Meloxicam TABLET

Get an overview of MELOXICAM (tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Meloxicam can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Meloxicam.

Drug Basics

Brand Name: Meloxicam

Generic Name: MELOXICAM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Packager: PD-Rx Pharmaceuticals, Inc.

Data Current As Of: 2021-04-19

Indications & Usage

Meloxicam is a non-steroidal anti-inflammatory drug indicated for:

  • Osteoarthritis (OA) ( 1.1)
  • Rheumatoid Arthritis (RA) ( 1.2)
  • Juvenile Rheumatoid Arthritis (JRA) in patients 2 years of age or older ( 1.3)

osteoarthritis (oa)

Meloxicam tablets, USP is indicated for relief of the signs and symptoms of osteoarthritis [ see Clinical Studies ( 14.1) ].

rheumatoid arthritis (ra)

Meloxicam tablets, USP is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see Clinical Studies ( 14.1) ].

juvenile rheumatoid arthritis (jra) pauciarticular & polyarticular course

Meloxicam tablets, USP is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years of age and older [ see Clinical Studies ( 14.2) ].

Patient Counseling Information

See FDA-approved Medication Guide

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy.

medication guide

Inform patients of the availability of a Medication Guide for NSAIDs that accompanies each prescription dispensed, and instruct them to read the Medication Guide prior to using meloxicam.

cardiovascular effects

NSAIDs including meloxicam may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [ see Warnings and Precautions ( 5.1) ].

gastrointestinal effects

NSAIDs including meloxicam, can cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up [ see Warnings and Precautions ( 5.2) ].

hepatotoxicity

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, instruct patients to stop therapy and seek immediate medical therapy [ see Warnings and Precautions ( 5.3) ].

adverse skin reactions

NSAIDs, including meloxicam, can cause serious skin side effects such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which may result in hospitalization and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Advise patients to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible [ see Warnings and Precautions ( 5.8) ].

weight gain & edema

Advise patients to promptly report signs or symptoms of unexplained weight gain or edema to their physicians [ see Warnings and Precautions ( 5.5) ].

anaphylactoid reactions

Inform patients of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). Instruct patients seek immediate emergency help [ see Warnings and Precautions ( 5.7) ].

effects during pregnancy

Starting at 30 weeks gestation, meloxicam should be avoided as premature closure of the ductus arteriosus in the fetus may occur [see Warnings and Precautions ( 5.9) and Use in Specific Populations ( 8.1)].

effects on female fertility

Advise females of reproductive potential who desire pregnancy that NSAIDs, including Meloxicam, may be associated with a reversible delay in ovulation For women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended [ see Use in Specific Populations 8.8) ].

Please address medical inquiries to 1-760-431-8284

Manufactured by:
Yung Shin Pharmaceutical Ind. Co., Ltd.

Tachia, Taichung 43769
TAIWAN

Distributed by:

Carlsbad Technology, Inc.

5923 Balfour Ct.
Carlsbad, CA 92008 USA

Revised: 08/13

MEDICATION GUIDE

MELOXICAM Tablets, USP

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
(See the end of this Medication Guide for a list of prescription NSAID medicines.)

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. This chance increases:

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

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • can happen without warning symptoms
  • may cause death

The chance of a person getting an ulcer or bleeding increases with:

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

NSAID medicines should only be used:

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

What are Non-Steroidal Anti- Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

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

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

Tell your healthcare provider:

  • 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.

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

Serious side effects include:

Other side effects include:

Get emergency help right away if you have any of the following symptoms:

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  • 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

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

  • 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.

NSAID medicines that need a prescription

Generic Name   Tradename
 Celecoxib

 Celebrex

 Diclofenac  Cataflam, Voltaren, Arthrotec (combined with misoprostol)
 Diflunisal  Dolobid
 Etodolac  Lodine, Lodine XL
 Fenoprofen  Nalfon, Nalfon 200
 Flurbiprofen  Ansaid
 Ibuprofen  Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
 Indomethacin  Indocin, Indocin SR, Indo-Lemmon, Indomethagan
 Ketoprofen  Oruvail
 Ketorolac  Toradol
 Mefenamic Acid  Ponstel
 Meloxicam  Mobic
 Nabumetone  Relafen
 Naproxen  Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan, Naprapac (co-packaged with lansoprazole)
 Oxaprozin  Daypro
 Piroxicam  Feldene
 Sulindac  Clinoril
 Tolmetin  Tolectin, Tolectin DS, Tolectin 600

*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAID label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured by:
Yung Shin Pharmaceutical Ind. Co., Ltd.

Tachia, Taichung 43769
TAIWAN

Distributed by:
Carlsbad Technology, Inc.

5923 Balfour Ct.
Carlsbad, CA 92008 USA

Revised: 08/13

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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