NAPROXEN tablet, delayed release

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

NAPROXEN

Composición:

NAPROXEN 500 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 ). All naproxen products are contraindicated in patients with known hypersensitivity to naproxen. All naproxen products should not be given to patients w

Resumen del producto:

Naproxen delayed-release tablets are available as follows: 500 mg tablet: White, round, unscored, imprinted with “G-NP-500” on one side, in light-resistant bottles of 100 and 1000. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Manufactured by: ALPHAPHARM PTY. LTD. 15 Garnet Street Carole Park Qld 4300 Australia PM No: 507/6 Revised April 2007 Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, OK       74146

Estat d'Autorització:

Abbreviated New Drug Application

Informació per a l'usuari

Physicians Total Care, Inc.
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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 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 to
show to your healthcare
provider and pharmacist.
•
if you are pregnant. NSAID medicines

Fitxa tècnica

NAPROXEN - NAPROXEN TABLET, DELAYED RELEASE
PHYSICIANS TOTAL CARE, INC.
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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
maybe at greater risk (see
WARNINGS).
Naproxen is 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 is a member of the arylacetic acid group of nonsteroidal
anti-inflammatory drugs. The
chemical name for naproxen is
(+)-6-Methoxy-a-methyl-2-naphthaleneacetic acid. Naproxen has the
following structural formula.
Molecular Formula: C
H O
Molecular Weight: 230.26
Naproxen is practically odourless, 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 are enteric-coated tablets containing
375 mg or 500 mg of naproxen
and croscarmellose sodium, povidone and magnesium stearate. The
enteric coating dispersion contains
sodium hydroxide, methacrylic acid copolymer, talc, polyethylene
glycol, titanium dioxide, simethicone
emulsion and purified water. The dissolution of this enteric-coated
naproxen tablet is pH dependent
with rapid dissolution above pH 6. There is no dissolution below pH 4.
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CLINICAL PHARMACOLOGY
Pharmacodynamics
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with
analgesic