NEO-CODION NOURRISSONS

contains rizatriptan benzoate, a selective 5-hydroxytryptamine 1B/1D (5-HT 1B/1D ) receptor agonist.

Rizatriptan benzoate is described chemically as

N,N -dimethyl-5-(1 H -1,2,4-triazol-1-ylmethyl)-1 H -indole-3-ethanamine monobenzoate and its structural formula is: Its empirical formula is C 15 H 19 N 5 •C 7 H 6 O 2, 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. image of rizatriptan benzoate Chemical Structure.

® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients to 17 years old.

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.

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 to 17 years of age Limitations of Use: Use only after clear diagnosis of migraine has been established Not indicated for the prophylactic therapy of migraine Not indicated for the treatment of cluster headache.

Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors.

MAXALT presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system. 12.3 Pharmacokinetics Absorption Rizatriptan is completely absorbed following oral administration.

The mean oral absolute bioavailability of the MAXALT Tablet is about 45%, and mean peak plasma concentrations (C max ) are reached in approximately 1-1.5 hours (T max ).

The presence of a migraine headache did not appear to affect the absorption or pharmacokinetics of rizatriptan.

Food has no significant effect on the bioavailability of rizatriptan but delays the time to reach peak concentration by an hour.

In clinical trials, MAXALT was administered without regard to food.

The bioavailability and

C max of rizatriptan were similar following administration of MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets, but the rate of absorption is somewhat slower with MAXALT-MLT, with T max delayed by up to 0.7 hour.

AUC of rizatriptan is approximately 30% higher in females than in males.

No accumulation occurred on multiple dosing.

The mean volume of distribution is approximately 140 liters in male subjects and 110 liters in female subjects.

Rizatriptan is minimally bound (14%) to plasma proteins.

The primary route of rizatriptan metabolism is via oxidative deamination by monoamine oxidase-A (MAO-A) to the indole acetic acid metabolite, which is not active at the 5-HT 1B/1D receptor.

N-monodesmethyl-rizatriptan, a metabolite with activity similar to that of parent compound at the 5-HT 1B/1D receptor, is formed to a minor degree.

Plasma concentrations of

N-monodesmethyl-rizatriptan are approximately 14% of those of parent compound, and it is eliminated at a similar rate.

Other minor metabolites, the N-oxide, the 6-hydroxy compound, and the sulfate conjugate of the 6-hydroxy metabolite are not active at the 5-HT 1B/1D receptor.

The total radioactivity of the administered dose recovered over 120 hours in urine and feces was 82% and 12%, respectively, following a single 10-mg oral administration of 14 C-rizatriptan.

Following oral administration of 14 C-rizatriptan, rizatriptan accounted for about 17% of circulating plasma radioactivity.

Approximately 14% of an oral dose is excreted in urine as unchanged rizatriptan while 51% is excreted as indole acetic acid metabolite, indicating substantial first pass metabolism.

The plasma half-life of rizatriptan in males and females averages 2-3 hours.

P450 Isoforms Rizatriptan is not an inhibitor of the activities of human liver cytochrome P450 isoforms 3A4/5, 1A2, 2C9, 2C19, or 2E1; rizatriptan is a competitive inhibitor (K i =1400 nM) of cytochrome P450 2D6, but only at high, clinically irrelevant concentrations.

Rizatriptan pharmacokinetics in healthy elderly non-migraineur volunteers (age 65-77 years) were similar to those in younger non-migraineur volunteers (age 18-45 years).

The pharmacokinetics of rizatriptan was determined in pediatric migraineurs to 17 years of age.

Exposures following single dose administration of 5 mg MAXALT-MLT to pediatric patients weighing 20-39 kg (44-87 lb) or 10 mg MAXALT-MLT to pediatric patients weighing ≥40 kg (88 lb) were similar to those observed following single dose administration of 10 mg MAXALT-MLT to adults.

The mean AUC 0-∞ and C max of rizatriptan (10 mg orally) were about 30% and 11% higher in females as compared to males, respectively, while T max occurred at approximately the same time.

Hepatic impairment

Following oral administration in patients with hepatic impairment caused by mild to moderate alcoholic cirrhosis of the liver, plasma concentrations of rizatriptan were similar in patients with mild hepatic insufficiency compared to a control group of subjects with normal hepatic function; plasma concentrations of rizatriptan were approximately 30% greater in patients with moderate hepatic insufficiency.

