mel-OX-i-kam

Commonly used brand name(s)

In the U.S.

• Mobic

Available Dosage Forms:

• Tablet
• Suspension

Therapeutic Class: Analgesic

Pharmacologic Class: NSAID

Chemical Class: Oxicam

Uses For meloxicam

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, meloxicam does not cure arthritis and will only help you as long as you continue to take it.

meloxicam is available only with your doctor's prescription.

Before Using meloxicam

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 meloxicam, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to meloxicam 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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of meloxicam in children with juvenile rheumatoid arthritis 2 years of age and older.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of meloxicam in the elderly. Caution should be used in elderly patients who are taking meloxicam because they may be at greater risk for serious gastrointestinal (GI) problems.

Pregnancy

Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Interactions with 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 meloxicam, 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 meloxicam 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 meloxicam 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
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Beta Glucan
• Bivalirudin
• Ceritinib
• Certoparin
• Cilostazol
• Citalopram
• Clopidogrel
• Clovoxamine
• Cyclosporine
• Dabigatran Etexilate
• Dabrafenib
• Dalteparin
• Danaparoid
• Desirudin
• Dipyridamole
• Duloxetine
• Edoxaban
• Enoxaparin
• Eptifibatide
• Erlotinib
• Escitalopram
• Femoxetine
• Feverfew
• Flesinoxan
• Fluoxetine
• Fondaparinux
• Ginkgo
• Gossypol
• Heparin
• Lepirudin
• Levomilnacipran
• Meadowsweet
• Methotrexate
• Milnacipran
• Nadroparin
• Nefazodone
• Nitisinone
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Pralatrexate
• Prasugrel
• Protein C
• Reviparin
• Rivaroxaban
• Sibutramine
• Tacrolimus
• Ticlopidine
• Tinzaparin
• Tirofiban
• Venlafaxine
• Vilazodone
• Vortioxetine
• Zimeldine

Using meloxicam 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
• Alacepril
• Alprenolol
• Amiloride
• Amlodipine
• Arotinolol
• Atenolol
• Azilsartan Medoxomil
• Azosemide
• Befunolol
• Bemetizide
• Benazepril
• Bendroflumethiazide
• Benzthiazide
• Bepridil
• Betaxolol
• Bevantolol
• Bisoprolol
• Bopindolol
• Bucindolol
• Bumetanide
• Bupranolol
• Buthiazide
• Candesartan Cilexetil
• Canrenoate
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Chlorothiazide
• Chlorpropamide
• Chlorthalidone
• Cholestyramine
• Cilazapril
• Clopamide
• Cyclopenthiazide
• Delapril
• Desvenlafaxine
• Dilevalol
• Diltiazem
• Enalaprilat
• Enalapril Maleate
• Eprosartan
• Esmolol
• Ethacrynic Acid
• Felodipine
• Fluconazole
• Flunarizine
• Fosinopril
• Furosemide
• Gallopamil
• Glimepiride
• Glipizide
• Glyburide
• Hydrochlorothiazide
• Hydroflumethiazide
• Imidapril
• Indapamide
• Irbesartan
• Isradipine
• Itraconazole
• Labetalol
• Lacidipine
• Landiolol
• Levobunolol
• Lidoflazine
• Lisinopril
• Lithium
• Losartan
• Manidipine
• Mepindolol
• Methyclothiazide
• Metipranolol
• Metolazone
• Metoprolol
• Moexipril
• Nadolol
• Nateglinide
• Nebivolol
• Nicardipine
• Nifedipine
• Nilvadipine
• Nimodipine
• Nipradilol
• Nisoldipine
• Nitrendipine
• Olmesartan Medoxomil
• Oxprenolol
• Penbutolol
• Pentopril
• Perindopril
• Pindolol
• Piretanide
• Polythiazide
• Pranidipine
• Propranolol
• Quinapril
• Ramipril
• Repaglinide
• Sotalol
• Spirapril
• Spironolactone
• Talinolol
• Tasosartan
• Telmisartan
• Temocapril
• Tertatolol
• Timolol
• Tolazamide
• Tolbutamide
• Torsemide
• Trandolapril
• Triamterene
• Trichlormethiazide
• Valsartan
• Verapamil
• Voriconazole
• Warfarin
• Xipamide
• Zofenopril

Interactions with Food/Tobacco/Alcohol

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 meloxicam. 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, history of or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Kidney disease 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 (e.g., coronary artery bypass graft [CABG])—Meloxicam should not be used for pain right before or after the surgery.

Proper Use of meloxicam

For safe and effective use of meloxicam, 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 meloxicam may increase the chance of side effects.

meloxicam should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

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.

You may take meloxicam with or without food.

Dosing

The dose of meloxicam 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 meloxicam. 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 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 meloxicam, 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 meloxicam

It is very important that your doctor check the progress of you or your child at regular visits to make sure that meloxicam is working properly. Blood tests may be needed to check for unwanted effects.

