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etodolac
Overview
What is LODINE?
Etodolac tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet 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. 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 CHNO, and it has the following structural formula:
Each Tablet, for oral administration, contains 400 mg
Etodolac
. In addition, each tablet contains the following inactive ingredients:
What does LODINE look like?
What are the available doses of LODINE?
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What should I talk to my health care provider before I take LODINE?
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How should I use LODINE?
Carefully consider the potential benefits and risks of Etodolac tablets and other treatment options before deciding to use Etodolac tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
Etodolac Capsules and Tablets are indicated:
Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see ).
After observing the response to initial therapy with etodolac capsules and tablets, the dose and frequency should be adjusted to suit an individual patient's needs.
Dosage adjustment of etodolac capsules and tablets is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see
).
Analgesia
The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials.
Osteoarthritis and Rheumatoid Arthritis
The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials.
In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required.
What interacts with LODINE?
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What are the warnings of LODINE?
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What are the precautions of LODINE?
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What are the side effects of LODINE?
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What should I look out for while using LODINE?
Etodolac Capsules and Tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac.
Etodolac Capsules and Tablets 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
and
).
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 ].
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 ].
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 capsules and tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If etodolac capsules and tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension
NSAIDs, including etodolac capsules and tablets, can lead to onset of new hypertension or worsening of pre-existing 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 capsules and 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, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
Use of etodolac may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] [see ].
Avoid the use of etodolac capsules and tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If etodolac capsules and tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
What might happen if I take too much LODINE?
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 and coma has occurred following massive ibuprofen or mefenamic-acid overdose. Hypertension, acute renal failure, and respiratory depression may occur but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following 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 would probably not be useful due to etodolac's high protein binding.
How should I store and handle LODINE?
Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature].Dispense in tight container as defined in the USP, with a child-resistant closure (as required).Lodine Tablets, USP400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain)-in bottles of 30, NDC 69036-503-30Store at 20°-25°C (68°-77°F) Store tablets in original container until ready to use. Dispense in light-resistant container.Lodine Tablets, USP400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain)-in bottles of 30, NDC 69036-503-30Store at 20°-25°C (68°-77°F) Store tablets in original container until ready to use. Dispense in light-resistant container.Lodine Tablets, USP400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain)-in bottles of 30, NDC 69036-503-30Store at 20°-25°C (68°-77°F) Store tablets in original container until ready to use. Dispense in light-resistant container.Lodine Tablets, USP400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain)-in bottles of 30, NDC 69036-503-30Store at 20°-25°C (68°-77°F) Store tablets in original container until ready to use. Dispense in light-resistant container.Lodine Tablets, USP400 mg tablets (peach, oval shaped, film coated tablet engraved with "T88" on one side and other side plain)-in bottles of 30, NDC 69036-503-30Store at 20°-25°C (68°-77°F) Store tablets in original container until ready to use. Dispense in light-resistant container.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Etodolac is a nonsteroidal 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 the 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
Non-Clinical Toxicology
Etodolac Capsules and Tablets are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac.Etodolac Capsules and Tablets 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 and ).
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 ].
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 ].
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 capsules and tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If etodolac capsules and tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
Hypertension
NSAIDs, including etodolac capsules and tablets, can lead to onset of new hypertension or worsening of pre-existing 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 capsules and 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, hospitalization for heart failure, and death.
Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
Use of etodolac may blunt the CV effects of several therapeutic agents used to treat these medical conditions [e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers (ARBs)] [see ].
Avoid the use of etodolac capsules and tablets in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If etodolac capsules and tablets are used in patients with severe heart failure, monitor patients for signs of worsening heart failure.
ACE-inhibitors
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors (see ).
Antacids
The concomitant administration of antacids has no apparent effect on the extent of absorption of etodolac capsules and tablets. However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak.
Aspirin
When etodolac capsules and tablets are administered with aspirin, its protein binding is reduced, although the clearance of free etodolac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of etodolac and aspirin is not generally recommended because of the potential of increased adverse effects.
Cyclosporine, Digoxin, Methotrexate
Etodolac, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increased toxicity. Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given etodolac, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs. NSAIDs, such as etodolac, should not be administered prior to or concomitantly with high doses of methotrexate. NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. In general, caution should be used when NSAIDs are administered concomitantly with methotrexate.
Diuretics
Etodolac has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. Nevertheless, clinical studies, as well as postmarketing observations have shown that etodolac can reduce the natriuretic effect of furosemide and thiazides in some patients with possible loss of blood pressure control. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal insufficiency or failure (see ), as well as to assure diuretic efficacy.
