THERAPROXEN-90- naproxen, .gamma.-aminobutyric acid kit

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

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Κατεβάστε Αρχείο Π.Χ.Π. (SPC)
01-08-2011

Δραστική ουσία:

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

Διαθέσιμο από:

Physician Therapeutics LLC

INN (Διεθνής Όνομα):

NAPROXEN

Σύνθεση:

NAPROXEN 250 mg

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Naproxen Tablets, USP and other treatment options before deciding to use Naproxen Tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Naproxen as Naproxen Tablets, USP 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 For relief of the signs and symptoms of tendonitis For relief of the signs and symptoms of bursitis For relief of the signs and symptoms of acute gout For the management of pain For the management of primary dysmenorrhea CONTRAINDICATIONS Naproxen Tablets, USP are contraindicated in patients with known hypersensitivity to naproxen. Naproxen Tablets, USP should not be given to patients who have experienced asth

Περίληψη προϊόντος:

How Supplied Theramine is supplied in purple and white, size 0 capsules in bottles of 60 or 90 capsules. Physician Supervision Theramine is a Medical Food product available by prescription only and must be used while the patient is under ongoing physician supervision. U.S. patent pending. Manufactured by Arizona Nutritional Supplements, Inc. Chandler AZ 85225 Distributed by Physician Therapeutics LLC, Los Angeles, CA 90077. www.ptlcentral.com Copyright 2003-2006, Physician Therapeutics LLC, all rights reserved   NDC: 68405-1008-03

Καθεστώς αδειοδότησης:

unapproved drug other

Αρχείο Π.Χ.Π.

                                THERAPROXEN-90 - NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID
PHYSICIAN THERAPEUTICS LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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THERAPROXEN-90
DESCRIPTION Naproxen is a proprionic acid derivative related to the
arylacetic acid group of
nonsteroidal anti-inflammatory drugs. The chemical name for naproxen
is (S)-6-methoxy-α-methyl-2-
naphthaleneacetic acid. Naproxen has the following structure:
Naproxen has a molecular weight of 230.26 and a molecular formula of
C14H14O3. 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. Naproxen Tablets, USP are available as white
tablets containing 250 mg of
naproxen, white tablets containing 375 mg of naproxen and white
tablets containing 500 mg of naproxen
for oral administration. The inactive ingredients are Croscarmellose
Sodium, Povidone and Magnesium
Stearate.
Pharmacodynamics Naproxen is a nonsteroidal anti-inflammatory drug
(NSAID) with analgesic and
antipyretic properties. The mechanism of action of the naproxen anion,
like that of other NSAIDs, is not
completely understood but may be related to prostaglandin synthetase
inhibition.
Pharmacokinetics Naproxen is rapidly and completely absorbed from the
gastrointestinal tract with an in
vivo bioavailability of 95%. The different dosage forms of naproxen
are bioequivalent in terms of
extent of absorption (AUC) and peak concentration (Cmax); however, the
products do differ in their
pattern of absorption. These differences between naproxen products are
related to both the chemical
form of naproxen used and its formulation. Even with the observed
differences in pattern of absorption,
the elimination half-life of naproxen is unchanged across products
ranging from 12 to 17 hours. Steady-
st
                                
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