Renal impairment

In patients with renal impairment (creatinine clearance 10-60 mL/min/1.73 m 2 ), the AUC 0-∞ of rizatriptan was not significantly different from that in subjects with normal renal function.

In hemodialysis patients, (creatinine clearance <2 mL/min/1.73 m 2 ), however, the AUC for rizatriptan was approximately 44% greater than that in patients with normal renal function.

Pharmacokinetic data revealed no significant differences between African American and Caucasian subjects.

Drug Interactions Monoamine oxidase inhibitors

Rizatriptan is principally metabolized via monoamine oxidase, 'A' subtype (MAO-A).

Plasma concentrations of rizatriptan may be increased by drugs that are selective MAO-A inhibitors (e.g., moclobemide) or nonselective MAO inhibitors [type A and B] (e.g., isocarboxazid, phenelzine, tranylcypromine, and pargyline).

In a drug interaction study, when MAXALT 10 mg was administered to subjects (n=12) receiving concomitant therapy with the selective, reversible MAO-A inhibitor, moclobemide 150 mg t.i.d., there were mean increases in rizatriptan AUC and C max of 119% and 41% respectively; and the AUC of the active N-monodesmethyl metabolite of rizatriptan was increased more than 400%.

The interaction would be expected to be greater with irreversible MAO inhibitors.

No pharmacokinetic interaction is anticipated in patients receiving selective MAO-B inhibitors.

In a study of concurrent administration of propranolol 240 mg/day and a single dose of rizatriptan 10 mg in healthy adult subjects (n=11), mean plasma AUC for rizatriptan was increased by 70% during propranolol administration, and a four-fold increase was observed in one subject.

The AUC of the active

N-monodesmethyl metabolite of rizatriptan was not affected by propranolol.

Nadolol/Metoprolol: In a drug interactions study, effects of multiple doses of nadolol 80 mg or metoprolol 100 mg every 12 hours on the pharmacokinetics of a single dose of 10 mg rizatriptan were evaluated in healthy subjects (n=12).

No pharmacokinetic interactions were observed.

In a study of the interaction between the selective serotonin reuptake inhibitor (SSRI) paroxetine 20 mg/day for two weeks and a single dose of MAXALT 10 mg in healthy subjects (n=12), neither the plasma concentrations of rizatriptan nor its safety profile were affected by paroxetine.

Oral contraceptives

In a study of concurrent administration of an oral contraceptive during 6 days of administration of MAXALT (10-30 mg/day) in healthy female volunteers (n=18), rizatriptan did not affect plasma concentrations of ethinyl estradiol or norethindrone.

The following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina.

Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure.

The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co.fda.gov/medwatch. 6.1 Clinical Trials Experience 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.

Adults Incidence in Controlled Clinical Trials Adverse reactions to MAXALT were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of MAXALT Tablets.

The most common adverse reactions during treatment with MAXALT (≥5% in either treatment group and greater than placebo) were asthenia/fatigue, somnolence, pain/pressure sensation and dizziness.

These adverse reactions appeared to be dose related.

Table 1 lists the adverse reactions (incidence ≥2% and greater than placebo) after a single dose of MAXALT in adults.

Table 1: Incidence (≥2% and Greater than Placebo) of Adverse Reactions After a Single Dose of MAXALT Tablets or Placebo in Adults % of Patients Adverse Reactions MAXALT 5 mg (N=977) MAXALT 10 mg (N=1167) Placebo (N=627) Atypical Sensations 4 5 4 Paresthesia 3 4 <2 Pain and other Pressure Sensations 6 9 3 Chest Pain: tightness/pressure and/or heaviness <2 3 1 Neck/throat/jaw: pain/tightness/pressure <2 2 1 Regional Pain: tightness/pressure and/or heaviness <1 2 0 Pain, location unspecified 3 3 <2 Digestive 9 13 8 Dry Mouth 3 3 1 Nausea 4 6 4 Neurological 14 20 11 Dizziness 4 9 5 Headache <2 2 <1 Somnolence 4 8 4 Other Asthenia/fatigue 4 7 2 The frequencies of adverse reactions in clinical trials did not increase when up to three doses were taken within 24 hours.

Adverse reaction frequencies were also unchanged by concomitant use of drugs commonly taken for migraine prophylaxis (including propranolol), oral contraceptives, or analgesics.

The incidences of adverse reactions were not affected by age or gender.

There were insufficient data to assess the impact of race on the incidence of adverse reactions.

