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Lodine (ETODOLAC)
Lodine (ETODOLAC) is a nonsteroidal anti-inflammatory drug (NSAID) developed by WYETH PHARMS INC, targeting prostaglandin G/H synthase 2. It is a small molecule modality, FDA-approved in 1991 for treating juvenile rheumatoid arthritis, osteoarthritis, pain, and rheumatoid arthritis. Lodine is now off-patent with 25 generic manufacturers, offering a commercial alternative. Key safety considerations include its potential to cause gastrointestinal issues and renal impairment. As an NSAID, Lodine works by inhibiting the enzyme responsible for producing prostaglandins, which are mediators of inflammation and pain.
At a glance
| Generic name | ETODOLAC |
|---|---|
| Sponsor | Pfizer |
| Drug class | Nonsteroidal Anti-inflammatory Drug [EPC] |
| Target | Prostaglandin G/H synthase 2 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1991 |
Approved indications
- Juvenile rheumatoid arthritis
- Osteoarthritis
- Pain
- Rheumatoid arthritis
Boxed warnings
- 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 tablets, 400 mg and 500 mg 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 ).
Common side effects
- Dyspepsia
- GI ulcers (gastric/duodenal)
- Abdominal pain
- Diarrhea
- Flatulence
- Nausea
- Constipation
- Gastrointestinal bleeding/perforation
- Heartburn
- Vomiting
- Abnormal renal function
- Anemia
Drug interactions
- lithium
- methotrexate
- phenprocoumon
- rofecoxib
- warfarin
Key clinical trials
- Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis (NA)
- Etodolac Nanogel as an Adjunct to Physiotherapy for Knee Osteoarthritis (PHASE2)
- Inhibiting Beta-adrenergic and COX-2 Signaling During the Perioperative Period to Reduce Ovarian Cancer Progression (PHASE2)
- A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE) (NA)
- Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction (PHASE3)
- Lornoxicam Versus Etodolac After Third Molar Surgery (PHASE4)
- Evaluation of the Effects of Treatments Applied to Patients With Facial Myalgia on Occlusion Parameters (NA)
- Magnesium Oral Supplementation for Acute Non-specific Low Back Pain (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |