Side effects, dosage, uses, and more

1. Meloxicam oral tablet is available as both a generic and brand-name drug. Brand name: Mobic.
2. Meloxicam comes in three forms: an oral tablet, an injection, and an oral capsule.
3. Meloxicam oral tablets are nonsteroidal anti-inflammatory drugs (NSAIDs). They’re used to treat pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

Meloxicam is a prescription drug. It comes in three forms: an oral tablet, an injection, and an oral capsule.

Meloxicam oral tablet is available as the brand-name drug Mobic.

Meloxicam oral tablet is also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Why it’s used

Meloxicam decreases inflammation and pain. It’s approved to treat:

• osteoarthritis
• rheumatoid arthritis
• juvenile idiopathic arthritis (JIA) in children ages 2 years and older

How it works

Meloxicam belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs help reduce pain, inflammation, and fever.

It isn’t known how this medication works to decrease pain. It may help reduce swelling by lowering levels of prostaglandin, a hormone-like substance that usually causes inflammation.

Meloxicam can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking meloxicam. This list does not include all possible side effects.

For more information on the possible side effects of meloxicam, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects that can occur with meloxicam include:

• abdominal pain
• diarrhea
• indigestion or heartburn
• nausea
• dizziness
• headache
• itching or rash

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Heart attack. Symptoms can include:
  • chest pain or discomfort
  • trouble breathing
  • cold sweat
  • pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or area above your belly button
• Stroke. Symptoms can include:
  • numbness or weakness of your face, arm, or leg on one side of your body
  • sudden confusion
  • trouble speaking or understanding speech
  • vision problems in one or both eyes
  • trouble walking or loss of balance or coordination
  • dizziness
  • severe headache with no other cause
• Stomach and intestinal problems, such as bleeding, ulcers, or tearing. Symptoms can include:
  • severe stomach pain
  • vomiting blood
  • bloody stools
  • black, sticky stools
• Liver damage. Symptoms can include:
  • dark urine or pale stools
  • nausea
  • vomiting
  • not wanting to eat
  • pain in your stomach area
  • yellowing of your skin or whites of your eyes
• Increased blood pressure: Symptoms of extreme high blood pressure can include:
  • dull headache
  • dizzy spells
  • nosebleeds
• Water retention or swelling. Symptoms can include:
  • rapid weight gain
  • swelling in your hands, ankles, or feet
• Skin problems, such as blistering, peeling, or red skin rash
• Kidney damage. Symptoms can include:
  • changes in how much or how often you urinate
  • pain with urination
  • Decreased red blood cells (anemia)

GASTROINTESTINAL SIDE EFFECTS
Abdominal pain, diarrhea, upset stomach, and nausea occur very often with this drug. Pain, vomiting, and diarrhea may occur more often in children than adults. Sometimes these side effects can cause more serious stomach problems.

Was this helpful?

If you or your child has these side effects and they bother you or don’t go away, talk to your doctor.

Meloxicam oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with meloxicam. This list does not contain all drugs that may interact with meloxicam.

Before taking meloxicam, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Antidepressants and anxiety drugs

Taking meloxicam with certain antidepressant and anxiety medications raises your risk of bleeding. Examples of these drugs include:

• selective serotonin reuptake inhibitors, such as citalopram
• selective serotonin and norepinephrine reuptake inhibitors, such as venlafaxine

Corticosteroids

Taking meloxicam with corticosteroids can increase your risk of stomach ulcers or bleeding. Examples of these drugs include:

• prednisone
• dexamethasone

Cancer drug

Taking pemetrexed with meloxicam can increase your risk for infection, kidney problems, and stomach issues.

Transplant drug

Taking cyclosporine with meloxicam can increase the levels of cyclosporine in your body, causing kidney problems. If you take these drugs together, your doctor should monitor your kidney function.

Disease-modifying antirheumatic drug

Taking methotrexate with meloxicam can increase the levels of methotrexate in your body. This can result in kidney problems and an increased risk of infection.

Anticoagulant/blood thinner

Taking warfarin with meloxicam increases your risk of stomach bleeding.

Bipolar disorder medication

Taking lithium with meloxicam can cause amounts of lithium in your blood to increase to dangerous levels. Symptoms of lithium toxicity may include tremors, excessive thirst, or confusion. If you take these drugs together, your doctor may monitor your lithium levels.

Blood pressure drugs

Taking these medications with meloxicam may reduce the blood pressure-lowering effects of these drugs. Examples of these drugs include:

• angiotensin receptor blockers (ARBs), such as candesartan and valsartan
• angiotensin-converting enzyme (ACE) inhibitors, such as benazepril and captopril
• beta blockers, such as propranolol and atenolol

Diuretics (water pills)

Taking certain diuretics with meloxicam can decrease the effect of these drugs. Examples of these diuretics include:

• hydrochlorothiazide
• furosemide

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Meloxicam is an NSAID. Combining it with other NSAIDs may increase your risk of side effects, such as stomach bleeding or ulcers. Examples of NSAIDs include:

• aspirin
• ibuprofen
• naproxen
• etodolac
• diclofenac
• fenoprofen
• ketoprofen
• tolmetin
• indomethacin

The meloxicam dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using meloxicam to treat
• your age
• the form of meloxicam you take
• other medical conditions you may have, such as kidney damage

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Forms and strengths

Generic: Meloxicam

• Form: oral tablet
• Strengths: 7.5 mg, 15 mg

Brand: Mobic

• Form: oral tablet
• Strengths: 7.5 mg, 15 mg

Dosage for osteoarthritis

Adult dosage (ages 18 years and older)

• Typical starting dosage: 7.5 mg taken once per day.
• Maximum dosage: 15 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established. This drug has not been found to be safe and effective in this age group for this condition.

Dosage for rheumatoid arthritis

Adult dosage (ages 18 years and older)

• Typical starting dosage: 7.5 mg taken once per day.
• Maximum dosage: 15 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established. This drug has not been found to be safe and effective in this age group for this condition.

Dosage for juvenile idiopathic arthritis (JIA)

Child dosage (ages 2–17 years)

• Typical starting dosage (130 lbs/60 kg): 7.5 mg once daily.
• Maximum dosage: 7.5 mg per day.

Child dosage (ages 0–1 years)

Dosage for children younger than 2 years hasn’t been established. This drug has not been found to be safe and effective in this age group.

Special dosage considerations

For people receiving hemodialysis: This drug isn’t removed in dialysis. Taking a typical dosage of meloxicam while receiving hemodialysis may cause a buildup of the drug in your blood. This could cause worsened side effects. The maximum daily dose for people ages 18 years and older and receiving hemodialysis is 7. 5 mg per day.

FDA warnings

• This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• Heart risk warning: This drug may increase your risk of developing a blood clot, heart attack, or stroke, which can be fatal. Your risk may be higher if you’re taking it long term, at high doses, or if you already have heart problems or risk factors for heart disease, such as high blood pressure. You shouldn’t take meloxicam for pain before, during, or after coronary artery bypass graft surgery. This can increase your risk for a heart attack or stroke.
• Stomach problems warning: This medication may increase your risk of developing stomach and intestinal problems. These include bleeding, ulcers, and holes in your stomach or intestines, which can be fatal. These effects can occur any time while you’re taking this drug. They may happen without any signs or symptoms. Adults ages 65 years and older are at higher risk of these stomach or intestinal problems.

Was this helpful?

Allergy warning

Don’t take meloxicam if you’ve had itchy skin, symptoms of asthma, or an allergic reaction to aspirin or other NSAIDs. A second reaction could be much more severe.

Liver damage warning

This drug may affect your liver. Symptoms may include yellowing of your skin or whites of your eyes and liver inflammation, damage, or failure. Your doctor may check your liver function while you take this drug.

Blood pressure warning

This medication may increase or worsen your blood pressure. This can increase your risk of heart attack or stroke. Your doctor may check your blood pressure while you’re taking meloxicam. Some medicines for high blood pressure may not work as well as they should when you’re taking meloxicam.

