NAPROXEN SODIUM- naproxen sodium tablet

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

NAPROXEN SODIUM (UNII: 9TN87S3A3C) (NAPROXEN - UNII:57Y76R9ATQ)

Sẵn có từ:

PD-Rx Pharmaceuticals, Inc.

INN (Tên quốc tế):

NAPROXEN SODIUM

Thành phần:

NAPROXEN SODIUM 275 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Naproxen Naproxen tablets and naproxen sodium tablets are indicated for: The relief of the signs and symptoms of: - rheumatoid arthritis - osteoarthritis - ankylosing spondylitis - Polyarticular Juvenile Idiopathic Arthritis Naproxen tablets, and 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 tablets, or naproxen sodium tablets, during the third trimester of pregnancy increases the risk of premature closure of the fetal du

Tóm tắt sản phẩm:

Naproxen Sodium Tablets USP, 275 mg: blue, oval, film-coated tablets with ‘G 0’ engraved on one side and ‘275’ engraved on the other side. Packaged in bottles of 6, 10, 21 and 30 6’s (bottle): NDC 55289-467-06 10’s (bottle): NDC 55289-467-10 21’s (bottle): NDC 55289-467-21 30’s (bottle): NDC 55289-467-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Dispense in well-closed containers.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Tờ rơi thông tin

PD-Rx Pharmaceuticals, Inc.
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MEDICATION GUIDE
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:
•
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
•
older age
•
increasing doses of NSAIDs
•
poor health
•
longer use of NSAIDs
•
advanced liver disease
•
smoking
•
bleeding problems
•
drinking alcohol
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 healthcare provider about all of your
medical conditions, including if
you:
•
have liver or kidney p

Đặc tính sản phẩm

NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
PD-RX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR
NAPROXEN TABLETS AND NAPROXEN SODIUM TABLETS.
NAPROXEN TABLETS AND 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 TABLETS AND 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
Boxed Warning 05/2016
Warnings and Precautions ( 5.1, 5.5) 05/2016
INDICATIONS AND USAGE
Naproxen tablets, and naproxen sodium tablets are non-steroidal
anti-inflammatory drugs indicated for: (1)
the relief of the signs and symptoms of: (1)
rheumatoid arthritis
Oste oarthritis
ankylosing spondylitis
polyarticular juvenile idiopathic arthritis
Naproxen tablets and naproxen sodium tablets are also indicated for:
(1)
the relief of signs and symptoms of: (1)
te ndonitis
burs itis
acute gout
the management of: (1)
pain
primary dysmenorrhea
DOSAGE AND ADMINISTRATION
Use the lowest effective dosage for shortest duration consistent with
individual patient treatment goals. ( 2