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

Meloxicam may cause bleeding in your stomach or intestines. 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 (such as steroids or a blood thinner).

Liver problems may occur while you are using meloxicam. Stop using meloxicam and 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.

Serious side effects can occur during treatment with meloxicam. Sometimes serious side effects can occur without warning. However, possible warning signs often occur, including severe stomach pain, tarry stools, and/or vomiting of blood or material that looks like coffee grounds; skin rash; swelling of the face, fingers, feet, and/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 skin. Stop taking meloxicam and 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, wheezing, 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 meloxicam. 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 meloxicam.

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

meloxicam may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using meloxicam.

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

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.

meloxicam Side Effects

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

• Arm, back, or jaw pain
• 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 tiredness and weakness
• headache
• hives or welts
• increased blood pressure
• increased sensitivity of the skin to sunlight
• increased thirst
• irregular breathing
• itching, redness, or other discoloration of the skin
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• 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
• redness, soreness, or itching skin
• 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
• sores, welting, or blisters
• stomach bloating, burning, cramping, tenderness, or pain
• sweating
• swelling or puffiness of the face
• swollen glands
• trembling or shaking of the hands or feet
• trouble with breathing
• 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 , tarry stools
• clay-colored stools
• cold, clammy skin
• continuing vomiting
• cough or hoarseness
• cracks in the skin
• difficulty with swallowing
• fast, weak pulse
• fever with or without chills
• greatly decreased frequency of urination or amount of urine
• 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
• red, swollen skin
• scaly skin
• severe stomach pain
• shortness of breath
• tightness in the chest
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• wheezing

Incidence not known

• 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 headaches of sudden onset
• slow speech
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes

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

Symptoms of overdose

• Blue lips, fingernails, or skin
• convulsions (seizures)
• pain in the chest, upper stomach, or throat
• severe stomach pain
• skin rash
• slow or fast heartbeat
• swelling around the eyes, face, lips, or tongue
• weight gain (rapid)

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 or rare

• Abdominal or stomach pain
• 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
• nausea or vomiting
• 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
• stomach upset
• sunken eyes
• tenderness in the stomach area
• thinning of the hair
• thirst
• tiredness
• trouble concentrating
• trouble sleeping
• wrinkled skin

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.

See also: Side effects (in more detail)

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Usual Adult Dose for Osteoarthritis

Initial dose: 7.5 mg orally once daily
Maintenance dose: 7.5 mg orally once daily
Maximum dose: 15 mg orally daily

Usual Adult Dose for Rheumatoid Arthritis

Initial dose: 7.5 mg orally once daily
Maintenance dose: 7.5 mg orally once daily
Maximum dose: 15 mg orally daily

Usual Pediatric Dose for Juvenile Rheumatoid Arthritis

Greater than or equal to 2 years: 0.125 mg/kg orally once daily

Maximum dose: 7.5 mg orally daily

There was no additional benefit demonstrated by increasing the dose above 0.125 mg/kg once daily in clinical trials.

Renal Dose Adjustments

No dosage adjustment is necessary in patients with mild to moderate renal failure.

CrCl less than 20 mL/min: Patients with severe renal impairment have not been adequately studied; use is not recommended.

Liver Dose Adjustments

No dosage adjustment is necessary in patients with mild to moderate (Child-Pugh A and B) hepatic insufficiency.

Patients with severe hepatic impairment have not been adequately studied.

Dose Adjustments

Some patients may obtain additional benefit by increasing the dose to 15 mg once daily.

Precautions

Caution should be exercised when administering meloxicam to patients 65 years old or older.

Safety and effectiveness have not been established in pediatric patients under the age of 2 years.

Dialysis

Meloxicam is not dialyzable

Other Comments

Meloxicam can be administered without regard to timing of meals or concomitant administration of antacids.

The oral suspension is recommended in the dosing of smaller weight children.

Shake suspension well before using.

Meloxicam Side Effects

General

Meloxicam tablets cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids.

The pharmacological activity of meloxicam tablets in reducing fever and inflammation may diminish the utility of these diagnostic signs in detecting complications of presumed noninfectious, painful conditions.

Hepatic Effects

Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including meloxicam tablets. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported.

A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with meloxicam tablets. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), meloxicam tablets should be discontinued.

Renal Effects

Caution should be used when initiating treatment with meloxicam tablets in patients with considerable dehydration. It is advisable to rehydrate patients first and then start therapy with meloxicam tablets. Caution is also recommended in patients with pre-existing kidney disease (see WARNINGS, Renal Effects, and Advanced Renal Disease).

The extent to which metabolites may accumulate in patients with renal failure has not been studied with meloxicam tablets. Because some meloxicam tablets metabolites are excreted by the kidney, patients with significantly impaired renal function should be more closely monitored.

