OXAPROZIN tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

STAT RX USA LLC

INN (Rahvusvaheline Nimetus):

OXAPROZIN

Koostis:

OXAPROZIN 600 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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 settin

Toote kokkuvõte:

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 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.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

STAT RX USA LLC
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MEDICATION GUIDE
(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 medicines should not be used by pregnant
women late in their
pregnancy

Toote omadused

OXAPROZIN - OXAPROZIN TABLET
STAT RX USA LLC
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BOXED WARNING
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fatal. This risk may increase
with duration of use. Patients
with cardiovascular disease or risk factors for cardiovascular disease
may be at greater risk
(see WARNINGS).
Oxaprozin tablets are contraindicated for treatment of peri-operative
pain in the setting of
coronary artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
NSAID’s 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 (SEE WARNINGS).
DESCRIPTION
Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID), chemically
designated as 4,5-diphenyl-2-
oxazole-propionic acid, and has the following chemical structure:
The empirical formula for oxaprozin is C
H NO , and the molecular weight is 293. Oxaprozin is a
white to yellowish-white crystalline powder with a melting point of
162°C to 163°C. It is sparingly
soluble in methanol and in ethanol, slightly soluble in ether and
practically insoluble in water, with an
octanol/water partition coefficient of 4.8 at physiologic pH (7.4).
The pKa in water is 4.3.
Oxaprozin oral tablets contain 600 mg of oxaprozin.
Inactive ingredients in oxaprozin oral tablets are corn starch, D and
C Yellow No. 10, FD and C Yellow
No. 6, hydroxypropyl methylcellulose, lactose monohydrate, magnesium
stearate, methylcellulose,
microcrystalline cellulose, polydextrose, polyethylene glycol, sodium
starch glycolate, titanium
18
15
3
dioxide and triacetin.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
and antipyretic properties in animal models. Th