DICLOFENAC SODIUM- diclofenac sodium solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)

Available from:

Quality Care Products LLC

INN (International Name):

Diclofenac Sodium

Composition:

Diclofenac Sodium 16.05 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). Diclofenac sodium topical solution is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of diclofenac sodium topical solution. Diclofenac sodium topical solution is contraindicated in patients who have experienced asthma, urticaria, or 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 (5.7, 5.10)]. Diclofenac sodium topical solution is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)]. Pregnancy Category C prior to 30 weeks gestation; Category D starting 30 weeks gestation. Teratogenic Effects: There are no adequate and well-controlled studies of diclofenac sodium topical solution in pregnant w

Product summary:

Diclofenac Sodium Topical Solution is supplied as a clear, colorless to faintly pink-orange solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white high density polyethylene bottle with a white low-density dropper cap. NDC Number & Size 150 mL bottle    NDC # 55700-591-15 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled RoomTemperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Quality Care Products LLC
----------
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 no

Summary of Product characteristics

DICLOFENAC SODIUM - DICLOFENAC SODIUM SOLUTION
QUALITY CARE PRODUCTS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM
TOPICAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR DICLOFENAC
SODIUM TOPICAL SOLUTION.
DICLOFENAC SODIUM TOPICAL SOLUTION 1.5% W/W IS FOR TOPICAL USE ONLY.
INITIAL U.S. APPROVAL: 1988
WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK
SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
CARDIOVASCULAR RISK
NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) MAY CAUSE AN INCREASED
RISK OF
SERIOUS CARDIOVASCULAR THROMBOTIC EVENTS, MYOCARDIAL INFARCTION, AND
STROKE, WHICH
CAN BE FATAL. PATIENTS WITH CARDIOVASCULAR DISEASE OR RISK FACTORS FOR
CARDIOVASCULAR
DISEASE MAY BE AT GREATER RISK. (5.1)
DICLOFENAC SODIUM TOPICAL SOLUTION IS CONTRAINDICATED FOR THE
TREATMENT OF
PERIOPERATIVE PAIN IN THE SETTING OF CORONARY ARTERY BYPASS GRAFT
(CABG) SURGERY. (4)
GASTROINTESTINAL RISK
NSAIDS, INCLUDING DICLOFENAC SODIUM TOPICAL SOLUTION CAUSE AN
INCREASED RISK OF
SERIOUS GASTROINTESTINAL 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
ARE AT
GREATER RISK FOR SERIOUS GASTROINTESTINAL EVENTS. (5.2)
RECENT MAJOR CHANGES
Dosage and Administration (2). . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . .
. . . .
. . . 10/2013
INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory
drug (NSAID) indicated for the
treatment of signs and symptoms of osteoarthritis of the knee(s). (1)
DOSAGE AND ADMINISTRATION
FOR THE RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS OF THE
KNEE(S), THE
RECOMMENDED DOSE IS 40 DROPS ON EACH PAINFUL KNEE, 4 TIMES A DAY. (2)
Apply diclofenac sodium topical solution to clean, dry skin. (2.1)
Dispense diclofenac sodium topical solu