Meloxicam Injection

People who are treated with nonsteroidal anti-inflammatory drugs (NSAIDs) (other than aspirin) such as meloxicam injection may have a higher risk of having a heart attack or a stroke than people who do not take these medications. These events may happen without warning and may cause death. This risk may be higher for people who take NSAIDs for a long time. Do not take an NSAID such as meloxicam if you have recently had a heart attack, unless directed to do so by your doctor. Tell your doctor if you or anyone in your family has or has ever had heart disease, a heart attack, a stroke, if you smoke, and if you have or have ever had high cholesterol, high blood pressure, or diabetes. Get emergency medical help right away if you experience any of the following symptoms: chest pain, shortness of breath, weakness in one part or side of the body, or slurred speech.

If you will be undergoing a coronary artery bypass graft (CABG; a type of heart surgery), you should not receive meloxicam injection right before or right after the surgery.

NSAIDs such as meloxicam injection may cause ulcers, bleeding, or holes in the stomach or intestine. These problems may develop at any time during treatment, may happen without warning symptoms, and may cause death. The risk may be higher for people who take NSAIDs for a long time, are older in age, have poor health, smoke cigarettes, or drink alcohol while using meloxicam injection. Tell your doctor if you take any of the following medications: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); aspirin; other NSAIDs such as ibuprofen (Advil, Motrin) or naproxen (Aleve, Naprosyn); oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), fluoxetine (Prozac, Sarafem, Selfemra, in Symbyax), fluvoxamine (Luvox), paroxetine (Brisdelle, Paxil, Pexeva), and sertraline (Zoloft); or serotonin norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Khedezla, Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR). Also tell your doctor if you have or have ever had ulcers or bleeding in your stomach or intestines, or other bleeding disorders. If you experience any of the following symptoms, stop using meloxicam injection and call your doctor: stomach pain, heartburn, vomit that is bloody or looks like coffee grounds, blood in the stool, or black and tarry stools.

Your doctor will monitor your symptoms carefully and may order certain tests to check your body's response to meloxicam injection. Be sure to tell your doctor how you are feeling so that your doctor can prescribe the right amount of medication to treat your condition with the lowest risk of serious side effects.

Talk to your doctor about the risk(s) of receiving meloxicam injection.

Meloxicam injection is used alone or in combination with other pain medications for the short-term relief of moderate to severe pain in adults, usually after surgery. Meloxicam is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

Meloxicam injection comes as a solution (liquid) to inject intravenously (into a vein). It is usually given once a day as needed for pain by a healthcare provider in a hospital.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before using meloxicam injection,

• tell your doctor and pharmacist if you are allergic to meloxicam, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the ingredients in meloxicam injection. Ask your doctor or pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: amiodarone (Nexterone, Pacerone); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril, enalapril (Epaned, Vasotec, in Vaseretic), fosinopril, lisinopril (in Zestoretic), moexepril, perindopril (in Prestalia), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (in Tarka) ; angiotensin receptor blockers such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan, irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT, in Tribenzor), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Diovan, in Entresto, in Diovan HCT, in Exforge, in Exforge HCT); beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Kapspargo sprinkle, Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); cholestyramine (Prevalite); cyclosporine (Gengraf, Neoral, Sandimmune); diuretics ('water pills'); fluconazole (Diflucan); lithium (Lithobid); methotrexate (Otrexup, Rasuvo, Reditrex, Trexall, Xatmep); pemetrexed (Alimta); and phenytoin (Dilantin, Phenytek). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have kidney disease or if you have or recently have had severe vomiting or diarrhea or think you may be dehydrated. Your doctor may not want you to receive meloxicam injection.
• tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section; asthma, especially if you have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); heart failure; high levels of potassium in the blood; swelling of the hands, feet, ankles, or lower legs; or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant; or are breast-feeding. Meloxicam injection may harm the fetus and cause problems with delivery if it is used around 20 weeks or later during pregnancy. Do not use meloxicam injection around or after 20 weeks of pregnancy, unless you are told to do so by your doctor. If you become pregnant while receiving meloxicam injection, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Meloxicam injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• pain or itching at injection site

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• fever
• blisters
• rash
• skin blisters or peeling
• hives
• itching
• swelling of the eyes, face, tongue, lips, or throat
• difficulty breathing or swallowing
• pale skin
• fast heartbeat
• shortness of breath or difficulty breathing
• unexplained weight gain,
• swelling in the abdomen, ankles, feet, or legs
• nausea
• excessive tiredness
• lack of energy
• yellowing of the skin or eyes
• pain in the right upper part of the stomach
• flu-like symptoms
• cloudy, discolored, or bloody urine
• back pain
• difficult or painful urination

Meloxicam injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• lack of energy
• drowsiness
• nausea
• vomiting
• stomach pain
• bloody, black, or tarry stools
• vomit that is bloody or looks like coffee grounds
• difficulty breathing
• coma

Ask your doctor or pharmacist any questions you have about meloxicam injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Anjeso^®