Drugs Details

Drugs Info of Maxalt, Maxalt-MLT
Drugs Details
  • Drugs Type  : Multum
  • Date : 23rd Feb 2015 04:56 am
  • Brand Name : Maxalt, Maxalt-MLT
  • Generic Name : rizatriptan (Pronunciation: RYE za TRIP tan)
Descriptions

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:

 

MAXALT
  (rizatriptan benzoate) Structural Formula Illustration

 

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 strengths of 5 and 10 mg (corresponding to 7.265 mg or 14.53 mg of the benzoate salt, respectively). 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.

 

What are the possible side effects of rizatriptan (Maxalt, Maxalt-MLT)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with...

Read All Potential Side Effects and See Pictures of Maxalt »

What are the precautions when taking rizatriptan benzoate (Maxalt)?

Before using rizatriptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions,...

Read All Potential Precautions of Maxalt »

 

This monograph has been modified to include the generic and brand name in many instances.

Indications

MAXALT® and MAXALT-MLT® are indicated for the acute treatment ofmigraine 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].
  • MAXALT is not indicated for the prevention of migraine attacks.
  • Safety and effectiveness of MAXALT have not been established forcluster headache.

Dosage Administration

Dosing Information in Adults

The recommended starting dose of MAXALT 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].

Redosing in Adults

Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headachereturns, 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.

Dosing Information in Pediatric Patients (Age 6 to 17 Years)

Dosing in pediatric patients is based on the patient's body weight. The recommended dose of MAXALT is 5 mg in patients weighing less than 40 kg (88 Ib), and 10 mg in patients weighing 40 kg (88 Ib) or more.

The efficacy and safety of treatment with more than one dose of MAXALT within 24 hours in pediatric patients 6 to 17 years of age have not been established.

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 thetongue, where it will dissolve and be swallowed with the saliva.

Dosage Adjustment for Patients on Propranolol

Adult Patients

In adult patients taking propranolol, only the 5-mg dose of MAXALT is recommended, up to a maximum of 3 doses in any 24-hour period (15mg) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Pediatric Patients

For pediatric patients weighing ≥ 40 kg (88 Ib) taking propranolol, only a single 5-mg dose of MAXALT is recommended (maximum dose of 5 mg in a 24-hour period). MAXALT should not be prescribed to propranolol-treated pediatric patients who weigh less than 40 kg (88 Ib) [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

How Supplied

Dosage Forms and Strengths

MAXALT Tablets
  • 5 mg tablets are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other.
  • 10 mg tablets are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other.
MAXALT-MLT Orally Disintegrating Tablets
  • 5 mg orally disintegrating tablets are white to off-white, round lyophilized tablets debossed with a modified triangle on one side.
  • 10 mg orally disintegrating tablets are white to off-white, round lyophilized tablets debossed with a modified square on one side.

No. 3732 — MAXALT Tablets, 5 mg, are pale pink, capsule-shaped, compressed tablets coded MRK on one side and 266 on the other:

NDC 0006-0266-18, carton of 18 tablets.

No. 3733— MAXALT Tablets, 10 mg, are pale pink, capsule-shaped, compressed tablets coded MAXALT on one side and MRK 267 on the other:

NDC 0006-0267-18, carton of 18 tablets.

No. 3800 — MAXALT-MLT Orally Disintegrating Tablets, 5 mg, are white to off-white, round lyophilized orally disintegrating tablets debossed with a modified triangle on one side, and measuring 10.0-11.5 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 0006-3800-18, 6 x unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).

No. 3801— MAXALT-MLT Orally Disintegrating Tablets, 10mg, 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 0006-3801-18, 6 x unit of use carrying case of 3 orally disintegrating tablets (18 tablets total).

Storage

Store MAXALT Tablets at room temperature, 15-30°C (59-86T).

Store MAXALT-MLT Orally Disintegrating Tablets at room temperature, 15-30°C (59-86T).

MAXALT Tablets are manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK&CO.,INC,Whitehouse Station, NJ 08889, USA. By: MSD, Ltd. Cramlington, Northumberland, NE23 3JU, UK. MAXALT-MLT Orally Disintegrating Tablets are manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK&CO.,INC,Whitehouse Station, NJ 08889, USA By: Catalent UK Swindon, Zydis Ltd. Swindon, Wiltshire, SN5 8RU, UK. Revised: 12/2011

This monograph has been modified to include the generic and brand name in many instances.

