OXAPROZIN- oxaprozin tablet

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Oxaprozin (UNII: MHJ80W9LRB) (Oxaprozin - UNII:MHJ80W9LRB)

Saatavilla:

Caraco Pharmaceutical Laboratories, Ltd.

INN (Kansainvälinen yleisnimi):

Oxaprozin

Koostumus:

Oxaprozin 600 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Carefully consider the potential benefits and risks of oxaprozin tablet, USP and other treatment options before deciding to use oxaprozin tablet, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Oxaprozin Tablet, USP 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 Oxaprozin tablet, USP is contraindicated in patients with known hyper-sensitivity to oxaprozin. Oxaprozin tablet, USP 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 tablet, USP is contraindicated for the treatment of peri-operative pain in the setti

Tuoteyhteenveto:

Oxaprozin tablets, USP, 600 mg are available as: white to off-white, capsule shaped film coated tablets with “391” debossed on one side and scored on the other side in the bottles of 100 (NDC 57664-391-08), 500 (NDC 57664-391-13) and 1000 (NDC 57664-391-18). Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in tight, light-resistant container as defined in the USP, with child resistant closure. CARACO PHARMACEUTICAL LABORATORIES, LTD. DETROIT, MI 48202 C.S.No. 5220T09 Iss. 03/13

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Caraco Pharmaceutical Laboratories, Ltd.
----------
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 you are pregnant

Valmisteyhteenveto

OXAPROZIN- OXAPROZIN TABLET
CARACO PHARMACEUTICAL LABORATORIES, LTD.
----------
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 Tablet, USP, 600 mg 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 pK in water is 4.3.
Oxaprozin oral tablets contain 600 mg of oxaprozin, USP.
Inactive ingredients in oxaprozin tablets, USP are microcrystalline
cellulose, methylcellulose,
magnesium stearate, starch, sodium starch glycolate, polyethylene
glycol, polysorbate 80 and titanium
dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Oxaprozin is a nonsteroidal 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
prostaglandi