VOLTAREN- diclofenac sodium gel

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

STAT Rx USA LLC

Calea de administrare:

TOPICAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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, Volt

Rezumat produs:

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 42549-627-01      Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]  Keep from freezing.

Statutul autorizaţiei:

New Drug Application

Prospect

STAT Rx USA LLC
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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. NSAID medicines should no

Caracteristicilor produsului

VOLTAREN - DICLOFENAC SODIUM GEL
STAT RX USA LLC
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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
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) (1)
• Voltaren® Gel was not evaluated for use on joints of the spine,
hip, or shoulder. (14.1) (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) (2)
• 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) (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) (2)
DOSAGE FORMS AND STRENGTHS
• 1% gel (3) (3)
CONTRAINDICATIONS
• Known hypersensitivity to diclofenac, aspirin, or other NSAIDs.
(4, 5.2) (4)
• History of asthma, urticaria, or other allergic-type reactions
after taking aspirin or other NSAIDs. (4) (4)
• Use during the peri-operative period in the setting of coronary
artery bypass graft (CABG) surgery. (4) (4)
WARNINGS AND PRECAUTIONS
• Serious and potentially fatal cardiovascular (CV) thrombotic
events, myocardial infarction, and stroke can occur with
NSAID treatment. The lowest possible dose of Voltaren® Gel should be
used in patients with known CV disease or risk
factors for CV disease. (5.1) (5)
• NSAIDs, including diclofenac, can cause serious gastrointestinal
(GI) adverse events including inflammation, bleeding,
ulceration, and perforation. Voltaren® Gel should be prescribed with
caution in thos