Etodolac 600 mg Tablet, Film Coated, Extended Release
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Nonsteroidal Anti-inflammatory Drug class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Etodolac is used to treat the pain and inflammation of osteoarthritis and rheumatoid arthritis. The capsule and tablet forms are also approved for short-term acute pain. The extend...
- You can take etodolac with or without food — food doesn't significantly change the total amount your body absorbs. That said, if etodolac irritates your stomach, taking it with foo...
- The most common side effects are stomach-related — nausea, heartburn, diarrhea, or abdominal discomfort — along with dizziness, headache, and ringing in the ears. Most are mild. Th...
- What side effects should I actually watch out for?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Etodolac — tap one for details:
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 47MLB0F1MV
Ethylcellulose is a plant-based thickening agent made from cellulose. It slows how fast the medicine dissolves, helping control drug release in the stomach and intestines.
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UNII L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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UNII 1K09F3G675
Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII XHX3C3X673
Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.44 | $143.98 / 100 tablet |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Etodolac 600 mg 00093-1118-01 | Teva | 100 tablets | $1.126 | AB | Availability likely | — |
| Etodolac 600 mg 16714-0499-01 | NORTHSTAR | 60 tablets | $1.126 | AB | Availability likely | — |
| Etodolac 600 mg 51672-4053-01 | TaSun | 100 tablets | $1.126 | AB | Availability likely | — |
| Etodolac 600 mg 63629-8598-01 | Bryant | 30 tablets | — | AB | FDA listed | — |
| Etodolac 600 mg 65841-0779-01 | Zydus | 100 tablets | — | AB | FDA listed | — |
| Etodolac 600 mgthis 68382-0273-77 | Zydus | 1 tablet | — | AB | FDA listed | — |
| Etodolac ER 600 mg 80425-0126-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Etodolac ER 600 mg 80425-0181-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
| Etodolac 600 mg 80425-0381-01 | Advanced | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68382-0273-01 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-01) | $1.13 / ea | $112.56 | 2014-02-15 | Active |
| 68382-0273-05 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-05) | — | — | 2014-02-15 | Active |
| 68382-0273-10 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-10) | — | — | 2014-02-15 | Active |
| 68382-0273-14 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-273-14) | $1.13 / ea | $67.54 | 2014-02-15 | Active |
| 68382-0273-77 You're viewing this | 100 BLISTER PACK in 1 CARTON (68382-273-77) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-273-30) | — | — | 2014-02-15 | Active |
This pack shows little to no recent Medicaid volume — the 100 tablets pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 68382-0273-77?
What NDC number is used to bill for this package of Etodolac 600 mg Tablet, Film Coated, Extended Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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Do I need a prescription for this product?
Where does this data come from?
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
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 extended-release tablets 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 (GI) 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 events [ see Warnings ].
🎯 Indications and Usage ▾
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:
⏱️ Dosage and 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: Table 4 Body Weight Range ( kg ) Dose 20 to 30 400 mg Tablet x 1 31 to 45 600 mg Tablet x 1 46 to 60 400 mg Tablet x 2 > 60 500 mg Tablet x 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 chronic conditions, a therapeutic response to therapy with etodolac extended-release tablets is sometimes seen within one week of therapy, but most often is observed by two weeks.
⛔ 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 ) .
⚠️ 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 development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as etodolac, increases the risk of serious gastrointestinal (GI) events [see Warnings] . Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG [see Contraindications] . Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients.
Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of etodolac extended-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If etodolac extended-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension NSAIDs, including etodolac extended-release tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including etodolac extended-release tablets, should be used with caution in patients with hypertension.
Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospita…
🤒 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: * Adverse events that were observed in < 1% of patients in the first 30 days of treatment with etodolac extended-release tablets in clinical trials. abnormal renal function * Anemia * asthenia dizziness edema * elevated liver enzymes * headaches hypertension increased bleeding time * infection pharyngitis pruritus rashes rhinitis tinnitus * Additional NSAID Adverse Experiences Reported Occasionally with NSAIDs or Etodolac Extended-release Tablets Include Body as a whole Allergic reaction, anaphylactic/anaphylactoid reactions (including shock), chills, fever, sepsis Cardiovascular system Congestive heart failure, flushing, palpitations, tachycardia, syncope, vasculitis (including necrotizing and allergic) Digestive system Anorexia, cholestatic hepatitis, cholestatic jaundice, dry mouth, duodenitis, eructation, esophagitis, gastritis, gastric/peptic ulcers, glossitis, hepatic failure, hepatitis, hematemesis, intestinal ulceration, jaundice, liver necrosis, melena, pancreatitis, rectal bleeding, stomatitis Hemic and lymphatic system Agranulocytosis, ecchymosis, eosinophilia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, purpura, thrombocytopenia Metabolic and nutritional Hyperglycemia in previously controlled diabetic patients Nervous system Anxiety, confusion, depression, dream abnormalities, insomnia, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory system Asthma, dyspnea, pulmonary infiltration with eosinophilia Skin and appendages Angioedema, cutaneous vasculitis with purpura, erythema multiforme, hyperpigmentation, sweating, urticaria, vesiculobullous rash Special senses Blurred vision, photophobia, transient visual disturbances Urogenital system Dysuria, elevated BUN, oliguria/polyuria, proteinuria, renal failure, renal insufficiency, renal papillary necrosis, serum creatinine increase, urinary frequency Other NSAID Adverse Reactions, Which Occur Rarely Are Body as a whole Anaphylactic reactions, appetite changes, death Cardiovascular system Arrhythmia, cerebrovascular accident, hypotension, myocardial infarction Digestive system Colitis, esophagitis with or without stricture or cardiospasm, thirst, ulcerative stomatitis Hemic and lymphatic system Aplastic anemia, lymphadenopathy Metabolic and nutritional Change in weight Nervous system Coma, convulsions, hallucinations, meningitis Respiratory Bronchitis, pneumonia, respiratory depression, sinusitis Skin and appendages Alopecia, exfoliative dermatitis, maculopapular rash, photosensitivity, skin peeling, Stevens-Johnson Syndrome, toxic epidermal necrosis (TEN) and fixed drug eruption (FDE) (see WARNINGS ).
Special senses Conjunctivitis, deafness, hearing impairment, taste perversion Urogenital system Cystitis, hematuria, interstitial nephritis, leukorrhea, renal calculus, uterine bleeding irregularities
🔄 Drug Interactions ▾
Drug Interactions
🤰 Pregnancy ▾
Pregnancy Risk Summary Use of NSAIDs, including etodolac extended-release tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of etodolac extended-release tablets use between about 20 and 30 weeks of gestation, and avoid etodolac extended-release tablets use at about 30 weeks of gestation and later in pregnancy [see WARNINGS ; Fetal Toxicity]. Premature Closure of Fetal Ductus Arteriosus Use of NSAIDs, including etodolac extended-release tablets, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
Oligohydramnios/Neonatal Renal Impairment Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. Animal reproduction studies conducted in rats and rabbits have not demonstrated evidence of developmental abnormalities.
However, animal reproduction studies are not always predictive of human response. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as etodolac, resulted in increased pre- and post-implantation loss.
Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including etodolac extended-release tablets, can cause premature closure of the fetal ductus arteriosus (see WARNINGS; Fetal Toxicity).
Oligohydramnios/Neonatal Renal Impairment If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If etodolac extended-release tablets treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue etodolac extended-release tablets and follow up according to clinical practice (see WARNINGS ; Fetal Toxicity).
Data Human Data There are no adequate and well controlled studies in pregnant women. Premature Closure of Fetal Ductus Arteriosus: Published literature reports that the use of NSAIDs at about 30 weeks of gestation and later in pregnancy may cause premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Published studies and postmarketing reports describe maternal NSAID use at about 20 weeks gestation or later in pregnancy associated with fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment.
These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation. In many cases, but not all, the decrease in amniotic fluid was transient and reversible with cessation of the drug. There have been a limited number of case rep…
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in pediatric patients below the age of 6 years have not been established.
🧓 Geriatric Use ▾
Geriatric Use As with any NSAIDs, caution should be exercised in treating the elderly (65 years and older).
🆘 Overdosage ▾
OVERDOSAGE Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare.
Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes.
Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of the urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Pharmacodynamics Etodolac extended-release tablets are a non-steroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activities in animal models. The mechanism of action of etodolac extended-release tablets, like that of other NSAIDs, is not completely understood, but may be related to prostaglandin synthetase inhibition. Pharmacokinetics Absorption Etodolac extended-release tablets and etodolac tablets both contain etodolac, but differ in their release characteristics.