Glyburide
Etodolac has no apparent pharmacokinetic interaction when administered with glyburide.
Lithium
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Careful monitoring of lithium levels is advised in the event NSAID dosage adjustments are required.
Phenylbutazone
Phenylbutazone causes increase (by about 80%) in the free fraction of etodolac. Although studies have not been done to see if etodolac clearance is changed by coadministration of phenylbutazone, it is not recommended that they be coadministered.
Phenytoin
Etodolac has no apparent pharmacokinetic interaction when administered with phenytoin.
Warfarin
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that of users of either drug alone. Short-term pharmacokinetic studies have demonstrated that concomitant administration of warfarin and etodolac capsules and tablets results in reduced protein binding of warfarin, but there was no change in the clearance of free warfarin. There was no significant difference in the pharmacodynamic effect of warfarin administered alone and warfarin administered with etodolac capsules and tablets as measured by prothrombin time. Thus, concomitant therapy with warfarin and etodolac should not require dosage adjustment of either drug. However, caution should be exercised because there have been a few spontaneous reports of prolonged prothrombin times, with or without bleeding, in etodolac-treated patients receiving concomitant warfarin therapy. Close monitoring of such patients is therefore recommended.
Etodolac capsules and tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered solely if a decision is made to discontinue corticosteroids.
The pharmacological activity of etodolac capsules and tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.
In patients taking etodolac capsules and tablets or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
Gastrointestinal experiences including:
Other events including:
Adverse-reaction information for etodolac was derived from 2,629 arthritic patients treated with etodolac capsules and tablets in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with etodolac.
New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of etodolac b.i.d. (i.e., 600 to 1000 mg/day).
Incidence Greater Than Or Equal To 1% - Probably Causally Related
Body as a whole - Chills and fever.
Digestive system - Dyspepsia (10%), abdominal pain, diarrhea, flatulence, nausea, abdominal distension, epigastric pain, abnormal stools, constipation, gastritis, melena, vomiting.
Nervous system - Asthenia/malaise, dizziness, depression, nervousness, fatigue.
Skin and appendages - Pruritus, rash.
Special senses - Blurred vision, tinnitus.
Urogenital system - Dysuria, urinary frequency.
Musculoskeletal—Arthralgia.
________________________________
Incidence Less Than 1% - Probably Causally Related
(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)
Body as a whole -
Cardiovascular system - Hypertension, congestive heart failure, flushing, palpitations, syncope,
Digestive system - Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, hepatitis, peptic ulcer with or without bleeding and/or perforation,
Hemic and lymphatic system - Ecchymosis, anemia, thrombocytopenia, bleeding time increased,
Metabolic and nutritional - Edema, serum creatinine increase,
Nervous system - Insomnia, somnolence.
Respiratory system - Asthma, .
Skin and appendages - Angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, hyperpigmentation
Special senses - Photophobia, transient visual disturbances.
Urogenital system -
Incidence Less Than 1% - Causal Relationship Unknown
(Medical events occurring under circumstances where causal relationship to etodolac is uncertain. These reactions are listed as alerting information for physicians.)
Body as a whole - Infection, headache.
Cardiovascular system - Arrhythmias, myocardial infarction, cerebrovascular accident.
Digestive system - Esophagitis with or without stricture or cardiospasm, colitis, GI discomfort, burning sensation, blood in stools, gastralgia, upper abdominal discomfort.
Metabolic and nutritional - Change in weight.
Nervous system - Paresthesia, confusion, irritability.
Respiratory system - Bronchitis, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis.
Skin and appendages - Alopecia, maculopapular rash, photosensitivity, skin peeling.
Special senses - Conjunctivitis, deafness, taste perversion, loss of taste.
Urogenital system - Cystitis, hematuria, leukorrhea, renal calculus, interstitial nephritis, uterine bleeding irregularities, renal impairment.
Musculoskeletal—Muscle pain.
Additional Adverse Reactions Reported with NSAIDs
Body as a whole - Sepsis, death
Cardiovascular system – Tachycardia
Digestive system - Gastric ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis
Hemic and lymphatic system – Lymphadenopathy
Nervous system - Anxiety, dream abnormalities, convulsions, coma, hallucinations, meningitis, tremors, vertigo
Respiratory system - Respiratory depression, pneumonia
Urogenital system - Oliguria/polyuria, proteinuria
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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