Meloxicam, Rizatriptan
Generic Name: meloxicam, rizatriptan
Brand Names:
Symbravo
11 DESCRIPTION SYMBRAVO contains meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan (as rizatriptan benzoate), a selective 5-HT 1B/1D receptor agonist. Meloxicam Meloxicam has the molecular formula C 14 H 13 N 3 O 4 S 2 and is chemically designated as 4-hydroxy-2-methyl-N-(5 methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. It has a molecular weight of 351.4 g/mole.
Overview
11 DESCRIPTION SYMBRAVO contains meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), and rizatriptan (as rizatriptan benzoate), a selective 5-HT 1B/1D receptor agonist. Meloxicam Meloxicam has the molecular formula C 14 H 13 N 3 O 4 S 2 and is chemically designated as 4-hydroxy-2-methyl-N-(5 methyl-2-thiazolyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-dioxide. It has a molecular weight of 351.4 g/mole.
Uses
1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks. SYMBRAVO is not indicated for the preventive treatment of migraine attacks. SYMBRAVO is not indicated for the treatment of cluster headache. SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a serotonin (5-HT) 1B/1D receptor agonist (triptan)), indicated for the acute treatment of migraine with or without aura in adults ( 1 ).
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dose of SYMBRAVO is one tablet by mouth as needed ( 2.1 ). The maximum daily dose is 20 mg meloxicam and 10 mg rizatriptan (1 tablet) ( 2.1 ). 2.1 Recommended Dose The recommended dose of SYMBRAVO is one tablet (containing 20 mg meloxicam and 10 mg rizatriptan) by mouth, as needed for the acute treatment of migraine. The maximum daily dose should not exceed one tablet. The safety and effectiveness of a second dose for the same migraine attack have not been established. The safety of treating, on average, more than 7 headaches in a 30-day period has not been established. Use for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5) ] . 2.2 Administration Swallow SYMBRAVO tablets whole.
Side Effects
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Thrombotic Events and Myocardial Infarction [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Cerebrovascular Events [see Warnings and Precautions (5.4) ] Anaphylactic Reactions [see Warnings and Precautions (5.5)] Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.6) ] Other Vasospasm Reactions [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Hypertension/Increase in Blood Pressure [see Warnings and Precautions (5.9) ] Heart Failure and Edema [see Warnings and Precaut...
Interactions
7 DRUG INTERACTIONS Drugs that Interfere with Hemostasis (e.g., warfarin, aspirin, SSRIs/SNRIs): Monitor patients for bleeding who are concomitantly taking SYMBRAVO with drugs that interfere with hemostasis. Concomitant use of SYMBRAVO and analgesic doses of aspirin is not generally recommended ( 7.1 ). ACE Inhibitors, ARBs, or Beta-Blockers: Concomitant use with SYMBRAVO may diminish the antihypertensive effect of these drugs. Monitor blood pressure ( 7.1 ). ACE Inhibitors and ARBs: Concomitant use with SYMBRAVO in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function ( 7.1 ). Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics.
Warnings
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings & Precautions (5.1) ] . 5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events, Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ). Arrhythmias: Discontinue dosing if arrhythmia occurs ( 5.3 ). Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke: Discontinue dosing if occurs ( 5.4 ). Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.5 ). Chest/Throat/Neck/Jaw Pain, Tightness, Pressure, or Heaviness: Generally not associated with myocardial ischemia; evaluate patients at high risk ( 5.6 ). Gastrointestinal Ischemic Events, Peripheral Vasospastic Reactions: Discontinue dosing if occurs ( 5.7 ). 4 CONTRAINDICATIONS SYMBRAVO is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings & Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal’s angina [see Warnings & Precautions (5.1) ] .
Pregnancy
8.1 Pregnancy SYMBRAVO has not been studied in pregnant women. However, there are data pertaining to the use of the individual components, meloxicam and rizatriptan during pregnancy. These data are described below. Risk Summary In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied SYMBRAVO tablets are white, modified capsule-shaped, film-coated and debossed with "MXRZ" on one side and "20/10" on the other.
Frequently Asked Questions
What is Meloxicam, Rizatriptan used for?▼
1 INDICATIONS AND USAGE SYMBRAVO is indicated for the acute treatment of migraine with or without aura in adults. Limitations of Use SYMBRAVO should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with SYMBRAVO, the diagnosis of migraine should be reconsidered before SYMBRAVO is administered to treat any subsequent attacks. SYMBRAVO is not indicated for the preventive treatment of migraine attacks. SYMBRAVO is not indicated for the treatment of cluster headache. SYMBRAVO is a combination of meloxicam (an NSAID) and rizatriptan (a serotonin (5-HT) 1B/1D receptor agonist (triptan)), indicated for the acute treatment of migraine with or without aura in adults ( 1 ).
What are the side effects of Meloxicam, Rizatriptan?▼
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Thrombotic Events and Myocardial Infarction [see Warnings and Precautions (5.1) ] GI Bleeding, Ulceration, and Perforation [see Warnings and Precautions (5.2) ] Arrhythmias [see Warnings and Precautions (5.3) ] Cerebrovascular Events [see Warnings and Precautions (5.4) ] Anaphylactic Reactions [see Warnings and Precautions (5.5)] Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.6) ] Other Vasospasm Reactions [see Warnings and Precautions (5.7) ] Hepatotoxicity [see Warnings and Precautions (5.8) ] Hypertension/Increase in Blood Pressure [see Warnings and Precautions (5.9) ] Heart Failure and Edema [see Warnings and Precaut...
Can I take Meloxicam, Rizatriptan during pregnancy?▼
8.1 Pregnancy SYMBRAVO has not been studied in pregnant women. However, there are data pertaining to the use of the individual components, meloxicam and rizatriptan during pregnancy. These data are described below. Risk Summary In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
What are the important warnings for Meloxicam, Rizatriptan?▼
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Risk Non-steroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see Warnings & Precautions (5.1) ] . 5 WARNINGS AND PRECAUTIONS Cardiovascular Thrombotic Events, Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ). Arrhythmias: Discontinue dosing if arrhythmia occurs ( 5.3 ). Cerebral Hemorrhage, Subarachnoid Hemorrhage, and Stroke: Discontinue dosing if occurs ( 5.4 ). Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs ( 5.5 ). Chest/Throat/Neck/Jaw Pain, Tightness, Pressure, or Heaviness: Generally not associated with myocardial ischemia; evaluate patients at high risk ( 5.6 ). Gastrointestinal Ischemic Events, Peripheral Vasospastic Reactions: Discontinue dosing if occurs ( 5.7 ). 4 CONTRAINDICATIONS SYMBRAVO is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings & Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal’s angina [see Warnings & Precautions (5.1) ] .
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.