Brand Name

    US Brand Name

    Symbravo


    Description

    Meloxicam and rizatriptan combination is used to treat acute migraine headaches with or without aura. It is not used to prevent migraine headaches and is not used for cluster headaches. Meloxicam is a nonsteroidal anti-inflammatory drug (NSAID). Rizatriptan works in the brain to relieve the pain from migraine headaches. It belongs to the group of medicines called triptans.

    Rizatriptan is not an ordinary pain reliever. It will not relieve any kind of pain other than migraine headaches. This medicine is usually used for people whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

    This medicine is available only with your doctor's prescription.


    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 Symbravo® 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 Symbravo® in the elderly. However, elderly patients are more likely to have diabetes, high blood pressure, and serious stomach, heart, kidney, or liver 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 taking 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.

    • Almotriptan
    • Bromocriptine
    • Dihydroergotamine
    • Eletriptan
    • Ergoloid Mesylates
    • Ergonovine
    • Ergotamine
    • Frovatriptan
    • Isocarboxazid
    • Ketorolac
    • Linezolid
    • Lisuride
    • Metergoline
    • Methylene Blue
    • Methylergonovine
    • Methysergide
    • Naratriptan
    • Nicergoline
    • Phenelzine
    • Procarbazine
    • Propranolol
    • Sumatriptan
    • Tranylcypromine
    • Zolmitriptan

    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
    • Acoramidis
    • Alfentanil
    • Amiloride
    • Amineptine
    • Amitriptyline
    • Amitriptylinoxide
    • Amoxapine
    • Amphetamine
    • Amtolmetin Guacil
    • Anagrelide
    • Apixaban
    • Ardeparin
    • Argatroban
    • Asciminib
    • Aspirin
    • Balsalazide
    • Bemetizide
    • Bemiparin
    • Bendroflumethiazide
    • Benzhydrocodone
    • Benzphetamine
    • Benzthiazide
    • Betrixaban
    • Bismuth Subsalicylate
    • Bivalirudin
    • Bromfenac
    • Budesonide
    • Bufexamac
    • Bumetanide
    • Buprenorphine
    • Butorphanol
    • Cangrelor
    • Carbamazepine
    • Celecoxib
    • Ceritinib
    • Certoparin

    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
    • Atenolol
    • Azilsartan
    • Azilsartan Medoxomil
    • Benazepril
    • Betaxolol
    • Bisoprolol
    • Candesartan
    • Captopril
    • Carteolol
    • Carvedilol
    • Celiprolol
    • Cholestyramine
    • Enalapril
    • Enalaprilat
    • Eprosartan
    • Esmolol
    • Fosinopril
    • Irbesartan
    • Itraconazole
    • Labetalol
    • Levobunolol
    • Lisinopril
    • Losartan
    • Mavacamten
    • Metipranolol
    • Metoprolol
    • Moexipril
    • Nadolol
    • Nebivolol
    • Olmesartan
    • Oxprenolol
    • Penbutolol
    • Perindopril
    • Pindolol
    • Propranolol
    • Quinapril
    • Ramipril
    • Sotalol
    • Spirapril

    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
    • Congestive heart failure or
    • Edema (fluid retention or body swelling) or
    • Heart rhythm problems or
    • Hyperkalemia (high blood potassium) or
    • Hypertension (high blood pressure) or
    • Liver disease or
    • Stomach ulcers or bleeding, history of—Use with caution. May make these conditions worse.
    • Angina (chest pain) or
    • Aspirin-sensitive asthma or
    • Aspirin sensitivity, history of
    • Basilar migraine (migraine with vision and hearing problems) or
    • Heart attack, history of or
    • Heart or blood vessel disease or
    • Hemiplegic migraine (migraine with some paralysis) or
    • Hypertension (high blood pressure), uncontrolled or
    • Ischemic bowel disease (bowels have low blood supply) or
    • Kidney disease, moderate to severe (eg, patients on dialysis) or
    • Peripheral vascular disease (clogged arteries) or
    • Stroke, history of or
    • Transient ischemic attack (TIA), or history of—Should not be used in patients with these conditions.
    • Coronary artery disease, family history of or
    • Diabetes or
    • Obesity or
    • Raynaud's syndrome—Use with caution. May increase risk for certain side effects.
    • Dehydration or
    • Hypovolemia—Must be corrected first before using this medicine.
    • Heart surgery (eg, coronary artery bypass graft [CABG])—Should not be used to relieve pain right before or after the surgery.

    Proper Use

    Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Taking too much of this medicine may increase the chance of side effects.

    Do not use this medicine for a headache that is not a migraine headache. Talk to your doctor about what to do for regular headaches.

    This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

    To relieve your migraine as soon as possible, use this medicine as soon as the headache pain begins. Even if you get warning signals of a coming migraine (an aura), you should wait until the headache pain starts before using this medicine.

    Swallow the tablet whole. Do not crush, divide, or chew it.

    You may take this medicine with or without food.

