NAPROXEN tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Lake Erie Medical DBA Quality Care Products LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Naproxen Tablets, USP, 250 mg, are supplied as white, round, biconvex tablets, debossed with “IP 188” on obverse and “250” on the reverse. They are available as follows: NaproxenTablets, USP, 375 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 189” on obverse and “375” on the reverse. They are available as follows: Naproxen Tablets, USP, 500 mg, are supplied as white, capsule-shaped, biconvex tablets, debossed with “IP 190” on obverse and “500” on the reverse. They are available as follows: 55700-316-20 55700-316-30 55700-316-60 55700-316-90 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]. Dispense in well-closed, light-resistant containers as defined in the USP. Rx only Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA  382220 Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 07-2015-01

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

Lake Erie Medical DBA Quality Care Products LLC
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MEDICATION GUIDE FOR NONSTEROIDAL
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 Nonsteroidal 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 increasing doses of NSAID medicines
•
in people who have heart disease
•
with longer use of NSAID medicines
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:
•
increasing doses of NSAID medicines
•
smoking
•
taking medicines called “corticosteroids” and “anticoagulants”
•
drinking alcohol
•
older age
•
longer use
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
for the shortest time needed
•
at the lowest dose possible for your treatment
What are Nonsteroidal 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 Nonsteroidal 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 yo

Produktens egenskaper

NAPROXEN- NAPROXEN TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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NAPROXEN TABLETS, USP
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 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, USP is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. Naproxen,
USP has the following structure:
Naproxen, USP has a molecular weight of 230.26 and a molecular formula
of C
H O .
Naproxen, USP 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, USP at pH 7.4 is 1.6 to 1.8.
Naproxen, USP is available as white tablets containing 250 mg of
naproxen, USP, white tablets
containing 375 mg of naproxen, USP and white tablets containing 500 mg
of naproxen, USP for oral
administration. The inactive ingredients are croscarmellose sodium,
povidone and magnesium stearate.
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 t