 
 

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].
  • Arrhythmias [see WARNINGS AND PRECAUTIONS].
  • Chest and or Throat, Neck and/or Jaw Pain/Tightness/Pressure [seeWARNINGS and PRECAUTIONS].
  • Cerebrovascular Events [see WARNINGS AND PRECAUTIONS].
  • Other Vasospasm Reactions [see WARNINGS AND PRECAUTIONS].
  • Medication Overuse Headache [see WARNINGS AND PRECAUTIONS].
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS].
  • Increase in Blood Pressure [see WARNINGS AND PRECAUTIONS].

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

ADVERSE REACTIONS % OF PATIENTS
MAXALT 
5MG 
(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 MAXAL T 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.

General: Infrequent was facial edema. Rare were syncope and edema/swelling.

Atypical Sensations: Frequent were warm sensations.

Cardiovascular: Frequent was palpitation. Infrequent were tachycardia, cold extremities, and bradycardia.

Digestive: Frequent were diarrhea and vomiting. Infrequent weredyspepsia, tongue edema and abdominal distention.

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

Neurological/Psychiatric: Frequent were hypoesthesia, euphoria andtremor. Infrequent were vertigo, insomnia, confusion/disorientation, gaitabnormality, memory impairment, and agitation.

Respiratory: Frequent was dyspnea. Infrequent was pharyngeal edema.

Special Senses: Infrequent were blurred vision and tinnitus. Rare was eye swelling.

Skin and Skin Appendage: Frequent was flushing. Infrequent weresweating, 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.

Pediatric Patients 6 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) [seeClinical Studies]. 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. 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 pediatric patients 6 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). 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 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.

General: 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.

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.

Neurological/Psychiatric: Seizure.

General: Allergic conditions including anaphylaxis/anaphylactoid reaction,angioedema, wheezing, and toxic epidermal necrolysis [seeCONTRAINDICATIONS].

Special Senses: Dysgeusia.

Read the Maxalt (rizatriptan benzoate) Side Effects Center for a complete guide to possible side effects

Learn More »
 
 
 

Interactions

Propranolol

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 and CLINICAL PHARMACOLOGY].

Ergot-Containing Drugs

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 [seeCONTRAINDICATIONS].

Other 5-HT1 Agonists

Because their vasospastic effects may be additive, co-administration of MAXALT and other 5-HT-i agonists within 24 hours of each other is contraindicated [see CONTRAINDICATIONS].

SSRIs/SNRIs and Serotonin Syndrome

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 ANDPRECAUTIONS].

Monoamine Oxidase Inhibitors

MAXALT is contraindicated in patients taking MAO-A inhibitors and non-selective MAO inhibitors. A specific MAO-A inhibitor increased the systemicexposure of rizatriptan and its metabolite [see CONTRAINDICATIONS andCLINICAL PHARMACOLOGY].

Read the Maxalt Drug Interactions Center for a complete guide to possible interactions

Learn More »
 

This monograph has been modified to include the generi

Warnings

Included as part of the PRECAUTIONS section.

Precautions

Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina

MAXALT should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiacadverse 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-HT1agonists including MAXALT may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD.

Triptan-naTve 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]. 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.

Arrhythmias

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.

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

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.

Cerebrovascular Events

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 [seeCONTRAINDICATIONS].

Other Vasospasm Reactions

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 bloodydiarrhea), 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.

Medication Overuse Headache

Overuse of acute migraine drugs (e.g., ergotamine, triptans, opioids, or a combination of drugs for 10 or more days per month) may lead toexacerbation 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

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]. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labileblood 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 and PATIENT INFORMATION].

Increase in Blood Pressure

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 (10mg 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 [seeCONTRAINDICATIONS].

Patient Counseling Information

See FDA-Approved Patient Labeling (PATIENT INFORMATION).

Risk of Myocardial Ischemia and/or Infarction, Prinzmetal's Angina, Other Vasospasm-related Events, and Cerebrovascular Events

Inform patients that MAXALT may cause serious cardiovascular side effects such as myocardial infarction or stroke. Although serious cardiovascular events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up [see WARNINGS AND PRECAUTIONS].

Serotonin Syndrome

Patients should be cautioned about the risk of serotonin syndrome with the use of MAXALT or other triptans, particularly during combined use with selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIsJ [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Pregnancy

Inform patients that MAXALT should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus [see Use in Specific Populations].