Allergy warning

Meloxicam can cause a severe allergic reaction. Symptoms may include:

• trouble breathing
• swelling of your throat or tongue
• hives

Don’t take meloxicam if you have asthma, runny nose, and nasal polyps (aspirin triad). Don’t take it if you’ve had itching, trouble breathing, or an allergic reaction to aspirin or other NSAIDs.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Multiorgan hypersensitivity/DRESS warning

This medication can cause multiorgan hypersensitivity. This is also known as a drug reaction with eosinophilia and systemic symptoms (DRESS). This syndrome can be life threatening. Call your doctor right away if you have symptoms, such as a rash, a fever, or swollen lymph nodes.

Harm to developing fetus warning

You shouldn’t take meloxicam if you’re pregnant or planning to become pregnant. Meloxicam can cause harm to a developing fetus if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only take this drug if your doctor has told you to. Do not take this drug if you are more than 30 weeks pregnant.

Warnings for people with certain health conditions

For people with heart or blood vessel diseases: This medication increases your risk of blood clots, which can cause a heart attack or stroke. It may also cause fluid retention, which is common with heart failure.

For people with high blood pressure: This medication may make your blood pressure worse, which can increase your risk of having a heart attack or stroke.

For people with stomach ulcer or bleeding: Meloxicam can make these conditions worse. If you have a history of these conditions, you have a higher chance of having them again if you take this medicine.

For people with liver damage: Meloxicam can cause liver disease and changes in your liver function. It may make your liver damage worse.

For people with kidney disease: If you take meloxicam for a long time, it may decrease your kidney function, making your kidney disease worse. Stopping this drug could reverse kidney damage caused by the drug.

For people with asthma: Meloxicam can cause bronchial spasm and difficulty breathing, especially if your asthma gets worse if you take aspirin.

Warnings for other groups

For pregnant women: Using meloxicam during your third trimester of pregnancy increases the risk of negative effects to your pregnancy. You should not take meloxicam after 30 weeks of pregnancy. If you’re pregnant, talk to your doctor. Meloxicam should be used during pregnancy only if the potential benefit justifies the potential risk.

You should also talk to your doctor if you’re trying to get pregnant. Meloxicam can cause a reversible delay in ovulation. If you’re having a hard time getting pregnant or are getting tested for infertility, don’t take meloxicam.

For women who are breastfeeding: It isn’t known if meloxicam passes into breast milk. If it does, it could cause side effects in your child if you breastfeed and take meloxicam. You and your doctor may decide whether you’ll take meloxicam or breastfeed.

For seniors: If you’re age 65 years or older, you may have a higher risk of side effects from meloxicam.

For children: For the treatment of JIA, this drug has been found to be safe and effective for use in children 2 years and older. It should not be used in children younger than 2 years.

For the treatment of other conditions, this drug has not been found to be safe and effective for children of any age. It should not be used in people younger than 18 years.

Meloxicam oral tablet may be used for short-term or long-term treatment. It comes with risks if you don’t take it as prescribed by your doctor.

If you stop taking the drug or don’t take it at all: Your symptoms will remain and may worsen.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• nausea
• vomiting
• stomach pain
• stomach bleeding

Overdosing on meloxicam can cause organ failure or serious heart problems. If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose, take it as soon as you can, However, if it’s just a few hours until your next dose, skip the missed dose and take the next one on time.

Never try to catch up by taking two doses at once. This could result in serious side effects.

How to tell if the drug is working: You should have less pain and inflammation.

Keep these considerations in mind if your doctor prescribes meloxicam oral tablet for you.

General

• You can take meloxicam with or without food. If it upsets your stomach, take it with food or milk.
• You can cut or crush the oral tablet.

Storage

• Store this medication at room temperature, 77°F (25°C). If needed, you can keep it for short periods at temperatures between 59°F and 86°F (15°C and 30°C).
• Keep this medication away from high temperatures.
• Keep your medications away from areas where they could get damp, such as bathrooms.

Refills

A prescription for this medication is refillable.You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

During your treatment with this drug, your doctor may check your:

• blood pressure
• liver function
• kidney function
• red blood cell count to check for anemia

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Side effects, dosage, uses, and more

1. Meloxicam oral tablet is available as both a generic and brand-name drug. Brand name: Mobic.
2. Meloxicam comes in three forms: an oral tablet, an injection, and an oral capsule.
3. Meloxicam oral tablets are nonsteroidal anti-inflammatory drugs (NSAIDs). They’re used to treat pain and inflammation caused by osteoarthritis, rheumatoid arthritis, and juvenile rheumatoid arthritis.

Meloxicam is a prescription drug. It comes in three forms: an oral tablet, an injection, and an oral capsule.

Meloxicam oral tablet is available as the brand-name drug Mobic.

Meloxicam oral tablet is also available as a generic drug. Generic drugs usually cost less than the brand-name version. In some cases, they may not be available in all strengths or forms as the brand-name drug.

Why it’s used

Meloxicam decreases inflammation and pain. It’s approved to treat:

• osteoarthritis
• rheumatoid arthritis
• juvenile idiopathic arthritis (JIA) in children ages 2 years and older

How it works

Meloxicam belongs to a class of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAIDs help reduce pain, inflammation, and fever.

It isn’t known how this medication works to decrease pain. It may help reduce swelling by lowering levels of prostaglandin, a hormone-like substance that usually causes inflammation.

Meloxicam can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking meloxicam. This list does not include all possible side effects.

For more information on the possible side effects of meloxicam, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects that can occur with meloxicam include:

• abdominal pain
• diarrhea
• indigestion or heartburn
• nausea
• dizziness
• headache
• itching or rash

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Heart attack. Symptoms can include:
  • chest pain or discomfort
  • trouble breathing
  • cold sweat
  • pain or discomfort in one or both arms, your back, shoulders, neck, jaw, or area above your belly button
• Stroke. Symptoms can include:
  • numbness or weakness of your face, arm, or leg on one side of your body
  • sudden confusion
  • trouble speaking or understanding speech
  • vision problems in one or both eyes
  • trouble walking or loss of balance or coordination
  • dizziness
  • severe headache with no other cause
• Stomach and intestinal problems, such as bleeding, ulcers, or tearing. Symptoms can include:
  • severe stomach pain
  • vomiting blood
  • bloody stools
  • black, sticky stools
• Liver damage. Symptoms can include:
  • dark urine or pale stools
  • nausea
  • vomiting
  • not wanting to eat
  • pain in your stomach area
  • yellowing of your skin or whites of your eyes
• Increased blood pressure: Symptoms of extreme high blood pressure can include:
  • dull headache
  • dizzy spells
  • nosebleeds
• Water retention or swelling. Symptoms can include:
  • rapid weight gain
  • swelling in your hands, ankles, or feet
• Skin problems, such as blistering, peeling, or red skin rash
• Kidney damage. Symptoms can include:
  • changes in how much or how often you urinate
  • pain with urination
  • Decreased red blood cells (anemia)

GASTROINTESTINAL SIDE EFFECTS
Abdominal pain, diarrhea, upset stomach, and nausea occur very often with this drug. Pain, vomiting, and diarrhea may occur more often in children than adults. Sometimes these side effects can cause more serious stomach problems.

Was this helpful?

If you or your child has these side effects and they bother you or don’t go away, talk to your doctor.

Meloxicam oral tablet can interact with several other medications. Different interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Below is a list of medications that can interact with meloxicam. This list does not contain all drugs that may interact with meloxicam.

Before taking meloxicam, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Antidepressants and anxiety drugs

Taking meloxicam with certain antidepressant and anxiety medications raises your risk of bleeding. Examples of these drugs include:

• selective serotonin reuptake inhibitors, such as citalopram
• selective serotonin and norepinephrine reuptake inhibitors, such as venlafaxine

Corticosteroids

Taking meloxicam with corticosteroids can increase your risk of stomach ulcers or bleeding. Examples of these drugs include:

• prednisone
• dexamethasone

Cancer drug

Taking pemetrexed with meloxicam can increase your risk for infection, kidney problems, and stomach issues.

Transplant drug

Taking cyclosporine with meloxicam can increase the levels of cyclosporine in your body, causing kidney problems. If you take these drugs together, your doctor should monitor your kidney function.

Disease-modifying antirheumatic drug

Taking methotrexate with meloxicam can increase the levels of methotrexate in your body. This can result in kidney problems and an increased risk of infection.

