.e. less than
3 times the ULN [ULN = the upper limit of normal range]) or greater
elevations of transaminases occurred in about 15%
of diclofenac-treated patients. Of the markers of hepatic function,
ALT (SGPT) is recommended for the monitoring of
liver injury.
In clinical trials, meaningful elevations (i.e., more than 3 times the
ULN) of AST (GOT) (ALT was not measured in all
studies) occurred in about 2% of approximately 5,700 patients at some
time during diclofenac treatment. In a large,
open-label, controlled trial of 3,700 patients treated for 2-6 months,
patients were monitored first at 8 weeks and 1,200
patients were monitored again at 24 weeks. Meaningful elevations of
ALT and/orAST occurred in about 4% of patients
and included marked elevations (i.e., more than 8 times the ULN) in
about 1% of the 3,700 patients. In that open-label
study, a higher incidence of borderline (less than 3 times the ULN),
moderate (3-8 times the ULN), and marked (>8
times the ULN) elevations of ALT or AST was observed in patients
receiving diclofenac when compared to other
NSAIDs. Elevations in transaminases were seen more frequently in
patients with osteoarthritis than