ETODOLAC tablet, film coated, extended release

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Zydus Pharmaceuticals USA Inc.

INN (Kansainvälinen yleisnimi):

ETODOLAC

Koostumus:

ETODOLAC 400 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated: *    For relief of signs and symptoms of juvenile arthritis *    For relief of the signs and symptoms of rheumatoid arthritis *    For relief of the signs and symptoms of osteoarthritis Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. Etodolac extended-release tablets should not be given to patients who have experienced asthma, urticaria, or 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 extended-release tablets are

Tuoteyhteenveto:

Etodolac Extended-Release Tablets USP, 400 mg are orange-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "271" on one side and plain on other side and are supplied as follows: NDC 68382-271-14 in bottles of 60 tablets with child–resistant closures NDC 68382-271-01 in bottles of 100 tablets NDC 68382-271-05 in bottles of 500 tablets NDC 68382-271-10 in bottles of 1,000 tablets NDC 68382-271-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Etodolac Extended-Release Tablets USP, 500 mg are grey-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "272" on one side and plain on other side and are supplied as follows: NDC 68382-272-14 in bottles of 60 tablets with child–resistant closures NDC 68382-272-01 in bottles of 100 tablets NDC 68382-272-05 in bottles of 500 tablets NDC 68382-272-10 in bottles of 1,000 tablets NDC 68382-272-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Etodolac Extended-Release Tablets USP, 600 mg are blue-colored, oval-shaped, beveled edged, film-coated tablets debossed with "273" on one side and plain on other side and are supplied as follows: NDC 68382-273-14 in bottles of 60 tablets with child–resistant closures NDC 68382-273-01 in bottles of 100 tablets NDC 68382-273-05 in bottles of 500 tablets NDC 68382-273-10 in bottles of 1,000 tablets NDC 68382-273-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat and humidity. Dispense in a tight, light-resistant container with a child-resistant closure. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.

Valtuutuksen tilan:

Abbreviated New Drug Application

Pakkausseloste

Zydus Pharmaceuticals USA Inc.
----------
Medication Guide
For Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
Etodolac (ee" toe doe ' lak)
Extended-Release Tablets, USP
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:
○ with increasing doses of NSAIDs
○ 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.
•
Increased risk of bleeding, ulcers, and tears (perforation) of the
esophagus (tube leading from the
mouth to the stomach), stomach and intestines:
○ 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 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

Valmisteyhteenveto

ETODOLAC - ETODOLAC TABLET, FILM COATED, EXTENDED RELEASE
ZYDUS PHARMACEUTICALS USA INC.
----------
ETODOLAC EXTENDED-RELEASE TABLETS, USP
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 EXTENDED-RELEASE TABLETS ARE 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 (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
ARE AT GREATER RISK FOR SERIOUS GASTROINTESTINAL EVENTS [_SEE
WARNINGS_
].
DESCRIPTION
Etodolac extended-release tablets, USP contain etodolac, which is a
member of the
pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs
(NSAIDs). Each
tablet contains etodolac for oral administration. Etodolac is a
racemic mixture of [+]S
and [-]R-enantiomers. Etodolac, USP is a white to off-white
crystalline powder, 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. It has the following structural formula:
C
H
NO M.W. 287.36
Each etodolac extended-release tablet, USP intended for oral
administration contains
400 mg or 500 mg or 600 mg of etodolac. In addition, each tablet
contains the following
inactive ingredients: disodium hydrogen phosphate, ethylcellulose,
hypromellose, lactose
monohydrate, magnesium stearate, polyethylene glycol, talc, titanium
dioxide and
triacetin. Additionally each 400 mg tablet contains: D&C yellow # 10
aluminum lake,
FD&C Red # 40 aluminum