Organon LLC
Maxalt-mlt
BrandGeneric: Rizatriptan benzoate
ID: 78206014301
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TL;DR — Quick Summary
Key facts from the full medication guide below
🩺What it's for
MAXALT and MAXALT-MLT are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT 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 MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks.
💊How to take it
Although rizatriptan benzoate 5 mg tablets and orally disintegrating tablets are available in the marketplace, MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are no longer marketed in the 5 mg strength.
ℹ️Common side effects
The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions (5.1)]. Arrhythmias [see Warnings and Precautions (5.2)]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3)]. Cerebrovascular Events [see Warnings and Precautions (5.4)]. Other Vasospasm Reactions [see Warnings and Precautions (5.5)].
⚠️Serious risks
Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1) Arrhythmias: Discontinue dosing if occurs (5.2) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk (5.3) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs (5.4) Gastrointestinal ischemic events, peripheral…
📋Interactions & cautions
Drug Interactions [See also Drug Interactions (7).]
📦Storage & missed dose
MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other: NDC 78206-142-01, carton of 18 tablets. MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor.
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Rizatriptan benzoate (Maxalt-mlt) Prices
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MAXALT and MAXALT-MLT are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT 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 MAXALT, the diagnosis of migraine should be reconsidered before MAXALT is administered to treat any subsequent attacks. MAXALT is not indicated for use in the management of hemiplegic or basilar migraine [see Contraindications (4)]. MAXALT is not indicated for the prevention of migraine attacks. Safety and effectiveness of MAXALT have not been established for cluster headache. MAXALT is a serotonin (5-HT) 1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years of age (1) Limitations of Use: Use only after clear diagnosis of migraine has been established (1) Not indicated for the prophylactic therapy of migraine (1) Not indicated for the treatment of cluster headache (1)
Although rizatriptan benzoate 5 mg tablets and orally disintegrating tablets are available in the marketplace, MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are no longer marketed in the 5 mg strength. Adults: 5 or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg (2.1) Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more (2.2) Adjust dose if co-administered with propranolol (2.4)
The recommended starting dose of rizatriptan benzoate is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions [see Clinical Studies (14.1)].
MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are distributed by:Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USA For patent information: www.organon.com/our-solutions/patent/ The brands listed are the trademarks of their respective owners. Copyright 2021 Organon Global Inc. All rights reserved. Revised: 6/2021 usppi-og0462-t-tol-2106r000
Dosing in pediatric patients is based on the patient's body weight. The recommended dose of rizatriptan benzoate is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more. The efficacy and safety of treatment with more than one dose of rizatriptan benzoate within 24 hours in pediatric patients 6 to 17 years of age have not been established.
For MAXALT-MLT Orally Disintegrating Tablets, administration with liquid is not necessary. Orally disintegrating tablets are packaged in a blister within an outer aluminum pouch and patients should not remove the blister from the outer pouch until just prior to dosing. The blister pack should then be peeled open with dry hands and the orally disintegrating tablet placed on the tongue, where it will dissolve and be swallowed with the saliva.
MAXALT Tablets: 10 mg (3) MAXALT-MLT Orally Disintegrating Tablets: 10 mg (3)
MAXALT 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 and Precautions (5.1)]. Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions (5.1)]. History of stroke or transient ischemic attack (TIA) [see Warnings and Precautions (5.4)]. Peripheral vascular disease (PVD) [see Warnings and Precautions (5.5)]. Ischemic bowel disease [see Warnings and Precautions (5.5)]. Uncontrolled hypertension [see Warnings and Precautions (5.8)]. Recent use (i.e., within 24 hours) of another 5-HT1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) [see Drug Interactions (7.2 and 7.3)]. Hemiplegic or basilar migraine [see Indications and Usage (1)]. Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see Drug Interactions (7.5) and Clinical Pharmacology (12.3)]. Hypersensitivity to rizatriptan or any of the excipients (angioedema and anaphylaxis seen) [see Adverse Reactions (6.2)]. History of ischemic heart disease or coronary artery vasospasm (4) History of stroke or transient ischemic attack (4) Peripheral vascular disease (4) Ischemic bowel disease (4) Uncontrolled hypertension (4) Recent (within 24 hours) use of another 5-HT1 agonist (e.g., another triptan), or of an ergotamine-containing medication (4) Hemiplegic or basilar migraine (4) MAO-A inhibitor used in the past 2 weeks (4) Hypersensitivity to rizatriptan or any of the excipients (4)
Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors (5.1) Arrhythmias: Discontinue dosing if occurs (5.2) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk (5.3) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs (5.4) Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs (5.5) Medication overuse headache: Detoxification may be necessary (5.6) Serotonin syndrome: Discontinue dosing if occurs (5.7)
MAXALT should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of MAXALT. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT1 agonists, including MAXALT may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD. Triptan-na ve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) should have a cardiovascular evaluation prior to receiving MAXALT. If there is evidence of CAD or coronary artery vasospasm, MAXALT should not be administered [see Contraindications (4)]. For patients who have a negative cardiovascular evaluation, consideration should be given to administration of the first MAXALT dose in a medically-supervised setting and performing an electrocardiogram (ECG) immediately following MAXALT administration. Periodic cardiovascular evaluation should be considered in intermittent long-term users of MAXALT who have cardiovascular risk factors.