The systemic availability of etodolac from etodolac extended-release tablets is generally greater than 80%. Etodolac does not undergo significant first-pass metabolism following oral administration. After oral administration of etodolac extended-release tablets in doses up to 800 mg once daily, peak concentrations occur approximately 6 hours after dosing and are dose proportional for both total and free etodolac.
Table 1 shows the comparison of etodolac pharmacokinetic parameters after the administration of etodolac tablets and etodolac extended-release tablets. Table 2 shows the etodolac pharmacokinetic parameters in various populations. The data from patients with renal and hepatic impairment were obtained following administration of (immediate-release) etodolac tablets.
Table 1 * % Coefficient of variation Mean (CV)% * Pharmacokinetic Parameters Etodolac Tablets Etodolac Extended-release Tablets Extent of Oral Absorption (Bioavailability) [F] ≥ 80% ≥ 80% Time to Peak Concentration (T max ), h 1.4 (61%) 6.7 (47%) Oral Clearance (CL/F), mL/h/kg 49.1 (33%) 46.8 (37%) Apparent Volume of Distribution (Vd/F), mL/kg 393 (29%) 566 (26%) Terminal Half-Life (t 1/2 ), h 6.4 (22%) 8.4 (30%) Table 2 Mean (CV%) * Pharmacokinetic Parameters of Etodolac in Normal Healthy Adults and Various Special Populations * % Coefficient of variation † Pharmacokinetic parameters obtained following administration of etodolac tablets ‡ Age range (years) NA = not available Etodolac Extended-release Tablets Etodolac Tablets PK Parameters Normal Healthy Adults Healthy Males Healthy Females Elderly (> 65 yr) Hemodialysis † (24 to 65) (n = 9) Renal Impairment † Hepatic Impairment † (18 to 44) ‡ (n = 116) (18 to 43) (n = 102) (25 to 44) (n = 14) (66 to 88) (n = 24) Dialysis On Dialysis Off (46 to 73) (n = 10) (34 to 60) (n = 9) T max , h 6.7 (47%) * 6.8 (45%) 4.5 (56%) 6.2 (51%) 1.7 (88%) 0.9 (67%) 2.1 (46%) 1.1 (15%) Oral Clearance, mL/h/kg (CL/F) 46.8 (37%) 46.8 (37%) 47.2 (38%) 51.6 (40%) NA NA 58.3 (19%) 42 (43%) Apparent Volume of Distribution, mL/kg (Vd/F) 566 (26%) 580 (26%) 459 (28%) 552 (34%) NA NA NA NA Terminal Half- Life, h 8.4 (30%) 8.4 (29%) 7.6 (45%) 7.8 (26%) 5.1 (22%) 7.5 (34%) NA 5.7 (24%) Food/Antacid Effects Food has no significant effect on the extent of etodolac extended-release tablets absorption, however, food significantly increased C max (54%) following a 600 mg dose.
The extent of absorption of etodolac is not affected when etodolac is administered with antacid. Coadministration, with an antacid, decreases the peak concentration reached by about 15 to 20% with no measurable effect on time-to-peak. Distribution The mean apparent volume of distribution (Vd/F) of etodolac following administration of etodolac extended-release tablets is 566 mL/kg.
Etodolac is more than 99% bound to plasma proteins, primarily to albumin, and is independent of etodolac concentration over the dose range studied. It is not known whether etodolac is excreted in human milk. However, based on its physical-chemical properties, excretion into breast milk is expected.
Metabolism Etodolac metabolites do not contribute significantly to the pharmacological activity of etodolac extended-release tablets. Following administration of immediate-release etodolac, several metabolites have been identified in human plasma and urine. Other metabolites remain to be identified.
