ETODOLAC- etodolac tablet, film coated
Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
Navodilo za uporabo
(PIL)
21-05-2018
Lastnosti izdelka
(SPC)
21-05-2018
Aktivna sestavina:
ETODOLAC (UNII: 2M36281008) (ETODOLAC - UNII:2M36281008)
Dostopno od:
Preferred Pharmaceuticals, Inc.
INN (mednarodno ime):
ETODOLAC
Sestava:
ETODOLAC 400 mg
Pot uporabe:
ORAL
Tip zastaranja:
PRESCRIPTION DRUG
Terapevtske indikacije:
Carefully consider the potential benefits and risks of etodolac tablets and other treatment options before deciding to use etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac tablets are indicated: Etodolac tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac tablets. Etodolac tablets 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 tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
Povzetek izdelek:
Etodolac tablets USP, 400 mg are available as pink, capsule-shaped, film-coated tablets debossed “93” on one side and “892” on the other side. Bottle of 20 - 68788-9928-2 Bottle of 30 - 68788-9928-3 Bottle of 60 - 68788-9928-6 Bottle of 90 - 68788-9928-9 Bottle of 100 - 68788-9928-1 Bottle of 120 - 68788-9928-8 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454 Rev. M 7/2015 Repackaged by Preferred Pharmaceuticals, Inc.
Status dovoljenje:
Abbreviated New Drug Application
Navodilo za uporabo
ETODOLAC TABLETS USP
0892
1893
Rx only
ETODOLAC-
etodolac tablet, film coated
Preferred
Pharmaceuticals, Inc.
----------
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:
-
-
with increasing doses of NSAIDs
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Lastnosti izdelka
ETODOLAC- ETODOLAC TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
----------
ETODOLAC TABLETS USP
0892
1893
RX ONLY
1.
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).
•
•
DESCRIPTION
Etodolac 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 is a white or almost 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 a pKa
of 4.65 and an n-octanol:water partition coefficient of 11.4 at pH
7.4. It has the following structural
formula:
C
H NO M.W. 287.37
The inactive ingredients in etodolac tablets include: colloidal
silicon dioxide, hypromellose, lactose
monohydrate, magnesium stearate, microcrystalline cellulose,
polyethylene glycol, polysorbate 80,
povidone, sodium starch glycolate, titanium dioxide, FD&C Red No. 40,
and FD&C Blue No. 2. The
400 mg tablet also contains D&C Yellow No. 10.
CARDIOVASCULAR THROMBOTIC EVENTS
Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk
of serious
Etodolac 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 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).
17
21
3
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) that
exhib
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