NAPROXEN DELAYED RELEASE- naproxen tablet, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvKARE, Inc.

INN (International Name):

NAPROXEN

Composition:

NAPROXEN 375 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Carefully consider the potential benefits and risks of Naproxen delayed-release tablets and other treatment options before deciding to use naproxen delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen delayed-release 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 delayed-release tablets are not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION). Naproxen delayed-release tablets are contraindicated in patients with known hypersensitivity to naproxen. Naproxen delayed-release

Product summary:

Naproxen Delayed-release Tablets USP: 375 mg: White Enteric coated, Capsule-shaped, biconvex tablets de-bossed with ‘I 1’ on one side, supplied in bottles of 100’s count (NDC 42291-629-01). Naproxen Delayed-release Tablets USP: 500 mg: White Enteric coated, Capsule-shaped, biconvex tablets de-bossed with ‘I 11’ on one side, supplied in bottles of 100’s count (NDC 42291-630-01). Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light­-resistant containers. Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 12/11         AV 10/13 (P)

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

AvKARE, Inc.
----------
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 other
and c

Summary of Product characteristics

NAPROXEN DELAYED RELEASE- NAPROXEN TABLET, DELAYED RELEASE
AVKARE, INC.
----------
NAPROXEN DELAYED-RELEASE 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 delayed-release 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 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 delayed-release tablets USP are available as enteric coated,
white tablets
containing 375 mg of naproxen and 500 mg of naproxen, USP for oral
administration.
The inactive ingredients are croscarmellose sodium, povidone,
colloidal silicon dioxide
14
14
3
and magnesium stearate. The enteric coating dispersion contains
methacrylic acid
copolymer dispersion, talc, titanium dioxide triethyl citrate and
purified water. The
dissolution of this enteric-coated naprox