NAPROXEN SODIUM tablet, film coated

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

Naproxen sodium (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Доступно од:

Dr. Reddy's Laboratories Inc.

INN (Међународно име):

Naproxen sodium

Састав:

NAPROXEN 275 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Naproxen sodium tablets are indicated for:   the relief of the signs and symptoms of:   • rheumatoid arthritis • osteoarthritis • ankylosing spondylitis • Polyarticular Juvenile Idiopathic Arthritis   Naproxen sodium tablets are also indicated for:   the relief of signs and symptoms of:   • tendonitis • bursitis • acute gout   the management of: • pain • primary dysmenorrhea   Naproxen sodium tablets are contraindicated in the following patients:   • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen or any components of the drug product [see Warnings and Precautions (5.7, 5.9)] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7, 5.8)] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1)] Risk Summary Use of NSAIDs, including naproxen sodium ta

Резиме производа:

Naproxen sodium tablets USP, 275 mg are white, film coated, capsule shaped, biconvex tablets, debossed ‘RDY’ on one side and ‘107’ on other side and are supplied in bottles of 30’s, 100’s, 500’s and 1000’s.   Bottles of 30 NDC 43598-494-30 Bottles of 100 NDC 43598-494-01 Bottles of 500 NDC 43598-494-05 Bottles of 1000 NDC 43598-494-10   Naproxen sodium tablets USP, 550 mg are white, film coated, capsule shaped, biconvex tablets, debossed ‘RDY’ on one side and ‘108’ separating ‘1’ and ‘08’ with a breakline on other side and are supplied in bottles of 30’s, 100’s, 500’s and 1000’s.   Bottles of 30 NDC 43598-495-30 Bottles of 100 NDC 43598-495-01 Bottles of 500 NDC 43598-495-05 Bottles of 1000 NDC 43598-495-10   Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature] in well-closed containers.

Статус ауторизације:

Abbreviated New Drug Application

Информативни летак

Dr. Reddy's Laboratories Inc.
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Medication Guide for Nonsteroidal 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:
•
anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
o past history of stomach ulcers, or stomach or intestinal bleeding
with use of
NSAIDs
o taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o increasing doses of NSAIDs
o longer use of NSAIDs
o smoking
o drinking alcohol
o older age
o poor health
o advanced liver disease
o bleeding problems
NSAIDs should only be used:
o exactly as prescribed
o at the lowest dose possible for your treatment
o 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 healthcare provider about all of your
medical conditions, includ

Карактеристике производа

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET, FILM COATED
DR. REDDY'S LABORATORIES INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN SODIUM
TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR NAPROXEN SODIUM TABLETS.
NAPROXEN SODIUM TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1976
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
• 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. (5.1)
• NAPROXEN SODIUM TABLETS ARE CONTRAINDICATED IN THE SETTING OF
CORONARY ARTERY BYPASS
GRAFT (CABG) SURGERY. (4, 5.1)
• 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. (5.2)
RECENT MAJOR CHANGES
Warnings and Precautions (5.10, 5.11) 04/2021
INDICATIONS AND USAGE
Naproxen sodium tablets are non-steroidal anti-inflammatory drugs
indicated for: (1)
the relief of the signs and symptoms of: (1)
• rheumatoid arthritis (1)
• osteoarthritis (1)
• ankylosing spondylitis (1)
• polyarticular juvenile idiopathic arthritis (1)
Naproxen sodium tablets are also indicated for: (1)
the relief of signs and symptoms of: (1)
• tendonitis (1)
• bursitis (1)
• acute gout the management of: (1)
• pain (1)
• primary dysmenorrhea (1)
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals.
(2.1)
Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Sp