Other Events Observed in Association with the Administration of MAXALT in Adults In the following section, the frequencies of less commonly reported adverse events are presented that were not reported in other sections of the labeling.

Because the reports include events observed in open studies, the role of MAXALT in their causation cannot be reliably determined.

Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, limit the value of the quantitative frequency estimates provided.

Event frequencies are calculated as the number of patients who used MAXALT and reported an event divided by the total number of patients exposed to MAXALT (N=3716).

All reported events occurred at an incidence ≥1%, or are believed to be reasonably associated with the use of the drug.

Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those defined as those occurring in at least (>)1/100 patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.

Infrequent was facial edema.

Rare were syncope and edema/swelling.

Frequent were warm sensations.

Frequent was palpitation.

Infrequent were tachycardia, cold extremities, and bradycardia.

Frequent were diarrhea and vomiting.

Infrequent were dyspepsia, tongue edema and abdominal distention.

Infrequent were muscle weakness, stiffness, myalgia and muscle cramp/spasm.

Neurological/Psychiatric: Frequent were hypoesthesia, euphoria and tremor.

Infrequent were vertigo, insomnia, confusion/disorientation, gait abnormality, memory impairment, and agitation.

Frequent was dyspnea.

Infrequent was pharyngeal edema.

Infrequent were blurred vision and tinnitus.

Rare was eye swelling.

Frequent was flushing.

Infrequent were sweating, pruritus, rash, and urticaria.

Rare was erythema, hot flashes.

The adverse reaction profile seen with MAXALT-MLT Orally Disintegrating Tablets was similar to that seen with MAXALT Tablets.

Patients to 17 Years of Age Incidence in Controlled Clinical Trials in Pediatric Patients Adverse reactions to MAXALT-MLT were assessed in a controlled clinical trial in the acute treatment of migraines (Study 7) that included a total of 1382 pediatric patients 6-17 years of age, of which 977 (72%) administered at least one dose of study treatment (MAXALT-MLT and/or placebo) .

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.

Other Events Observed in Association with the Administration of MAXALT-MLT in Pediatric Patients In the following section, the frequencies of less commonly reported adverse events are presented.

Because the reports include events observed in open studies, the role of MAXALT-MLT in their causation cannot be reliably determined.

Event frequencies are calculated as the number of pediatric patients to 17 years of age who used MAXALT-MLT and reported an event divided by the total number of patients exposed to MAXALT-MLT (N=1068).

Events are further classified within system organ class and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are those occurring in (>)1/100 pediatric patients; infrequent adverse experiences are those occurring in 1/100 to 1/1000 pediatric patients; and rare adverse experiences are those occurring in fewer than 1/1000 patients.

Frequent was fatigue.

Ear and labyrinth disorders

Infrequent was hypoacusis.

Gastrointestinal disorders

Frequent was abdominal discomfort.

Nervous system disorders

Infrequent were coordination abnormal, disturbance in attention, and presyncope.

Psychiatric disorders

Infrequent was hallucination. 6.2 Postmarketing Experience 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.

Allergic conditions including anaphylaxis/anaphylactoid reaction, angioedema, wheezing, and toxic epidermal necrolysis.

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 to 17 years of age (of which 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 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.

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.

Coronary artery vasospasm including

Prinzmetal's angina.

History of stroke or transient ischemic attack (TIA) .

Peripheral vascular disease (PVD) .

Ischemic bowel disease.

Uncontrolled hypertension.

Recent use (i.e., within 24 hours) of another 5-HT 1 agonist, ergotamine-containing medication, or ergot-type medication (such as dihydroergotamine or methysergide) .

Hemiplegic or basilar migraine.

Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor.

Hypersensitivity to rizatriptan or any of the excipients (angioedema and anaphylaxis seen) .

History of ischemic heart disease or coronary artery vasospasm History of stroke or transient ischemic attack Peripheral vascular disease Ischemic bowel disease Uncontrolled hypertension Recent (within 24 hours) use of another 5-HT 1 agonist (e.g., another triptan), or of an ergotamine-containing medication Hemiplegic or basilar migraine MAO-A inhibitor used in the past 2 weeks Hypersensitivity to rizatriptan or any of the excipients.

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 Pediatric patients 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 Adjust dose if co-administered with propranolol 2.1 Dosing Information in Adults 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.

Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose.

The maximum daily dose should not exceed 30 mg in any 24-hour period.

