NAPROXEN tablet EC-NAPROXEN- naproxen tablet, delayed release NAPROXEN SODIUM tablet NAPROXEN SODIUM DS- naproxen sodium tabl

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

naproxen (UNII: 57Y76R9ATQ) (naproxen - UNII:57Y76R9ATQ)

Available from:

Cameron Pharmaceuticals, LLC

INN (International Name):

naproxen

Composition:

naproxen 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of NAPROXEN, EC-NAPROXEN, ANAPROX, ANAPROX DS or NAPROXEN Suspension and other treatment options before deciding to use NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Naproxen as NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM or NAPROXEN SODIUM DS is 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 as NAPROXEN Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient’s weight. Naproxen as NAPROXEN, NAPROXEN SODIUM and NAPROXEN SODIUM DS is also indicated: - For relief of the

Product summary:

NAPROXEN Tablets: 250 mg: round, yellow, biconvex, engraved with NPR LE 250 on one side and scored on the other. Packaged in light-resistant bottles of 500. 500’s (bottle): NDC 42494-403-05. 375 mg: pink, biconvex oval, engraved with NPR LE 375 on one side. Packaged in light-resistant bottles of 500. 500’s (bottle): NDC 42494-404-05. 500 mg: yellow, capsule-shaped, engraved with NPR LE 500 on one side and scored on the other. Packaged in light-resistant bottles of 100 and 1000. 100’s (bottle): NDC 42494-405-01. 1000’s (bottle): NDC 42494-406-10. Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers. EC-NAPROXEN Delayed-Release Tablets: 375 mg: white, oval biconvex coated tablets imprinted with NPR EC 375 on one side. Packaged in light-resistant bottles of 100. 100’s (bottle): NDC 42494-407-01. 500 mg: white, oblong coated tablets imprinted with NPR EC 500 on one side. Packaged in light-resistant bottles of 100. 100’s (bottle): NDC 42494-408-01. Store at 15° to 30°C (59° to 86°F) in well-closed containers; dispense in light-resistant containers. NAPROXEN SODIUM Tablets: Naproxen sodium 275 mg: light blue, oval-shaped, engraved with NPS-275 on one side. Packaged in bottles of 100. 100’s (bottle): NDC 42494-402-01. Store at 15° to 30°C (59° to 86°F) in well-closed containers. NAPROXEN SODIUM DS Tablets: Naproxen sodium 550 mg: dark blue, oblong-shaped, engraved with NPS 550 on one side and scored on both sides. Packaged in bottles of 100 and 500. 100’s (bottle): NDC 42494-400-01. 500’s (bottle): NDC 42494-400-05. Store at 15° to 30°C (59° to 86°F) in well-closed containers. Manufactured for: Cameron Pharmaceuticals, LLC 1009 Twilight Trail, Suite 107 Frankfort, Kentucky 40601

Authorization status:

New Drug Application

Patient Information leaflet

NAPROXEN- NAPROXEN TABLET
EC-NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
NAPROXEN SODIUM DS- NAPROXEN SODIUM TABLET
Cameron Pharmaceuticals, LLC
----------
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal 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:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called "corticosteroids", "anticoagulants", "SSRIs",
or "SNRIs"
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
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

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET
EC-NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
NAPROXEN SODIUM- NAPROXEN SODIUM TABLET
NAPROXEN SODIUM DS- NAPROXEN SODIUM TABLET
CAMERON PHARMACEUTICALS, LLC
----------
NAPROXEN
R ONLY
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL
EVENTS
CARDIOVASCULAR THROMBOTIC EVENTS
• Nonsteroidal anti-inflammatory drugs (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 (see WARNINGS).
• NAPROXEN, EC-NAPROXEN, NAPROXEN SODIUM and/ NAPROXEN SODIUM DS are
contraindicated for the treatment of peri-operative pain 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 is a proprionic acid derivative related to the arylacetic
acid group of nonsteroidal anti-
inflammatory drugs.
The chemical names for naproxen and naproxen sodium are
(S)-6-methoxy-α-methyl-2-
naphthaleneacetic acid and (S)-6-methoxy-α-methyl-2-naphthaleneacetic
acid, sodium salt, respectively.
Naproxen and naproxen sodium have the following structures,
respectively:
Naproxen has a molecular weight of 230.26 and a molecular formula of C
H O . Naproxen sodium
has a molecular weight of 252.23 and a molecular formula of C
H NaO .
Naproxen 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. Naproxe