Mobic meloxicam

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

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

Drug Basics

Brand Name: Mobic

Generic Name: MELOXICAM

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Data Current As Of: 2019-05-20

indications & usage

osteoarthritis (oa)

MOBIC is indicated for reliefof the signs and symptoms of osteoarthritis [see ClinicalStudies (14.1)].

rheumatoid arthritis (ra)

MOBIC is indicated for relief of the signsand symptoms of rheumatoid arthritis [see Clinical Studies(14.1)].

juvenile rheumatoidarthritis (jra) pauciarticular & polyarticular course

MOBIC isindicated for relief of the signs and symptoms of pauciarticular orpolyarticular course Juvenile Rheumatoid Arthritis in patients whoweigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].

patient counseling information

Advise the patient to read the FDA-approvedpatient labeling (Medication Guide) that accompanies each prescriptiondispensed.

Informpatients, families or their caregivers of the following informationbefore initiating therapy with an NSAID and periodically during thecourse of ongoing therapy.

Cardiovascular Thrombotic Events

Advise patientsto be alert for the symptoms of cardiovascular thrombotic events,including chest pain, shortness of breath, weakness, or slurring ofspeech, and to report any of these symptoms to their healthcare providerimmediately [see Warnings and Precautions (5.1)].

Gastrointestinal Bleeding, Ulceration,and Perforation

Advise patients to report symptoms of ulcerationsand bleeding, including epigastric pain, dyspepsia, melena, and hematemesisto their healthcare provider. In the setting of concomitant use oflow-dose aspirin for cardiac prophylaxis, inform patients of the increasedrisk for the signs and symptoms of GI bleeding [see Warningsand Precautions (5.2)].

Hepatotoxicity

Inform patientsof the warning signs and symptoms of hepatotoxicity (e.g., nausea,fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadranttenderness, and "flu‑like" symptoms). If these occur, instruct patientsto stop MOBIC and seek immediate medical therapy [see Warningsand Precautions (5.3)].

Heart Failure andEdema

Advise patients to be alert for the symptoms of congestive heartfailure including shortness of breath, unexplained weight gain, oredema and to contact their healthcare provider if such symptoms occur[see Warnings and Precautions (5.5)].

Anaphylactic Reactions

Inform patients of the signs of an anaphylacticreaction (e.g., difficulty breathing, swelling of the face or throat).Instruct patients to seek immediate emergency help if these occur[see Contraindications (4)and Warnings and Precautions (5.7)].

Serious Skin Reactions

Advise patients to stop MOBIC immediatelyif they develop any type of rash and to contact their healthcare provideras soon as possible [see Warnings and Precautions (5.9)].

Female Fertility

Advise females of reproductivepotential who desire pregnancy that NSAIDs, including MOBIC, may beassociated with a reversible delay in ovulation [see Use inSpecific Populations (8.3)].

FetalToxicity

Inform pregnant women to avoid use of MOBIC and other NSAIDs startingat 30 weeks gestation because of the risk of the premature closingof the fetal ductus arteriosus [see Warnings and Precautions(5.10) and Use in Specific Populations(8.1)].

Avoid Concomitant Use of NSAIDs

Inform patientsthat the concomitant use of MOBIC with other NSAIDs or salicylates(e.g., diflunisal, salsalate) is not recommended due to the increasedrisk of gastrointestinal toxicity, and little or no increase in efficacy[see Warnings and Precautions (5.2) and Drug Interactions (7)]. Alert patients that NSAIDs may be present in “over the counter”medications for treatment of colds, fever, or insomnia.

Use of NSAIDs andLow-Dose Aspirin

Inform patients not to use low-dose aspirinconcomitantly with MOBIC until they talk to their healthcare provider[see Drug Interactions (7)].

For current prescribinginformation, scan the code below or call Boehringer Ingelheim Pharmaceuticals,Inc. at 1-800-542-6257 or TTY 1-800-459-9906.

mobic qr code.jpg

Distributed by:   BoehringerIngelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Licensed from: Boehringer IngelheimInternational GmbH

Copyright 2016 Boehringer Ingelheim International GmbH
ALL RIGHTS RESERVED

090340141/11
OT1407KF302016

This Medication Guide has been approved by the U.S. Food and DrugAdministration. Revised: May 2016
Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
What is themost important information I should know about medicines called NonsteroidalAnti-inflammatory Drugs (NSAIDs)?
NSAIDs cancause serious side effects, including:
  • Increased risk of a heart attack or stroke that canlead to death. This risk may happen early in treatment andmay increase:
    • with increasing doses of NSAIDs
    • with longer use of NSAIDs

    Do not take NSAIDs right before or after a heart surgerycalled a “coronary artery bypass graft (CABG).”
    Avoid taking NSAIDs after a recent heart attack, unless your healthcareprovider tells you to. You may have an increased risk of another heartattack if you take NSAIDs after a recent heart attack.

