Etodolac

Etodolac
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Cardiovascular Risk & Gastrointestinal Risk See full prescribing information for complete Boxed Warning. Cardiovascular Risk: NSAIDs1 may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Etodolac extended-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. 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 events. 1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.

Overview

Etodolac is an analgesic, anti-inflammatory agent that is FDA approved for the treatment of juvenile arthritis, rheumatoid arthritis, osteoarthritis. There is a Black Box Warning for this drug as shown here. Common adverse reactions include edema, abdominal pain, dairrhea, flatulance, indigestion, nausea, increased liver function test, dizziness, headache, malaise.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Etodolac in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Etodolac in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Etodolac in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Etodolac in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Etodolac in pediatric patients.

Contraindications

• Condition1

Warnings

Cardiovascular Risk & Gastrointestinal Risk See full prescribing information for complete Boxed Warning. Cardiovascular Risk: NSAIDs1 may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Etodolac extended-release tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. 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 events. 1 Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Etodolac in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Etodolac in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Etodolac in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Etodolac during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Etodolac with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Etodolac with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Etodolac with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Etodolac with respect to specific gender populations.

Race

There is no FDA guidance on the use of Etodolac with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Etodolac in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Etodolac in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Etodolac in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Etodolac in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Etodolac in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Etodolac in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Etodolac in the drug label.

Pharmacology

There is limited information regarding Etodolac Pharmacology in the drug label.

Mechanism of Action

Structure

• Etodolac extended-release tablets 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. It 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. It has the following structural formula:

• The inactive ingredients in etodolac extended-release tablets are calcium phosphate dibasic anhydrous, carbomer 934P, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, sodium lauryl sulfate, and titanium dioxide. In addition, the following colorants are used: 400 mg tablets - D&C Yellow #10 Lake, FD&C Red #40, and FD&C Yellow #6; 500 mg tablets - D&C Yellow #10 Lake, FD&C Blue No. 2 Indigo Carmine Aluminum Lake, and iron oxide black; 600 mg tablets - FD&C Blue No. 2 Indigo Carmine Lake, iron oxide black, and iron oxide yellow.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Etodolac in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Etodolac in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Etodolac in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Etodolac in the drug label.

How Supplied

Storage

There is limited information regarding Etodolac Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Etodolac |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Etodolac |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Etodolac in the drug label.

Precautions with Alcohol

• Alcohol-Etodolac interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Lodine, Lodine XL

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Etodolac
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Etodolac
 |Label Name=Etodolac11.png

}}

{{#subobject:

 |Label Page=Etodolac
 |Label Name=Etodolac11.png

}}