Nursing Mothers

Advise patients to notify their healthcare provider if they are breastfeeding or plan to breastfeed [see Use In Specific Populations].

Ability To Perform Complex Tasks

Since migraines or treatment with MAXALT may cause somnolence and dizziness, instruct patients to evaluate their ability to perform complex tasks during migraine attacks and after administration of MAXALT.

Medication Overuse Headache

Inform patients that use of acute migraine drugs for 10 or more days per month may lead to an exacerbation of headache, and encourage patients to record headache frequency and drug use (e.g., by keeping a headache diary) [see WARNINGS AND PRECAUTIONS].

Handling of Orally Disintegrating Tablets Packages

Instruct patients not to remove the blister from the outer aluminum pouch until ready to use the orally disintegrating tablet inside [see DOSAGE AND ADMINISTRATION].

Patients with Phenylketonuria

Inform phenylketonuric patients that MAXALT-MLT Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). Each 5-mg orally disintegrating tablet contains 1.1 mg phenylalanine, and each 10-mg orally disintegrating tablet contains 2.1 mg phenylalanine [see Use In Specific Populations].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinoaenesis: Oral carcinogenicity studies were conducted in mice (100 weeks) and rats (106 weeks) at doses of up to 125 mg/kg/day. Plasmaexposures (AUC) at the highest dose tested were approximately 150 (mice) and 240 times (rats) that in humans at the maximum recommended daily dose (MRDD) of 30 mg/day. There was no evidence of an increase in tumor incidence related to rizatriptan in either species.

Mutaaenesis: Rizatriptan was neither mutagenic nor clastogenic in a battery of in vitro and in vivo genetic toxicity studies, including: the microbial mutagenesis (Ames) assay, in vitro mammalian cell mutagenesis and chromosomal aberration assays, and the in vivo chromosomal aberration assay in mouse.

Impairment of Fertility: In a fertility study in rats, altered estrus cyclicity and delays in time to mating were observed in females treated orally with 100 mg/kg/day rizatriptan. The no-effect dose was 10 mg/kg/day (approximately 15 times the human exposure at the MRDD). There were no other fertility-related effects in the female rats. There was no impairment of fertility or reproductive performance in male rats treated with up to 250 mg/kg/day (approximately 550 times the human exposure at the MRDD).

Use In Specific Populations

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies in pregnant women. MAXALT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

In a general reproductive study in rats, birth weights and pre- and post-weaning weight gain were reduced in the offspring of females treated prior to and during mating and throughout gestation and lactation with doses of 10 and 100 mg/kg/day. In a pre- and post-natal developmental toxicity study in rats, an increase in mortality of the offspring at birth and for the first three days after birth, a decrease in pre- and post-weaning weight gain, and decreased performance in a passive avoidance test (which indicates a decrease in learning capacity of the offspring) were observed at doses of 100 and 250 mg/kg/day. The no-effect dose for all of these effects was 5 mg/kg/day, associated with a maternal plasma exposure (AUC) approximately 7.5 times that in humans receiving the MRDD. With doses of 100 and 250 mg/kg/day, the decreases in average weight of both the male and female offspring persisted into adulthood. All effects on the offspring in both studies occurred in the absence of any apparent maternal toxicity.

In embryofetal development studies, no teratogenic effects were observed when pregnant rats and rabbits were administered doses of 100 and 50 mg/kg/day, respectively, during organogenesis. Fetal weights were decreased in conjunction with decreased maternal weight gain at the highest doses tested. The developmental no-effect dose in these studies was 10 mg/kg/day in both rats and rabbits (maternal exposures approximately 15 times human exposure at the MRDD). Toxicokinetic studies demonstrated placenta! transfer of drug in both species.

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., maintains aregistry to monitor the pregnancy outcomes of women exposed to MAXALT while pregnant. Healthcare providers are encouraged to report any prenatalexposure to MAXALT by calling the Pregnancy Registry at 1-800-986-8999.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXALT is administered to a nursing woman. Rizatriptan is extensively excreted in rat milk, with levels in milk at least 5-fold higher than levels in maternal plasma.

Pediatric Use

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].

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.

Geriatric Use

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].

Patients with Phenylketonuria

Orally Disintegrating Tablets contain phenylalanine (a component of aspartame). The 5 and 10 mg orally disintegrating tablets contain 1.1 and 2.1 mg phenylalanine, respectively.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

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 abdominaldiscomfort, 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.

