ETODOLAC capsule, gelatin coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

Etodolac (UNII: 2M36281008) (Etodolac - UNII:2M36281008)

Disponible depuis:

Rebel Distributors Corp

DCI (Dénomination commune internationale):

Etodolac

Composition:

Etodolac 300 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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: - For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis - Osteoarthritis - Rheumatoid arthritis - For the management of acute pain Etodolac capsules are contraindicated in patients with known hypersensitivity to etodolac. 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 for the treatment of peri-operative pain in the setting of

Descriptif du produit:

Etodolac capsules USP, 300 mg are available as opaque, dark red body and cap, size # 0 hard gelatin capsules, with radial imprint using gray ink, N 397 / 300 on cap portion and three narrow bands on body portion of capsules. 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.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

ETODOLAC- ETODOLAC CAPSULE, GELATIN COATED
REBEL DISTRIBUTORS CORP
----------
ETODOLAC CAPSULES USP
8397
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 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 the use and without warning symptoms. Elderly
patients are at greater
risk for serious gastrointestinal (GI) events (see WARNINGS).
DESCRIPTION
Etodolac is a member of the pyranocarboxylic acid group of
non-steroidal 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.
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 capsules USP include: colloidal
silicon dioxide, D&C Red #28,
D&C Red #33, D&C Yellow #10, FD&C Red #40, FD&C Blue #1, gelatin,
lactose monohydrate,
magnesium stearate, polyethylene glycol, povidone, silicon dioxide,
sodium lauryl sulfate, sodium
starch glycolate, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
Etodolac is a non-steroidal anti-inflammatory drug (NSAID) that
exhibits anti-inflammatory, analgesic,