Life-threatening disturbances of cardiac rhythm, including ventricular tachycardia and ventricular fibrillation leading to death, have been reported within a few hours following the administration of 5-HT1 agonists. Discontinue MAXALT if these disturbances occur.
As with other 5-HT1 agonists, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck and jaw commonly occur after treatment with MAXALT and are usually non-cardiac in origin. However, if a cardiac origin is suspected, patients should be evaluated. Patients shown to have CAD and those with Prinzmetal's variant angina should not receive 5-HT1 agonists.
Cerebral hemorrhage, subarachnoid hemorrhage, and stroke have occurred 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 5-HT1 agonist having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. Also, patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack). Discontinue MAXALT if a cerebrovascular event occurs. As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. MAXALT should not be administered to patients with a history of stroke or transient ischemic attack [see Contraindications (4)].
5-HT1 agonists, including MAXALT, may cause non-coronary vasospastic reactions, such as peripheral vascular ischemia, gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), splenic infarction, and Raynaud's syndrome. In patients who experience symptoms or signs suggestive of non-coronary vasospasm reaction following the use of any 5-HT1 agonist, the suspected vasospasm reaction should be ruled out before receiving additional MAXALT doses. Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.
Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead to exacerbation of headache (medication overuse headache). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks. Detoxification of patients, including withdrawal of the overused drugs, and treatment of withdrawal symptoms (which often includes a transient worsening of headache) may be necessary.
Serotonin syndrome may occur with triptans, including MAXALT particularly during co-administration with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), and MAO inhibitors [see Drug Interactions (7.5)]. 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). The onset of symptoms can occur within minutes to hours of receiving a new or a greater dose of a serotonergic medication. MAXALT treatment should be discontinued if serotonin syndrome is suspected [see Drug Interactions (7.4) and Patient Counseling Information (17)].
Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients with and without a history of hypertension receiving 5-HT1 agonists, including MAXALT. In healthy young adult male and female patients 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. MAXALT is contraindicated in patients with uncontrolled hypertension [see Contraindications (4)].
The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions (5.1)]. Arrhythmias [see Warnings and Precautions (5.2)]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3)]. Cerebrovascular Events [see Warnings and Precautions (5.4)]. Other Vasospasm Reactions [see Warnings and Precautions (5.5)]. Medication Overuse Headache [see Warnings and Precautions (5.6)]. Serotonin Syndrome [see Warnings and Precautions (5.7)]. Increase in Blood Pressure [see Warnings and Precautions (5.8)]. The most common adverse reactions in adults were (incidence 5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
The following section enumerates potentially important adverse events that have occurred in clinical practice and which have been reported spontaneously to various surveillance systems. The events enumerated include all except those already listed in other sections of the labeling or those too general to be informative. Because the reports cite events reported spontaneously from worldwide postmarketing experience, frequency of events and the role of MAXALT in their causation cannot be reliably determined. Neurological/Psychiatric: Seizure. General: Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis [see Contraindications (4)]. Special Senses: Dysgeusia.
The dose of MAXALT should be adjusted in propranolol-treated patients, as propranolol has been shown to increase the plasma AUC of rizatriptan by 70% [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)].
Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine-containing or ergot-type medications (like dihydroergotamine or methysergide) and MAXALT within 24 hours is contraindicated [see Contraindications (4)].