ContrainDications

MAXALT is contraindicated in patients with:

  • Ischemic coronary artery disease (angina pectoris, history of myocardialinfarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see WARNINGS ANDPRECAUTIONS].
  • Coronary artery vasospasm including Prinzmetal's angina [seeWARNINGS AND PRECAUTIONS].
  • History of stroke or transient ischemic attack (TIA) [see WARNINGS AND PRECAUTIONS].
  • Peripheral vascular disease (PVD) [see WARNINGS ANDPRECAUTIONS].
  • Ischemic bowel disease [see WARNINGS AND PRECAUTIONS].
  • Uncontrolled hypertension [see WARNINGS AND PRECAUTIONS].
  • 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].
  • Hemiplegic or basilar migraine.
  • Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
  • Hypersensitivity to MAXALT or MAXALT-MLT (angioedema and anaphylaxis seen) [see ADVERSE REACTIONS].

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

Rizatriptan binds with high affinity to human cloned 5-HT1B/1D receptors. MAXALT presumably exerts its therapeutic effects in the treatment ofmigraine headache by binding to 5-HT1B/1D receptors located onintracranial blood vessels and sensory nerves of the trigeminal system.

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 (Cmax) are reached in approximately 1-1.5 hours (Tmax). 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 Cmax 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 Tmax 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.

Distribution

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.

Metabolism

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-HT1B/1D receptor. N-monodesmethyl-rizatriptan, a metabolite with activity similar to that of parent compound at the 5-HT1B/1Dreceptor, 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-HT1B/1D receptor.

Elimination

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

Cytochrome 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,=1400 nM) of cytochrome P450 2D6, but only at high, clinically irrelevant concentrations.

Special Populations

Geriatric: 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).

Pediatric: The pharmacokinetics of rizatriptan was determined in pediatric migraineurs 6 to 17 years of age. Exposures following single dose administration of 5 mg MAXALT-MLT to pediatric patients weighing 20-39 kg (44-87 Ib) or 10 mg MAXALT-MLT to pediatric patients weighing ≥ 40 kg (88 Ib) were similar to those observed following single dose administration of 10 mg MAXALT-MLT to adults.

Gender: The mean AUC0-∞ and Cmax of rizatriptan (10 mg orally) were about 30% and 11% higher in females as compared to males, respectively, while Tmax 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 m2), the AUC0-∞, of rizatriptan was not significantly different from that in subjects with normal renal function. In hemodialysispatients, (creatinine clearance < 2 mL/min/1.73 m2), however, the AUC for rizatriptan was approximately 44% greater than that in patients with normal renal function.

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

Drug Interactions

[See also 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 10mg 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 Cmax 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 [see CONTRAINDICATIONS and DRUG INTERACTIONS].

Propranolol: 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 [see DOSAGE AND ADMINISTRATION andDRUG INTERACTIONS].

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.

Paroxetine: 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 [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS, andPATIENT INFORMATION].

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.

Clinical Studies

Adults

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 TABLETS 
5MG
MAXALT TABLETS
10 MG
1 35% (n=304) 62%* (n=458) 71%*,† (n=456)
2‡ 37% (n=82) - 77%* (n=320)
3 23% (n=80) 63%* (n=352) -
4 40% (n=159) 60%* (n=164) 67%* (n=385)
* p-value < 0.05 in comparison with placebo 
†p-value < 0.05 in comparison with 5 mg 
‡Results for initial headache only.

 

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††

Estimated Probability of Achieving an Initial Headache Response by 2 Hours - Illustration

 

††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 4†††

Estimated Probability of Patients Taking a Second Dose of MAXALT Tablets or Other Medication for Migraines Over the 24 Hours - Illustration

 

†††This 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.

MAXALT-MLT Orally Disintegrating Tablets

The efficacy of MAXALT-MLT was established in two multicenter, randomized, placebo-controlled trials that were similar in design to the trials of MAXALT Tablets (Studies 5 and 6). Patients were instructed to treat a moderate to severe headache. Patients treated in these studies were primarily female (88%) and Caucasian (95%), with a mean age of 42 years (range 18-72).

In both studies, the percentage of patients achieving headache response 2 hours after treatment was significantly greater in patients who received either MAXALT-MLT 5 or 10 mg compared to those who received placebo. The results from Studies 5 and 6 are summarized in Table 3.