Anticoagulant/blood thinner

Taking warfarin with meloxicam increases your risk of stomach bleeding.

Bipolar disorder medication

Taking lithium with meloxicam can cause amounts of lithium in your blood to increase to dangerous levels. Symptoms of lithium toxicity may include tremors, excessive thirst, or confusion. If you take these drugs together, your doctor may monitor your lithium levels.

Blood pressure drugs

Taking these medications with meloxicam may reduce the blood pressure-lowering effects of these drugs. Examples of these drugs include:

• angiotensin receptor blockers (ARBs), such as candesartan and valsartan
• angiotensin-converting enzyme (ACE) inhibitors, such as benazepril and captopril
• beta blockers, such as propranolol and atenolol

Diuretics (water pills)

Taking certain diuretics with meloxicam can decrease the effect of these drugs. Examples of these diuretics include:

• hydrochlorothiazide
• furosemide

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Meloxicam is an NSAID. Combining it with other NSAIDs may increase your risk of side effects, such as stomach bleeding or ulcers. Examples of NSAIDs include:

• aspirin
• ibuprofen
• naproxen
• etodolac
• diclofenac
• fenoprofen
• ketoprofen
• tolmetin
• indomethacin

The meloxicam dosage your doctor prescribes will depend on several factors. These include:

• the type and severity of the condition you’re using meloxicam to treat
• your age
• the form of meloxicam you take
• other medical conditions you may have, such as kidney damage

Typically, your doctor will start you on a low dosage and adjust it over time to reach the dosage that’s right for you. They’ll ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Forms and strengths

Generic: Meloxicam

• Form: oral tablet
• Strengths: 7.5 mg, 15 mg

Brand: Mobic

• Form: oral tablet
• Strengths: 7.5 mg, 15 mg

Dosage for osteoarthritis

Adult dosage (ages 18 years and older)

• Typical starting dosage: 7.5 mg taken once per day.
• Maximum dosage: 15 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established. This drug has not been found to be safe and effective in this age group for this condition.

Dosage for rheumatoid arthritis

Adult dosage (ages 18 years and older)

• Typical starting dosage: 7.5 mg taken once per day.
• Maximum dosage: 15 mg per day.

Child dosage (ages 0–17 years)

Dosage for people younger than 18 years hasn’t been established. This drug has not been found to be safe and effective in this age group for this condition.

Dosage for juvenile idiopathic arthritis (JIA)

Child dosage (ages 2–17 years)

• Typical starting dosage (130 lbs/60 kg): 7.5 mg once daily.
• Maximum dosage: 7.5 mg per day.

Child dosage (ages 0–1 years)

Dosage for children younger than 2 years hasn’t been established. This drug has not been found to be safe and effective in this age group.

Special dosage considerations

For people receiving hemodialysis: This drug isn’t removed in dialysis. Taking a typical dosage of meloxicam while receiving hemodialysis may cause a buildup of the drug in your blood. This could cause worsened side effects. The maximum daily dose for people ages 18 years and older and receiving hemodialysis is 7. 5 mg per day.

FDA warnings

• This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.
• Heart risk warning: This drug may increase your risk of developing a blood clot, heart attack, or stroke, which can be fatal. Your risk may be higher if you’re taking it long term, at high doses, or if you already have heart problems or risk factors for heart disease, such as high blood pressure. You shouldn’t take meloxicam for pain before, during, or after coronary artery bypass graft surgery. This can increase your risk for a heart attack or stroke.
• Stomach problems warning: This medication may increase your risk of developing stomach and intestinal problems. These include bleeding, ulcers, and holes in your stomach or intestines, which can be fatal. These effects can occur any time while you’re taking this drug. They may happen without any signs or symptoms. Adults ages 65 years and older are at higher risk of these stomach or intestinal problems.

Was this helpful?

Allergy warning

Don’t take meloxicam if you’ve had itchy skin, symptoms of asthma, or an allergic reaction to aspirin or other NSAIDs. A second reaction could be much more severe.

Liver damage warning

This drug may affect your liver. Symptoms may include yellowing of your skin or whites of your eyes and liver inflammation, damage, or failure. Your doctor may check your liver function while you take this drug.

Blood pressure warning

This medication may increase or worsen your blood pressure. This can increase your risk of heart attack or stroke. Your doctor may check your blood pressure while you’re taking meloxicam. Some medicines for high blood pressure may not work as well as they should when you’re taking meloxicam.

Allergy warning

Meloxicam can cause a severe allergic reaction. Symptoms may include:

• trouble breathing
• swelling of your throat or tongue
• hives

Don’t take meloxicam if you have asthma, runny nose, and nasal polyps (aspirin triad). Don’t take it if you’ve had itching, trouble breathing, or an allergic reaction to aspirin or other NSAIDs.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

Multiorgan hypersensitivity/DRESS warning

This medication can cause multiorgan hypersensitivity. This is also known as a drug reaction with eosinophilia and systemic symptoms (DRESS). This syndrome can be life threatening. Call your doctor right away if you have symptoms, such as a rash, a fever, or swollen lymph nodes.

Harm to developing fetus warning

You shouldn’t take meloxicam if you’re pregnant or planning to become pregnant. Meloxicam can cause harm to a developing fetus if taken at 20 weeks or later in pregnancy. If you are between 20 to 30 weeks of pregnancy, only take this drug if your doctor has told you to. Do not take this drug if you are more than 30 weeks pregnant.

Warnings for people with certain health conditions

For people with heart or blood vessel diseases: This medication increases your risk of blood clots, which can cause a heart attack or stroke. It may also cause fluid retention, which is common with heart failure.

For people with high blood pressure: This medication may make your blood pressure worse, which can increase your risk of having a heart attack or stroke.

For people with stomach ulcer or bleeding: Meloxicam can make these conditions worse. If you have a history of these conditions, you have a higher chance of having them again if you take this medicine.

For people with liver damage: Meloxicam can cause liver disease and changes in your liver function. It may make your liver damage worse.

For people with kidney disease: If you take meloxicam for a long time, it may decrease your kidney function, making your kidney disease worse. Stopping this drug could reverse kidney damage caused by the drug.

For people with asthma: Meloxicam can cause bronchial spasm and difficulty breathing, especially if your asthma gets worse if you take aspirin.

Warnings for other groups

For pregnant women: Using meloxicam during your third trimester of pregnancy increases the risk of negative effects to your pregnancy. You should not take meloxicam after 30 weeks of pregnancy. If you’re pregnant, talk to your doctor. Meloxicam should be used during pregnancy only if the potential benefit justifies the potential risk.

You should also talk to your doctor if you’re trying to get pregnant. Meloxicam can cause a reversible delay in ovulation. If you’re having a hard time getting pregnant or are getting tested for infertility, don’t take meloxicam.

For women who are breastfeeding: It isn’t known if meloxicam passes into breast milk. If it does, it could cause side effects in your child if you breastfeed and take meloxicam. You and your doctor may decide whether you’ll take meloxicam or breastfeed.

For seniors: If you’re age 65 years or older, you may have a higher risk of side effects from meloxicam.

For children: For the treatment of JIA, this drug has been found to be safe and effective for use in children 2 years and older. It should not be used in children younger than 2 years.

For the treatment of other conditions, this drug has not been found to be safe and effective for children of any age. It should not be used in people younger than 18 years.

Meloxicam oral tablet may be used for short-term or long-term treatment. It comes with risks if you don’t take it as prescribed by your doctor.

If you stop taking the drug or don’t take it at all: Your symptoms will remain and may worsen.

If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

• nausea
• vomiting
• stomach pain
• stomach bleeding

Overdosing on meloxicam can cause organ failure or serious heart problems. If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

What to do if you miss a dose: If you miss a dose, take it as soon as you can, However, if it’s just a few hours until your next dose, skip the missed dose and take the next one on time.

Never try to catch up by taking two doses at once. This could result in serious side effects.

How to tell if the drug is working: You should have less pain and inflammation.

Keep these considerations in mind if your doctor prescribes meloxicam oral tablet for you.

General

• You can take meloxicam with or without food. If it upsets your stomach, take it with food or milk.
• You can cut or crush the oral tablet.

