DICLOFENAC SODIUM gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Par Pharmaceutical Inc

INN (International Name):

DICLOFENAC SODIUM

Sammensetning:

DICLOFENAC SODIUM 10 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

DICLOFENAC SODIUM TOPICAL 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. DICLOFENAC SODIUM TOPICAL GEL 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 SODIUM TOPICAL GEL, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including DICLOFENAC SODIUM TOPICAL GEL, in pregnant women starting at 30 weeks of gestation (third trimester). There are no adequate and well-controlled studies of DICLOFENAC SODIUM TOPICAL GEL in pregnant women. Human and animal studies indicate that diclofenac crosses the placenta. 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 clinic

Produkt oppsummering:

DICLOFENAC SODIUM TOPICAL GEL, 1% is available in tubes containing 100 grams 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 grams tube………………………………NDC 49884-935-47 Storage Store at room temperature 68°F to 77°F (20°C to 25°C) [see USP Controlled Room Temperature]. Keep from freezing. Store the dosing card with your DICLOFENAC SODIUM TOPICAL GEL.

Autorisasjon status:

New Drug Application Authorized Generic

Informasjon til brukeren

Par Pharmaceutical 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:
o
with increasing doses of NSAIDs
o
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:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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
you:
•
have

Preparatomtale

DICLOFENAC SODIUM- DICLOFENAC SODIUM GEL
PAR PHARMACEUTICAL INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DICLOFENAC SODIUM TOPICAL GEL
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DICLOFENAC SODIUM TOPICAL GEL.
DICLOFENAC SODIUM TOPICAL GEL 1%, FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 1988
WARNING: RISK OF SERIOUS CARDIOVASCULAR
AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
DICLOFENAC SODIUM TOPICAL GEL is a nonsteroidal 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)
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
WARNINGS AND PRECAUTIONS
•
•
•
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 GEL 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)
DICLOFENAC SODIUM TOPICAL GEL was not evaluated for use on joints of
the spine, hip, or shoulder. (14.1)
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals (2.1)
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 lowe