Meloxicam
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- MELOXICAM DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACOKINETICS
- INDICATIONS & USAGE
- MELOXICAM CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- MELOXICAM ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
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● 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 greater risk (seeWARNINGSandCLINICAL TRIALS).
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● Meloxicam 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).
MELOXICAM DESCRIPTION
CLINICAL PHARMACOLOGY
Mechanism of ActionPHARMACOKINETICS
AbsorptionFood and Antacid Effects
Distribution
Metabolism
Excretion
Special populations
Geriatric
Gender
Hepatic Insufficiency
Renal Insufficiency
WARNINGSAdvanced Renal Disease
Hemodialysis
CLINICAL TRIALS
Osteoarthritis and Rheumatoid Arthritis
INDICATIONS & USAGE
WARNINGSMELOXICAM CONTRAINDICATIONS
WARNINGSAnaphylactoid ReactionsPRECAUTIONSPre-existing Asthma
WARNINGS
WARNINGS
Cardiovascular EffectsCardiovascular Thrombotic Events
WARNINGSGastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation
CONTRAINDICATIONS
Hypertension
Congestive Heart Failure and Edema
Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation
Renal Effects
Advanced Renal Disease
Anaphylactoid Reactions
CONTRAINDICATIONSPRECAUTIONSPre-existing Asthma
Skin Reactions
Pregnancy
PRECAUTIONS
GeneralHepatic Effects
Renal Effects
WARNINGSRenal EffectsAdvanced Renal Disease
Hematological Effects
Pre-existing Asthma
INFORMATION FOR PATIENTS
WARNINGSCardiovascular Effects
WARNINGSGastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation
WARNINGS
LABORATORY TESTS
DRUG INTERACTIONS
ACE-inhibitorsAspirin
Cholestyramine
Cimetidine
Digoxin
Furosemide
WARNINGSRenal Effects
Lithium
Methotrexate
Warfarin
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
PREGNANCY
Teratogenic Effects:Pregnancy Category C.Nonteratogenic Effects
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
GERIATRIC USE
MELOXICAM ADVERSE REACTIONS
AdultsOsteoarthritis and Rheumatoid Arthritis
OVERDOSAGE
DOSAGE & ADMINISTRATION
Osteoarthritis and Rheumatoid ArthritisWARNINGS
HOW SUPPLIED
STORAGE AND HANDLING
SPL MEDGUIDE
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● 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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● 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
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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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● NSAID medicines that need a prescription
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
MeloxicamMeloxicam TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
