NAPROXEN tablet

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Rebel Distributors Corp.

INN (International Name):

NAPROXEN

Sammensetning:

NAPROXEN 250 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 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. Naproxen Tablets, USP should not be given to patients who have experienced asthma, urticaria, or allergic-type rea

Produkt oppsummering:

Naproxen Tablets, USP: 250 mg : white, round, biconvex, debossed with “IP 188” on obverse and “250” on the reverse. Packaged in bottles of 30 and 60. 375 mg : white, capsule-shaped, biconvex, debossed with “IP 189” on obverse and “375” on the reverse. Packaged in bottles of 20, 30, 60, 90 and 120. 500 mg : white, capsule-shaped, biconvex, debossed with “IP 190” on obverse and “500” on the reverse. Packaged in bottles of 14, 15, 20, 28, 30, 40 45, 60 and 90. Store at 15°-30°C (59°-86°F) in well-closed containers; dispense in light-resistant containers. Rx only Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Repackaged by: Rebel Distributors Corp. Thousand Oaks, CA 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: 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: The chance of a person getting an ulcer or bleeding increases with: NSAID medicines should only be used: 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: Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)? Do not take an NSAID medicine: Tell your healthcare provider: What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? Get emergency help right away if you have any of the following symptoms: Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms: These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) NSAID medicines that need a prescription * Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke. This Medication Guide has been approved by the U.S. Food and Drug Administration.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NAPROXEN- NAPROXEN TABLET
REBEL DISTRIBUTORS CORP.
----------
NAPROXEN TABLETS, USP
RX ONLY
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction, and stroke, which can be fate. This risk may increase with
duration of use. Patient
with cardiovascular disease or risk factor for cardiovascular disease
may be at great risk (see
WARNINGS).
Naproxen as Naproxen Tablets, USP is contraindicated for the treatment
of peri0operative
pain in the setting of coronary artery bypass graft (CABG) surgery
(see WARNINGS).
GASTROINTESTINAL RISK
NSAIDs cause increased risk of serious gastrointestinal adverse event
including, 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-α-methyl-2-naphthaleneacetic acid. Naproxen has the
following structure:
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, USP are available as white tablets containing 250 mg
of naproxen, white tablets
containing 375 mg of naproxen and white tablets containing 500 mg of
naproxen 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.
14
14
3
The mechanism of action of the naproxen anion, like that of other
NSAIDs, is not completely understood
but may be