Storage

• Store this medication at room temperature, 77°F (25°C). If needed, you can keep it for short periods at temperatures between 59°F and 86°F (15°C and 30°C).
• Keep this medication away from high temperatures.
• Keep your medications away from areas where they could get damp, such as bathrooms.

Refills

A prescription for this medication is refillable.You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

• Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
• Don’t worry about airport X-ray machines. They won’t damage your medication.
• You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
• Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

During your treatment with this drug, your doctor may check your:

• blood pressure
• liver function
• kidney function
• red blood cell count to check for anemia

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk with your doctor about other drug options that may work for you.

Disclaimer: Medical News Today has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Tolerability and safety of meloxicam | Badokin V.

V.

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used drugs in clinical practice. In Europe, this class of pharmacological agents in polyclinic practice is prescribed by 82% of general practitioners and 84% of rheumatologists, and in the hospital they are used in 20% of patients. The main property of NSAIDs is to suppress the inflammatory process or significantly reduce its intensity. In addition, they have a distinct analgesic and antipyretic effect.

NSAIDs are most widely used in the treatment of inflammatory and degenerative diseases of the joints and spine, diffuse connective tissue diseases, microcrystalline arthropathies, extra-articular soft tissue diseases, a large group of diseases accompanied by pain in the lower back, osteoporosis and other bone diseases accompanied by pain. They are also used in cardiology for inflammatory cardiopathy and as a means of preventing thrombosis, in preoperative preparation and management of patients after “small” operations, with headaches, oligomenorrhea, and many other inflammatory processes accompanied by fever and pain. Their positive effect in oncology as a means of preventing colonorectal cancer or metastasis of malignant tumors, in neurology in the treatment of Alzheimer’s dementia, as well as their preventive effect on the development of atherosclerosis, especially in patients with immunoinflammatory diseases, are discussed.
In rheumatology, NSAIDs are the main symptom-modifying drugs for short-term and long-term therapy of a large number of diseases, as well as drugs of choice for the initial therapy of arthritis of various origins. Recently, there have been isolated reports that NSAIDs have not only a symptomatic effect. It is believed that they are able to slow down the progression of certain diseases, such as ankylosing spondylitis and osteoarthritis. In one of the papers published at 1999, it was indicated that among the direct costs of treatment in patients with rheumatoid arthritis, 75% are accounted for by NSAIDs [1]. The generally accepted point of view on the need for basic anti-inflammatory therapy at an early stage of rheumatoid arthritis and the introduction of high technologies in the complex therapy of this disease have, of course, reduced this percentage, but it remains quite significant in the structure of the cost of treating this inflammatory joint disease, like many other diseases.
The main mechanism of action of NSAIDs is the suppression of prostaglandin biosynthesis. As is known, prostaglandins are characterized by a wide range of biological effects (Table 1). [2,3].
The pharmacological activity of NSAIDs is not limited to the suppression of prostaglandin production. In addition, they inhibit the synthesis of leukotrienes, the formation of superoxide radicals and the release of lysosomal enzymes, affect the activation of cell membranes, the aggregation and adhesion of neutrophils, the functions of lymphocytes, and the synthesis of leukotrienes. Hence it is clear why NSAIDs have not only a positive (therapeutic) effect, but also have a fairly large range of adverse events (Table 2). The most frequently observed gastrointestinal disorders of varying severity – from mild to incompatible with life. NSAIDs have nephro- and hepatotoxicity, contribute to fluid retention, the development of heart failure, arterial hypertension, and have a dystrophogenic effect on the myocardium. They affect the metabolism of brain cells and cause severe headaches and other manifestations of cerebral toxicity. Hematological disorders are possible, up to the development of severe cytopenias, hypo- and aplastic anemia, inhibition of platelet aggregation, impaired hemostasis with massive bleeding. NSAIDs often cause a variety of allergic reactions and broncho-obstructive syndrome (“aspirin” asthma), which is associated with their effect on the synthesis and release of leukotrienes.
When choosing an NSAID and its daily dose, one should take into account their anti-inflammatory activity and tolerability, the possibility of combination with other types of therapy, the presence of concomitant diseases, metabolic features in the body, pharmacokinetics, COX (cyclooxygenase) – selectivity. Of great importance is the identification of risk factors for adverse events of NSAIDs, which include older age, a history of gastrointestinal pathology, concomitant diseases (arterial hypertension, heart failure, liver and kidney disease), taking high doses of NSAIDs, combined therapy of NSAIDs with glucocorticoids, low doses of acetylsalicylic acid or indirect anticoagulants. It is generally accepted that selective COX-2 inhibitors, which include meloxicam (Movasin et al.), have a higher safety.
Meloxicam is a derivative of enoliconic acid. It, like all other NSAIDs, has anti-inflammatory, analgesic and antipyretic activity. More than 99.5% of meloxicam is protein bound. In the synovial fluid, its concentration is 2 times less than in the blood plasma, but still high enough to suppress the inflammatory process in the tissues of the joint. Its half-life is 20 hours, and this gives rise to a single dose during the day. It is excreted from the body in urine and feces. The drug has a cumulative property, while its maximum concentration occurs on the 3-5th day of admission. For a faster therapeutic effect, it is advisable to carry out the so-called “stepwise” therapy, which consists in intramuscular administration of 15 mg of meloxicam in the first three days of treatment, followed by transfer of the patient to oral administration of the drug [4]. The daily dose of meloxicam is 15 mg. A lower dose is indicated for patients with erosive gastritis, gastric ulcer or decreased glomerular filtration rate, as well as for elderly patients who have a decrease in the excretion of many drugs. Meloxicam in the body does not interact with other drugs, including cytostatics, diuretics, cardiac glycosides, b-blockers, and others, which is of great importance for the rational treatment of patients with concomitant (comorbid) diseases.
High clinical efficacy of meloxicam has been demonstrated in patients with rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, pain in the lower back and many other diseases. The evidence base for meloxicam is based on numerous randomized, placebo-controlled trials in which its efficacy and tolerability were compared with placebo and the main NSAIDs – COX-selective and COX-non-selective [5-7]. The duration of therapy in these studies ranged from 4 weeks. up to 18 months Significant improvement, which occurred after 2 weeks. from the start of therapy with meloxicam, lasted for 18 months, i. e. the entire observation period. In terms of its effectiveness, meloxicam was not inferior to diclofenac, naproxen and piroxicam. Good results of treatment with meloxicam were obtained not only in patients with rheumatoid arthritis, but also with ankylosing spondylitis in its 12 months. application. According to its therapeutic activity, 15 mg of meloxicam had the same effect as 20 mg of piroxicam, and a further increase in the daily dose (up to 22.5 mg/day) was not accompanied by an increase in its anti-inflammatory and analgesic effect.
The greatest number of studies on the clinical efficacy and safety of meloxicam has been carried out in osteoarthritis. The expediency of prescribing meloxicam in osteoarthritis is dictated by its positive effect on the metabolism of hyaline cartilage, the main springboard for the development of the pathological process in this disease [8,9]. Meloxicam has an anabolic effect, inhibits interleukin-1, expresses growth factors, including transforming growth factor-1, inhibits the degradation of aggrecan, neutralizes the action of metalloproteinases and inhibits chondrocyte apoptosis, i. e. actively intervenes in the development of the pathological process in this disease [10,11].
Most of the studies evaluating meloxicam in osteoarthritis met the current requirements for approbation of drug preparations. They were multicenter, prospective, double-blind and performed according to a single protocol [12–14]. Meloxicam led to a significant decrease in the subjective manifestations of the disease with a decrease in the intensity of pain when walking and at rest. In some cases, there was complete relief of pain, a significant decrease in the intensity of morning stiffness or its cessation, resolution of manifestations of secondary (reactive) synovitis, and improvement in the function of the affected joints.
The efficacy of meloxicam in patients with osteoarthritis was studied in the MELISSA (Meloхicam Large Scale International Study Safety Assessment) and SELECT (Safety and Efficacy Large scale Evaluation of COX inhibiting Therapies) studies, in which the therapeutic activity of meloxicam (7. 5 mg/day) was compared with diclofenac (100 mg/day) or piroxicam (20 mg/day) [12,13]. Nearly 20,000 patients participated in these two trials. Meloxicam was found to be equivalent in clinical efficacy to diclofenac and piroxicam. Cancellation of the drug due to its low efficiency in the groups of diclofenac, piroxicam and meloxicam did not exceed 1.7%.
In the treatment of NSAIDs, a wide range of adverse events are observed. Prevention and treatment of these complications is one of the most important iatrogenic problems of modern medicine. The most common is gastrotoxicity. Every year, 100,000 patients develop adverse events associated with taking NSAIDs, which can have serious consequences due to the possible development of profuse bleeding, perforation of the wall of the stomach or intestines [15]. NSAID gastropathy is largely due to the half-life of individual drugs, differences in their systemic absorption, the basic pH of gastric juice, but above all, the degree of suppression of prostaglandin synthesis. Adverse events that develop when taking COX-non-selective drugs in 30% of patients are manifested by gastric and intestinal dyspepsia, 15% – endoscopically confirmed gastric ulcers, 1.7% – perforations or hemorrhages. Such severe prognostic gastroenterological complications as bleeding, perforation and ulcers in most cases occur without pain, which makes their timely diagnosis difficult, and in some patients lead to death.
