Meloxicam description, usages, side effects, indications, overdosage, supplying and lots more!

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Meloxicam

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING



  • ●     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).
  • ●     Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (seeWARNINGS).

  • ●     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


Meloxicam






CLINICAL PHARMACOLOGY

Mechanism of Action


PHARMACOKINETICS

Absorption




Food and Antacid Effects



Distribution



Metabolism


Excretion



USE IN SPECIFIC POPULATIONS

Geriatric


Gender


Hepatic Insufficiency


Renal Insufficiency
WARNINGSAdvanced Renal Disease

Hemodialysis


CLINICAL TRIALS

Osteoarthritis and Rheumatoid Arthritis




INDICATIONS & USAGE

WARNINGS


MELOXICAM CONTRAINDICATIONS


WARNINGSAnaphylactoid ReactionsPRECAUTIONSPre-existing Asthma
WARNINGS

WARNINGS

Cardiovascular Effects

Cardiovascular 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

General



Hepatic Effects



Renal Effects
WARNINGSRenal EffectsAdvanced Renal Disease


Hematological Effects




Pre-existing 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 (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation



WARNINGS


LABORATORY TESTS



DRUG INTERACTIONS


ACE-inhibitors


Aspirin



Cholestyramine


Cimetidine


Digoxin


Furosemide
WARNINGSRenal Effects

Lithium


Methotrexate



Warfarin



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Pregnancy Category C.


Nonteratogenic Effects



LABOR & DELIVERY




NURSING MOTHERS




PEDIATRIC USE



GERIATRIC USE



MELOXICAM ADVERSE REACTIONS

Adults

Osteoarthritis and Rheumatoid Arthritis
















OVERDOSAGE





DOSAGE & ADMINISTRATION

Osteoarthritis and Rheumatoid Arthritis
WARNINGS





HOW SUPPLIED













STORAGE AND HANDLING





INFORMATION FOR PATIENTS




Medication Guide

Cardiovascular Effects
Warnings and Precautions (5.1)
Gastrointestinal Effects
Warnings and Precautions (5.2)
Hepatotoxicity
Warnings and Precautions (5.3)
Adverse Skin Reactions
Warnings and Precautions (5.8)
Weight Gain and Edema
Warnings and Precautions (5.5)
Anaphylactoid Reactions
Warnings and Precautions (5.7)
Effects During Pregnancy
Warnings and Precautions (5.9)Use in Specific Populations (8.1)



SPL MEDGUIDE





  • ●     with longer use of NSAID medicines
  • ●     in people who have heart disease


  • ●     can happen without warning symptoms
  • ●     may cause death

  • ●     taking medicines called "corticosteroids" and "anticoagulants"
  • ●     longer use
  • ●     smoking
  • ●     drinking alcohol
  • ●     older age
  • ●     having poor health

  • ●     exactly as prescribed
  • ●     at the lowest dose possible for your treatment
  • ●     for the shortest time needed


  • ●     different types of arthritis
  • ●     menstrual cramps and other types of short-term pain


  • ●     if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
  • ●     for pain right before or after heart bypass surgery

  • ●     about all of your medical conditions
  • ●     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.
  • ●     if you are pregnant. NSAID medicines should not be used by pregnant and women late in their pregnancy.
  • ●     if you are breastfeeding. Talk to your doctor.


  • ●     heart attack
  • ●     stroke
  • ●     high blood pressure
  • ●     heart failure from body swelling (fluid retention)
  • ●     kidney problems including kidney failure
  • ●     bleeding and ulcers in the stomach and intestine
  • ●     low red blood cells (anemia)
  • ●     life-threatening skin reactions
  • ●     life-threatening allergic reactions
  • ●     liver problems including liver failure
  • ●     asthma attacks in people who have asthma

  • ●     stomach pain
  • ●     constipation
  • ●     diarrhea
  • ●     gas
  • ●     heartburn
  • ●     nausea
  • ●     vomiting
  • ●     dizziness

  • ●     shortness of breath or trouble breathing
  • ●     chest pain
  • ●     weakness in one part or side of your body
  • ●     slurred speech
  • ●     swelling of the face or throat

  • ●     nausea
  • ●     more tired or weaker than usual
  • ●     itching
  • ●     your skin or eyes look yellow
  • ●     stomach pain
  • ●     flu-like symptoms
  • ●     vomit blood
  • ●     there is blood in your bowel movement or it is black and sticky like tar
  • ●     unusual weight gain
  • ●     skin rash or blisters with fever
  • ●     swelling of the arms and legs, hands and feet



  • ●     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.
  • ●     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.










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Meloxicam

Meloxicam

Meloxicam

Meloxicam TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-734(NDC:29300-124)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MELOXICAM MELOXICAM 7.5 mg

Inactive Ingredients

Ingredient Name Strength
CROSPOVIDONE
lactose monohydrate
MAGNESIUM STEARATE
SILICON DIOXIDE
TRISODIUM CITRATE DIHYDRATE
POVIDONE K29/32
cellulose, microcrystalline

Product Characteristics

Color Size Imprint Code Shape
yellow 7 mm U;L;7;5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-734-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077927 2011-08-24


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Be sure to consult your doctor before taking any medication!
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