The safety of treating, on average, more than four headaches in a 30-day period has not been established. 2.2 Dosing Information in Pediatric Patients (Age to 17 Years) 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 to 17 years of age have not been established. 2.3 Administration of MAXALT-MLT Orally Disintegrating Tablets 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. 2.4 Dosage Adjustment for Patients on Propranolol Adult Patients In adult patients taking propranolol, only the 5-mg dose of rizatriptan benzoate is recommended, up to a maximum of 3 doses in any 24-hour period (15 mg) .

For pediatric patients weighing 40 kg (88 lb) or more, taking propranolol, only a single 5-mg dose of rizatriptan benzoate is recommended (maximum dose of 5 mg in a 24-hour period).

Rizatriptan benzoate should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 lb) .

Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK on the other: NDC 78206-142-01, carton of 18 tablets.

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).

Tablets at room temperature, 15°C-30°C (59°F-86°F).

Tablets at room temperature, 15°C-30°C (59°F-86°F).

Risk Summary Available human data on the use of MAXALT in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage.

In animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma exposures greater than that expected at therapeutic doses in humans.

In the

U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

The reported rate of major birth defects among deliveries to women with migraine range from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which are similar to rates reported in women without migraine.

Maternal and/or Embryo/Fetal Risk In women with migraine, there is an increased risk of adverse perinatal outcomes in the mother, including pre-eclampsia and gestational hypertension.

Data Human Data The Pregnancy Registry for MAXALT did not identify any pattern of congenital anomalies or other adverse birth outcomes over the period of to 2018.

However, the lack of identification of any pattern should be viewed with caution, as the number of prospective reports with outcome information was low and did not provide sufficient power to detect an increased risk of individual birth defects associated with the use of MAXALT.

Additionally, there was significant loss to follow-up in the prospective pregnancy reports, further complicating this assessment of an association between MAXALT and any pattern of congenital anomalies or other adverse birth outcomes.

In a study using data from the Swedish Medical Birth Register, live births to women who reported using triptans or ergots during pregnancy were compared with those of women who did not.

Of the 157 births with first-trimester exposure to rizatriptan, 7 infants were born with malformations (relative risk 1.01 [95% CI: 0.40 to 2.08]).

A study using linked data from the Medical Birth Registry of Norway to the Norwegian Prescription Database compared pregnancy outcomes in women who redeemed prescriptions for triptans during pregnancy, as well as a migraine disease comparison group who redeemed prescriptions for triptans before pregnancy only, compared with a population control group.

Of the 310 women who redeemed prescriptions for rizatriptan during the first trimester, 10 had infants with major congenital malformations (OR 1.03 [95% CI: 0.55 to 1.93]), while for the 271 women who redeemed prescriptions for rizatriptan before, but not during, pregnancy, 12 had infants with major congenital malformations (OR 1.48 [95% CI: 0.83 to 2.64]), each compared with the population comparison group.

When rizatriptan (0, 2, 10, or 100 mg/kg/day) was administered orally to pregnant rats throughout organogenesis, a decrease in fetal body weight was observed at the highest doses tested.

At the mid dose (10 mg/kg/day), which was a no-effect dose for adverse effects on embryofetal development, plasma exposure (AUC) was approximately 15 times that in humans at the maximum recommended human dose (MRHD) of 30 mg/day. When rizatriptan (0, 5, 10, or 50 mg/kg/day) was administered orally to pregnant rabbits throughout organogenesis, no adverse fetal effects were observed.

Plasma exposure (AUC) at the highest dose tested was 115 times that in humans at the MRHD.

Placental transfer of drug to the fetus was demonstrated in both species.

Oral administration of rizatriptan (0, 2, 10, or 100 mg/kg/day) to female rats prior to and during mating and continuing throughout gestation and lactation resulted in reduced body weight in offspring from birth and throughout lactation at all but the lowest dose tested (2 mg/kg/day).

Plasma exposure (AUC) at the no-effect dose (2 mg/kg/day) for adverse effects on postnatal development was similar to that in humans at the MRHD.

Oral administration of rizatriptan (0, 5, 100, or 250 mg/kg/day) throughout organogenesis and lactation resulted in neonatal mortality, reduced body weight (which persisted into adulthood), and impaired neurobehavioral function in offspring at all but the lowest dose tested.

Plasma exposure (AUC) at the no-effect dose for adverse effects on postnatal development (5 mg/kg/day) was approximately 8 times that in humans at the MRHD.

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 to 17 years was established in an adequate and well-controlled study.

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 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.