Pronunciation:

mel-OX-i-kam

Brand Names:

• Mobic
• Qmiiz
• Vivlodex

Dosage Forms:

• Tablet
• Suspension
• Capsule
• Tablet, Disintegrating

Warnings:

NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Meloxicam is contraindicated in the setting of CABG surgery. NSAIDs also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and those with a prior history of peptic ulcer disease or GI bleeding are at a greater risk for serious GI events .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

NSAID

Chemical—

Oxicam

Uses of This Medicine:

Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve the symptoms of arthritis (juvenile rheumatoid arthritis, osteoarthritis, and rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. However, this medicine does not cure arthritis and will only help you as long as you continue to take it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of meloxicam oral liquid or tablets to treat juvenile rheumatoid arthritis in children 2 years of age and older or meloxicam disintegrating tablets in children 2 years of age and older weighing 60 kilograms (kg) or more.

Appropriate studies have not been performed on the relationship of age to the effects of meloxicam capsules in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of meloxicam in the elderly. However, elderly patients are more likely to have serious stomach, heart, or kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Ceritinib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dabrafenib
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Fluconazole
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Inotersen
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Polystyrene Sulfonate
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tocilizumab
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cholestyramine
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Itraconazole
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan
• Voriconazole

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Asthma or
• Bleeding problems or
• Congestive heart failure or
• Dehydration or
• Edema (fluid retention or body swelling) or
• Heart attack, recent or history of or
• Heart or blood vessel disease or
• Hyperkalemia (high blood potassium) or
• Hypertension (high blood pressure) or
• Liver disease or
• Stomach ulcers or bleeding, history of or
• Stroke, history of—Use with caution. May make these conditions worse.

• Aspirin-sensitive asthma or
• Aspirin sensitivity, history of—Should not be used in patients with these conditions.

• Heart surgery (eg, coronary artery bypass graft [CABG])—Meloxicam should not be used for pain right before or after the surgery.

• Kidney disease, severe—Qmiiz™ ODT is not recommended in patients with this condition.

• Phenylketonuria—Qmiiz™ ODT contains aspartame, which can make this condition worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of side effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Shake the oral liquid well before each use. Measure the dose with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the capsule or tablet whole. Do not crush, break, or chew it.

To use the disintegrating tablet:

• Make sure your hands are dry before you handle the tablet.
• Do not open the blister pack that contains the tablet until you are ready to use it.
• Peel back the foil on the blister to remove the tablet. Do not push the tablet through the foil.
• Place the tablet in your mouth or onto your tongue. It should melt quickly. Swallow the melted tablet with or without drinking any liquid.

You may take this medicine with or without food.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. If you refill your medicine and it looks different, check with your pharmacist.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For osteoarthritis:
    • Adults—At first, 5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 10 mg per day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (disintegrating tablets):
  • For juvenile rheumatoid arthritis:
    • Children 2 years of age and older and weighing 60 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is 7.5 milligrams (mg) once a day.
    • Children younger than 2 years of age and weighing less than 60 kg—Use and dose must be determined by your doctor.
  • For osteoarthritis and rheumatoid arthritis:
    • Adults—At first, 7.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 15 mg once a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage forms (suspension or tablets):
  • For juvenile rheumatoid arthritis:
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The dose is 0.125 milligram (mg) per kilogram (kg) of body weight once a day. Your doctor may increase the dose as needed. However, the dose is usually not more than 7.5 mg once a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For osteoarthritis or rheumatoid arthritis:
    • Adults—At first, 7.5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 15 mg once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may increase your risk of having a heart attack, blood clot, or stroke. This is more likely to occur in people who already have heart and blood vessel disease and who are using this medicine for a long time. Check with your doctor right away if you are having chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, slurred speech, or weakness.

Meloxicam may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely to occur if you or your child have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids, blood thinner).

