NAPROXEN tablet

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Blenheim Pharmacal,Inc.

INN (International Adı):

NAPROXEN

Kompozisyon:

NAPROXEN 500 mg

Uygulama yolu:

ORAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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, urticar

Ürün özeti:

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: Bottles of 100:            NDC 53746-188-01 Bottles of 500:            NDC 53746-188-05 Bottles of 1000:          NDC 53746-188-10 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: Bottles of 100:            NDC 53746-189-01 Bottles of 500:            NDC 53746-189-05 Bottles of 1000:          NDC 53746-189-10 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: Bottles of 100:            NDC 53746-190-01 Bottles of 500:            NDC 53746-190-05 Bottles of 1000:          NDC 53746-190-10 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 of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Rev. 04-2015-00

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

NAPROXEN- NAPROXEN TABLET
BLENHEIM PHARMACAL,INC.
----------
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).
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 inhibition.
PHARMACOKINETICS
Naproxen is rapidly and completely absorbed from the gastrointestinal
tract with an _in vivo_
bioavailability of 95%. The different dosage forms of naproxen are
bioequivalent in terms of extent of
absorption (AUC) and peak concentration (C
); however, the products do differ in their pattern of
absorption. These differences between naproxen products are related to
both the chemical form of
naproxen used and its formulation. Even with the observed differences
in pattern of absorption, the
elimination half-life of naproxen is unchanged across products ranging
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. This suggests that the differences in
pattern of release play only a
negligi