NAPROXEN tablet

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Direct_Rx

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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)] 8.1 Pregnancy Risk Summary Use of NSAIDs, including naproxen tablets, or naproxen sodium tablets, during the third trimester of

Περίληψη προϊόντος:

Naproxen Tablets USP, 250 mg: circular, light orange colored, flat, uncoated tablets, engraved with ‘G’ and ‘32’ on either side of break line on one side and ‘250’ on the other side. Packaged in light-resistant bottles of 100 and 500. 100’s (bottle): 500’s (bottle): Naproxen Tablets USP, 375 mg: oval, light orange colored, biconvex, uncoated tablets, engraved with ‘G 32’ on one side and ‘375’ on the other side. Packaged in light-resistant bottles of 100 and 500. 100’s (bottle): 500’s (bottle): Naproxen Tablets USP, 500 mg: capsule shaped, light orange colored, uncoated tablets, debossed with ‘G’ and ‘32’ on either side of break line on one side and ‘500’ on the other side. Packaged in light-resistant bottles of 30, 50, 100 and 500. 30’s (bottle): 50’s (bottle): 100’s (bottle): 500’s (bottle): 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. 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 100 and 500 100’s (bottle): 500’s (bottle): Naproxen Sodium Tablets USP, 550 mg: blue colored, modified capsule shaped, biconvex, film-coated tablets, engraved with ‘G’ and ‘0’ on either side of break line and break line on the other side. Packaged in bottles of 100 and 500. 100’s (bottle): 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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Φύλλο οδηγιών χρήσης

NAPROXEN- NAPROXEN TABLET
Direct_Rx
----------
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 problems
�

Αρχείο Π.Χ.Π.

NAPROXEN- NAPROXEN TABLET
DIRECT_RX
----------
NAPROXEN
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 and
Precautions (5.1)].
•
Naproxen tablets and naproxen sodium tablets are contraindicated in
the setting of coronary artery
bypass graft (CABG) surgery [see Contraindications (4), Warnings and
Precautions (5.1)].
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 and Precautions (5.2)].
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
2.1 General Dosing Instructions
Carefully consider the potential benefits and risks of naproxen
tablets and naproxen sodium tablets and
other treatment options before deciding to use naproxen tablets and
naproxen sodium tablets. Use the
lowest effective dose for the shortest duration consistent with
individual patient treatment goals [see
Warnings and Precautions (5)].
After observing the response to initial therapy with naproxen tablets
or naproxen sodium tablets, the
dose and frequency should be adjusted to suit an individual
patient’s needs.
Naproxen-containing products such as naproxen and naproxen sodium
tablets, and other naproxen
products should not be used concomi