Liver problems may occur while you are using this medicine. Check with your doctor right away if you or your child are having more than one of these symptoms: abdominal or stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Serious side effects can occur during treatment with this medicine and can occur without warning. However, possible warning signs often occur, including severe stomach pain, black tarry stools, vomiting of blood or material that looks like coffee grounds, skin rash, swelling of the face, fingers, feet, or lower legs. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor immediately if you or your child notice any of these warning signs.

Meloxicam may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in skin color of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once. Ask someone to drive you to the nearest hospital emergency room. Call an ambulance, lie down, cover yourself to keep warm, and prop your feet higher than your head. Stay in that position until help arrives.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you or your child are using this medicine.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a delay in ovulation for women and may decrease sperm count in men, which can affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Mobic® oral liquid contains sorbitol which may cause a very serious bowel problem when taken with sodium polystyrene sulfonate (Kayexalate®). Do not take the oral liquid together with Kayexalate®.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Bleeding gums

bloating

blood in the urine

blurred vision

burning upper abdominal or stomach pain

canker sores

chest tightness or heaviness

chills

cloudy urine

cough

cramping

dark urine

decreased frequency or amount of urine

difficult or labored breathing

dilated neck veins

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

general feeling of tiredness and weakness

headache

hives or welts

increased blood pressure

increased sensitivity of the skin to sunlight

increased thirst

irregular breathing

itching, soreness, or redness other discoloration of the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

light-colored stools

loss of appetite

lower side or back pain

noisy breathing

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pinpoint red or purple spots on the skin

pounding in the ears

seizures

severe and continuing nausea

severe sunburn

shakiness in the legs, arms, hands, or feet

skin blisters

sore throat

sores, ulcers, or white spots on the lips or tongue or inside the mouth

stomach bloating, burning, cramping, tenderness, or pain

sweating

swelling or puffiness of the face

swollen glands

trembling or shaking of the hands or feet

unusual bleeding or bruising

upper right abdominal or stomach pain

watery or bloody diarrhea

weight gain or loss

yellow eyes or skin

Rare

Area rash

blistering, peeling, or loosening of the skin

bloody or black, tarry stools

clay-colored stools

cold, clammy skin

continuing vomiting

cough

cracks in the skin

difficulty with swallowing

fast, weak pulse

fever with or without chills

greatly decreased frequency of urination or amount of urine

hoarseness

joint or muscle pain

lightheadedness

loss of heat from the body

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red skin lesions, often with a purple center

red, irritated eyes

scaly skin

severe stomach pain

tightness in the chest

unpleasant breath odor

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

Incidence not known

Difficulty in passing urine (dribbling)

difficulty with speaking

double vision

inability to move the arms, legs, or facial muscles

inability to speak

pains in the chest, groin or legs, especially the calves

severe headache of sudden onset

slow speech

stomach pain, continuing

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

swelling of the feet or lower legs

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blue lips, fingernails, or skin

pain in the chest, upper stomach, or throat

rapid weight gain

severe stomach pain

seizures

slow or fast heartbeat

swelling around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

gas

heartburn

indigestion

Less common

Abnormal dreaming

anxiety

appetite increased

bad, unusual, or unpleasant after taste

belching

bloated or full feeling

burning feeling in the chest or stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning, dry, or itching eyes

change in taste

changes in vision

confusion

constipation

continuing ringing or buzzing or other unexplained noise in the ears

decreased urination

discharge

discouragement

dry mouth

excess air or gas in the stomach

excessive tearing

feeling of constant movement of self or surroundings

feeling sad or empty

general feeling of discomfort or illness

hair loss

hearing loss

hot flushes

irritability

loss of interest or pleasure

nervousness

pain or burning in the throat

rapid breathing

redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid

sensation of spinning

sleepiness

sunken eyes

thinning of the hair

thirst

trouble concentrating

trouble sleeping

wrinkled skin

Incidence not known

Mood changes

trouble getting pregnant

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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