NAPROXEN tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

RedPharm Drug, Inc.

INN (שם בינלאומי):

NAPROXEN

הרכב:

NAPROXEN 500 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation). Naproxen as 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 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 are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to

leaflet_short:

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 65162-188-10 Bottles of 500: NDC 65162-188-50 Bottles of 1000: NDC 65162-188-11 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 65162-189-10 Bottles of 500: NDC 65162-189-50 Bottles of 1000: NDC 65162-189-11 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 65162-190-10 Bottles of 500: NDC 65162-190-50 Bottles of 1000: NDC 65162-190-11 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. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA 382220 Distributed by: Amneal Pharmaceuticals Bridgewater, NJ 08807 Rev. 06-2016-01

מצב אישור:

Abbreviated New Drug Application

עלון מידע

NAPROXEN- NAPROXEN TABLET
RedPharm Drug, Inc.
----------
MEDICATION GUIDE FOR
NONSTEROIDAL ANTI-
INFLAMMATORY DRUGS (NSAIDS)
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
Increased risk of a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
with increasing doses of NSAIDs
with longer use of NSAIDs
Do not take NSAIDs right before or after a heart surgery called a
“coronary artery bypass graft (CABG).”
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the mouth
to the stomach), stomach and intestines:
anytime during use
without warning symptoms
that may cause death
The risk of getting an ulcer or bleeding increases with:
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
increasing doses of NSAIDs
longer use of NSAIDs
smoking
drinking alcohol
older age
poor health
advanced liver disease
bleeding problems
NSAIDs should only be used:
exactly as prescribed
at the lowest dose possible for your treatment
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDS:
if you have had an asthma attack, hives, or other allergic reaction
with aspirin or any other NSAIDs.
right before or after heart bypass surgery.
Before taking NSAIDs, tell your health care provider about all of your
medi

מאפייני מוצר

NAPROXEN- NAPROXEN TABLET
REDPHARM DRUG, INC.
----------
NAPROXEN 500MG
BOXED WARNING
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
Cardiovascular Thrombotic Events
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
cardiovascular thrombotic events, including myocardial infarction and
stroke, which can be fatal.
This risk may occur early in treatment and may increase with duration
of use (see WARNINGS).
Naproxen Tablets are contraindicated in the setting of coronary artery
bypass graft (CABG)
surgery (see CONTRAINDICATIONS, WARNINGS).
Gastrointestinal Bleeding, Ulceration, and Perforation
NSAIDs cause an increased risk of serious gastrointestinal (GI)
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 and
patients with a prior history of peptic ulcer disease and/or GI
bleeding are at greater risk for
serious GI 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:
[hjl]
Naproxen, USP has a molecular weight of 230.26 and a molecular formula
of C14H14O3.
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
Mechanism of Action
Naproxen has analgesic, anti-inflammatory, and