Nudroxipak E-400
Generic name: etodolac,methyl salicylate/menthol/capsaicin
Dosage form: kit
On This Page
- Boxed Warning
- Description
- Clinical Pharmacology
- Use In Specific Populations
- Clinical Studies
- Indications and Usage
- Contraindications
- Warnings
- Precautions
- Patient Counseling Information
- Drug Interactions
- Adverse Reactions/Side Effects
- Overdosage
- Dosage and Administration
- How Supplied/Storage and Handling
- Medication Guide
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 is 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 a greater risk for serious gastrointestinal (GI) events (see WARNINGS).
DESCRIPTION
Etodolac is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). 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 C 17H 21NO 3, and it has the following structural formula:
Each etodolac tablet, USP is for oral administration, contains 400 mg or 500 mg of etodolac. In a...
