OXAPROZIN tablet

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Dispensing Solutions, Inc.

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 USP and other treatment options before deciding to use  oxaprozin tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Oxaprozin  tablets USP are indicated: Oxaprozin  is contraindicated in patients with known hypersensitivity to oxaprozin. Oxaprozin  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, Pre-existing Asthma ). Oxaprozin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Oxaprozin is a non-narcotic drug. Usually reliable animal studies have indicated that oxaprozin has no known addiction potential in humans. No patient

Toote kokkuvõte:

Oxaprozin tablets USP for oral administration are available as: 600 mg: White, capsule-shaped, film-coated, debossed with “E 141” on one side and bisected on the other, and supplied as: NDC 66336-0722-60 bottles of 60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep bottles tightly closed. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required.

Volitamisolek:

Abbreviated New Drug Application

Infovoldik

OXAPROZIN- OXAPROZIN TABLET
Dispensing Solutions, Inc.
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MEDICATION GUIDE
FOR
NON-STEROIDAL ANTI-INFLAMMATORY
DRUGS (NSAIDS)
(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 yo

Toote omadused

OXAPROZIN- OXAPROZIN TABLET
DISPENSING SOLUTIONS, INC.
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OXAPROZIN TABLETS USP
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 is contraindicated for treatment of peri-operative pain in
the setting of coronary
artery bypass graft (CABG) surgery (see WARNINGS).
GASTROINTESTINAL RISK
- NSAIDs 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 USP 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 USP is C
H NO , and the molecular weight is 293. Oxaprozin
USP 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 pKa in water is 4.3.
Oxaprozin tablets USP contain 600 mg of oxaprozin USP.
In addition, each tablet of oxaprozin USP contains the following
inactive ingredients: colloidal silicon
dioxide, microcrystalline cellulose, hypromellose, methylcellulose,
magnesium stearate, polacrilin
potassium, starch, polyethylene glycol, titanium dioxide, and
polysorbate 80.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Oxaprozin is a nonsteroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,
18
15
3
and antipyretic properties in animal models. The mechanism of action
of oxaprozin, like that of o