NSAID-induced lesions of the gastrointestinal tract extend to all its departments and are characterized by polymorphism of manifestations. The mechanisms underlying such damage to the gastrointestinal tract are diverse and are associated with a decrease in blood flow in the mucosa and a violation of its trophism, the basic pH of gastric juice, the difference in systemic absorption of NSAIDs and adhesion of neutrophils. The direct toxic effect of NSAIDs on the digestive tract is an important component only at the beginning of treatment. The importance of genetic factors in the genesis of gastrointestinal bleeding caused by NSAIDs is discussed. Apoptosis of cells, especially the gastric mucosa, is also important. But the main cause of gastrointestinal complications of NSAIDs is associated with suppression of prostaglandin synthesis.
However, selective COX-2 inhibitors can also lead to severe complications. Interestingly, the relative risk of gastrointestinal bleeding in the appointment of specific COX-2 inhibitors is more pronounced than in the treatment of standard NSAIDs. Thus, this indicator in patients over 65 years of age treated with lumiracoxib is 3.18, and with non-selective COX – 2.3, in males – 2.6 and 1.7, respectively. A high risk of bleeding was noted in patients who take combination therapy with lumiracoxib and aspirin (2.89) [16]. The presented data are the key to the prevention of gastropathy, possible bleeding and other serious complications in the treatment of NSAIDs. These measures should be carried out in all patients with risk factors and should include the appointment of selective NSAIDs and proton pump inhibitors, as well as monitoring for possible adverse events.
NSAID-gastropathy is significantly less common when taking meloxicam. The European pharmacoepidemiological multicentre prospective study evaluated the tolerance of meloxicam and other NSAIDs in patients with rheumatic diseases [10]. The duration of therapy was 6 months. Groups of patients in individual centers were randomized according to the main parameters of the pathological process. In the treatment with meloxicam, adverse events such as abdominal pain, gastritis, dyspepsia were significantly less common, and gastrointestinal bleeding was registered only in two out of 2530 patients, while other NSAIDs led to such a complication in 10 out of 1996 patients.
Interesting data were obtained in the MELISSA study, in which the tolerability of meloxicam 7.5 mg / day was studied in a comparative aspect. and diclofenac 100 mg/day. in 9323 patients with osteoarthritis. The duration of therapy was 4 weeks. This study involved 27 countries, including Russia [4,13]. The overall frequency of gastrointestinal adverse events in the appointment of diclofenac was significantly higher than in the treatment of meloxicam (19 and 13%, respectively), and according to E. S. Tsvetkova – in 22.2 and 6.8%, respectively [9]. Gastric dyspepsia, abdominal pain, nausea and vomiting, and diarrhea were significantly less common. Due to the development of adverse events, 2 times more patients stopped treatment with diclofenac than with meloxicam. The overall tolerability of meloxicam, according to doctors, was good in 91% and satisfactory in 9%, and the tolerability of diclofenac was good (84%), satisfactory (9%) and unsatisfactory (7%). Similar results were obtained in the SELECT study, in which meloxicam 7.5 mg/day. compared with piroxicam 20 mg/day. in 8227 patients with osteoarthritis.
It is interesting to note that when using meloxicam, the risk of developing gastrointestinal complications was also lower in individuals who simultaneously took acetylsalicylic acid to prevent thromboembolic complications (10.3% and 15.4%). A meta-analysis of a large number of studies showed that meloxicam compared with traditional NSAIDs (diclofenac, piroxicam and naproxen) reduces the risk of drug withdrawal due to the development of gastrointestinal complications by 41%, the risk of serious adverse reactions (perforation, ulceration, bleeding) – by 48% and the risk of intestinal dyspepsia – by 27%.
When taking NSAIDs, damage to the small intestine is more common than damage to the stomach. Enteropathy can develop rapidly, for example, after 14 days from the start of NSAID therapy. It is manifested by nonspecific edema, diaphragmatitis, ulcers, penetration, strictures, intestinal dyspepsia, bleeding, and iron deficiency anemia [17]. Selective COX-2 inhibitors reduce the risk of enteropathy by 50% compared with standard NSAIDs. Intestinal endoscopy using special capsules or double balloon endoscopy allows a detailed analysis of pathological changes in the small intestine when prescribing this group of drugs.
Recently began to pay close attention to NSAID-colonopathy, which occurs relatively often. Morphologically, the lesion of the large intestine is manifested by ischemic or collagenous colitis. The clinical stigmata of such colonopathy are ulcers, perforations, strictures of ischemic origin, obstructions, and recurrent irritable bowel syndrome [18]. In rare cases, massive intestinal bleeding is observed. Standard NSAIDs are 2 times more likely to lead to NSAID-colonopathy compared with selective COX-2 inhibitors.
One of the complications of NSAID therapy is hepatotoxicity [19]. An increase in aminotransferases by 3 times or more is detected both with the appointment of standard and selective COX-2 inhibitors. Genetic factors, in particular the expression of cytochrome P450, are also involved in the induction of hepatotoxicity. Meloxicam has less hepatotoxicity than the widely used diclofenac. So, when taking meloxicam, an increase in AST was registered in 3%, and diclofenac – in 9% [9,12].
Much attention is paid to the cardiovascular adverse events of NSAIDs, in particular myocardial infarction and cerebrovascular accident [20, 21]. It should be noted that all traditional and selective NSAIDs are COX-2 inhibitors, although, of course, to varying degrees, and all of them dose-dependently increase the risk of thromboembolic complications [22]. On the other hand, almost all NSAIDs, both non-selective and selective, contribute to an increase in blood pressure, which, in turn, can also lead to thrombosis. However, there is no doubt that the higher the COX-2 selectivity, the more likely the development of cardiovascular and cerebral thrombotic complications. This primarily applies to specific COX-2 inhibitors – coxibs. According to Layton (2003), cardiovascular thrombotic complications during long-term treatment with meloxicam are observed in 0.1% of patients, celecoxib – in 0.16% and rofecoxib – in 0.14%, and cerebrovascular – in 0.27%, 0.39% and 0.48%, respectively. According to the FDA and the European Medical Agency, a contraindication to the use of specific COX-2 inhibitors is coronary heart disease or a history of stroke. With great caution, they should be used in individuals with risk factors for coronary heart disease and in elderly people.
Meloxicam differs from other selective COX-2 inhibitors in its effect on platelet aggregation, which is explained by the peculiarities of its structure. In particular, it binds to the upper part of the COX-2 channel, and highly selective coxibs – to the side pocket of the COX-2 channel, while they inhibit thromboxane to a lesser extent, and this explains the increased risk of thromboembolic complications in their use, t. to. thromboxane is actively involved in platelet aggregation.
NSAID prostaglandin inhibition leads to cardiorenal effects, which include impaired water and salt metabolism, arterial hypertension, congestive heart failure, nephrotic syndrome, acute renal failure. Some of these effects are associated with impaired cerebral circulation, and above all with arterial hypertension. Cerebral strokes against the background of long-term use of NSAIDs are associated not so much with an increase in diastolic blood pressure as systolic and, even more so, with the value of pulse pressure. Individual NSAIDs that increase systolic blood pressure include ibuprofen, rofecoxib, and etoricoxib. These three drugs are considered risk factors for ischemic stroke. Meloxicam is the least likely to increase blood pressure, both systolic and diastolic. In this regard, it is close to diclofenac, which also does not lead to an increase in blood pressure [23].
G. Singh et al. conducted a large study involving 3. 1 million people [data presented at the EULAR congress in Barcelona in 2007]. The vast majority of individuals included in this study were taking NSAIDs for various diseases. In this work, 15659 cases of cerebrovascular accident were identified. The relative risk of ischemic stroke for rofecoxib and indomethacin was 1.26, piroxicam -1.25, naproxen – 1.24, ibuprofen – 1.19, diclofenac – 0.98, celecoxib – 0.97. The value of this risk for meloxicam was 0.88, and it was the same as in the control group, not taking NSAIDs. Thus, meloxicam is not a risk factor for stroke. A positive feature of this drug is the lack of interaction with antihypertensive drugs when they are used together.
Often, NSAIDs contribute to the development of skin reactions, which are among the most common adverse events in the appointment of this group of drugs. Skin reactions are characterized by polymorphism of their manifestations and are divided into characteristic and uncharacteristic. The former include allergic contact dermatitis, photoallergic contact dermatitis, acute urticaria or angioedema, recurrent chronic urticaria, contact urticaria, fixed drug rash, and the atypical ones include bullous vasculitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS– syndrome (drug rash with eosinophilia and systemic manifestations).
Most often, skin rashes are caused by standard NSAIDs – acetylsalicylic acid, ketoprofen, ibuprofen, piroxicam, but reactions to selective COX-2 inhibitors are also possible. These reactions are based on an immunological mechanism. In Stevens-Johnson syndrome and toxic epidermal necrolysis, massive apoptosis of epidermal cells is observed, caused by cytotoxic T cells that release perforin and grancime B. The development of acute urticaria on NSAIDs is a consequence of immunoglobulin E (IgE)-dependent reaction. In such cases, they act as a hapten. Repeated exposure of the drug leads to an immune-dependent reaction with the formation of antibodies directed to a specific NSAID.
With the appointment of COX-1 inhibitors, an increased production of leukotrienes (LTA4) is observed. Therapy with leukotriene receptor antagonists can block NSAID-induced urticaria or significantly reduce their severity. COX-2 selective drugs show good tolerance in patients with chronic urticarial rash and aspirin-induced asthma, which fully applies to meloxicam [24].
Thus, meloxicam not only has a pronounced anti-inflammatory and analgesic effect, but is also characterized by good tolerability and high safety. The spectrum of adverse events is much lower than that of non-selective and selective COX inhibitors. These properties, along with its high clinical efficacy, have contributed to its widespread introduction into the complex therapy of not only inflammatory and degenerative rheumatic diseases, but also many other pathological conditions.

