Label: MOBIC- meloxicam 7.5mg tablet
- NDC Code(s): 80425-0043-3
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 69097-158
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated October 23, 2020
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Medication Guide Section
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:
with increasing doses of NSAIDs
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:
anytime during use
without warning symptoms
that may cause death
The risk of getting an ulcer or bleeding increases with:
○ past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
○ older age
○ taking medicines called “corticosteroids”, “anticoagulants”, “SSRIs”, or “SNRIs”
○ poor health
○ increasing doses of NSAIDs
○ advanced liver disease
○ longer use of NSAIDs
○ bleeding problems
○ drinking alcohol
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 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.
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
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:
● there is blood in your bowel movement or it is black
● more tired or weaker than usual
● vomit blood
● there is blood in your bowel movement or it is black and sticky like tar
● 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.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Instructions
Carefully consider the potential benefits and risks of meloxicam and other treatment options before deciding to use meloxicam. 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, adjust the dose to suit an individual patient's needs.
In adults, the maximum recommended daily oral dose of meloxicam is 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 may be taken without regard to timing of meals.
For the relief of the signs and symptoms of osteoarthritis the recommended starting and maintenance oral dose of meloxicam 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 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 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 is indicated for relief of the signs and symptoms of osteoarthritis [see Clinical Studies (14.1)].
1.2 Rheumatoid Arthritis (RA)
Meloxicam is 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 is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in
- Package Label Principal Display Panel
INGREDIENTS AND APPEARANCE
meloxicam 7.5mg tablet
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80425-0043(NDC:69097-158) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MELOXICAM (UNII: VG2QF83CGL) (MELOXICAM - UNII:VG2QF83CGL) MELOXICAM 7.5 mg Product Characteristics Color yellow Score no score Shape ROUND Size 8mm Flavor Imprint Code C;158 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0043-3 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/19/2006 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077929 07/19/2006 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0043)