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|Meloxicam

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MELOXICAM (Systemic)

Some commonly used brand names are:

In the U.S.—

Mobic

In Canada—

Mobicox

Description

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

This medicine is available only with your doctor"s prescription, in the following dosage forms:

Oral
Suspension (U.S.)
Tablets (U.S. and Canada)

Before Using This Medicine

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to meloxicam, aspirin, or other nonsteroidal anti-inflammatory drugs. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Meloxicam has not been studied in pregnant women. However, studies in animals have shown that meloxicam causes birth defects. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Studies to determine if meloxicam passes into human breast milk have not been done. However, meloxicam has been found in the milk of rats. Meloxicam may cause unwanted effects in nursing babies. It may be necessary for you to take another medicine or stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Meloxicam has been tested in children 2 to 17 years of age. Studies show that meloxicam may reduce signs and symptoms in patients with juvenile rheumatoid arthritis.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Caution should be used in elderly patients who are taking this medicine because they may be at greater risk for serious gastrointestinal (GI) problems.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking meloxicam, it is especially important that your doctor and pharmacist know if you are taking any of the following:

Aspirin—Use of aspirin with meloxicam may cause stomach or intestinal bleeding

Lithium (e.g., Lithane)—When you take meloxicam, your dose of lithium may need to be changed because higher blood levels of lithium may occur

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:

Alcohol abuse or
Bleeding problems or
Stomach ulcer or other stomach problems or
Tobacco (or recent history of )—The chance of side effects may be increased.

Anemia or
Asthma or
Dehydration or
Fluid retention (swelling of feet or lower legs) or
High blood pressure or
Kidney disease or
Liver disease—Meloxicam may make these conditions worse.

Aspirin triad (asthma, nasal polyps, and aspirin intolerance) or
Previous allergic or anaphylactic response to aspirin or other nonsteroidal anti-inflammatory drugs—Use of meloxicam may cause a serious allergic reaction.

Coronary artery bypass graft (CABG) surgery—Meloxicam should NOT be used for pain during this surgery.

Heart disease or
Risk factors for heart disease—This medicine may cause you to be at greater risk for serious problems with blood clots.

Proper Use of This Medicine

For oral suspension: Shake gently before using.

For safe and effective use of this medicine, do not take more of it, do not take it more often, and do not take it for a longer time than ordered by your health care professional. Taking too much of this medicine may increase the chance of unwanted side effects.

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 dose of meloxicam. If your dose is different, do not change it unless your doctor tells you to do so.

For oral dosage form (suspension ortablets):
- For symptoms of osteoarthritis or rheumatoid arthritis:
  - Adults—7.5 milligrams (mg) once a day
  - Children—Use must be determined by your doctor
- For symptoms of juvenile rheumatoid arthritis:
  - Children—Dose is based on weight and must be determined by your doctor.

Missed dose—If you miss a dose of this medicine, take the missed dose as soon as possible. However, if you do not remember the missed dose until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—To store this medicine:

Keep out of the reach of children.
Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
Do not refrigerate or freeze.
Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any blood problems that may be caused by this medicine.

Stomach problems may be more likely to occur if you drink alcoholic beverages while being treated with this medicine. Therefore, do not regularly drink alcoholic beverages while taking this medicine, unless otherwise directed by your doctor .

Taking two or more of the nonsteroidal anti-inflammatory drugs together on a regular basis may increase the chance of unwanted effects. Also, taking acetaminophen, aspirin or other salicylates, or ketorolac (e.g., Toradol) regularly while you are taking a nonsteroidal anti-inflammatory drug may increase the chance of unwanted effects. The risk will depend on how much of each medicine you take every day, and on how long you take the medicines together. If your health care professional directs you to take these medicines together on a regular basis, follow his or her directions carefully. However, do not take acetaminophen or aspirin or other salicylates together with this medicine for more than a few days, and do not take any ketorolac (e.g., Toradol) while taking this medicine, unless your doctor has directed you to do so and is following your progress .

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

If you notice signs of liver toxicity including nausea, unusual tiredness, itching of the skin, stomach pain or fever,

Stop taking this medicine and check with your doctor immediately if you 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 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 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.

Side Effects of This Medicine

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

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

Less common

Arm, back, or jaw pain; bleeding gums; bloating; blood in urine; blurred vision; burning upper abdominal pain; canker sores; chest tightness or heaviness; chills; cloudy urine; cough; cramping; dark urine; decreased frequency/amount or urine; difficult or labored breathing; dilated neck veins; dizziness; dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; extreme fatigue; general tiredness and weakness; headache; hives or welts; increased blood pressure; increased sensitivity of skin to sunlight; increased thirst; irregular breathing; itching, redness or other discoloration of skin; large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs; light-colored stools; loss of appetite; lower back/side pain; noisy breathing; pain or discomfort in arms, jaw, back, or neck; painful or difficult urination; pains in stomach, side, or abdomen, possibly radiating to the back; pinpoint red or purple spots on skin; pounding in the ears; redness, soreness or itching skin; seizures; severe and continuing nausea; severe sunburn; shakiness in legs, arms, hands, feet; skin blisters; sore throat; sores, ulcers, or white spots on lips or tongue or inside the mouth; sores, welting or blisters; stomach bloating, burning, cramping, tenderness, or pain; sweating; swelling or puffiness of face; swollen glands; trembling or shaking of hands or feet; trouble breathing; unusual bleeding or bruising; upper right abdominal pain; watery or bloody diarrhea; weight gain or loss; yellow eyes or skin

Rare

Area rash; blistering, peeling, loosening of skin; bloody or black, tarry stools; clay-colored stools; cold, clammy skin; continuing vomiting; cough or hoarseness; cracks in the skin; difficulty 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 irritated eyes; red skin lesions, often with a purple center; red, swollen skin; scaly skin; severe stomach pain; shortness of breath; tightness in chest; unpleasant breath odor; unusual tiredness or weakness; vomiting of blood or material that looks like coffee grounds; wheezing

Incidence not known

Difficulty in speaking; double vision; inability to move arms, legs, or facial muscles; inability to speak; pains in chest, groin or legs, especially 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

Symptoms of overdose

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

Bloody or black tarry stools; blue lips, fingernails or skin; blurred vision; confusion; convulsions (seizures); dark urine; decreased urine output; difficulty breathing; difficulty swallowing; dizziness; fever with or without chills; pain in chest, upper stomach, or throat; pounding in ears; skin rash; slow or fast heartbeat; swelling around eyes, face, lips, or tongue; shortness of breath; severe stomach pain; unusual tiredness or weakness; tightness in chest; vomiting of blood or material that looks like coffee grounds; weight gain (rapid); wheezing; yellow eyes or skin

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

More common

Diarrhea; gas; heartburn; indigestion

Less common or rare

Abdominal pain; abnormal dreaming; anxiety; appetite increased; bad, unusual or unpleasant aftertaste; belching; bloated full feeling; burning feeling in 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 ears; decreased urination; discharge; discouragement; dry mouth; excess air or gas in stomach; excessive tearing; feeling sad or empty; feeling of constant movement of self or surroundings; general feeling of discomfort or illness; hair loss; hearing loss; hot flushes; increase in heart rate; irritability; loss of interest or pleasure; nausea and/or vomiting; nervousness; pain or burning in throat; rapid breathing; redness, pain, swelling of eye, eyelid, or inner lining of eyelid; sensation of spinning; sleepiness; stomach upset; sunken eyes; tenderness in stomach area; thinning of hair; thirst; tiredness; trouble concentrating; trouble sleeping; wrinkled skin

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

Developed: 06/08/2000
Revised: 09/13/2005

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