DAYPRO- oxaprozin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

PD-Rx Pharmaceuticals, Inc.

INN (International Name):

OXAPROZIN

Composition:

OXAPROZIN 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

DAYPRO is 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 DAYPRO 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 CABG surgery [ see Warnings and Precautions (5.1) ] Risk Summary Use of NSAIDs, including DAYPRO, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfun

Product summary:

DAYPRO (oxaprozin) 600 mg caplets are white, capsule-shaped, scored, film-coated, with DAYPRO debossed on one side and 1381 on the other side, supplied as: Storage Keep bottles tightly closed. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Protect the unit dose from light.

Authorization status:

New Drug Application

Patient Information leaflet

PD-Rx Pharmaceuticals, Inc.
----------
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised: April 2021
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:
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
•
if you have had an asthma attack, hives, or oth

Summary of Product characteristics

DAYPRO- OXAPROZIN TABLET, FILM COATED
PD-RX PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DAYPRO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DAYPRO.
DAYPRO (OXAPROZIN) CAPLETS, 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)
DAYPRO 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)
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
DAYPRO 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)
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 caplets) given orally once a day ( 2.2, 2.5,
14.1)
RA: 1200 mg (two 600 mg caplets) given orally once a day ( 2.3, 2.5,
14.2)
JRA: 600 mg once daily in patients 22–31 kg. 900 mg once daily in
patients 32–54 kg