ETODOLAC- etodolac capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Aphena Pharma Solutions - Tennessee, LLC

Designación común internacional (DCI):

ETODOLAC

Composición:

ETODOLAC 300 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Carefully consider the potential benefits and risks of etodolac and other treatment options before deciding to use etodolac.  Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: - Osteoarthritis - Rheumatoid arthritis • For the management of acute pain Etodolac is contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. 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 )

Resumen del producto:

Etodolac Capsules, USP are available as: 200 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap.  “APO 039” is imprinted on each capsules in black ink) - in bottles of 100, NDC 42291-404-01 300 mg capsules (Hard gelatin capsules with a white opaque body and a light gray cap.  “APO 040” is imprinted on each capsules in black ink) - in bottles of 100, NDC 42291-405-01 Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Protect from moisture. Dispense in tight, light-resistant container [see USP].                                           Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Mfg. Rev. 07/16 AV 01/17 (P)                   

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

ETODOLAC - ETODOLAC CAPSULE
Aphena Pharma Solutions - Tennessee, LLC
----------
MEDICATION GUIDE
for
Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is the most important information I should know about medicines
called Nonsteroidal Anti-
inflammatory Drugs (NSAIDs)?
NSAIDs can cause serious side effects, including:
•
Increased risk of heart attack or stroke that can lead to death. This
risk may happen early in
treatment and may increase:
•
with increasing doses of NSAIDs
•
with longer use of NSAIDs
Do not take NSAIDs right before or after heart surgery called a
“coronary artery bypass graft (CABG)”.
Avoid taking NSAIDs after a recent heart attack, unless your
healthcare provider tells you to. You may
have an increased risk of another heart attack if you take NSAIDs
after a recent heart attack.
•
Increased risk of bleeding, ulcers and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
•
at anytime during use
•
without warning symptoms
•
that may cause death
The risk of getting an ulcer or bleeding increases with:
•
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
•
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
•
increasing doses of NSAIDs
•
longer use of NSAIDs
•
smoking
•
drinking alcohol
•
older age
•
poor health
•
advanced liver disease
•
bleeding problems
NSAIDs should only be used:
•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed
What are NSAIDs?
NSAIDs 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 NSAIDs?
Do not take NSAIDs:
•
if you had an asthma attack, hives, or other allergic reaction with
aspirin or any other NSAIDs.
•
right before or after heart bypass surgery.
Before taking NSAIDs, tell your healthc

Ficha técnica

ETODOLAC - ETODOLAC CAPSULE
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
ETODOLAC CAPSULES, USP
200 AND 300 MG
RX ONLY
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 and PRECAUTIONS).
Etodolac is contraindicated in the setting of coronary artery bypass
graft (CABG) surgery
(see CONTRAINDICATIONS and 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 a greater
risk for serious gastrointestinal (GI) events (see WARNINGS).
DESCRIPTION
Etodolac is a member of the pyranocarboxylic acid group of
nonsteroidal anti-inflammatory drugs
(NSAIDs). Etodolac is a racemic mixture of [+]S and [-]R-enantiomers.
Etodolac 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 etodolac capsule, USP is for oral administration, contains 200 mg
or 300 mg of etodolac. In
addition, each capsule contains the following inactive ingredients:
black iron oxide, black SW-
9008/SW-9009, colloidal silicon dioxide, croscarmellose sodium,
gelatin, lactose monohydrate,
sodium lauryl sulfate, stearic acid, talc and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
17
21
3
Etodolac is a nonsteroidal anti-inflammatory drug (NSAID) that
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