Literature
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3. Schwartz G.Ya. Modern non-steroidal anti-inflammatory drugs. M, Reaform, 2004, 95 s.
4. Tsvetkova E.C. Evaluation of the effectiveness of Movalis in osteoarthritis and rheumatoid arthritis (data from a multicenter Russian study). Scientific and practical. rheumatol. 2005; 2:29–31.
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6. Huskinsson E.C., Ghozlan R., Kurthen R. et al. A long-term study to evaluate the safety and efficacy of meloxicam therapy in patients with rheumatoid arthritis. Br J Rheumatol 1996; 35 (suppl 1): 29–34.
7. Wojtulewsky J.A., Schattenkirchner M., Barselo P. et al. A six-month double-blend trial to compare the efficacy and safety of meloxicam 7.5 and naproxen 750 mg daily in patients with rheumatoid arthritis. Br J Rheumatol 1996; 35 (suppl 1): 22–8.
8. Nasonova V.A. Meloxicam (Movalis) is a selective COX-2 inhibitor in clinical practice. Scientific and practical. rheumatol. 2000; 4:16–21.
9. Tsvetkova E.S. Movalis in the treatment of osteoarthritis. Scientific and practical. rheumatol. 2001; 1:67–71.
10. Degner F., Lanes S., van Ryn J., Sigmund R. Pharmacological and clinical profile meloxicam. Therapeutic roles of selective COX-2 inhibitors. Eds Vane JR, Botting RM. William Harvey Press, London, 2001.
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data from an observational non-interventional multicenter study

Non-specific back pain (NBP) is the most common pathology of the musculoskeletal system, causing suffering and significantly reducing the quality of life in a huge number of patients. In 2013, 19million 451 thousand cases of NBS, i.e., almost 15% of the population sought medical help in connection with the development of this pathology [1].

The main principle of NBS treatment is the most rapid and complete relief of pain and restoration of the patient’s functional activity. Effective analgesic therapy not only alleviates the patient’s condition, but is also the most important element in preventing chronic pain, since chronic back pain is a serious pathology that often leads to permanent disability and even disability and requires long-term and expensive complex treatment [2–4].

The etiology and pathogenesis of acute NBS are still the subject of discussion: most likely, its development is determined by the combined effect of a number of negative factors. Violation of the functional stability of the spinal column, resulting from a non-physiological load, causes local damage to the ligamentous apparatus, which is accompanied by a local inflammatory reaction and provokes a pronounced muscle spasm. At the same time, in the overwhelming majority of cases, an unambiguous relationship between the appearance of acute pain and the presence of structural changes in the spinal column, such as hernia and other degenerative pathology of the intervertebral discs (IVD), osteoarthritis of the facet joints, osteophytes, etc., is not determined [3, 5]. Therefore, the use of instrumental methods of visualization of spinal pathology, in particular, radiography and magnetic resonance imaging, in the absence of symptoms of a life-threatening pathology (the so-called red flags) is inappropriate and is not recommended by many leading experts [6–8].

Non-steroidal anti-inflammatory drugs (NSAIDs) are the main class of pharmacological agents for the treatment of acute LBP [7, 8]. NSAIDs have a complex pathogenetic effect: they block the synthesis of the most important pain mediator prostaglandin E2, reduce the activation of peripheral pain receptors, suppress the development of local inflammation, and prevent the development of peripheral and central sensitization of the nociceptive system. These drugs should be used as soon as NBS is diagnosed, unless there are red flags and absolute contraindications for NSAIDs.

The appointment of NSAIDs can be justified not only in acute NBS, but also at the beginning of the treatment of lumboischialgia, i.e., with damage to the sciatic nerve caused by IVD hernia [9]. Thus, according to the results of a meta-analysis [10] of 13 studies that determined the natural course of cervical and lumbar radiculopathy, 4-week conservative therapy led to complete relief of this pathology in 88 and 70% of cases, respectively.

However, as practice shows, the use of NSAIDs does not provide rapid and complete pain relief in far from all patients. There are factors that have a significant impact on the effectiveness of NSAIDs. Their identification will make it possible to more accurately predict the volume of therapeutic care in acute NBS and improve the results of treatment of this socially significant pathology.

The purpose of this study is to evaluate the effectiveness of NSAIDs (meloxicam) for the relief of acute LBP, depending on the influence of a number of clinical and anamnestic factors.

Material and methods

In order to study the therapeutic potential of the original drug meloxicam (Movalis) in acute NBS, the CAROMBOL study (Clinical Analysis of the Results of Analgesia with Meloxicam and its Safety in Acute Lumbodynia) was conducted. The work was of an observational nature – there were no interventions in the usual medical process, the appointment of new drugs or therapeutic methods. The duration of the use of NSAIDs for the relief of NBS was determined by the attending physician, based on clinical recommendations and personal experience. The appointment of other drugs was not limited: muscle relaxants, B vitamins and proton pump inhibitors (PPIs).

The study included 2078 patients with NBS, mean age 46.3±13.4 years, 56.6% women. In 34.8% of patients, a real episode of NBS occurred for the first time, in 65.2% – again. Over the previous year, patients experienced from 2 to 12 (average 2.61 ± 1.35) cases of NBS: 2 episodes – in 59. 3%, 3 – in 27.5%, 4 – in 10.5%, 5 and more – in 2.7% of patients.

Inclusion criteria for in the study: age 18 years and older, the fact of visiting a doctor due to acute severe pain in the lower back (duration no more than 2 weeks, severity 4 points or more on a numerical rating scale – NRS), presence of indications for the appointment of meloxicam, in the opinion of the attending physician, the consent of the patient to participate.