The metabolites include 6-, 7-, and 8-hydroxylated etodolac and etodol…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Etodolac Extended-Release Tablets USP, 400 mg are orange-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "271" on one side and plain on other side and are supplied as follows: NDC 68382-271-14 in bottles of 60 tablets with child–resistant closure NDC 68382-271-01 in bottles of 100 tablets NDC 68382-271-05 in bottles of 500 tablets NDC 68382-271-10 in bottles of 1,000 tablets NDC 68382-271-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Etodolac Extended-Release Tablets USP, 500 mg are grey-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "272" on one side and plain on other side and are supplied as follows: NDC 68382-272-14 in bottles of 60 tablets with child–resistant closure NDC 68382-272-01 in bottles of 100 tablets NDC 68382-272-05 in bottles of 500 tablets NDC 68382-272-10 in bottles of 1,000 tablets NDC 68382-272-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Etodolac Extended-Release Tablets USP, 600 mg are blue-colored, oval-shaped, beveled edged, film-coated tablets, debossed with "273" on one side and plain on other side and are supplied as follows: NDC 68382-273-14 in bottles of 60 tablets with child–resistant closure NDC 68382-273-01 in bottles of 100 tablets NDC 68382-273-05 in bottles of 500 tablets NDC 68382-273-10 in bottles of 1,000 tablets NDC 68382-273-77 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Storage: Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].
Protect from excessive heat and humidity. Dispense in a tight, light-resistant container with a child-resistant closure. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779.
📋 Description ▾
DESCRIPTION Etodolac extended-release tablets, USP contain etodolac, which is a member of the pyranocarboxylic acid group of non-steroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers.
Etodolac, USP is a white to off-white crystalline powder, 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 the following structural formula: C 17 H 21 NO 3 M.W.
287.36 Each etodolac extended-release tablet, USP intended for oral administration contains 400 mg or 500 mg or 600 mg of etodolac. In addition, each tablet contains the following inactive ingredients: disodium hydrogen phosphate, ethylcellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, talc, titanium dioxide and triacetin. Additionally each 400 mg tablet contains: D&C Yellow # 10 aluminum lake, FD&C Red # 40 aluminum lake and FD&C yellow # 6 aluminum lake and each 500 mg tablet contains: FD&C Blue # 2 aluminum lake, iron oxide black and iron oxide yellow and each 600 mg tablet contains: FD&C blue # 2 aluminum lake, iron oxide red and iron oxide yellow.
Etodolac Extended-release Tablets, USP
💬 Information for Patients ▾
Information for Patients Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed. Cardiovascular Thrombotic Events: Advise patients to be alert for the symptoms of cardiovascular thrombotic events, including chest pain, shortness of breath, weakness, or slurring of speech, and to report any of these symptoms to their health care provider immediately [ see Warnings ].
Etodolac extended-release tablets, like other NSAIDs, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (see WARNINGS , Gastrointestinal Effects - Risk of Ulceration , Bleeding , and Perforation ).
Serious Skin Reactions, including DRESS: Advise patients to stop taking etodolac extended-release tablets immediately if they develop any type of rash or fever and to contact their healthcare provider as soon as possible [see Warnings]. Heart Failure and Edema: Advise patients to be alert for the symptoms of congestive heart failure including shortness of breath, unexplained weight gain, or edema and to contact their healthcare provider if such symptoms occur [ see Warnings ]. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms).
If these occur, patients should be instructed to stop therapy and seek immediate medical therapy. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS ).
Fetal Toxicity: Inform pregnant women to avoid use of etodolac extended-release tablets and other NSAIDs starting at 30 weeks gestation because of the risk of the premature closing of the fetal ductus arteriosus. If treatment with etodolac extended-release tablets is needed for a pregnant woman between about 20 to 30 weeks gestation, advise her that she may need to be monitored for oligohydramnios, if treatment continues for longer than 48 hours [see WARNINGS ; Fetal Toxicity, PRECAUTIONS; Pregnancy ].
💬 Medication Guide ▾
Medication Guide For Nonsteroidal Anti-inflammatory Drugs (NSAIDs) Etodolac ( ee" toe doe ' lak ) Extended-Release Tablets , USP What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death . This risk may happen early in treatment and may increase: ○ with increasing doses of NSAIDs ○ with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to.
You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: ○ anytime during use ○ without warning symptoms ○ that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery.
Before taking NSAIDS, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby.
You should not take NSAIDs after 30 weeks of pregnancy. are breastfeeding or plan to breast feed . Tell your healthcare provider about all of the medicines you take, including prescription or over-the- counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects.
Do not start taking any new medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "What is the most important information I should know about medicines called Nonsteroidal Anti- inflammatory Drugs (NSAIDs)? new or worse high blood pressure heart failure liver problems including liver failure kidney problems including kidney failure low red blood cells (anemia) life-threatening skin reactions life threatening allergic reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness.
Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea more tired or weaker than usual diarrhea itching your skin or eyes look yellow indigestion or stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling…