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:

Proficient Rx LP

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. 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, VOLTAREN® GEL should be avoided because it may cause premature closure o

Product summary:

VOLTAREN® GEL is available in tubes containing 100 g 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 g tube……………………………………NDC 63187-582-00 Storage Store at 20°C to 25°C (68°F to 77°F). Keep from freezing. Store the dosing card with your VOLTAREN® GEL.

Authorization status:

New Drug Application

Patient Information leaflet

Proficient Rx LP
----------
Medication Guide
for Non-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. NSAID medicines should

Summary of Product characteristics

VOLTAREN- DICLOFENAC SODIUM GEL
PROFICIENT RX LP
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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: CARDIOVASCULAR AND GASTROINTESTINAL RISK
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CARDIOVASCULAR RISK
•
•
GASTROINTESTINAL RISK (4, 5.1)
•
INDICATIONS AND USAGE
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. (1)
•
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)
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
®
®
®
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) MAY CAUSE AN INCREASED
RISK OF SERIOUS
CARDIOVASCULAR THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND STROKE,
WHICH CAN BE FATAL. (5.1).
VOLTAREN GEL IS CONTRAINDICATED FOR THE TREATMENT OF PERI-OPERATIVE
PAIN IN THE SETTING OF
CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY.
®
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS), INCLUDING VOLTAREN
GEL, CAUSE AN INCREASED
RISK OF SERIOUS GASTROINTESTINAL ADVERSE EVENTS INCLUDING BLEEDING,
ULCERATION, AND PERFORATION OF THE
STOMACH OR INTESTINES, WHICH CAN BE FATAL. ELDERLY PATIENTS ARE AT
GREATER RISK FOR SERIOUS
GASTROINTESTINAL EVENTS. (5.2)
®
®
VOLTAREN GEL has not been evaluated for use on the spine, hip, or
shoulder. (14.1)
®
®
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 o