NAPROXEN tablet

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Camber Pharmaceuticals

INN (Algemene Internationale Benaming):

NAPROXEN

Samenstelling:

NAPROXEN 250 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Carefully consider the potential benefits and risks of naproxen tablets and other treatment options before deciding to use naproxen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). 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 arthritits 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  dymenorrhea Naproxen tablets are contraindicated in patients with known hypersensitivity to naproxen. Naproxen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type r

Product samenvatting:

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 31722-340-01) and 500’s count (NDC 31722-340-05). 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 31722-341-01) and 500’s count (NDC 31722-341-05). 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 31722-342-01) and 500’s count (NDC 31722-342-05). Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light­resistant containers.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

Camber Pharmaceuticals
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MEDGUIDE
Medication Guide for non-steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
__________________________________________________________________________
What is the most important information I should know about medicines
called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke
that can lead to death. This chance
increases:
•
with longer use of NSAID medicines
•
in people who have heart disease
NSAID medicines should never be used right before or after a heart
surgery called a “coronary artery
bypass graft (CABG).”
NSAID medicines can cause ulcers and bleeding in the stomach and
intestines at any time during
treatment. Ulcers and bleeding:
•
can happen without warning symptoms
•
may cause death
The chance of a person getting an ulcer or bleeding increases with:
•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
___________________________________________________________________________
What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines 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 a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAID
medicine
•
for pain right before or after heart bypass surgery
Tell your healthcare provider:
•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
o

Productkenmerken

NAPROXEN - NAPROXEN TABLET
CAMBER PHARMACEUTICALS
----------
NAPROXEN TABLETS, USP
Rx only
CARDIOVASCULAR RISK NSAIDs may cause an increased risk of serious
cardiovascular
thrombotic events, myocardial infarction, and stroke, which can be
fatal. This risk may
increase with duration of use. Patients with cardiovascular disease or
risk factors for
cardiovascular disease may be at greater risk (see WARNINGS). Naproxen
tablets are
contraindicated for the treatment of peri-operative pain in the
setting of coronary artery
bypass graft (CABG) surgery (see WARNINGS). GASTROINTESTINAL RISK
NSAIDs cause an
increased risk of serious gastrointestinal 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 are
at greater risk for
serious gastrointestinal events (see WARNINGS).
DESCRIPTION
Naproxen, USP is a proprionic 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 C14H14O3.
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.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic and antipyretic properties.
The mechanism of