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:

NuCare Pharmaceuticals,Inc.

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 dosage for the shortest duration consistent with individual patient treatment goals ( see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). 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, DOSAGE AND ADMINISTRATION). Naproxen de

Product summary:

Naproxen Delayed-release Tablets, USP: 500 mg: White Enteric coated, Capsule-shaped, biconvex tablets de-bossed with ' I 11 ' on one side. NDC 66267-373-20 Bottles of 20 NDC 66267-373-30 Bottles of 30 NDC 66267-373-60 Bottles of 60 Store at 20° to 25°C (68° to 77°F); [See USP Controlled Room Temperature]. Dispense in tight, light-resistant containers. *All brand names mentioned are registered trademark of their respective owners and are not of Cipla Limited. Revised: 07/2016

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
NuCare Pharmaceuticals,Inc.
----------
Symptoms following acute NSAID overdosages have been typically limited
to lethargy, drowsiness,
nausea, vomiting, and epigastric pain, which have been generally
reversible with supportive care.
Gastrointestinal bleeding has occurred. Hypertension, acute renal
failure, respiratory depression, and
coma have occurred, but were rare. Because naproxen sodium may be
rapidly absorbed, high and early
blood levels should be anticipated. A few patients have experienced
convulsions, but it is not clear
whether or not these were drug-related. It is not known what dose of
the drug would be life threatening.
(see WARNINGS; Cardiovascular Thrombotic Events, Gastrointestinal
Bleeding, Ulceration, and
Perforation, Hypertension, Renal Toxicity and Hyperkalemia).
Manage patients with symptomatic and supportive care following an
NSAID overdosage. There are no
specific antidotes. Hemodialysis does not decrease the plasma
concentration of naproxen because of the
high degree of its protein binding. Consider emesis and/or activated
charcoal (60 to 100 g in adults, 1 to 2
g/kg of body weight in pediatric patients) and/or osmotic cathartic in
symptomatic patients seen within
four hours of ingestion or in patients with a large overdosage (5 to
10 times the recommended dosage).
Forced diuresis, alkalinization of urine, hemodialysis, or
hemoperfusion may not be useful due to high
protein binding.
For additional information about overdosage treatment contact a poison
control center (1-800-222-1222).
Close
DOSAGE AND ADMINISTRATION
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 ...
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 individua

Summary of Product characteristics

NAPROXEN- NAPROXEN TABLET, DELAYED RELEASE
NUCARE PHARMACEUTICALS,INC.
----------
NAPROXEN DELAYED-RELEASE TABLETS USP, 375 MG AND 500 MG
RX ONLY
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)._
NAPROXEN DELAYED-RELEASE TABLETS ARE CONTRAINDICATED 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, USP is a propionic 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 and
magnesium stearate. The enteric
coating dispersion c