NAPROXEN- naproxen tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Lake Erie Medical DBA Quality Care Products LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Tablets are indicated: Naproxen as naproxen suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen Tablets are also indicated: Naproxen tablets are contraindicated in the following patients:

Resumen del producto:

Naproxen Tablets USP are supplied as follows: 250 mg: Light brick red, mottled, round, biconvex, unscored tablets debossed with "93" on one side and "147" on the other. 375 mg: Peach, mottled, capsule-shaped, unscored tablets debossed with "93" on one side and "148" on the other. 500 mg: Light brick red, mottled, capsule-shaped, unscored tablets debossed with "TEVA" on one side and "149" on the other. 35356-684-20 35356-684-30 35356-684-60 35356-684-90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Manufactured In Canada By: TEVA CANADA LIMITED Toronto, Canada M1B 2K9 Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. W 5/2016

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

Lake Erie Medical DBA Quality Care Products LLC
----------
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:
owith increasing doses of NSAIDs
owith 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:
oanytime during use
owithout warning symptoms
othat may cause death
The risk of getting an ulcer or bleeding increases with:
opast history of stomach ulcers, or stomach or intestinal bleeding
with use of NSAIDs
otaking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
oincreasing doses of NSAIDs
oolder age
olonger use of NSAIDs
opoor health
osmoking
oadvanced liver disease
odrinking alcohol
obleeding problems
NSAIDs should only be used:
oexactly as prescribed
oat the lowest dose possible for your treatment
ofor 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 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 healthcare provider about all of your
medical conditions, including if
you:
•have

Ficha técnica

NAPROXEN- NAPROXEN TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
NAPROXEN TABLETS USP
0147
0148
0149
RX ONLY
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION
•
DESCRIPTION
Naproxen, USP is a propionic acid derivative related to the arylacetic
acid group of non-steroidal anti-
inflammatory drugs.
The chemical name for naproxen, USP is
(+)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the
following structural formula:
C
H O M.W. 230.26
Naproxen, USP is a practically 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
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_).
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_).
14
14
3
partition coefficient of naproxen, USP at pH 7.4 is 1.6 to 1.8.
Naproxen Tablets USP are available as mottled, light brick red tablets
containing 250 mg of naproxen,
USP; mottled peach tablets containing 375 mg of naproxen, USP; and
mottled, light brick red tablets
containing 500 mg of naproxen, USP for oral administration. In
addition, each tablet contains the
following inactive ingredients: corn starch, croscarmellose sodium,
magnes