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:

Rebel Distributors Corp

INN (International Name):

OXAPROZIN

Composition:

OXAPROZIN 600 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of oxaprozin tablets and other treatment options before deciding to use oxaprozin tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). 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 patients with known hypersensitivity to oxaprozin. Oxaprozin tablets should not be given to 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 , Anaphylactoid Reactions and PRECAUTIONS , Preexisting Asthma ). Oxaprozin tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary a

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Rebel Distributors Corp
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
Rx only
(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. NSAID m

Summary of Product characteristics

OXAPROZIN- OXAPROZIN TABLET, FILM COATED
REBEL DISTRIBUTORS CORP
----------
OXAPROZIN
DESCRIPTION
Oxaprozin is a non-steroidal anti-inflammatory drug (NSAID),
chemically designated as 4,5-diphenyl-2-
oxazole-propionic acid, and has the following chemical structure:
C
H NO M.W. 293
Oxaprozin is a white to off-white powder with a slight odor and a
melting point of 162°C to 163°C. It is
slightly soluble in alcohol and insoluble in water, with an
octanol/water partition coefficient of 4.8 at
physiologic pH (7.4). The pK in water is 4.3.
Oxaprozin oral tablets contain 600 mg of oxaprozin.
Inactive ingredients in oxaprozin oral tablets are carnauba wax,
hypromellose, magnesium stearate,
methylcellulose, microcrystalline cellulose, polacrilin potassium,
polyethylene glycol, polysorbate 80,
pregelatinized starch, and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Oxaprozin is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
and antipyretic properties in animal models. The mechanism of action
of oxaprozin, like that of other
NSAIDs, is not completely understood but may be related to
prostaglandin synthetase inhibition.
PHARMACOKINETICS (SEE TABLE 1)
Absorption
Oxaprozin is 95% absorbed after oral administration. Food may reduce
the rate of absorption of
oxaprozin, but the extent of absorption is unchanged. Antacids do not
significantly affect the extent and
rate of oxaprozin absorption.
TABLE 1: OXAPROZIN PHARMACOKINETIC
PARAMETERS [MEAN (% CV)] (1200 MG)
Healthy Adults (19 to 78 years)
18
15
3
a
Total Drug
Unbound Drug
Single
N = 35
Multiple
N = 12
Single
N = 35
Multiple
N = 12
T
(hr)
3.09 (39)
2.44
(40)
3.03 (48) 2.33 (35)
Oral
Clearance
(L/hr/70 kg)
0.150
(24)
0.301
(29)
136 (24)
102 (45)
Apparent
Volume of
Distribution
at Steady
State (V /F;
L/70 kg)
11.7 (13)
16.7
(14)
6230
(28)
2420
(38)
Elimination
Half-life
(hr)
54.9
(49)
41.4
(27)
27.8 (34) 19.5 (15)
Distribution
In dose proportionality studies utilizing 600, 1200, and 1800 mg
doses, the pharmacokinetics of
ox