Hematological Effects

Anemia is sometimes seen in patients receiving NSAIDs, including meloxicam tablets. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including meloxicam tablets, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia.

Drugs which inhibit the biosynthesis of prostaglandins may interfere to some extent with platelet function and vascular responses to bleeding.

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving meloxicam tablets who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored.

Pre-existing Asthma

Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirinsensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, meloxicam tablets should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with pre-existing asthma.

Information For Patients

Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

1. Meloxicam tablets, like other NSAIDs, 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, Cardiovascular Effects).
2. Meloxicam tablets, like other NSAIDs, 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, Gastrointestinal (GI) Effects - Risk of GI Ulceration, Bleeding, and Perforation).
3. Meloxicam tablets, like other NSAIDs, can cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations 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. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.
4. Patients should promptly report signs or symptoms of unexplained weight gain or edema to their physicians.
5. Patients should be informed 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, patients should be instructed to stop therapy and seek immediate medical therapy.
6. Patients should be informed of the signs of an anaphylactoid reaction (e.g., difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (see WARNINGS).
7. In late pregnancy, as with other NSAIDs, meloxicam tablets should be avoided because it will cause premature closure of the ductus arteriosus.

Laboratory Tests

Because serious GI tract ulcerations and bleeding can occur without warning symptoms, physicians should monitor for signs or symptoms of GI bleeding. Patients on long-term treatment with NSAIDs should have their CBC and a chemistry profile checked periodically. If clinical signs and symptoms consistent with liver or renal disease develop, systemic manifestations occur (e.g., eosinophilia, rash, etc.) or if abnormal liver tests persist or worsen, meloxicam tablets should be discontinued.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No carcinogenic effect of meloxicam was observed in rats given oral doses up to 0.8 mg/kg/day (approximately 0.4-fold the human dose at 15 mg/day for a 50 kg adult based on body surface area conversion) for 104 weeks or in mice given oral doses up to 8.0 mg/kg/day (approximately 2.2-fold the human dose, as noted above) for 99 weeks.

Meloxicam was not mutagenic in an Ames assay, or clastogenic in a chromosome aberration assay with human lymphocytes and an in vivo micronucleus test in mouse bone marrow.

Meloxicam did not impair male and female fertility in rats at oral doses up to 9 and 5 mg/kg/day, respectively (4.9-fold and 2.5-fold the human dose, as noted above). However, an increased incidence of embryolethality at oral doses ≥ 1 mg/kg/day (0.5-fold the human dose, as noted above) was observed in rats when dams were given meloxicam 2 weeks prior to mating and during early embryonic development.

Pregnancy

Teratogenic Effects

Pregnancy Category C.

Meloxicam caused an increased incidence of septal defect of the heart, a rare event, at an oral dose of 60 mg/kg/day (64.5-fold the human dose at 15 mg/day for a 50 kg adult based on body surface area conversion) and embryolethality at oral doses ≥ 5 mg/kg/day (5.4-fold the human dose, as noted above) when rabbits were treated throughout organogenesis. Meloxicam was not teratogenic in rats up to an oral dose of 4 mg/kg/day (approximately 2.2-fold the human dose, as noted above) throughout organogenesis. An increased incidence of stillbirths was observed when rats were given oral doses ≥ 1 mg/kg/day throughout organogenesis. Meloxicam crosses the placental barrier. There are no adequate and well-controlled studies in pregnant women. Meloxicam tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects

Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.

Meloxicam caused a reduction in birth index, live births, and neonatal survival at oral doses ≥ 0.125 mg/kg/day (approximately 0.07-fold the human dose at 15 mg/day for a 50 kg adult based on body surface area conversion) when rats were treated during the late gestation and lactation period. No studies have been conducted to evaluate the effect of meloxicam on the closure of the ductus arteriosus in humans; use of meloxicam during the third trimester of pregnancy should be avoided.

Labor And Delivery

Studies in rats with meloxicam, as with other drugs known to inhibit prostaglandin synthesis, showed an increased incidence of stillbirths, prolonged delivery, and delayed parturition at oral dosages ≥ 1 mg/kg/day (approximately 0.5-fold the human dose at 15 mg/day for a 50 kg adult based on body surface area conversion), and decreased pup survival at an oral dose of 4 mg/kg/day (approximately 2.1-fold the human dose, as noted above) throughout organogenesis. Similar findings were observed in rats receiving oral dosages ≥ 0.125 mg/kg/day (approximately 0.07-fold the human dose, as noted above) during late gestation and the lactation period. The effects of meloxicam tablets on labor and delivery in pregnant women are unknown.

Nursing Mothers

It is not known whether this drug is excreted in human milk however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma.

Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from meloxicam tablets, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Use of this drug product for a pediatric indication is protected by marketing exclusivity.

Geriatric Use

As with any NSAID, caution should be exercised in treating the elderly (65 years and older).