NAPROXEN- naproxen sodium tablet, film coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Blenheim Pharmacal, Inc.

INN (Alþjóðlegt nafn):

NAPROXEN SODIUM

Samsetning:

NAPROXEN SODIUM 550 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 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 is contraindicated in patients with known hypers

Vörulýsing:

Naproxen Sodium Tablets USP, 275 mg is available as white, unscored, capsule shaped, film coated tablets imprinted "H 1" Bottles of 100 tablets. Naproxen Sodium Tablets USP, 550 mg is available as white, unscored, capsule shaped, film coated tablets imprinted "H 2". Bottles of 100 tablets. Bottles of 500 tablets. Store at 20-25°C (68-77°F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in well-closed containers as defined in the USP using a child-resistant closure. West-ward Pharmaceutical Corp.   Eatontown, NJ 07724 Distributor Manufactured by: Hikma Pharmaceuticals   P. O. Box 182400 AMMAN 11118 - JORDAN Revised: June 2006

Leyfisstaða:

Abbreviated New Drug Application

Upplýsingar fylgiseðill

Blenheim Pharmacal, Inc.
----------
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 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

Vara einkenni

NAPROXEN- NAPROXEN SODIUM TABLET, FILM COATED
BLENHEIM PHARMACAL, INC.
----------
NAPROXEN SODIUM
Rev. 11/07
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 is contraindicated for the treatment of
perioperative 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).
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS :
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The sodium salt of naproxen has been developed as a more rapidly
absorbed formulation of naproxen
for use as an analgesic. The mechanism of action of the naproxen
anion, like that of other NSAIDs, is
not completely understood but may be related to prostaglandin
synthetase inhibition.
PHARMACOKINETICS :
Naproxen itself is rapidly and completely absorbed from the
gastrointestinal tract with an _in vivo_
bioavailability of 95%. The elimination half-life of naproxen ranges
from 12 to 17 hours. Steady-state
levels of naproxen are reached in 4 to 5 days and the degree of
naproxen accumulation is consistent
with this half-life.
_Absorption:_ After oral administration of naproxen sodium tablets,
peak plasma levels are attained in 1 to
2 hours.
_Distribution:_ Naproxen has a volume of distribution of 0.16 L/kg. At
therapeutic levels naproxen is
greater than 99% albumin-bound. At doses of naproxen greater than 500
mg/day there is less than
pr