NAPRELAN- naproxen sodium tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX USA

INN (International Name):

NAPROXEN SODIUM

Composition:

NAPROXEN SODIUM 750 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of NAPRELAN® Tablets and other treatment options before deciding to use NAPRELAN® Tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea. NAPRELAN® is contraindicated in patients with known hypersensitivity to naproxen. NAPRELAN® should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS- Anaphylactoid Reactions , and PRECAUTIONS- Preexisting Asthma ). NAPRELAN® is contraindicated for the treatment of peri-operative pain in the setting of cor

Product summary:

NAPRELAN® (naproxen sodium) Controlled-Release Tablets are available as follows: Rx Only US Patent 5,637,320 Store at controlled room temperature, 20° - 25° C (68° - 77° F). Dispense in a well-closed container. ______________________________________________________________ * Registered Trademark of Elan Corporation plc ** Registered Trademark of Elan Pharma Int. Ltd. *** Naprosyn ® is a registered trademark of Syntex Puerto Rico, Inc. Manufactured for: Victory Pharma, Inc., San Diego, CA 92130 Manufactured by: Elan Pharma International Ltd., Athlone, Ireland PI3750107 Rev 8/09

Authorization status:

New Drug Application

Patient Information leaflet

STAT RX USA
----------
Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID
medicines.)
NAPRELAN®
(naproxen sodium)
CONTROLLED-RELEASE TABLETS
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
“anti-coagulants”
•
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 your medical conditions
•
about all of the medicines you take. NSAIDs and some other medicines
can interact with each
other and cause serious side effects. Keep a list of your medicines

Summary of Product characteristics

NAPRELAN - NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE
STAT RX USA
----------
NAPRELAN (NAPROXEN SODIUM)
_CONTROLLED-RELEASE TABLETS_
Equivalent to 375mg, 500mg and 750mg naproxen
NAPRELAN Controlled-Release Tablets, 375mg, 500mg and 750mg
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 AS NAPRELAN IS CONTRAINDICATED FOR THE TREATMENT OF
PERI-OPERATIVE PAIN IN
THE SETTING OF CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY
(SEEWARNINGS).
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
PEOPLE ARE AT GREATER RISK FOR SEROUS GASTROINTESTINAL EVENTS.
(SEEWARNINGS).
DESCRIPTION
NAPRELAN
Tablets contain naproxen sodium, a member of the arylacetic acid group
of
nonsteroidal anti-inflammatory drugs (NSAIDs). NAPRELAN Tablets use
the proprietary IPDAS
(Intestinal Protective Drug Absorption System) technology. It is a
rapidly disintegrating tablet system
combining an immediate release component and a sustained release
component of microparticles that are
widely dispersed, allowing absorption of the active ingredient
throughout the gastrointestinal (GI) tract,
maintaining blood levels over 24 hours. The chemical name for naproxen
sodium is 2-naphthaleneacetic
acid, 6-methoxy-a-methyl-sodium salt, (S)- with the following
structural formula:
Naproxen sodium is an odorless crystalline powder, white to creamy in
color. It is soluble in methanol
and water. NAPRELAN Tablets contain 412.5 mg, 550 mg, or 825 mg of
naproxen sodium, equivalent
to 375 mg, 500 mg, and 750 mg of naproxen and 37.5, mg 50 mg, and 75
mg sodium respec