Table 3: Response Rates 2 Hours Following Treatment of Initial Headache in Studies 5 and 6

STUDY PLACEBO MAXALT-MLT
5MG
MAXALT-MLT
10 MG
5 47% (n=98) 66%* (n=100) 66%* (n=113)
6 28% (n=180) 59%* (n=181) 74%*;† (n=186)
* p-value < 0.01 in comparison with placebo
†p-value < 0.01 in comparison with 5 mg

 

The estimated probability of achieving an initial headache response by 2 hours following treatment with MAXALT-MLT in pooled Studies 5 and 6 is depicted in Figure 3.

Figure 3: Estimated Probability of Achieving an Initial Headache Response with MAXALT-MLT by 2 Hours in Pooled Studies 5 and 6‡

Estimated Probability of Achieving an Initial Headache Response with MAXALT-MLT by 2 Hours - Illustration

 

‡Figure 3 shows the Kaplan-Meier plot of the probability over time of obtaining headache response (no or mild pain) following treatment with MAXALT-MLT or placebo. The averages displayed are based on pooled data from 2 placebo-controlled, outpatient trials providing evidence of efficacy (Studies 5 and 6). Patients taking additional treatment or not achieving headache response prior to 2 hours were censored at 2 hours.

For patients with migraine-associated photophobia and phonophobia at baseline, there was a decreased incidence of these symptoms following administration of MAXALT-MLT as 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 4.

Figure 4: Estimated Probability of Patients Taking a Second Dose of MAXALT-MLT or Other Medication for Migraines Over the 24 Hours Following the Initial Dose of Study Treatment in Pooled Studies 5 and 6‡‡

Estimated Probability of Patients Taking a Second Dose of MAXALT-MLT or Other Medication for Migraines Over the 24 Hours - Illustration

 

‡‡This Kaplan-Meier plot is based on data obtained in 2 placebo-controlled outpatient clinical trials (Studies 5 and 6). 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.

Pediatric Patients 6 to 17 Years of Age

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 Ib to < 88 Ib) received MAXALT-MLT 5 mg or placebo, and patients ≥ 40 kg (88 Ib) 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
No headache pain at 2 hours post-dose 24% 
(n/m = 94/388)
33%
(n/m = 126/382)
0.01
n = Number of evaluable patients with no headache pain at 2 hours post-dose.
m = Number of evaluable patients in population.

 

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

Observed Percentage of Patients Reporting No Headache Pain by 2 Hours - Illustration

 

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.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

MAXALT® 
(max-awlt) and MAXALT-MLT®
(rizatriptan benzoate) tablets 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 clusterheadaches.

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 boweldisease
  • 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 inhibitorwithin 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: o 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 about registering with the pregnancyregistry at the Merck National Service Center. You can enroll in this registry by calling 1-800-986-8999. The purpose of this registry is to collect information about the safety of MAXALT in pregnancy.
  • 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 chronicheadaches. 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.

For more information, go to www.maxalt.com or call 1-800-986-8999.

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 5-mg contain 1.1 mg of phenylalanine. 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.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

RIZATRIPTAN TABLET - ORAL

 

(RYE-za-TRIP-tan)

 

COMMON BRAND NAME(S): Maxalt

 

USES: Rizatriptan is used to treat migraines. It helps to relieve headache, pain, and other migraine symptoms (including nausea, vomiting, sensitivity to light/sound). Prompt treatment helps you return to your normal routine and may decrease your need for other pain medications. Rizatriptan belongs to a class of drugs known as triptans. It affects a certain natural substance (serotonin) that causes narrowing of blood vessels in the brain. It may also relieve pain by affecting certain nerves in the brain.

Rizatriptan does not prevent future migraines or lessen how often you get migraine attacks.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking rizatriptan and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, at the first sign of a migraine. It may be taken with or without food, but may work faster when it is taken on an empty stomach. The dosage is based on your medical condition, age, response to treatment, and other drugs you may be taking. For children, the dosage is also based on weight. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If there is no improvement in your symptoms, do not take more doses of this medication before talking to your doctor. If your symptoms are only partly relieved, or if your headache comes back, adults may take another dose at least 2 hours after the first dose. Children should not take more than one dose, or 5 milligrams in a 24-hour period. For adults, the US manufacturer recommends a maximum dose of 30 milligrams in a 24-hour period. The Canadian manufacturer recommends a maximum dose of 20 milligrams (for adults) in a 24-hour period.

