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:

Preferred Pharmaceuticals Inc.

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 indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution 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 diclofenac, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including diclofenac, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of diclofenac sodium topical solution in pregnant women. 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 to 4% for major malformations, and 15 to 20% for pregna

Product summary:

Diclofenac sodium topical solution 1.5% w/w is supplied as a clear, colorless to yellow solution containing 16.05 mg of diclofenac sodium per mL of solution, in a white opaque low density polyethylene bottle with a white linear low density polyethylene valve seal dispensing cap. NDC Number & Size 150 mL bottle NDC # 60505-0399-5 Storage Store at room temperature 20°C to 25°C (68°F to 77°F); [See USP Controlled Room Temperature]. Keep product stored upright at all times.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
Preferred 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:
1.
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in
treatment and may increase:
1.
with increasing doses of NSAIDs
2.
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.
1.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
1.
anytime during use
2.
without warning symptoms
3.
that may cause death
The risk of getting an ulcer or bleeding increases with:
1.
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
2.
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
3.
increasing doses of NSAIDs
4.
longer use of NSAIDs
5.
smoking
6.
drinking alcohol
7.
older age
8.
poor health
9.
advanced liver disease
10.
bleeding problems
NSAIDs should only be used:
1.
exactly as prescribed
2.
at the lowest dose possible for your treatment
3.
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:
1.
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
2.
right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
PREFERRED PHARMACEUTICALS INC.
----------
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, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. _
4.
5.
6.
RECENT MAJOR CHANGES
Boxed Warning 5/2016
Warnings and Precautions, Cardiovascular Thrombotic Events (5.1)
5/2016
Warnings and Precautions, Heart Failure and Edema (5.5) 5/2016
INDICATIONS AND USAGE
Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory
drug indicated for the treatment of signs and
symptoms of osteoarthritis of the knee(s). (1)
DOSAGE AND ADMINISTRATION
9.
10.
11.
12.
13.
14.
15.
16.
DOSAGE FORMS AND STRENGTHS
• Diclofenac sodium topical solution 1.5% w/w (3)
CONTRAINDICATIONS
• Known hypersensitivity to diclofenac or any components of the drug
product. (4)
• History of asthma, urticaria, or allergic-type reactions after
taking aspirin or other NSAIDs. (4)
• In the setting of CABG surgery (4)
WARNINGS AND PRECAUTIONS
13.
14.
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)
DICLOFENAC SODIUM TOPICAL SOLUTION 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