NAPROXEN tablet

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

Aphena Pharma Solutions - Tennessee, LLC

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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: - 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 tablets are 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 tablets are contraindicated in the following patents: - Known hypersensitivity (e.g., anaphylactic reactions and serious skin react

Ապրանքի ամփոփագիր:

​Naproxen Tablets, USP: ​250 mg: Light Yellow, Round, biconvex tablets de-bossed with ‘I’ ​ on the left side of bisect and ‘G’ ​ on the right side of bisect on one side and ‘340’ ​ on the other, supplied in bottles of 100’s count (NDC 76282-340-01) and 500’s count (NDC 76282-340-05). Naproxen Tablets, USP: ​375 mg: Light Pink, Capsule shaped, biconvex tablets de-bossed with ‘IG’ ​ on one side and ‘341’ ​ on the other, supplied in bottles of 100’s count (NDC 76282-341-01) and 500’s count (NDC 76282-341-05). ​Naproxen Tablets, USP: ​500 mg: Light Yellow, Capsules shaped, biconvex tablets de-bossed with ‘I’ ​ on the left side of bisect and ‘G’ ​ on the right side of bisect on one side and ‘342’ ​ on the other, supplied in bottles of 100’s count (NDC 76282-342-01) and 500’s count (NDC 76282-342-05). Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. *All brand names mentioned are registered trademark of their respective owners and are not of Exelan Pharmaceuticals, Inc. Rev: 06/2016

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Տեղեկատվական թերթիկ

NAPROXEN- NAPROXEN TABLET
Aphena Pharma Solutions - Tennessee, LLC
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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:
o with increasing doses of NSAIDs
o 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:
o anytime during use
o without warning symptoms
o 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

Ապրանքի հատկությունները

NAPROXEN- NAPROXEN TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
NAPROXEN TABLETS, USP
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 TABLETS ARE 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, USP is a propionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical name for naproxen, USP is
(S)-6-methoxy-α-methyl-2-naphthaleneacetic acid. It has the
following structural formula:
Naproxen, USP has a molecular weight of 230.26 and a molecular formula
of C
H O .
Naproxen, USP 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.
Naproxen tablets, USP are available as yellow tablets containing 250
mg of naproxen USP, pink tablets
containing 375 mg of naproxen USP, and yellow tablets containing 500
mg of naproxen USP for oral
administration. The inactive ingredients are croscarmellose sodium,
povidone, iron oxide yellow, iron
oxide red colloidal silicon dioxide and magnesium stearate.
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