If you have a higher risk for heart problems (see Precautions), your doctor may perform a heart exam before you start taking rizatriptan. He/she may also direct you to take your first dose of this medication in the office/clinic to monitor for serious side effects (such as chest pain). Talk to your doctor for details.

Overuse of drugs to treat sudden migraine attacks can sometimes lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use this medication more often or for longer than prescribed. Tell your doctor if you need to use this medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add another medication to help prevent headaches.

Consumer Overview Side Effect

SIDE EFFECTS: Flushing, feelings of tingling/numbness/prickling/heat, tiredness, weakness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: blue fingers/toes/nails, cold hands/feet, hearing changes, mental/mood changes.

Chest/jaw/neck tightness can commonly occur soon after using rizatriptan. Only rarely are these signs of a serious condition. However, you may not be able to tell it apart from a serious reaction due to a lack of blood flow to the heart, brain, or other parts of the body. Get medical help right away if you have any very serious side effects, including: chest pain, jaw/left arm pain, fainting, fast/irregular/pounding heartbeat, vision changes, weakness on one side of the body, confusion, slurred speech, sudden or severe stomach/abdominal pain, bloody diarrhea, change in the amount of urine.

This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Maxalt (rizatriptan benzoate) Side Effects Center for a complete guide to possible side effects

Learn More »
 

PRECAUTIONS: Before using rizatriptan, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), liver disease, seizure, stroke or "mini-stroke" (transient ischemic attack).

Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, smoker, postmenopausal (women), age more than 40 years (men).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

The risk of heart disease, liver disease, and high blood pressure increases with age. Older adults may be more sensitive to the side effects of this drug, especially increased blood pressure and heart problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Taking MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication. Ask your doctor when to start or stop taking this medication.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy," St. John's wort, certain antidepressants (including SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

If you also take any ergotamine medication (such as dihydroergotamine or methysergide) or other "triptan" drugs (such as sumatriptan, zolmitriptan), you will need to separate your rizatriptan dose at least 24 hours apart from your dose of these other medications to lessen the chance of serious side effects.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these "triggers" may help lessen migraine attacks. Consult your doctor for more details.

Laboratory and/or medical tests (such as blood pressure) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: Not applicable. (See How to Use section.)

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

Information last revised October 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Maxalt, Maxalt-MLT

Generic Name: rizatriptan (Pronunciation: RYE za TRIP tan)

  • What is rizatriptan (Maxalt)?
  • What are the possible side effects of rizatriptan (Maxalt)?
  • What is the most important information I should know about rizatriptan (Maxalt)?
  • What should I discuss with my healthcare provider before using rizatriptan (Maxalt)?
  • How should I use rizatriptan (Maxalt)?
  • What happens if I miss a dose (Maxalt)?
  • What happens if I overdose (Maxalt)?
  • What should I avoid while using rizatriptan (Maxalt)?
  • What other drugs will affect rizatriptan (Maxalt)?
  • Where can I get more information?

What is rizatriptan (Maxalt)?

 

Rizatriptan is a headache medicine that narrows the blood vessels around the brain. Rizatriptan also reduces substances in the body that can trigger headache pain, nausea, sensitivity to light and sound, and other migraine symptoms.

Rizatriptan is used to treat migraine headaches. Rizatriptan will only treata headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Rizatriptan should not be used to treat a common tension headache, a headache that causes loss of movement on one side of your body, or any headache that seems to be different from your usual migraine headaches. Use this medication only if your condition has been confirmed by a doctor as migraine headaches.

Rizatriptan may also be used for purposes not listed in this medication guide.

Maxalt 5 mg

oblong, pink, imprinted with 266, MRK

What are the possible side effects of rizatriptan (Maxalt)?

 

Get emergency medical help if you have any of thesesigns of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rizatriptan and call your doctor at once if you have a serious side effect such as:

  • feeling of pain or tightness in your jaw, neck, or throat;
  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden severe headache, confusion, problems with vision, speech, or balance;
  • sudden and severe stomach pain and bloody diarrhea;
  • numbness or tingling and a pale or blue-colored appearance in your fingers or toes; or
  • (if you are also taking an antidepressant) -- agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting.

Less serious side effects may include:

  • mild headache (not a migraine);
  • dry mouth, mild nausea;
  • pressure or heavy feeling in any part of your body;
  • dizziness, drowsiness, tired feeling; or
  • warmth, redness, or mild tingling under your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Maxalt (rizatriptan benzoate) Side Effects Center for a complete guide to possible side effects

Learn More »
 

What is the most important information I should know about rizatriptan (Maxalt)?

