ETODOLAC- etodolac tablet, coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)

Disponibil de la:

Preferred Pharmaceuticals, Inc.

INN (nume internaţional):

ETODOLAC

Compoziție:

ETODOLAC 500 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Carefully consider the potential benefits and risks of etodolac tablets USP, and other treatment options before deciding to use etodolac tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets USP are indicated: Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac. Etodolac should not be given to patients who have experienced asthma, urticaria or other 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 , Pre-existing Asthma). In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

Rezumat produs:

Etodolac Tablets USP, for oral administration, are available as: 500 mg : White, oval, unscored, film-coated tablets, debossed “E 139” on one side and plain on the other side and supplied as: Bottle of 20 - 68788-9990-2 Bottle of 30 - 68788-9990-3 Bottle of 60 - 68788-9990-6 Bottle of 90 - 68788-9990-9 Bottle of 100 - 68788-9990-1 Bottle of 120 - 68788-9990-8 Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. Store tablets in original container until ready to use. Dispense in light-resistant container. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

ETODOLAC TABLETS USP

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ETODOLAC-
etodolac tablet, coated  Preferred
Pharmaceuticals, Inc.
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Medication Guide
For Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs)
What is the most important information
I should know about medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects,
including:

with increasing doses of NSAIDs

coronary artery bypass graft (CABG).

Increased risk of bleeding, ulcers, and
tears (perforation) of the esophagus (tube leading from the mouth
to the stomach), stomach and intestines:

without warning symptoms

past history of stomach ulcers, or stomach or intestinal
bleeding with use of NSAIDs

corticosteroidsanticoagulantsSSRIsSNRIs

increasing doses of NSAIDs

Citiți documentul complet

Caracteristicilor produsului

ETODOLAC- ETODOLAC TABLET, COATED
PREFERRED PHARMACEUTICALS, INC.
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ETODOLAC TABLETS USP
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
DESCRIPTION
Etodolac tablets USP are a member of the pyranocarboxylic acid group
of nonsteroidal anti-
inflammatory drugs (NSAIDs). Each tablet contains etodolac USP for
oral administration. Etodolac USP
is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac USP is a
white crystalline compound,
insoluble in water but soluble in alcohols, chloroform, dimethyl
sulfoxide, and aqueous polyethylene
glycol.
The chemical name is (±)
1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The
molecular weight of the base is 287.37. It has a pKa of 4.65 and an
n-octanol:water partition coefficient
of 11.4 at pH 7.4. The molecular formula for etodolac is C
H NO and it has the following structural
formula:
Each tablet, for oral administration contains 400 mg and 500 mg of
etodolac USP. In addition, each
tablet contains the following inactive ingredients: lactose
monohydrate, magnesium stearate,
microcrystalline cellulose, polyethylene glycol, povidone, sodium
starch glycolate (potato), talc and
titanium dioxide.
CLINICAL PHARMACOLOGY
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
WARNINGSandPRECAUTIONS).
Etodolac tablets are contraindicated in the setting of coronary artery
bypass graft (CABG)
surgery (see CONTRAINDICATIONS and WARNINGS).
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 (GI) events (see
WARNINGS).
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21
3
PHARMACODYNAMICS
Etodolac is a nonsteroidal anti-inflam