Because their vasospastic effects may be additive, co-administration of MAXALT and other 5-HT1 agonists within 24 hours of each other is contraindicated [see Contraindications (4)].
Cases of serotonin syndrome have been reported during co-administration of triptans and selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs) [see Warnings and Precautions (5.7)].
MAXALT is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemic exposure of rizatriptan and its metabolite [see Contraindications (4) and Clinical Pharmacology (12.3)].
Pregnancy: Based on animal data, may cause fetal harm (8.1) Phenylketonurics: MAXALT-MLT contains phenylalanine (8.6)
Safety and effectiveness in pediatric patients under 6 years of age have not been established. The efficacy and safety of MAXALT in the acute treatment of migraine in patients aged 6 to 17 years was established in an adequate and well-controlled study [see Clinical Studies (14.2)]. The incidence of adverse reactions reported for pediatric patients in the acute clinical trial was similar in patients who received MAXALT to those who received placebo. The adverse reaction pattern in pediatric patients is expected to be similar to that in adults.
Clinical studies of MAXALT did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Although the pharmacokinetics of rizatriptan were similar in elderly (aged 65 years) and in younger adults (n=17), in general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range. This reflects the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Geriatric patients who have other cardiovascular risk factors (e.g., diabetes, hypertension, smoking, obesity, strong family history of coronary artery disease) should have a cardiovascular evaluation prior to receiving MAXALT [see Warnings and Precautions (5.1)].
Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). The 10-mg orally disintegrating tablets contain 2.1 mg phenylalanine.
No overdoses of MAXALT were reported during clinical trials in adults. Some adult patients who received 40 mg of MAXALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence. In a clinical pharmacology study in which 12 adult subjects received MAXALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence. In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of MAXALT-MLT within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea. In addition, based on the pharmacology of MAXALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT. Clinical and electrocardiographic monitoring should be continued for at least 12 hours, even if clinical symptoms are not observed. The effects of hemo- or peritoneal dialysis on serum concentrations of rizatriptan are unknown.
MAXALT contains rizatriptan benzoate, a selective 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptor agonist. Rizatriptan benzoate is described chemically as: N,N-dimethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-1H-indole-3-ethanamine monobenzoate and its structural formula is: Its empirical formula is C15H19N5 C7H6O2, representing a molecular weight of the free base of 269.4. Rizatriptan benzoate is a white to off-white, crystalline solid that is soluble in water at about 42 mg per mL (expressed as free base) at 25 C. MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are available for oral administration in a strength of 10 mg (corresponding to 14.53 mg of the benzoate salt). Each compressed tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Each lyophilized orally disintegrating tablet contains the following inactive ingredients: gelatin, mannitol, glycine, aspartame, and peppermint flavor.
Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. MAXALT presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.
Drug Interactions [See also Drug Interactions (7).]
The efficacy of MAXALT Tablets was established in four multicenter, randomized, placebo-controlled trials. Patients enrolled in these studies were primarily female (84%) and Caucasian (88%), with a mean age of 40 years (range of 18 to 71). Patients were instructed to treat a moderate to severe headache. Headache response, defined as a reduction of moderate or severe headache pain to no or mild headache pain, was assessed for up to 2 hours (Study 1) or up to 4 hours after dosing (Studies 2, 3 and 4). Associated symptoms of nausea, photophobia, and phonophobia and maintenance of response up to 24 hours post-dose were evaluated. A second dose of MAXALT Tablets was allowed 2 to 24 hours after dosing for treatment of recurrent headache in Studies 1 and 2. Additional analgesics and/or antiemetics were allowed 2 hours after initial treatment for rescue in all four studies. In all studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater in patients who received either MAXALT 5 or 10 mg compared to those who received placebo. In a separate study, doses of 2.5 mg were not different from placebo. Doses greater than 10 mg were associated with an increased incidence of adverse effects. The results from the four controlled studies are summarized in Table 2. Table 2: Response Rates 2 Hours Following Treatment of Initial Headache in Studies 1, 2, 3, and 4 Study Placebo MAXALT Tablets5 mg MAXALT Tablets10 