Label: MOBIC- meloxicam 7.5mg tablet

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 23, 2020

If you are a consumer or patient please visit this version.

  • Medication Guide Section

    MEDICATION GUIDE

    Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs)

    What is the most important information I should know about medicines called

    Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?

    NSAIDs can cause serious side effects, including:

    Increased risk of a heart attack or stroke that can lead to death . This risk may happen early in treatment and may increase:

    o with increasing doses of NSAIDs

    o with longer use of NSAIDs

    Do not take NSAIDs right before or after a heart surgery called a "coronary artery

    bypass graft (CABG)."

    Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack 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), stomach and intestines:

    o anytime during use

    o without warning symptoms

    o that may cause death

    The risk of getting an ulcer or bleeding increases with:

    o past history of stomach ulcers, or stomach or intestinal bleeding with use of

    NSAIDs

    o taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs"

    o increasing doses of NSAIDs

    o older age

    o longer use of NSAIDs

    o poor health o smoking

    o advanced liver disease

    o drinking alcohol

    o bleeding problems

    NSAIDs should only be used:

    o exactly as prescribed

    o at the lowest dose possible for your treatment

    o 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 different types of arthritis, menstrual cramps, and other types of short-term pain.

    Who should not take NSAIDs?

    Do not take NSAIDs:

    if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.
    right before or after heart bypass surgery.

    Before taking NSAIDs, 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 healthcare provider 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 medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements.

    NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

    What are the possible side effects of NSAIDs?

    NSAIDs can cause serious side effects, including:

    See "What is the most important information I should know about medicines called

    Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?"

    new or worse high blood pressure
    heart failure
    liver problems including liver failure
    kidney problems including kidney failure
    low red blood cells (anemia)
    life-threatening skin reactions
    life-threatening allergic reactions
    Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas,
    heartburn, nausea, vomiting, and dizziness.

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

    shortness of breath or trouble breathing

    slurred speech
    chest pain
    swelling of the face or throat
    weakness in one part or side of your body

    Stop taking your NSAID and call your healthcare provider right away if you get any

    of the following symptoms:

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

    If you take too much of your NSAID, call your healthcare provider or get medical

    help right away.

    These are not 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 may report side effects to

    FDA at 1-800-FDA-1088.

    Other information about NSAIDs:

    Aspirin is an NSAID 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 NSAIDs 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.

    General information about the safe and effective use of NSAIDs Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

    Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.

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

    This product's label may have been updated. For current full prescribing information,

    please visit www.zydususa.com.

  • Dosage and Administration Section

    2 DOSAGE AND ADMINISTRATION

    2.1 General Dosing Instructions

    Carefully consider the potential benefits and risks of meloxicam tablets and other treatment options before deciding to use meloxicam tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5)].

    After observing the response to initial therapy with meloxicam tablets, adjust the dose to suit an individual patient's needs.

    In adults, the maximum recommended daily oral dose of meloxicam tablets are 15 mg regardless of formulation. In patients with hemodialysis, a maximum daily dosage of 7.5 mg is recommended [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

    Meloxicam tablets may be taken without regard to timing of meals.

    2.2 Osteoarthritis

    For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

    2.3 Rheumatoid Arthritis

    For the relief of the signs and symptoms of rheumatoid arthritis, the recommended starting and maintenance oral dose of meloxicam tablets is 7.5 mg once daily. Some patients may receive additional benefit by increasing the dose to 15 mg once daily.

    2.4 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

    For the treatment of juvenile rheumatoid arthritis, the recommended oral dose of meloxicam tablets is 7.5 mg once daily in children who weigh ≥60 kg. There was no additional benefit demonstrated by increasing the dose above 7.5 mg in clinical trials.

    Meloxicam tablets should not be used in children who weigh <60 kg.

    2.5 Renal Impairment

    The use of meloxicam in subjects with severe renal impairment is not recommended.

    In patients on hemodialysis, the maximum dosage of meloxicam is 7.5 mg per day [see Clinical Pharmacology (12.3)].

    2.6 Non-Interchangeability with Other Formulations of Meloxicam

    Meloxicam tablets have not shown equivalent systemic exposure to other approved formulations of oral meloxicam. Therefore, meloxicam tablets are not interchangeable with other formulations of oral meloxicam product even if the total milligram strength is the same. Do not substitute similar dose strengths of meloxicam tablets with other formulations of oral meloxicam product.

  • Indications and Usage Section

    1 INDICATIONS AND USAGE

    1.1 Osteoarthritis (OA)

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

    1.2 Rheumatoid Arthritis (RA)

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

    1.3 Juvenile Rheumatoid Arthritis (JRA) Pauciarticular and Polyarticular Course

    Meloxicam tablets are indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients who weigh ≥60 kg [see Dosage and Administration (2.4) and Clinical Studies (14.2)].

  • Contraindications Section

    4 CONTRAINDICATIONS

    Meloxicam is contraindicated in the following patients:

    Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to meloxicam or any components of the drug product [see Warnings and Precautions (5.7, 5.9) ]
    History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7,5.8) ]
    In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions (5.1) ]

  • Package Label Principal Display Panel

    Meloxicam 7.5mg

  • INGREDIENTS AND APPEARANCE
    MOBIC 
    meloxicam 7.5mg tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0042(NDC:68382-050)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL) MELOXICAM7.5 mg
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize6mm
    FlavorImprint Code ZC;25
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0042-390 in 1 BOTTLE; Type 0: Not a Combination Product07/19/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07792107/19/2006
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0042)