NAPROXEN- naproxen tablet

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

West-Ward Pharmaceuticals Corp

ИНН (Международная Имя):

NAPROXEN

состав:

NAPROXEN 250 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Carefully consider the potential benefits and risks of naproxen 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 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 Naproxen is also indicated: - 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 is contraindicated in the following patients: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, naproxen sodiu

Обзор продуктов:

Naproxen Tablets USP, 250 mg are White, Round, Unscored Tablets, Debossed “West-ward 346” and are available in: Bottles of 30 tablets:         NDC 0143-1346-30 Bottles of 100 tablets:       NDC 0143-1346-01 Bottles of 500 tablets:       NDC 0143-1346-05 Naproxen Tablets USP, 375 mg are White, Capsule Shape, Unscored Tablets, Debossed “West-ward 347” and are available in: Bottles of 30 tablets:         NDC 0143-1347-30 Bottles of 100 tablets:       NDC 0143-1347-01 Bottles of 500 tablets:       NDC 0143-1347-05 Naproxen Tablets USP, 500 mg are White, Capsule Shape Tablets, Debossed “West-ward 348” and are available in: Bottles of 30 tablets:         NDC 0143-1348-30 Bottles of 100 tablets:       NDC 0143-1348-01 Bottles of 500 tablets:       NDC 0143-1348-05 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 using a child-resistant closure. Manufactured By: West-W ard Pharmaceutical s Corp. Eatontown, NJ 07724 Revised June 2016

Статус Авторизация:

Abbreviated New Drug Application

тонкая брошюра

NAPROXEN- NAPROXEN TABLET
West-Ward Pharmaceuticals Corp
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Non-Steroidal 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:
○ any time 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 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 pro

Характеристики продукта

NAPROXEN- NAPROXEN TABLET
WEST-WARD PHARMACEUTICALS CORP
----------
NAPROXEN TABLETS
NAPROXEN TABLETS, USP
Rev. 06/16
RX ONLY
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 IS 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 is a propionic 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.
Each tablet, for oral administration, contains 250 mg, 375 mg or 500
mg of naproxen. In addition, each
tablet contains the following inactive ingredients: colloidal silicon
dioxide, magnesium stearate,
14
14
3
polyvinylpyrrolidone, and sodium starch glycolate.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION Naproxen has analgesic, anti-inflammatory, and antipyretic
pr