Indomethacin
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- INDOMETHACIN DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- INDOMETHACIN 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
- INDOMETHACIN ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- PEDIATRIC USE
- GERIATRIC USE
- HOW SUPPLIED
- STORAGE AND HANDLING
- 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, 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 a greater risk. (SeeWARNINGS.)
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● Indomethacin is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).
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● 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. (SeeWARNINGS.)
INDOMETHACIN DESCRIPTION
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
INDICATIONS & USAGE
WARNINGSINDOMETHACIN CONTRAINDICATIONS
DESCRIPTIONWARNINGSAnaphylactic/Anaphylactoid ReactionsPRECAUTIONSPreexisting Asthma
WARNINGS
WARNINGS
Cardiovascular Effects
Cardiovascular Thrombotic Events
WARNINGSGastrointestinal Effects
CONTRAINDICATIONS
Hypertension
Congestive Heart Failure and Edema
Gastrointestinal Effects
Risk of Ulceration, Bleeding, and Perforation
Renal Effects
PRECAUTIONSDrug Interactions
Advanced Renal Disease
Anaphylactic/Anaphylactoid Reactions
CONTRAINDICATIONSPRECAUTIONSPreexisting Asthma
Skin Reactions
Pregnancy
Ocular Effects
Central Nervous System Effects
PRECAUTIONS
GeneralHepatic Effects
Hematological Effects
Preexisting Asthma
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.WARNINGSCardiovascular Effects
WARNINGSGastrointestinal EffectsRisk of Ulceration, Bleeding, and Perforation
WARNINGS
LABORATORY TESTS
DRUG INTERACTIONS
ACE-Inhibitors and Angiotensin II Antagonists
Aspirin
Beta-adrenoceptor blocking agents
Cyclosporine
Diflunisal
Digoxin
Diuretics
WARNINGSRenal Effects
Lithium
Methotrexate
NSAIDs
Oral Anticoagulants
Probenecid
DRUG & OR LABORATORY TEST INTERACTIONS
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic EffectsPregnancy Category C
Nonteratogenic Effects
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
WARNINGSGastrointestinal EffectsDOSAGE AND ADMINISTRATIONWARNINGSGastrointestinal EffectsADVERSE REACTIONS
This drug is known to be substantially excreted by the kidney and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function (seeWARNINGS:Renal Effects).
INDOMETHACIN ADVERSE REACTIONS
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Causal Relationship Unknown
Cardiovascular
Hematologic
Genitourinary
PRECAUTIONSGeneral
OVERDOSAGE
DOSAGE & ADMINISTRATION
WARNINGSPEDIATRIC USE
PRECAUTIONSPediatric UseGERIATRIC USE
Dosage Recommendations for Active Stages of the FollowingPRECAUTIONSGeriatric Use
HOW SUPPLIED
STORAGE AND HANDLING
SPL MEDGUIDE
MEDICATION GUIDE for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?
NSAID medicines may increase the chance of a heart attack or stroke that can lead to death.
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● with longer use of NSAID medicines
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● in people who have heart disease
NSAID medicines can cause ulcers and bleeding in the stomach and intestines at anytime during treatment. Ulcers and bleeding:
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● can happen without warning symptoms
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● may cause death
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● taking medicines calledcorticosteroidsandanticoagulants
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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
Do not take an NSAID medicine:
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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.
Get emergency help right away if you have any of the following symptoms:
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● shortness of breath or trouble breathing
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● chest pain
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● weakness in one part or side of your body
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● slurred speech
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● swelling of the face or throat
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● nausea
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● more tired or weaker than usual
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● itching
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● your skin or eyes look yellow
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● stomach pain
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● flu-like symptoms
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● vomit blood
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● there is blood in your bowel movement or it is black and sticky like tar
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● unusual weight gain
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● skin rash or blisters with fever
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● swelling of the arms and legs, hands and feet
Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
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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 (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
IndomethacinIndomethacin CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
