OXAPROZIN tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

OXAPROZIN (UNII: MHJ80W9LRB) (OXAPROZIN - UNII:MHJ80W9LRB)

Disponible des:

California Pharmaceuticals LLC

Designació comuna internacional (DCI):

OXAPROZIN

Composición:

OXAPROZIN 600 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Oxaprozin tablets is a non-steroidal anti-inflammatory drug indicated for: - Relief of signs and symptoms of Osteoarthritis (OA) (1) - Relief of signs and symptoms of Rheumatoid Arthritis (RA) (1) - Relief of signs and symptoms of Juvenile Rheumatoid Arthritis (JRA) (1) - Known hypersensitivity to oxaprozin or any components of the drug product (4) - History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (4) - In the setting of CABG surgery (4) Oxaprozin is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to oxaprozin 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 coron

Resumen del producto:

Oxaprozin tablets USP, 600 mg are yellow, oval shaped, scored, film-coated tablets debossed “C” on one side and “01|70” on the other side supplied in bottles of 100 and 500. Bottles of 100 NDC 55111-170-01 Bottles of 500 NDC 55111-170-05 Storage Keep bottles tightly closed. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure.

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

OXAPROZIN- OXAPROZIN TABLET, FILM COATED
California Pharmaceuticals LLC
----------
MEDICATION GUIDE
Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal 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”, “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,

Fitxa tècnica

OXAPROZIN- OXAPROZIN TABLET, FILM COATED
CALIFORNIA PHARMACEUTICALS LLC
----------
OXAPROZIN 600 MG - 310
WARNING: RISK OF SERIOUSCARDIOVASCULAR AND GASTROTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
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
[SEE WARNINGS AND PRECAUTIONS (5.1)].
OXAPROZIN IS CONTRAINDICATED IN THE SETTING OF CORONARY ARTERY BYPASS
GRAFT (CABG)
SURGERY [SEE CONTRAINDICATIONS (4) AND WARNINGS AND PRECAUTIONS
(5.1)].
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
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 [SEE WARNINGS AND PRECAUTIONS (5.2)].
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)
OXAPROZIN 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)
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTES