NAPROXEN SODIUM- naproxen sodium tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Adı):

NAPROXEN SODIUM

Kompozisyon:

NAPROXEN SODIUM 550 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Carefully consider the potential benefits and risks of naproxen sodium tablets, USP and other treatment options before deciding to use naproxen sodium tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen, USP as naproxen sodium tablets, USP 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 - 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 tablets, USP are contraindicated in patients with known hypersensitivity to naproxen, USP and naproxen sodium, USP. Naproxen sodium, USP should not be given to patie

Ürün özeti:

Naproxen Sodium Tablets, USP 275 mg, are supplied as blue, oval, biconvex, film coated tablets debossed “IP193” on obverse and plain on reverse. They are available as follows: Naproxen Sodium Tablets, USP 550 mg, are supplied as blue, oval, biconvex, film coated tablets debossed “IP” bisect “194” on obverse and plain on reverse. They are available as follows: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature] in well-closed containers. Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 10-2015-01

Yetkilendirme durumu:

Abbreviated New Drug Application

Bilgilendirme broşürü

Lake Erie Medical DBA Quality Care Products LLC
----------
MEDICATION GUIDE
FOR
NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
(NSAIDS)
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
pregn

Ürün özellikleri

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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 as naproxen sodium tablets, USP is 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).
DESCRIPTION
Naproxen, USP is a propionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen sodium, USP is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid,
sodium salt. Naproxen sodium, USP has the following structure:
Naproxen sodium, USP has a molecular weight of 252.23 and a molecular
formula of C
H NaO .
Naproxen sodium, USP is a white to creamy white, crystalline solid,
freely soluble in water at neutral
pH.
Naproxen sodium, USP is available as blue tablets containing 275 mg of
naproxen sodium, USP and as
blue tablets containing 550 mg of naproxen sodium, USP for oral
administration. The inactive
ingredients are croscarmellose sodium, macrogol, magnesium stearate,
polyvinly alcohol, povidone,
talc, titanium dioxide and FD&C Blue #2.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
14
13
3
The sodium salt of naproxen has been developed as a more rapidly
absorbed formulat