mg 1 35% (n=304) 62%p-value <0.05 in comparison with placebo. (n=458) 71% , p-value <0.05 in comparison with 5 mg. (n=456) 2Results for initial headache only. 37% (n=82) 77% (n=320) 3 23% (n=80) 63% (n=352) 4 40% (n=159) 60% (n=164) 67% (n=385) Comparisons of drug performance based upon results obtained in different clinical trials may not be reliable. Because studies are conducted at different times, with different samples of patients, by different investigators, employing different criteria and/or different interpretations of the same criteria, under different conditions (dose, dosing regimen, etc.), quantitative estimates of treatment response and the timing of response may be expected to vary considerably from study to study. The estimated probability of achieving an initial headache response within 2 hours following treatment in pooled Studies 1, 2, 3, and 4 is depicted in Figure 1. Figure 1: Estimated Probability of Achieving an Initial Headache Response by 2 Hours in Pooled Studies 1, 2, 3, and 4 Figure 1 shows the Kaplan-Meier plot of the probability over time of obtaining headache response (no or mild pain) following treatment with MAXALT or placebo. The averages displayed are based on pooled data from 4 placebo-controlled, outpatient trials providing evidence of efficacy (Studies 1, 2, 3, and 4). Patients taking additional treatment or not achieving headache response prior to 2 hours were censored at 2 hours. For patients with migraine-associated photophobia, phonophobia, and nausea at baseline, there was a decreased incidence of these symptoms following administration of MAXALT compared to placebo. Two to 24 hours following the initial dose of study treatment, patients were allowed to use additional treatment for pain response in the form of a second dose of study treatment or other medication. The estimated probability of patients taking a second dose or other medication for migraine over the 24 hours following the initial dose of study treatment is summarized in Figure 2. Figure 2: Estimated Probability of Patients Taking a Second Dose of MAXALT Tablets or Other Medication for Migraines Over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Studies 1, 2, 3, and 4This Kaplan-Meier plot is based on data obtained in 4 placebo-controlled outpatient clinical trials (Studies 1, 2, 3, and 4). Patients not using additional treatments were censored at 24 hours. The plot includes both patients who had headache response at 2 hours and those who had no response to the initial dose. Remedication was not allowed within 2 hours post-dose. Efficacy was unaffected by the presence of aura; by the gender, or age of the patient; or by concomitant use of common migraine prophylactic drugs (e.g., beta-blockers, calcium channel blockers, tricyclic antidepressants) or oral contraceptives. In two additional similar studies, efficacy was unaffected by relationship to menses. There were insufficient data to assess the impact of race on efficacy.
The efficacy of MAXALT-MLT in pediatric patients 6 to 17 years was evaluated in a multicenter, randomized, double-blind, placebo-controlled, parallel group clinical trial (Study 7). Patients had to have at least a 6-month history of migraine attacks (with or without aura) usually lasting 3 hours or more (when untreated). The patient population was historically non-responsive to NSAIDs and acetaminophen therapy. Patients were instructed to treat a single migraine attack with headache pain of moderate to severe intensity. The treatment phase of the study had two stages. Stage 1 was used to identify placebo non-responders, who then entered into Stage 2, in which patients were randomized to MAXALT-MLT or placebo. Using a weight-based dosing strategy, patients 20 kg to <40 kg (44 lb to <88 lb) received MAXALT-MLT 5 mg or placebo, and patients 40 kg (88 lb) received MAXALT-MLT 10 mg or placebo. The mean age for the studied patient population was 13 years. Sixty-one percent of the patients were Caucasian, and fifty-six percent of the patients were female. The percentage of patients achieving the primary efficacy endpoint of no headache pain at 2 hours after treatment was significantly greater in patients who received MAXALT-MLT, compared with those who received placebo (33% vs. 24%). Study 7 results are summarized in Table 4. Table 4: Response Rates 2 Hours Following Treatment of Initial Headache in Pediatric Patients 6 to 17 Years of Age in Study 7 Endpoint Placebo MAXALT-MLT p-Value n = Number of evaluable patients with no headache pain at 2 hours post-dose.m = Number of evaluable patients in population. No headache pain at2 hours post-dose 24%(n/m=94/388) 33%(n/m=126/382) 0.01 The observed percentage of pediatric patients achieving no headache pain within 2 hours following initial treatment with MAXALT-MLT is shown in Figure 5. Figure 5: Observed Percentage of Patients Reporting No Headache Pain by 2 Hours Post-Dose in Study 7 The prevalence of the exploratory endpoints of absence of migraine-associated symptoms (nausea, photophobia, and phonophobia) at 2 hours after taking the dose was not statistically significantly different between patients who received MAXALT-MLT and those who received placebo.
MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other: NDC 78206-142-01, carton of 18 tablets. MAXALT-MLT Orally Disintegrating Tablets, 10 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified square on one side, and measuring 12.0-13.8 mm (side-to-side) with a peppermint flavor. Each orally disintegrating tablet is individually packaged in a blister inside an aluminum pouch (sachet). They are supplied as follows: NDC 78206-143-01, 6 unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).
Storage Store MAXALT Tablets at room temperature, 15 C-30 C (59 F-86 F). Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15 C-30 C (59 F-86 F).
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Patient Information MAXALT (max-awlt) and MAXALT-MLT rizatriptan benzoateTablets and Orally Disintegrating Tablets Read this Patient Information before you start taking MAXALT and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment. Unless otherwise stated, the information in this Patient Information leaflet applies to both MAXALT Tablets and to MAXALT-MLT Orally Disintegrating Tablets. What is MAXALT? MAXALT is a prescription medicine that belongs to a class of medicines called Triptans. MAXALT is available as a traditional tablet (MAXALT) and as an orally disintegrating tablet (MAXALT-MLT). MAXALT and MAXALT-MLT are used to treat migraine attacks with or without aura in adults and in children 6 to 17 years of age. MAXALT is not to be used to prevent migraine attacks. MAXALT is not for the treatment of hemiplegic or basilar migraines. It is not known if MAXALT is safe and effective for the treatment of cluster headaches. It is not known if taking more than 1 dose of MAXALT in 24 hours is safe and effective in children 6 to 17 years of age. It is not known if MAXALT is safe and effective in children under 6 years of age. Who should not take MAXALT? Do not take MAXALT if you: have or have had heart problems have or have had a stroke or a transient ischemic attack (TIA) have or have had blood vessel problems including ischemic bowel disease have uncontrolled high blood pressure have taken other Triptan medicines in the last 24 hours have taken ergot-containing medicines in the last 24 hours have hemiplegic or basilar migraines take monoamine oxidase (MAO) inhibitor or have taken a MAO inhibitor within the last 2 weeks are allergic to rizatriptan benzoate or any of the ingredients in MAXALT. See the end of this leaflet for a complete list of ingredients in MAXALT. Talk to your doctor before taking this medicine if you have any of the conditions listed above or if you are not sure if you take any of these medicines. What should I tell my doctor before taking MAXALT? Before you take MAXALT, tell your doctor if you: have or have had heart problems, high blood pressure, chest pain, or shortness of breath have any risk factors for heart problems or blood vessel problems such as: high blood pressure high cholesterol smoking obesity diabetes family history of heart problems you are post menopausal you are a male over 40 have phenylketonuria (PKU). MAXALT-MLT orally disintegrating tablets contain phenylalanine. have kidney or liver problems have any other medical condition are pregnant or plan to become pregnant. It is not known if MAXALT will harm your unborn baby. If you become pregnant while taking MAXALT, talk to your healthcare provider. are breastfeeding or plan to breastfeed. It is not known if MAXALT passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take MAXALT. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. MAXALT and other medicines may affect each other causing side effects. MAXALT may affect the way other medicines work, and other medicines may affect how MAXALT works. Especially tell your doctor if you take: propranolol containing medicines such as Inderal , Inderal LA, or Innopran XL medicines used to treat mood disorders, including selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs). Ask your doctor or pharmacist for a list of these medicines, if you are not sure. