OXAPROZIN tablet, film coated

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

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Активний інгредієнт:

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

Доступна з:

PD-Rx Pharmaceuticals, Inc.

ІПН (Міжнародна Ім'я):

OXAPROZIN

Склад:

OXAPROZIN 600 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Oxaprozin tablets are indicated: - For relief of the signs and symptoms of osteoarthritis - For relief of the signs and symptoms of rheumatoid arthritis - For relief of the signs and symptoms of juvenile rheumatoid arthritis Oxaprozin tablets are 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 CABG surgery [ see Warnings and Precautions ( 5.1) ] Risk Summary   Use of NSAIDs, including oxaprozin, can

Огляд продуктів:

Oxaprozin Tablets USP, 600 mg are white to off-white, capsule-shaped, film-coated tablets. On one side scored and debossed with the numbers “9” and “3” on each side of the score. On the other side unscored and debossed “0924”. Supplied in bottles of 20 (NDC 55289-601-20) ,30 (NDC 55289-601-30) and 60 (NDC55289-601-60). Storage Keep bottles tightly closed. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container, as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Статус Авторизація:

Abbreviated New Drug Application

інформаційний буклет

                                PD-Rx Pharmaceuticals, Inc.
----------
MEDICATION GUIDE FOR NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
Dispense with Medication Guide available at: www.tevausa.com/medguides
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”, “antiplatelet
drugs”, “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 afte
                                
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Характеристики продукта

                                OXAPROZIN- OXAPROZIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OXAPROZIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OXAPROZIN
TABLETS.
OXAPROZIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1992
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)
OXAPROZIN TABLETS ARE 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)
RECENT MAJOR CHANGES
Warnings and Precautions, Drug Reaction with Eosinophilia and Systemic
Symptoms (DRESS) (
5.10)
4/2021
Warnings and Precautions, Fetal Toxicity ( 5.11)
4/2021
INDICATIONS AND USAGE
Oxaprozin tablets are 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)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals
( 2.1)
OA: 1200 mg (two 600 mg tablets) given orally once a day ( 2.2, 2.5,
14.1)
RA: 1200 mg (two 600 mg tablets) given orally once a day ( 2.3, 2.5,
14.2)
JRA: 600 mg once daily in patients 22 to 31 kg.
                                
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