Etodolac
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- ETODOLAC DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACODYNAMICS
- PHARMACOKINETICS
- INDICATIONS & USAGE
- ETODOLAC CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- DRUG & OR LABORATORY TEST INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- ETODOLAC ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Cardiovascular Risk-
● NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction (MI), 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. (SeeWARNINGS).
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● Etodolac capsules USP, 200 mg and 300 mg, and Etodolac tablets USP, 400 mg and 500 mg are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (SeeWARNINGS).
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. (SeeWARNINGS).
ETODOLAC DESCRIPTION
CLINICAL PHARMACOLOGY
PHARMACODYNAMICS
PHARMACOKINETICS
AbsorptionTable 1
*
PK ParametersNormal Healthy Adults (18-65)Healthy Males (18-65)Healthy Females (27-65)Elderly (>65) (70-84)Hemodialysis (24-65) (n=9) Dialysis Renal Impairment (46-73)Hepatic Impairment (34-60)(n=179)(n=176)(n=3)Dialysis OnDialysis Off(n=10)(n=9)**
Distribution
Metabolism
Excretion
Special Populations
Geriatric
PRECAUTIONS, Geriatric Use
WARNINGS, Renal Effects
Pediatric
Race
Hepatic Insufficiency
Renal Insufficiency
CLINICAL TRIALS
Analgesia
Osteoarthritis
Rheumatoid Arthritis
INDICATIONS & USAGE
WARNINGS-
● For acute and long-term use in the management of signs and symptoms of the following:
-
● For the management of acute pain
ETODOLAC CONTRAINDICATIONS
WARNINGS, Anaphylactoid ReactionsPRECAUTIONS, Pre-existing Asthma
WARNINGS
WARNINGS
CARDIOVASCULAR EFFECTSCardiovascular Thrombotic Events
WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
CONTRAINDICATIONS
Hypertension
Congestive Heart Failure and Edema
Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
Renal Effects
Advanced Renal Disease
Anaphylactoid Reactions
CONTRAINDICATIONSPRECAUTIONS, General, Pre-existing Asthma
Skin Reactions
Pregnancy
PRECAUTIONS, Pregnancy, Nonteratogenic Effects
PRECAUTIONS
GeneralHepatic Effects
Hematological Effects
Pre-existing Asthma
INFORMATION FOR PATIENTS
WARNINGS, Cardiovascular Effects
WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, and Perforation
WARNINGS
LABORATORY TESTS
DRUG INTERACTIONS
ACE-inhibitorsWARNINGS
Antacids
Aspirin
Cyclosporine, Digoxin, Methotrexate
Diuretics
WARNINGS, Renal Effects
Glyburide
Lithium
Phenylbutazone
Phenytoin
Warfarin
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic Effects-Pregnancy Category CNonteratogenic Effects
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
WARNINGSCLINICAL PHARMACOLOGY, Special Populations
WARNINGS
WARNINGS, Renal Effects
ETODOLAC ADVERSE REACTIONS
Incidence Greater Than Or Equal To 1% - Probably Causally Related
1111
11
1
Incidence Less Than 1% - Probably Causally Related
Incidence Less Than 1% - Causal Relationship Unknown
Additional Adverse Reactions Reported with NSAIDs
OVERDOSAGE
DOSAGE & ADMINISTRATION
WARNINGSWARNINGS, Renal Effects
Analgesia
Osteoarthritis and Rheumatoid Arthritis
HOW SUPPLIED
SPL MEDGUIDE
-
● with longer use of NSAID medicines
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● in people who have heart disease
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● can happen without warning symptoms
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● may cause death
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● taking medicines called "corticosteroids" and "anticoagulants"
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● longer use
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● smoking
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● drinking alcohol
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● older age
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● having poor health
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● exactly as prescribed
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● at the lowest dose possible for your treatment
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● for the shortest time needed
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● different types of arthritis
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● menstrual cramps and other types of short-term pain
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● if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
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● for pain right before or after heart bypass surgery
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● about all of your medical conditions.
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● about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
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● if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
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● if you are breastfeeding. Talk to your doctor.
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● Aspirin is an NSAID medicine but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
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● Some of these NSAID medicines are sold in lower doses without a prescription (overthecounter). Talk to your healthcare provider before using overthecounter NSAIDs for more than 10 days.
Generic NameTradename* *
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
EtodolacEtodolac CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
