Meloxicam

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• SPL INDEXING DATA ELEMENTS
• BOXED WARNING
• INDICATIONS & USAGE
• DOSAGE & ADMINISTRATION
• DOSAGE FORMS & STRENGTHS
• MELOXICAM CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• MELOXICAM ADVERSE REACTIONS
• DRUG INTERACTIONS
• USE IN SPECIFIC POPULATIONS
• OVERDOSAGE
• MELOXICAM DESCRIPTION
• CLINICAL PHARMACOLOGY
• NONCLINICAL TOXICOLOGY
• CLINICAL STUDIES
• HOW SUPPLIED
• INFORMATION FOR PATIENTS
• SPL MEDGUIDE
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

SPL INDEXING DATA ELEMENTS

• ●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.(5.1)

• ●Meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.(4.2,5.1)

• ●

• ● INDICATIONS AND USAGE

• ●Rheumatoid Arthritis (RA)(1.2)

• ● DOSAGE AND ADMINISTRATION

• ●Starting dose: 7.5 mg once daily

• ●Dose may be increased to 15 mg once daily

• ● DOSAGE FORMS AND STRENGTHS

• ● CONTRAINDICATIONS

• ●History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs(4.1)

• ●Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery(4.2)

• ● WARNINGS AND PRECAUTIONS

• ●Serious gastrointestinal (GI) adverse events which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at higher risk for GI events, especially the elderly.(5.2)

• ●Elevated liver enzymes, and rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen.(5.3)

• ●New onset or worsening of hypertension. Blood pressure should be monitored closely during treatment.(5.4)

• ●Fluid retention and edema. Should be used with caution in patients with fluid retention or heart failure.(5.5)

• ●Renal papillary necrosis and other renal injury with long-term use. Use with caution in the elderly, those with impaired renal function, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors, or angiotensin II antagonists. The use of meloxicam in patients with severe renal impairment is not recommended.(5.6)

• ●Serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal and can occur without warning. Discontinue meloxicam at first appearance of rash or skin reactions.(5.8)

• ● ADVERSE REACTIONS

• ●Adverse events observed in pediatric studies were similar in nature to the adult clinical trial experience(6.1)

• ●To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• ●Concomitant use of meloxicam and aspirin is not generally recommended because of the potential of increased adverse effect including increased GI bleeding(7.2)

• ●Concomitant use with meloxicam increases lithium plasma levels(7.4)

• ●Concomitant use with NSAIDs may reduce the antihypertensive effect of ACE-inhibitors(7.1)

• ● USE IN SPECIFIC POPULATIONS

• ●Nursing Mothers: Use with caution, as meloxicam may be excreted in human milk(8.3)

• ●

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

DOSAGE FORMS & STRENGTHS

• ●7.5 mg: pastel yellow, round, biconvex, uncoated tablet debossed withC'on one side and79'on the other side.

• ●15 mg: pastel yellow, oblong, biconvex, uncoated tablet debossed withC'on one side and80'on the other side.

• ●

MELOXICAM CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

MELOXICAM ADVERSE REACTIONS

• ●Cardiovascular thrombotic events [seeBoxed WarningandWarnings and Precautions (5.1)]

• ●Gastrointestinal effectsrisk of GI ulceration, bleeding, and perforation [seeBoxed WarningandWarnings and Precautions (5.2)]

• ●Hepatic effects [seeWarnings and Precautions (5.3)]

• ●Hypertension [seeWarnings and Precautions (5.4)]

• ●Congestive heart failure and edema [seeWarnings and Precautions (5.5)]

• ●Renal effects [seeWarnings and Precautions (5.6)]

• ●Anaphylactoid reactions [seeWarnings and Precautions (5.7)]

• ●Adverse skin reactions [seeWarnings and Precautions (5.8)]

• ●

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

8.6 Hepatic Impairment
Warnings and Precautions (5.3) Clinical Pharmacology (12.3)
8.7 Renal Impairment
Dosage and Administration (2.1) Warnings and Precautions (5.6)Clinical Pharmacology (12.3)

OVERDOSAGE

10 OVERDOSAGE

MELOXICAM DESCRIPTION

11 DESCRIPTION

CLINICAL PHARMACOLOGY

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action


12.2 Pharmacodynamics


12.3 Pharmacokinetics





N18581212





































Warnings and Precautions (5.3)Use in Specific Populations (8.6)



Warnings and Precautions (5.6)Use in Specific Populations (8.7)


Dosage and Administration (2.1)Warnings and Precautions (5.6)Use in Specific Populations (8.7)



Drug Interactions (7.2)







Drug Interactions (7.4)

Drug Interactions (7.5)

Drug Interactions (7.7)

NONCLINICAL TOXICOLOGY

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

CLINICAL STUDIES

14 CLINICAL STUDIES

14.1 Osteoarthritis and Rheumatoid Arthritis

HOW SUPPLIED

16 HOW SUPPLIED/STORAGE AND HANDLING

INFORMATION FOR PATIENTS

17 PATIENT COUNSELING INFORMATION

FDA-approved Medication Guide


17.1 Medication Guide


17.2 Cardiovascular Effects

Warnings and Precautions (5.1)
17.3 Gastrointestinal Effects

Warnings and Precautions (5.2
17.4 Hepatotoxicity

Warnings and Precautions (5.3)
17.5 Adverse Skin Reactions

Warnings and Precautions (5.8)
17.6 Weight Gain and Edema

Warnings and Precautions (5.5)
17.7 Anaphylactoid Reactions

Warnings and Precautions (5.7)
17.8 Effects During Pregnancy

Warnings and Precautions (5.9)Use in Specific Populations (8.1)

SPL MEDGUIDE

MEDICATION GUIDE

• ●with longer use of NSAID medicines

• ●in people who have heart disease

• ●

• ●may cause death

• ●

• ●longer use

• ●smoking

• ●drinking alcohol

• ●older age

• ●having poor health

• ●

• ●at the lowest dose possible for your treatment

• ●for the shortest time needed

• ●

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

• ●

• ●for pain right before or after heart bypass surgery

• ●

• ●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 women late in their pregnancy.

• ●if you are breastfeeding. Talk to your doctor.

• ●

• ●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

• ●

• ●constipation

• ●diarrhea

• ●gas

• ●heartburn

• ●nausea

• ●vomiting

• ●dizziness

• ●

• ●chest pain

• ●weakness in one part or side of your body

• ●slurred speech

• ●swelling of the face or throat

• ●

• ●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

• ●

Generic NameTradename

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Meloxicam Meloxicam TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-239(NDC:65862-097) 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 CROSPOVIDONE lactose monohydrate MAGNESIUM STEARATE cellulose, microcrystalline POVIDONE K25 TRISODIUM CITRATE DIHYDRATE Product Characteristics Color Size Imprint Code Shape yellow 8 mm C;79 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-239-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078008 2011-05-03