ETODOLAC capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Proficient Rx LP

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac capsules are indicated:             1. Osteoarthritis             2. Rheumatoid arthritis Etodolac capsules are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. Etodolac capsules 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, Preexisting Asthma ). Etodolac capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).

ملخص المنتج:

Etodolac Capsules USP, are available as follows: 200 mg: hard gelatin capsules with an opaque pale red body and an opaque dark red cap, imprinted with “ANI” on the cap and “250” on the body in gray ink; available in bottles of 20 (NDC 71205-743-20), 30 (NDC 71205-743-30), 60 (NDC 71205-743-60), and 90 (NDC 71205-743-90). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature], protected from moisture. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep container tightly closed. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 9687 Rev 03/21

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

ETODOLAC- ETODOLAC CAPSULE
Proficient Rx LP
----------
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 a heart attack or stroke that can lead to death.
This risk may happen early in treatment
and may increase:
o
with increasing doses of NSAIDs
o
with longer use of NSAIDs
Do not take NSAIDs right before or after a 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.
1.
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
o
anytime during use
o
without warning symptoms
o
that may cause death
The risk of getting an ulcer or bleeding increases with:
o
past history of stomach ulcers, or stomach or intestinal bleeding with
use of NSAIDs
o
taking medicines called “corticosteroids”, “anticoagulants”,
“SSRIs”, or “SNRIs”
o
increasing doses of NSAIDs
o
longer use of NSAIDs
o
smoking
o
drinking alcohol
o
older age
o
poor health
o
advanced liver disease
o
bleeding problems
NSAIDs should only be used:
o
exactly as prescribed
o
at the lowest dose possible for your treatment
o
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 have 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 healthcare provider about all of your
medical conditions, includ

خصائص المنتج

ETODOLAC- ETODOLAC CAPSULE
PROFICIENT RX LP
----------
ETODOLAC CAPSULES USP
RX ONLY
CARDIOVASCULAR THROMBOTIC EVENTS
•
•
GASTROINTESTINAL RISK
•
Throughout this package insert, the term NSAID refers to a non-aspirin
nonsteroidal anti-inflammatory drug.
DESCRIPTION
Etodolac is a member of the pyranocarboxylic acid group of
nonsteroidal anti-
inflammatory drugs (NSAIDs). Each capsule contains etodolac for oral
administration.
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:
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).
1
Etodolac capsules 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).
1
17
21
3
Each capsule, for oral administration, contains 200 mg etodolac USP.
The inactive
ingredients in Etodolac Capsules USP include: lactose monohydrate,
povidone, sodium
starch glycolate, sodium lauryl sulfate, propylene glycol, colloidal
silicon dioxide,
magnesium stearate, talc, titanium dioxide, gelatin, D&C Red No. 28,
D&