DICLOFENAC SODIUM solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

REMEDYREPACK INC.

DCI (Dénomination commune internationale):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 16.05 mg in 1 mL

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium or any components of the drug product [see Warnings and Precautions ( 5.7, 5.9)] . - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions ( 5.7, 5.8)] . - In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ( 5.1)] . Risk Summary Use of NSAIDs, including diclofenac sodium topical solution, can

Descriptif du produit:

Diclofenac sodium topical solution, USP 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: 70518-0572-00 OUTER PACKAGING: 1 in 1 CARTON INNER PACKAGING: 150 mL in 1 BOTTLE , TYPE 0 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. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Statut de autorisation:

Abbreviated New Drug Application

Notice patient

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

Résumé des caractéristiques du produit

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
REMEDYREPACK 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. _
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
AND OR GI BLEEDING ARE AT GREATER RISK FOR SERIOUS GI EVENTS. ( 5.2)
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
Use the lowest effective dosage for the shortest duration consistent
with individual patient treatment
goals.
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 solution 10 drops at a time either
directly onto the knee or first into
the hand and then onto the knee. Spread diclofenac sodium topical
solution evenly around front, back
and sides of the knee. Repeat this procedure until 40