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take MAXALT? Take MAXALT exactly as your doctor tells you to take it. Your doctor will tell you how much MAXALT to take and when to take it. To take MAXALT-MLT: Leave MAXALT-MLT orally disintegrating tablets in the package it comes in until you are ready to take it. When you are ready to take it: Remove the blister from the foil pouch. Do not push the MAXALT-MLT orally disintegrating tablet through the blister. Peel open the blister pack with dry hands and place the MAXALT-MLT orally disintegrating tablet on your tongue. The tablet will dissolve and be swallowed with your saliva. No liquid is needed to take the orally disintegrating tablet. If your headache comes back after your first MAXALT dose: For adults: a second dose may be taken 2 hours after the first dose. Do not take more than 30 mg of MAXALT in a 24-hour period (for example, do not take more than 3 10-mg tablets in a 24-hour period). For children 6 to 17 years of age: It is not known if taking more than 1 dose of MAXALT in 24 hours is safe and effective. Talk to your doctor about what to do if your headache does not go away or comes back. If you take too much MAXALT, call your doctor or go to the nearest hospital emergency room right away. What should I avoid while taking MAXALT? MAXALT may cause dizziness, weakness, or fainting. If you have these symptoms, do not drive a car, use machinery, or do anything that needs you to be alert. What are the possible side effects of MAXALT? MAXALT may cause serious side effects. Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects of MAXALT including: heart attack. Symptoms of a heart attack may include: chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded stroke. Symptoms of a stroke may include the following sudden symptoms: numbness or weakness in your face, arm or leg, especially on one side of your body confusion, problems speaking or understanding problems seeing in 1 or both of your eyes problems walking, dizziness, loss of balance or coordination severe headache with no known cause blood vessel problems. Symptoms of blood vessel problems may include: stomach pain bloody diarrhea vision problems coldness and numbness of hands and feet serotonin syndrome. A condition called serotonin syndrome can happen when Triptan medicines such as MAXALT are taken with certain other medicines. Symptoms of serotonin syndrome may include: agitation hallucinations coma fast heartbeat fast changes in your blood pressure increased body temperature muscle spasm loss of coordination nausea, vomiting or diarrhea increased blood pressure. The most common side effects of MAXALT in adults include: feeling sleepy or tired pain or pressure in your chest or throat dizziness Tell your doctor if you have any side effect that bothers you or that does not go away. If you take MAXALT too often, this may result in you getting chronic headaches. In such cases, you should contact your doctor, as you may have to stop taking MAXALT. These are not all the possible side effects of MAXALT. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store MAXALT? Store MAXALT at room temperature between 59 F to 86 F (15 C to 30 C). Safely throw away medicine that is out of date or no longer needed. Keep MAXALT and all medicines out of the reach of children. General Information about the safe and effective use of MAXALT. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MAXALT for a condition for which it was not prescribed. Do not give MAXALT to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about MAXALT. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about MAXALT that is written for health professionals. What are the ingredients in MAXALT? Active ingredient in MAXALT and MAXALT-MLT orally disintegrating tablets: rizatriptan benzoate. Inactive ingredients in MAXALT: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, ferric oxide (red), and magnesium stearate. Inactive ingredients in MAXALT-MLT orally disintegrating tablets: gelatin, mannitol, glycine, aspartame, and peppermint flavor. MAXALT-MLT orally disintegrating tablets contain aspartame, a source of phenylalanine. Phenylketonurics: MAXALT-MLT orally disintegrating tablets 10-mg contain 2.1 mg of phenylalanine. This Patient Information has been approved by the U.S. Food and Drug Administration.
Maxalt (rizatriptan benzoate) 10 mg TABLETS NDC 78206-142-01 Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg rizatriptan. 18 Tablets USUAL DOSAGE: See accompanying circular. Rx only Manuf. by:Zhejiang Huahai Pharmaceutical Co., Ltd.Xunqiao, Linhai, Zhejiang 317024, ChinaDist. by: Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USARizatriptan benzoate (active ingred.) Made in Ireland.Formulated in China.
Maxalt-MLT (rizatriptan benzoate) ORALLY DISINTEGRATING TABLETS10 mg NDC 78206-143-01 Each tablet contains 14.53 mg of rizatriptan benzoate, equivalent to 10 mg rizatriptan. Phenylketonurics: contains phenylalanine (a component of aspartame)2.10 mg per 10-mg orally disintegrating tablet. 6 Carrying Cases, Each Containing3 Orally Disintegrating Tablets USUAL DOSAGE: See accompanying circular. Rx only Manuf. by: Catalent UK Swindon, Zydis Ltd.Swindon, Wiltshire, SN5 8RU, UK Dist. by: Organon LLC, a subsidiary ofORGANON & Co.,Jersey City, NJ 07302, USA Rizatriptan benzoate (active ingred.) Made in Ireland. Formulated in UK.