 

You should not take this medication if you are allergic to rizatriptan, if you have any history of heart disease, or if you have coronary heart disease, angina, blood circulation problems, lack of blood supply to the heart, uncontrolled high blood pressure, ischemic bowel disease, a history of a heart attack or stroke, or if your headache seems to be different from your usual migraine headaches.

Do not take rizatriptan within 24 hours before or after using another migraine headache medicine, including almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex, Treximet), zolmitriptan (Zomig), or ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Do not use rizatriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the past 14 days.

Before taking rizatriptan, tell your doctor if you have liver or kidney disease, high blood pressure, a heart rhythm disorder, or coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Also tell your doctor if you are also taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), venlafaxine (Effexor), or vilazodone (Viibryd).

Rizatriptan will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

After taking a rizatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 30 mg of rizatriptan in 24 hours.

Side Effects Centers
  • Maxalt

Patient Detailed How Take

What should I discuss with my healthcare provider before using rizatriptan (Maxalt)?

 

You should not take this medication if you are allergic to rizatriptan, or if you have:

  • coronary heart disease, angina (chest pain), blood circulation problems, lack of blood supply to the heart;
  • a history of heart disease, heart attack, or stroke, including "mini-stroke";
  • severe or uncontrolled high blood pressure;
  • ischemic bowel disease; or
  • a headache that seems different from your usual migraine headaches.

Do not take rizatriptan if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the past 14 days.

To make sure you can safely take rizatriptan, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease (especially if you are on dialysis);
  • high blood pressure, a heart rhythm disorder; or
  • coronary heart disease (or risk factors such as diabetes, menopause, smoking, being overweight, having high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

Rizatriptan disintegrating tablets may contain phenylalanine. Talk to your doctor before using this form of rizatriptan if you have phenylketonuria (PKU).

FDA pregnancy category C. It is not known whether rizatriptan will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether rizatriptan passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give a rizatriptan regular tablet to anyone under 18 years old. Only rizatriptan orally disintegrating tablets (Maxalt-MLT) are for use in children who are at least 6 years old.

How should I use rizatriptan (Maxalt)?

 

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Overuse of migraine headache medicine can actually make your headaches worse.

Take rizatriptan as soon as you notice headache symptoms, or after an attack has already begun.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to see if you have any serious side effects.

Take one rizatriptan tablet whole with a full glass of water.

To take rizatriptan orally disintegrating tablets (Maxalt-MLT):

  • Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
  • Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.
  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
  • Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

After taking a tablet: If your headache does not completely go away, or goes away and comes back, take a second tablet two (2) hours after the first. Do not take more than 30 mg of rizatriptan in 24 hours. If your symptoms have not improved, contact your doctor before taking any more tablets.

Contact your doctor if you have more than four headaches in one month (30 days).

If you use rizatriptan long-term, your doctor may want to check your heart function using an electrocardiograph or ECG (sometimes called an EKG), a machine that measures electrical activity of the heart. This will help your doctor determine if it is still safe for you to use this medication. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

Side Effects Centers
  • Maxalt

Patient Detailed Avoid Taking

What happens if I miss a dose (Maxalt)?

 

Since rizatriptan is used as needed, it does not have a daily dosing schedule. Call your doctor promptly if your symptoms do not improve after using rizatriptan.

After taking a rizatriptan tablet, you must wait two (2) hours before taking a second tablet. Do not take more than 30 mg of rizatriptan in 24 hours.

What happens if I overdose (Maxalt)?

 

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose could cause high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, or seizure).

What should I avoid while using rizatriptan (Maxalt)?

 

Do not take rizatriptan within 24 hours before or after using another migraine headache medicine, including:

  • almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex, Treximet), or zolmitriptan (Zomig); or
  • ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), or methylergonovine (Methergine).

Rizatriptan may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What other drugs will affect rizatriptan (Maxalt)?

 

Tell your doctor about all other medicines you use, especially:

  • propranolol (Inderal, InnoPran); or
  • an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Rapiflux, Sarafem, Selfemra, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil, Pexeva), sertraline (Zoloft), trazodone (Desyrel, Oleptro), venlafaxine (Effexor), or vilazodone (Viibryd).

This list is not complete and other drugs may interact with rizatriptan. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

 

Your pharmacist can provide more information about rizatriptan.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 10.01. Revision date: 1/16/2012.

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