Exclusion criteria: contraindications for the use of NSAIDs, the presence of symptoms of severe threatening pathology (“red flags”), as well as severe functional impairment, which makes it difficult to re-observe patients.

The data obtained during 2 visits of patients were analyzed: at the 1st visit, a standard clinical examination and a survey were performed before the appointment of therapy, at the 2nd visit, the result of therapy was evaluated after 14 days.

The severity of NBS was assessed by a 10-point NRS according to the following criteria: 0 points – no pain, 10 – the most severe pain. General well-being was also assessed using NRS, where: 0 points – no deterioration, 10 – the most pronounced deterioration in well-being. The average pain severity at the time of therapy was 6.69±1.65 points, deterioration of health — 5.68±2.09 points. Severe pain (7 points or more) was recorded in 57.0% of patients.

When interviewing patients who had previous episodes of NBS, they found out the fact of using NSAIDs and assessing their effects. As it turned out, the vast majority (70.2%) of patients had already received drugs of this group. The effectiveness of NSAIDs in history was assessed by patients as good in 28.0% of cases, as moderate in 54.6% and as low in 17.4%.

In many patients, when using NSAIDs, a history of adverse reactions (AR) was noted: dyspepsia (gastralgia, nausea, feeling of heaviness in the epigastrium, etc.) – in 44.7% of patients, development of gastric and / or duodenal ulcers – in 2, 7%, bleeding from the gastrointestinal tract (GIT) – in 0. 4%, increased blood pressure (BP) – in 14.1%, edema – in 6.2%, allergic reactions – in 3.4%.

In addition, a number of features of the clinical manifestations of acute NBS were analyzed. When questioning patients, the following symptoms were identified: pain persisting at rest – in 37.2% of patients, pain at night – in 19.0%, feeling of stiffness in the morning or after being at rest – in 60.7%, pain radiating to the leg – in 28.2%, signs of lumboischialgia (intense pain in the leg, which are accompanied by sensory disturbances) – in 9.6%.

All patients were prescribed the original meloxicam (Movalis) at a dose of 15 mg/day. In the majority of patients (86.1%), it was used according to a stepwise scheme: the first 3-5 days in the form of intramuscular (im) injections, with a further transition to the oral form. At 13.9% of patients used only oral meloxicam. According to the decision of the attending physicians, 52.3% of patients also received muscle relaxants (tolperisone – 31. 7%, tizanidine – 18.7%, baclofen – 1.7%), 17.4% – vitamins of group B (mainly for i / m introductions). To prevent the development of NSAID gastropathy, 21.6% of patients were prescribed PPIs, mainly omeprazole.

The result of treatment was determined by the frequency of complete cessation of pain and the dynamics of its severity (if it did not go away completely), as well as the general well-being of patients over 2 weeks of observation. In addition to this, patients were asked to evaluate the result of therapy on a 5-point scale, where: 1 point meant worsening of the condition, 5 – excellent result. We also studied the frequency and nature of NR recorded during the observation period.

Quantitative data obtained are presented as mean and standard error of the mean ( M± m ). Statistical differences in quantitative parameters were determined using the t Student’s t-test, the distribution of rank variables was determined using the odds ratio (OR) and Fisher’s exact test. Indicator O.Sh. is given in the paper along with the corresponding 95% confidence interval (CI).

Results

After 2 weeks, complete or almost complete cessation of NBS was achieved in 75.2% of patients, while the required duration of NSAID use for pain relief averaged 8.61±5.53 days.

Patients who retained NBS after 2 weeks of therapy noted a significant decrease in its intensity: on average, from 6.69±1.65 to 2.38±1.61 NRS points. There was a significant positive trend in the assessment of their well-being by patients: from 5.68±2.09up to 2.57±1.83 NRS points. In comparison with the baseline, the decrease in the severity of pain and improvement in general well-being reached 64.2±22.8 and 54.4±19.6%, respectively.

The result of treatment was rated as excellent by 30.6% of patients, as good by 52.9%, as satisfactory by 13.5%, as low or absent by 2.7%.

In 96 (4.6%) patients during therapy, adverse reactions were recorded: dyspepsia – in 82 (3. 9%), increased blood pressure – in 22 (1.1%), allergy – in 2 (0.1%) , heartburn – in 2 (0.1%) and constipation – in 2 (0.1%). All N.R. were mild to moderate and did not require interruption of therapy.

The relationship between the achievement of the main result of treatment (complete relief of pain after 2 weeks of observation) and the presence of a number of clinical and anamnestic factors was investigated. The frequency of relief of NBS, depending on the presence or absence of the studied factors, is shown in the figure. Influence of various factors on the effectiveness of NBS treatment. The abscissa shows the frequency of complete relief of back pain in the presence and absence of the studied factor (%). * — significant difference in the incidence of NBS relief (p<0.05). The gender of patients did not affect the outcome of treatment (OR 0.967, 95% CI 0.795–1.177, p = 0.763). Treatment efficacy was significantly higher in patients younger than 65 years (OR 2.053, 95% CI 1. 592–2.642, p = 0.000), in patients who had a first episode of NBS (OR 1.415, 95% CI 1.09–1.836, p = 0.009) and a good response to NSAIDs in history (OR 1.937, 1.513–2.481, p = 0.000). A lower outcome of therapy was associated with the presence of initially severe pain (7 points or more according to the NRS) (OR 0.481, 95% CI 0.393-0.588, p = 0.000), the presence of pain at rest and at night (OR 0.559, 95% CI 0.441-0.709, p = 0.000 and OR 0.511 95% CI 0.413-0.631, p = 0.000, respectively) and especially with the clinic of lumbar ischialgia (OR 0.346, 95% CI 0.2 56-0.466, p = 0.000). Compared with meloxicam monotherapy, the combined use of this drug with muscle relaxants and B vitamins did not increase the effectiveness of treatment (OR 0.827, 95% CI 0.594-0.889, p = 0.02 and OR 0.917, 95% CI 0.804-1.1201 , p = 0.452, respectively).

Talk

It has been shown that the use of the original meloxicam 15 mg/day makes it possible to achieve complete relief of pain in the vast majority (more than 75%) of patients. At the same time, the average duration of the course of NSAIDs before the cessation of pain was slightly more than 1 week (8.6±5.5 days). An important indicator of the effectiveness of this drug can also serve as a high rating (good or excellent), which was given to the results of treatment by more than 80% of patients.

The results are consistent with the literature on the efficacy of meloxicam in back pain. For example, K. Colberg et al. [11] compared the effects of meloxicam (15 mg/day once intravenously, i.v., then orally) and diclofenac (single intravenous injection, 75 mg, then orally, 100 mg/day) in 183 patients with acute NBS. After 1 week of treatment, the pain completely stopped in 64 and 47% of patients, respectively ( p <0.05). Moderate or severe pain remained only in 8 and 12% of patients, respectively. It is important to note that in 13% of patients treated with meloxicam, pain was completely relieved already on the 1st day of therapy.

Similar results were obtained by H. Bosch et al. [12], who conducted a comparative study of meloxicam 15 mg/day (single IV, then oral) and piroxicam 20 mg/day (IM on day 1, then oral) in 169 patients with acute NBS. After 7 days, the pain was completely relieved in 54 and 48% of patients, respectively. Moderate or severe pain persisted in 16 and 18% of patients, respectively (the difference was not statistically significant).

V.V. Alekseev and E.V. Podchufarova [13] studied the effectiveness of the original meloxicam at a dose of 15 mg/day in 767 patients with chronic back pain, 88.4% of whom had a lumbodynia clinic, 11.6% had radiculopathy. Meloxicam was used in the form of intramuscular injections for the first 3 days, then orally for up to 3–4 weeks, depending on the characteristics of the clinic. According to the data obtained, the decrease in pain in lumbodynia averaged 36.1%, in radiculopathy – 35.7%. The vast majority of patients (78.0%) gave a high rating to the action of meloxicam.

