PENNSAID- diclofenac sodium liquid

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

STAT RX USA LLC

INN (International Name):

DICLOFENAC SODIUM

Sammensetning:

DICLOFENAC SODIUM 16.05 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

PENNSAID is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). PENNSAID is contraindicated in patients with a known hypersensitivity to diclofenac sodium or any other component of PENNSAID. PENNSAID 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) ] . PENNSAID 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 PENNSAID in pregnant women. PENNSAID should not be used by pregnant women as its safe use has not been adequately determined and starting at 30 weeks gestation, diclofen

Produkt oppsummering:

PENNSAID 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 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Autorisasjon status:

New Drug Application

Informasjon til brukeren

STAT RX USA LLC
----------
17.10 MEDICATION GUIDE
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.

Preparatomtale

PENNSAID - DICLOFENAC SODIUM LIQUID
STAT RX USA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PENNSAID SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PENNSAID.
PENNSAID (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)
PENNSAID IS CONTRAINDICATED FOR THE TREATMENT OF PERIOPERATIVE PAIN IN
THE SETTING OF CORONARY ARTERY
BYPASS GRAFT (CABG) SURGERY. (4)
GASTROINTESTINAL RISK
NSAIDS, INCLUDING PENNSAID, 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)
INDICATIONS AND USAGE
PENNSAID 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 PENNSAID to clean, dry skin. (2.1)
Dispense PENNSAID 10 drops at a time either directly onto the knee or
first into the hand and then onto the knee.
Spread PENNSAID evenly around front, back and sides of the knee.
Repeat this procedure until 40 drops have been
applied and the knee is completely covered with solution. (2.1)
Wash hands completely after administering the product.
Wait until the area is completely dry bef