NAPROXEN SODIUM tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Доступно од:

State of Florida DOH Central Pharmacy

INN (Међународно име):

NAPROXEN SODIUM

Састав:

NAPROXEN SODIUM 550 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Carefully consider the potential benefits and risks of naproxen sodium tablets and other treatment options before deciding to use naproxen sodium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen sodium tablets are indicated: - For the relief of the signs and symptoms of rheumatoid arthritis - For the relief of the signs and symptoms of osteoarthritis - For the relief of the signs and symptoms of ankylosing spondylitis - For the relief of the signs and symptoms of juvenile arthritis Naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen sodium tablets are also indicated: - For relief of the signs and symptoms of tendonitis - For relief of the signs and symptoms of bursitis - For relief of the signs and symptoms of acute gout - For the management of pain - For the management of primary dysmenorrhea Naproxen sodium tab

Резиме производа:

Naproxen sodium tablets USP, 275 mg are available in film-coated, white to off-white, oval, unscored tablets debossed "93" and "536". Naproxen sodium tablets USP, 550 mg are available in film-coated, white to off-white, oval, unscored tablets debossed "93" and "537". They are supplied by State of Florida DOH Central Pharmacy as follows: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

State of Florida DOH Central Pharmacy
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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 you are pregnant.

Карактеристике производа

NAPROXEN SODIUM - NAPROXEN SODIUM TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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NAPROXEN SODIUM TABLETS USP
RX ONLY
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).
Naproxen sodium tablets are contraindicated for the 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).
1
DESCRIPTION
Naproxen is a propionic acid derivative related to the arylacetic acid
group of non-steroidal anti-
inflammatory drugs.
The chemical name for naproxen sodium is
(-)-sodium(_S_)-6-methoxy-α-methyl-2-naphthaleneacetate. It
has the following structural formula:
C
H NaO M.W. 252.24
Naproxen sodium is a white to creamy white, crystalline solid, freely
soluble in water at neutral pH.
Each tablet, for oral administration, contains 275 mg or 550 mg
naproxen sodium, equivalent to 250 mg
or 500 mg naproxen with 25 mg (about 1 mEq) or 50 mg (about 2 mEq) of
sodium, respectively. In
addition, each tablet contains the following inactive ingredients:
hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene glycol 8000, povidone,
silicon dioxide, talc, and titanium
dioxide.
11
Throughout this package insert, the term NSAID refers to a non-aspirin
non-steroidal anti-inflammatory
drug.
1
14
13
3
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a non-steroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
Th