Etodolac ER 600 mg/1
Etodolac · TABLET, EXTENDED RELEASE · Advanced Rx Pharmacy of Tennessee, LLC
Etodolac ER is a prescription nonsteroidal anti-inflammatory drug (NSAID) taken by mouth to reduce pain and inflammation. It is an extended-release tablet that works by decreasing substances in the body that cause pain and swelling.
Key Facts
- Brand Name
- Etodolac ER
- Generic Name
- Etodolac
- NDC Code (Product)
80425-0126- Manufacturer
- Advanced Rx Pharmacy of Tennessee, LLC
- Strength
- 600 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA076174
- Drug Class
- Nonsteroidal Anti-inflammatory Drug [EPC]
- Marketing Start
- 03/13/2003
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
Indications and Usage Section INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated: * For relief of signs and symptoms of juvenile arthritis * For relief of the signs and symptoms of rheumatoid arthritis * For relief of the signs and symptoms of osteoarthritis
Dosage & Administration
Dosage and Administration Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with etodolac extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Juvenile Rheumatoid Arthritis For the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 6 to 16 years of age, the recommended dose given orally once per day should be based on body weight, according to the following table: Body Weight Range (kg) Dose 20 to 30 400 mg Tablet × 1 31 to 45 600 mg Tablet × 1 46 to 60 400 mg Tablet × 2 >60 500 mg Tablet × 2 Rheumatoid Arthritis and Osteoarthritis For the relief of the signs and symptoms of osteoarthritis or rheumatoid arthritis, the recommended starting dose of etodolac extended-release tablets is 400 to 1000 mg given orally once per day. As with other NSAIDs, the lowest effective dose should be sought for each patient. In chr…
Warnings
Warnings Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the devel…
Contraindications
Contraindications Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. Etodolac extended-release tablets should not be given to patients who have experienced asthma, urticaria, or 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 extended-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
Adverse Reactions
Adverse Reactions A total of 1552 patients were exposed to etodolac extended-release tablets in controlled clinical studies of at least 4 weeks in length and using daily doses in the range of 400 to 1200 mg. In the tabulations below, adverse event rates are generally categorized based on the incidence of events in the first 30 days of treatment with etodolac extended-release tablets. As with other NSAIDs, the cumulative adverse event rates may increase significantly over time with extended therapy. In patients taking NSAIDs, including etodolac extended-release tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: gastrointestinal experiences including: abdominal pain constipation diarrhea dyspepsia flatulence GI ulcers (gastric/duodenal)* gross bleeding/perforation * nausea vomiting other events including: abnormal renal function* anemia* asthenia dizziness edema* elevated liver enzymes* headaches hypertension increased bleeding time* infection pharyngitis pruritus rashes rhinitis tinnitus* *Adverse events that were observed in < 1% of patients in the first 30 days of treatment with etodolac extended-release tablets in clinic…
Frequently Asked Questions
What is Etodolac ER used for?
Etodolac ER is a prescription nonsteroidal anti-inflammatory drug (NSAID) taken by mouth to reduce pain and inflammation. It is an extended-release tablet that works by decreasing substances in the body that cause pain and swelling.
Is Etodolac ER a controlled substance?
Etodolac ER is not classified as a controlled substance by the DEA.
What is the generic name for Etodolac ER?
The generic name for Etodolac ER is Etodolac. There are 12 other brand versions of Etodolac.
What is the NDC code for Etodolac ER 600 mg/1?
The NDC (National Drug Code) for Etodolac ER 600 mg/1 is 80425-0126, listed by Advanced Rx Pharmacy of Tennessee, LLC.