The good result obtained with the use of meloxicam in the present study and the high assessment of its therapeutic potential from the point of view of patients seem to be particularly significant in comparison with previous experience with NSAIDs – only 28. 0% of patients gave a good assessment of the effectiveness of NSAIDs in history. In addition, many patients noted various adverse events during the use of these drugs, such as dyspepsia (44.7%) and increased blood pressure (14.1%). Meloxicam showed excellent tolerability – AR occurred in only 4.6% of patients, and there were no serious, life-threatening complications. The results obtained almost completely coincide with the data of the study by V.V. Alekseeva and E.V. Podchufarova [13], who noted the appearance of HP only in 4.7% of patients.

Meloxicam belongs to the group of NSAIDs with a relatively low risk of developing adverse events, which is confirmed by a large number of clinical and observational studies. So, M. Yang et al. [14] presented data from a network meta-analysis of 36 randomized clinical trials (RCTs) ( n =112 351), which assessed the incidence of gastrointestinal adverse events while taking highly selective NSAIDs (coxibs) and moderately selective NSAIDs (meloxicam, nabumetone and etodolac). According to the calculations, the frequency of serious complications from the gastrointestinal tract when using moderately selective NSAIDs, including meloxicam, was almost equal to the frequency of complications when using coxibs. The OR for complicated ulcers was 1.38 (95% CI 0.47–3.27), for symptomatic ulcers 1.02 (95% CI 0.09–3.92), for total GI complications 1.04 (95% CI 0.87 -1.25), to cancel treatment due to gastrointestinal complications – 1.02 (95% CI 0.57-1.74).

The likelihood of developing cardiovascular and renal complications when using meloxicam was evaluated by W. Asghar et al. [15]. The authors conducted a meta-analysis of a series of RCTs, cohort studies and case-control studies (19 studies in total), in which this indicator was determined for the group of the most popular NSAIDs. Meloxicam had a minimal combined risk of cardiovascular and renal complications (OR 1.14, 95% CI 1.04-1.25).

In our country, 29 clinical trials of the original meloxicam were performed for various pathologies ( n = 3736) lasting from 7 days to 12 months. Of these studies, 11 were on the use of meloxicam for back pain. More than 2/3 of the study participants rated the result of using the drug as good or excellent. The total number of AEs during therapy with meloxicam was 6.4%, which was significantly lower than when using other NSAIDs that represented active control (30.5%) [16].

The present study found that not all patients respond equally to NSAID therapy and this difference may be due to certain clinical and history factors. In particular, it has been shown that the frequency of relief of NBS is significantly higher in patients younger than 65 years. The worse response to analgesic therapy and the tendency to chronic pain in elderly patients are noted by many scientists [17-19]. Probably, the aging process of the body leads to a slowdown in the rate of repair of damaged tissue and a slower rate of natural inhibition of the inflammatory response. It cannot be ruled out that older patients often have structural changes in the spine (degenerative changes in the vertebrae and IVD, osteophytes, osteoarthritis of the facet joints, etc. ), which can contribute to chronic inflammation and pain and, as a result, significantly affect the effectiveness of analgesic drugs.

Meloxicam “worked” significantly better in patients who had NBS for the first time, in comparison with those who had repeated back pain. Obviously, the frequent recurrence of NPS indicates the beginning of the formation of chronic pain syndrome [20, 21]. The appearance of acute pain is associated with local tissue damage and a local inflammatory process. The pathogenesis of chronic pain is much more complicated: it includes the development of dysfunction of the pain system, the appearance of the phenomenon of central sensitization, and insufficiency of antinociceptive mechanisms [22]. NSAIDs, the main target of which is the activation of peripheral nociceptors, are more effective in the early stages of the disease, when the central links in the development of chronic pain are not yet involved. In chronic pain, drugs are less effective than in acute pain [22], which is confirmed, in particular, by the work of W. Enthoven et al. [23]. The authors conducted a meta-analysis of 6 RCTs ( n =1354), which studied the effectiveness of NSAIDs in chronic NBS, and showed that their analgesic effect is almost equal to that of placebo: on a 100 mm VAS, the average difference was only 3.3 mm.

In the present study, the effect of meloxicam was significantly greater in those patients who had a history of good response to other NSAIDs. Probably, the successful use of these drugs in previous episodes of NBS is associated with a leading role in the development of the pathology of peripheral damage and inflammatory response, which in turn are the main pharmacological goal for any NSAIDs. It can be assumed that this variant of NBS is more susceptible to treatment with anti-inflammatory drugs, which determines the success when using meloxicam.

In other words, there was a contradiction: in the presence of characteristic clinical signs of the inflammatory process (decrease in the severity of pain during movement, its preservation at rest and at night), the effectiveness of NSAIDs was significantly lower, although NSAIDs, the main action of which is the suppression of the inflammatory response, should “work” better precisely with this NBS phenotype [24]. This contradiction can be explained as follows. Probably, the appearance of NBS at rest and at night indicates a more pronounced damage to soft tissues (ligaments, fascia, muscle fibers) than in the case when pain is noted only during physical exertion or movement. It is a serious injury that becomes the source of a clinically pronounced inflammatory reaction. However, the result of therapy in this situation may be lower, since it takes more time for the body to recover from serious damage [25]. To a certain extent, this theory is confirmed by the fact that the response to NSAIDs was clearly lower in patients with initially severe pain (7 points or more according to NRS). Thus, strong pain sensations are most likely associated with a greater amount of local damage. It cannot be ruled out that the formation of severe pain is associated with the individual characteristics of the nociceptive system, in particular, with the initially low pain threshold.

A less pronounced effect of NSAIDs in patients who had irradiation of pain in the leg, and especially in patients with signs of lumboischialgia, seems to be a completely natural phenomenon. The most important element in the formation of pain in this situation is the pathology of the nervous tissue, i.e. we are talking about neuropathic pain. But NSAIDs, unfortunately, are ineffective in such cases [26]. This position is confirmed by the work of E. Rasmussen-Barr et al. [27], who conducted a meta-analysis of 10 RCTs ( n =1651), which evaluated the effect of NSAIDs in lumboischialgia. According to the data obtained, NSAIDs were not superior to placebo in analgesic effect (mean difference -4.56, 95% CI -11.11-1.99) and only slightly differed in the effect on general well-being (OR 1.14, 95% CI 1 03-1.27).

The present study showed that the likelihood of success in the treatment of NBS does not increase with the combined use of meloxicam and muscle relaxants. This result is somewhat surprising, since muscle relaxants are widely used in the treatment of NPS [7, 8], and their therapeutic potential has been confirmed by a series of well-designed studies. Evidence for the effectiveness of muscle relaxants, in particular, comes from a meta-analysis of 5 RCTs ( n =496) by C. Abdel Shaheed et al. [28]. At the same time, it should be noted that there are works that have shown the absence of an increase in the effectiveness of NBS therapy when using a combination of NSAIDs and muscle relaxants in comparison with NSAID monotherapy [29, 30].

It should be taken into account that the design of the presented work did not provide for a unified scheme for the use of pharmacological agents. Indications for the appointment of muscle relaxants were determined by the attending physician, based on the clinical situation. It is possible that patients treated with a combination of meloxicam and muscle relaxants experienced more severe pain or painful hypertonicity of the muscles of the lower back. The difference in the clinic could affect the assessment of the results of therapy, so it seems premature to draw any global conclusions about the ineffectiveness of muscle relaxants based on our data.

Equally balanced approach should be taken when evaluating the results of the combined use of meloxicam with preparations of B vitamins. According to our data, the use of the latter did not increase the effectiveness of the treatment of NBS in comparison with meloxicam monotherapy. Of course, B vitamins (including in the form of intramuscular injections) are very popular in Russia as a treatment for NBS [31, 32], but they have a rather limited evidence base [33–35]. The appointment of B vitamins does not appear in the international guidelines for the management of patients with acute and chronic NBS [7, 8].

Thus, based on the results of a multicenter observational study, it should be concluded that the original meloxicam (Movalis) can be considered as the drug of choice for the treatment of acute NBS. This drug showed high efficacy and a favorable safety profile: its administration made it possible to achieve complete relief of NBS in most patients with a minimal incidence of AE.

The data obtained identified a group of patients requiring special attention in the treatment of NBS. These are elderly people, patients with frequent recurrences of back pain, who previously had low efficacy of NSAIDs.