Description

    Bupivacaine and meloxicam combination injection is used to numb an area of your body and relieve pain for up to 72 hours after soft tissue surgery (eg, surgery in the breast, groin, or stomach) or muscle or bone surgery (eg, surgery in the foot, knee, shoulder, or spine). Bupivacaine is a local anesthetic. It causes a loss of feeling and prevents pain by blocking signals at the nerve endings. It does not cause loss of consciousness. Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID).

    This medicine is to be given only by or under the direct supervision of your doctor.


    Before Using

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

    Allergies

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

    Pediatric

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

    Geriatric

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

    Breastfeeding

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

    Drug Interactions

    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 receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

    • Ketorolac

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

    • Abciximab
    • Aceclofenac
    • Acemetacin
    • Acenocoumarol
    • Amifampridine
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amtolmetin Guacil
    • Anagrelide
    • Apixaban
    • Ardeparin
    • Argatroban
    • Articaine
    • Asciminib
    • Aspirin
    • Balsalazide
    • Bemetizide
    • Bemiparin
    • Bendroflumethiazide
    • Benoxinate
    • Benzocaine
    • Benzthiazide
    • Benzyl Alcohol
    • Betrixaban
    • Bismuth Subsalicylate
    • Bivalirudin
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Bumetanide
    • Bupropion
    • Cangrelor
    • Carbamazepine
    • Celecoxib
    • Ceritinib
    • Certoparin
    • Chloroprocaine

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

    • Acebutolol
    • Alacepril
    • Atenolol
    • Azilsartan
    • Azilsartan Medoxomil
    • Benazepril
    • Betaxolol
    • Bisoprolol
    • Candesartan
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Cilazapril
    • Delapril
    • Enalapril
    • Enalaprilat
    • Enalapril Maleate
    • Eprosartan
    • Esmolol
    • Fosinopril
    • Imidapril
    • Irbesartan
    • Itraconazole
    • Labetalol
    • Levobunolol
    • Lisinopril
    • Losartan
    • Metipranolol
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Olmesartan
    • Oxprenolol
    • Penbutolol
    • Pentopril
    • Perindopril
    • Pindolol
    • Propranolol

    Other Interactions

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

    Other Medical Problems

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

    • Anemia or
    • Asthma or
    • Bleeding problems or
    • Blood clotting problems or
    • Dehydration or
    • Edema (fluid retention or body swelling) or
    • Heart attack, recent or history of or
    • Heart or blood vessel disease (eg, heart failure) or
    • Heart rhythm problems (eg, heart block) or
    • Hyperkalemia (high blood potassium) or
    • Hypertension (high blood pressure) or
    • Hypotension (low blood pressure) or
    • Liver disease or
    • Stomach ulcers or bleeding, history of or
    • Stroke, history of—Use with caution. May make these conditions worse.
    • Aspirin-sensitive asthma or
    • Aspirin sensitivity, history of or
    • Kidney disease, severe—Should not be used in patients with these conditions.
    • Glucose-6-phosphate dehydrogenase deficiency (G6PD) or
    • Lung or breathing problems or
    • Methemoglobinemia (blood disorder), hereditary or idiopathic (unknown cause)—Use with caution. May increase risk of having methemoglobinemia.
    • Kidney disease, mild to moderate or
    • Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a hospital. It is usually given in the area where you had surgery.

    This medicine should not be used to ease pains during childbirth or heart surgery (eg, coronary artery bypass graft [CABG]).

    This medicine should cause numbness only to the area where it is injected. You may experience temporary loss of sensation or movement in the injected area. This type of numbing procedure is called local anesthesia. It is not meant to cause you to fall asleep or become unconscious.


    Precautions

    It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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

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

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

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

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

    Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

    This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. It may occur often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

    This medicine may cause a bone or joint problem called chondrolysis. Check with your doctor right away if you have bone or joint pain or stiffness or an inability to move an area of your body.

    This medicine may cause a rare, but serious blood problem called methemoglobinemia. The risk may be increased in children younger than 6 months of age, elderly patients, or patients with certain inborn defects. It is more likely to occur in patients receiving too much of the medicine, but can also occur with small amounts. Check with your doctor right away if you have pale, gray, or blue-colored skin, lips, or nails, confusion, headache, lightheadedness, fast heartbeat, or unusual tiredness or weakness.

    Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur during treatment with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

    Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away. This medicine may cause a delay in ovulation in females and may decrease sperm count in males, which can affect the ability to have children. If you plan to have children, talk with your doctor before using this medicine.

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


    Side Effects

    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 or nurse immediately if any of the following side effects occur:

    More common

    • Blurred vision
    • chest pain or discomfort
    • chills
    • constipation
    • cough
    • dizziness
    • eye pain
    • fever
    • general feeling of illness
    • headache
    • lightheadedness, dizziness, or fainting
    • muscle twitching
    • nausea
    • pale skin
    • pounding in the ears
    • slow or irregular heartbeat
    • sore throat
    • trouble breathing
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting

    Incidence not known

    • Agitation
    • blistering, peeling, loosening of the skin
    • blood in the urine
    • bloody or black, tarry stools
    • bluish-colored lips, fingernails, or palms
    • chest tightness
    • coma
    • confusion
    • constipation
    • dark urine
    • decrease in amount of urine
    • depression
    • diarrhea
    • difficulty in speaking
    • difficulty swallowing
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • double vision
    • heartburn
    • hives, itching
    • inability to move the arms, legs, or facial muscles
    • inability to speak
    • indigestion
    • irritability
    • joint or muscle pain
    • lethargy
    • loss of appetite
    • noisy, rattling breathing
    • numbness or tingling in the hands, feet, or lips
    • pain or discomfort in the arms, jaw, back, or neck
    • painful or difficult urination
    • 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
    • seizures
    • shoulder discomfort, pain, or stiffness
    • stomach pain, cramping, or burning
    • stupor
    • sweating
    • swelling of the face, fingers, hands, feet, ankles, or lower legs
    • swollen glands
    • vomiting of blood or material that looks like coffee grounds
    • weakness or heaviness of the legs
    • weight gain
    • yellow eyes or skin

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

    More common

    • Change in taste
    • increased sweating
    • loss of taste
    • pain, redness, or swelling at the injection site
    • slow wound healing
    • unusual skin odor

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

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






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