  • Increased risk of bleeding, ulcers, and tears (perforation)of the esophagus (tube leading from the mouth to the stomach), stomachand intestines:
    • anytime during use
    • without warning symptoms
    • that may cause death

    The risk of gettingan ulcer or bleeding increases with:

    • past history of stomach ulcers, or stomach or intestinalbleeding with use of NSAIDs
    • taking medicines called “corticosteroids”, “anticoagulants”,“SSRIs”, or “SNRIs”
    • increasing doses of NSAIDs
    • longer use of NSAIDs
    • smoking
    • drinking alcohol
    • older age
    • poor health
    • advanced liver disease
    • bleeding problems
      NSAIDs should only be used:
    • exactly as prescribed
    • at the lowest dose possible for your treatment
    • for the shortest time needed
What are NSAIDs?
NSAIDs are used to treat pain and redness, swelling,and heat (inflammation) from medical conditions such as differenttypes of arthritis, menstrual cramps, and other types of short-termpain.
Who shouldnot take NSAIDs?
Do not take NSAIDs:
  • if you have had an asthma attack, hives, or other allergicreaction with aspirin or any other NSAIDs.
  • right before or after heart bypass surgery.
Before takingNSAIDs, tell your healthcare provider about all of your medical conditions,including if you:
  • have liver or kidney problems
  • have high blood pressure
  • have asthma
  • are pregnant or plan to become pregnant. Talk to your healthcareprovider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy.
  • are breastfeeding or plan to breast feed.

Tell your healthcare provider about all of the medicinesyou take, including prescription or over-the-counter medicines, vitaminsor herbal supplements. NSAIDs and some other medicines caninteract with each other and cause serious side effects. Donot start taking any new medicine without talking to your healthcareprovider first.

What are thepossible side effects of NSAIDs?
NSAIDs cancause serious side effects, including:
See“What is the most important information I should know about medicinescalled Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

Get emergency help right away if you get any of the followingsymptoms:

  • 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

Stop taking your NSAID and call your healthcare providerright away if you get any of the following symptoms:

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

If you take too much of your NSAID, call your healthcareprovider or get medical help right away.
These arenot all the possible side effects of NSAIDs. For more information,ask your healthcare provider or pharmacist about NSAIDs.
Call your doctor for medical advice about side effects. You mayreport side effects to FDA at 1-800-FDA-1088.

Other informationabout NSAIDs:
  • Aspirin is an NSAID but it does not increase the chanceof a heart attack. Aspirin can cause bleeding in the brain, stomach,and intestines. Aspirin can also cause ulcers in the stomach and intestines.
  • Some NSAIDs are sold in lower doses without a prescription(over-the-counter). Talk to your healthcare provider before usingover-the-counter NSAIDs for more than 10 days.

General informationabout the safe and effective use of NSAIDs
Medicinesare sometimes prescribed for purposes other than those listed in aMedication Guide. Do not use NSAIDs for a condition for which it wasnot prescribed. Do not give NSAIDs to other people, even if they havethe same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with yourhealthcare provider. You can ask your pharmacist or healthcare providerfor information about NSAIDs that is written for health professionals.

Distributed by:Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA

Licensed from: Boehringer Ingelheim International GmbH

Boehringer Ingelheim Pharmaceuticals, Inc. either ownsor uses the trademark Mobic® under license. The other trademarks referencedare owned by third parties not affiliated with Boehringer IngelheimPharmaceuticals, Inc.

Copyright 2016 BoehringerIngelheim International GmbH
ALL RIGHTSRESERVED

090340141/11
OT1407KF302016

Mobic® (meloxicam) Tablets Label
7.5 mg/100 Tablets
NDC: 0597­0029­01

0597 0029 01.jpg

Mobic® (meloxicam) Tablets Label
15 mg/100 Tablets
NDC: 0597­0030­01

0597 0030 01.jpg

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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