|Manufacturer:||Merck & Co., Inc.|
Keep your medicine in a safe place where children cannot reach it.
It may be harmful to children.
Store your medication away from heat, light, moisture, and at a controlled room temperature 59°-86°F (15°-30°C).
If your medication has expired, throw it away as instructed.
If your doctor decides to stop your treatment, do not keep any leftover medicine unless your doctor tells you to do so.
Throw away your medicine as instructed.
Be sure that the discarded tablets are out of the reach of children.If you are storing MAXALT-MLT, do not remove the blister from the outer aluminum pouch until you are ready to take the medication inside.This leaflet provides a summary of information about MAXALT.
If you have any questions or concerns about either MAXALT or migraine, talk to your doctor.
In addition, talk to your pharmacist or other health care provider.MAXALT Tablets are manufactured for:MERCK & CO., INC., Whitehouse Station, NJ 08889, USABy:MSD, Ltd.CramlingtonNorthumberland, NE23 3JU, UKMAXALT-MLT Orally Disintegrating Tablets are manufactured for:MERCK & CO., INC., Whitehouse Station, NJ 08889, USABy:Catalent UK Swindon, Zydis Ltd.Swindon, Wiltshire, SN5 8RU, UKUS Patent No.: 5,298,520Issued February 20089652506
MAXALT is indicated for the acute treatment of migraine attacks with or without aura in adults.MAXALT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS).Safety and effectiveness of MAXALT have not been established for cluster headache, which is present in an older, predominantly male population.
MAXALT should not be given to patients with ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have symptoms or findings consistent with ischemic heart disease, coronary artery vasospasm, including Prinzmetal’s variant angina, or other significant underlying cardiovascular disease (see WARNINGS).
Because MAXALT may increase blood pressure, it should not be given to patients with uncontrolled hypertension (see WARNINGS).
MAXALT should not be used within 24 hours of treatment with another 5-HT1 agonist, or an ergotamine-containing or ergot-type medication like dihydroergotamine or methysergide.MAXALT should not be administered to patients with hemiplegic or basilar migraine.Concurrent administration of MAO inhibitors or use of rizatriptan within 2 weeks of discontinuation of MAO inhibitor therapy is contraindicated (see CLINICAL PHARMACOLOGY, Drug Interactions and PRECAUTIONS, Drug Interactions).MAXALT is contraindicated in patients who are hypersensitive to rizatriptan or any of its inactive ingredients.
MAXALT should only be used where a clear diagnosis of migraine has been established.
Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events: Because of the potential of this class of compounds (5-HT1B/1D agonists) to cause coronary vasospasm, MAXALT should not be given to patients with documented ischemic or vasospastic coronary artery disease (see CONTRAINDICATIONS).
It is strongly recommended that rizatriptan not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, or male over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease.
The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best.
If, during the cardiovascular evaluation, the patient’s medical history, electrocardiographic or other investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, rizatriptan should not be administered (see CONTRAINDICATIONS).
For patients with risk factors predictive of CAD, who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of rizatriptan take place in the setting of a physician’s office or similar medically staffed and equipped facility unless the patient has previously received rizatriptan.
Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following MAXALT, in these patients with risk factors.It is recommended that patients who are intermittent long-term users of MAXALT and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use MAXALT.
The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to rizatriptan.Cardiac Events and Fatalities Associated with 5-HT1 Agonists: Serious adverse cardiac events, including acute myocardial infarction, have been reported within a few hours following the administration of rizatriptan.
Life-threatening disturbances of cardiac rhythm and death have been reported within a few hours following the administration of other 5-HT1 agonists.
Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low.
MAXALT can cause coronary vasospasm.
Because of the close proximity of the events to MAXALT use, a causal relationship cannot be excluded.
In the cases where there has been known underlying coronary artery disease, the relationship is uncertain.Premarketing experience with rizatriptan: Among the 3700 patients with migraine who participated in premarketing clinical trials of MAXALT, one patient was reported to have chest pain with possible ischemic ECG changes following a single dose of 10 mg.Postmarketing experience with rizatriptan: Serious cardiovascular events have been reported in association with the use of MAXALT.
The uncontrolled nature of postmarketing surveillance, however, makes it impossible to determine definitively the proportion of the reported cases that were actually caused by rizatriptan or to reliably assess causation in individual cases.Cerebrovascular Events and Fatalities Associated with 5-HT1 Agonists: Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5-HT1 agonists; and some have resulted in fatalities.
In a number of cases, it appears possible that the cerebrovascular events were primary, the agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not.
It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack).Other Vasospasm-Related Events: 5-HT1 agonists may cause vasospastic reactions other than coronary artery vasospasm.
Both peripheral vascular ischemia and colonic ischemia with abdominal pain and bloody diarrhea have been reported with 5-HT1 agonists.Increase in Blood Pressure: Significant elevation in blood pressure, including hypertensive crisis, has been reported on rare occasions in patients receiving 5-HT1 agonists with and without a history of hypertension.
In healthy young male and female subjects who received maximal doses of MAXALT (10 mg every 2 hours for 3 doses), slight increases in blood pressure (approximately 2-3 mmHg) were observed.
Rizatriptan is contraindicated in patients with uncontrolled hypertension (see CONTRAINDICATIONS).
An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5-HT1 agonist in a study evaluating subjects undergoing cardiac catheterization.Serotonin Syndrome: The development of a potentially life-threatening serotonin syndrome may occur with triptans, including MAXALT treatment, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs).
If concomitant treatment with rizatriptan and an SSRI (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram) or SNRI (e.g., venlafaxine, duloxetine) is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases.Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) (see PRECAUTIONS, Drug Interactions).