ETODOLAC tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

Northwind Pharmaceuticals, LLC

INN (국제 이름):

ETODOLAC

구성:

ETODOLAC 500 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

Carefully consider the potential benefits and risks of etodolac capsules and tablets, USP, and other treatment options before deciding to use etodolac capsules and tablets, USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac Capsules and Tablets, USP 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 Capsules and Tablets, USP are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac. Etodolac Capsules and Tablets, USP 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). Etodolac capsules and

승인 상태:

Abbreviated New Drug Application

제품 특성 요약

ETODOLAC- ETODOLAC TABLET
NORTHWIND PHARMACEUTICALS, LLC
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ETODOLAC
BOXED WARNING
CARDIOVASCULAR RISK
NSAIDs may cause an increased risk of serious cardiovascular
thrombotic events, myocardial
infarction (MI), and stroke, which can be fatal. This risk may
increase with duration of use.
Patients with cardiovascular disease or risk factors for
cardiovascular disease may be at greater
risk. (See WARNINGS).
Etodolac capsules USP, 200 mg and 300 mg, and Etodolac tablets USP,
400 mg and 500 mg are
contraindicated for the treatment of peri-operative pain in the
setting of coronary artery bypass
graft (CABG) surgery (See 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).
DESCRIPTION
Etodolac capsules and tablets, USP are members of the pyranocarboxylic
acid group of nonsteroidal
anti-inflammatory drugs (NSAIDs). Each tablet and 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 C17H21NO3.
Each Tablet, for oral administration, contains 400 mg or 500 mg of
Etodolac. In addition, each tablet
contains the following inactive ingredients: Hydroxypropyl
Methylcellulose USP, Lactose
Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF,
Polyethylene Glycol, Povidone
USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, ea