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

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 greater risk (seeWARNINGSandCLINICAL TRIALS).
  • ●     Meloxicam is contraindicated for the treatment of perioperative 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
WARNINGS: Advanced Renal Disease

Hemodialysis


CLINICAL TRIALS

Osteoarthritis and Rheumatoid Arthritis
The use of meloxicam for the treatment of the signs and symptoms of osteoarthritis of the knee and hip was evaluated in a 12 week double-blind controlled trial. Meloxicam (3.75 mg, 7.5 mg and 15 mg daily) was compared to placebo. The four primary endpoints were investigator's global assessment, patient global assessment, patient pain assessment, and total WOMAC score (a self-administered questionnaire addressing pain, function and stiffness). Patients on meloxicam 7.5 mg daily and meloxicam 15 mg daily showed significant improvement in each of these endpoints compared with placebo.
The use of meloxicam for the management of signs and symptoms of osteoarthritis was evaluated in six double-blind, active-controlled trials outside the U.S. ranging from 4 weeks to 6 months duration. In these trials, the efficacy of meloxicam, in doses of 7.5 mg/day and 15 mg/day, was comparable to piroxicam 20 mg/day and diclofenac SR 100 mg/day and consistent with the efficacy seen in the U.S. trial.
The use of meloxicam for the treatment of the signs and symptoms of rheumatoid arthritis was evaluated in a 12-week double-blind, controlled multinational trial. Meloxicam (7.5 mg, 15 mg and 22.5 mg daily) was compared to placebo. The primary endpoint in this study was the ACR20 response rate, a composite measure of clinical, laboratory and functional measures of RA response. Patients receiving meloxicam 7.5 mg and 15 mg daily showed significant improvement in the primary endpoint compared with placebo. No incremental benefit was observed with the 22.5 mg dose compared to the 15 mg dose.
Higher doses of meloxicam (22.5 mg and greater) have been associated with an increased risk of serious GI events; therefore the daily dose of meloxicam should not exceed 15 mg.

INDICATIONS & USAGE

WARNINGS


MELOXICAM CONTRAINDICATIONS


WARNINGS: Anaphylactoid ReactionsPRECAUTIONS: Preexisting Asthma
WARNINGS

WARNINGS

Cardiovascular Effects

Cardiovascular Thrombotic Events

WARNINGS: Gastrointestinal (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
CONTRAINDICATIONSPRECAUTIONS: Preexisting Asthma

Skin Reactions


Pregnancy


PRECAUTIONS

General



Hepatic Effects



Renal Effects
WARNINGS: Renal EffectsAdvanced Renal Disease


Hematological Effects




Preexisting Asthma


INFORMATION FOR PATIENTS


WARNINGS: Cardiovascular Effects
WARNINGS: Gastrointestinal (GI) Effects: Risk of GI Ulceration, Bleeding, and Perforation



WARNINGS


LABORATORY TESTS



DRUG INTERACTIONS

ACE Inhibitors


Aspirin



Cholestyramine


Cimetidine


Digoxin


Furosemide
WARNINGS: Renal 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

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
5.1

Gastrointestinal Effects
5.2

Hepatotoxicity
5.3

Adverse Skin Reactions
5.8

Weight Gain and Edema
5.5

Anaphylactoid Reactions
5.7

Effects During Pregnancy
5.98.1

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 seri- ous 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 women late in their pregnancy.
  • ●     if you are breastfeeding. Talk to your doctor.


  • ●     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
  • ●     skin rash or blisters with fever
  • ●     unusual weight gain
  • ●     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-theTalk 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:49349-722(NDC:61442-126)
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
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
cellulose, microcrystalline
POVIDONE K30
SODIUM CITRATE

Product Characteristics

Color Size Imprint Code Shape
yellow 8 mm 5 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-722-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077918 2011-08-30


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Be sure to consult your doctor before taking any medication!
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