LODINE � etodolac capsule, gelatin coated
bryant ranch prepack
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.
The inactive ingredients in etodolac capsules USP include: colloidal silicon dioxide, D and C Red #28, D and C Red #33, D and C Yellow #10, FD and C Red #40, FD and 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, and antipyretic activities in animal models. The mechanism of action of etodolac, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition.
Etodolac is a racemic mixture of [-]R- and [+]S-etodolac. As with other NSAIDs, it has been demonstrated in animals that the [+]S-form is biologically active. Both enantiomers are stable and there is no [-]R to [+]S conversion in vivo.
INDICATIONS And USAGE
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
For the management of acute pain
CONTRAINDICATIONS
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 coronary artery bypass graft (CABG) surgery (see WARNINGS).
