NAPROXEN DELAYED RELEASE- naproxen tablet

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Blenheim Pharmacal, Inc.

INN:

NAPROXEN

composition:

NAPROXEN 500 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Carefully consider the potential benefits and risks of Naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen delayed-release 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 Naproxen delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Naproxen delayed-release tablets are contraindicated in patients with known hypersensitivity to naproxen. Naproxen delayed

leaflet_short:

Naproxen Delayed-release Tablets USP: 375 mg: White Enteric coated, Capsule-shaped, biconvex tablets de-bossed with ‘I 1’ on one side, supplied in bottles of 100’s count (NDC 31722-338-01). Naproxen Delayed-release Tablets USP: 500 mg: White Enteric coated, Capsule-shaped, biconvex tablets de-bossed with ‘I 11’ on one side, supplied in bottles of 100’s count (NDC 31722-339-01) and 500’s count (NDC 31722-339-05). Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light­resistant containers.

authorization_status:

Abbreviated New Drug Application

PIL

Blenheim Pharmacal, Inc.
----------
MEDGUIDE
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:
•
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

SPC

NAPROXEN DELAYED RELEASE- NAPROXEN TABLET
BLENHEIM PHARMACAL, INC.
----------
NAPROXEN DELAYED-RELEASE TABLETS USP, 375 MG AND 500 MG
Rx only
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
delayed-
release tablets are 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 (Cmax); 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 suggest