    Ask your doctor ahead of time about any other medicine you may take if this medicine does not work. After you take the other medicine, check with your doctor as soon as possible. Headaches that are not relieved by meloxicam and rizatriptan combination are sometimes caused by conditions that need other treatment.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For migraine headaches:
      • Adults—1 tablet as needed. Each tablet contains 20 milligrams (mg) meloxicam and 10 mg rizatriptan. However, the dose is usually not more than 1 tablet per day.
      • Children —Use and dose must be determined by your doctor.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

    Do not use this medicine if you have used other triptan or ergot-type migraine medicines within the past 24 hours. Some examples of triptan medicines are almotriptan (Axert™), eletriptan (Relpax®), frovatriptan (Frova®), naratriptan (Amerge®), sumatriptan (Imitrex®, Treximet®), and zolmitriptan (Zomig®). Some examples of ergot-type medicines are dihydroergotamine (D.H.E. 45®, Migranal®), ergotamine (Bellergal®, Cafergot®, Ergomar®, or Wigraine®), and methysergide (Sansert®). Do not take this medicine within 2 weeks after taking an MAO inhibitor, such as Eldepryl®, Marplan®, Nardil®, or Parnate®. Do not use this medicine if you are using propranolol (Inderal®, Inderal® LA, InnoPran XL®).

    Check with your doctor if you used this medicine and your migraine did not go away, or if your migraine got worse or started occurring more often.

    This medicine may increase your risk of having abnormal heart rhythm, angina, heart attack, heart failure, blood clot, or stroke. This is more likely to occur in people who already have heart and blood vessel disease if you have diabetes, high blood pressure, high cholesterol, if you smoke, if you are male and over 40 years of age, or if you are female and have gone through menopause, 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.

    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). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.

    Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. 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.

    Check with your doctor right away if you have chest, jaw, or neck discomfort or tightness after taking this medicine. Also, tell your doctor if you have sudden or severe stomach pain or bloody diarrhea after using this medicine.

    Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

    Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

    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 with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

    Serious skin reactions, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, fixed drug eruption (FDE), and generalized bullous fixed drug eruption (GBFDE) can occur during treatment with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips.

    Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, 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. These may be symptoms of serious skin reaction called drug reaction with eosinophilia and systemic symptoms (DRESS).

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

    Using rizatriptan alone or in combination with other migraine medicines for 10 or more days per month may lead to worsening of headache. You may keep a headache diary to record the headache frequency and medicine use.

    This medicine may cause a serious condition called serotonin syndrome when taken with some medicines. This includes medicines to treat depression, including citalopram (Celexa®), duloxetine (Cymbalta®), escitalopram (Lexapro®), fluoxetine (Prozac®, Sarafem®, or Symbyax®), fluvoxamine (Luvox®), olanzapine (Zyprexa®), paroxetine (Paxil®), sertraline (Zoloft®), or venlafaxine (Effexor®). Check with your doctor right away if you have agitation, confusion, diarrhea, excitement while talking that is not normal, fever, overactive reflexes, poor coordination, restlessness, shivering, sweating, trembling or shaking that you cannot control, or twitching. These could be symptoms of serotonin syndrome.

    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, swelling of the face, fingers, feet, or lower legs. Also, signs of serious heart problems could occur such as 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.

    Some people feel dizzy, drowsy, or weak during or after a migraine, or after taking rizatriptan to relieve a migraine. As long as you are feeling dizzy, drowsy, or weak, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

    This medicine may cause a delay in ovulation for women and may decrease sperm count in men, which can affect their 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 immediately if any of the following side effects occur:

    Incidence not known

    • Agitation
    • blistering, peeling, or loosening of the skin
    • bloody or black, tarry stools
    • bloody or cloudy urine
    • blurred vision
    • chest pain, discomfort, or tightness
    • chills
    • coma
    • confusion
    • constipation
    • cough or hoarseness
    • cracks in the skin
    • dark urine
    • decrease in frequency of urination
    • decrease in urine volume
    • depression
    • diarrhea
    • difficulty in passing urine (dribbling)
    • difficulty in speaking
    • difficulty swallowing
    • dilated neck veins
    • dizziness
    • double vision
    • fainting
    • fast, pounding, or irregular heartbeat or pulse
    • fever with or without chills
    • general feeling of tiredness or weakness
    • headache
    • heartburn
    • hives, itching, skin rash
    • inability to move the arms, legs, or facial muscles
    • inability to speak
    • indigestion
    • irritability
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • lethargy
    • light-colored stools
    • loss of heat from the body
    • lower back or side pain
    • muscle twitching
    • nausea
    • nervousness
    • overactive reflexes
    • pain or discomfort in the arms, jaw, back, or neck
    • pain spreading to the left shoulder
    • painful or difficult urination
    • pale skin
    • paleness or cold feeling in the fingertips and toes
    • palpitations
    • poor coordination
    • pounding in the ears
    • 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
    • scaly skin
    • seizures
    • shivering
    • slow or fast heartbeat
    • slow speech
    • sore throat
    • sores, ulcers, or white spots on the lips or in the mouth
    • stomach pain, cramps, or burning
    • sweating
    • swelling of the face, ankles, hands, feet, or lower legs
    • talking or acting with excitement you cannot control
    • tightness or discomfort in your chest, neck, or jaw
    • tingling or pain in the fingers or toes when exposed to cold
    • trembling or shaking
    • trouble breathing
    • trouble getting pregnant
    • twitching
    • unusual bleeding or bruising
    • unusual tiredness or weakness
    • vomiting
    • 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:

    Less common

    • Sleepiness or unusual drowsiness

    Incidence not known

    • Change in taste
    • loss of taste

    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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