NAPROXEN tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

NAPROXEN (UNII: 57Y76R9ATQ) (NAPROXEN - UNII:57Y76R9ATQ)

Disponible desde:

Dispensing Solutions, Inc.

Designación común internacional (DCI):

NAPROXEN

Composición:

NAPROXEN 500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Carefully consider the potential benefits and risks of naproxen and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Naproxen 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 juvenilearthritis Naproxen 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 tablets are contraindicated in patients with known hypersensitivity to naproxen. Naproxen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions

Resumen del producto:

Naproxen Tablets 500 mg: white to off-white, capsule-shaped tablets with “140” debossed on one side and scored on the other side. NDC 66336-0815-30 NDC 66336-0815-60 Store at 20°-25°C (68°-77°F) excursions permitted to 15°-30°C (59°-86°F) in well-closed containers [see USP Controlled Room Temperature]. Dispense in light-resistant containers. Rx only

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Dispensing Solutions, Inc.
----------
SPL MEDGUIDE
Medication Guide
for
Non-steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescriptionNSAID
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. NSAID medicine

Ficha técnica

NAPROXEN- NAPROXEN TABLET
DISPENSING SOLUTIONS, INC.
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NAPROXEN TABLETS, USP 250MG, 375MG, 500 MG
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).
Naproxen 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 is a proprionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen is (S)-6-methoxy-
-methyl-2-naphthaleneacetic acid. It has the
following structure:
Molecular Formula: C
H O
MW = 230.26
Naproxen has a molecular weight of 230.26 and a molecular formula of C
H O .
Naproxen is an odorless, white to off-white crystalline substance. It
is lipid-soluble, practically
insoluble in water at low pH and freely soluble in water at high pH.
The octanol/water partition
coefficient of naproxen at pH 7.4 is 1.6 to 1.8.
Naproxen tablets are available as white tablets containing 500 mg of
naproxen for oral administration.
The inactive ingredients are croscarmellose sodium, povidone and
magnesium stearate.
14
14
3
14
14
3
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The mechanism of action of the naproxen anion, like that of other
NSAIDs, is not completely understood
but may be related to prostaglandin synthetase i