Maxalt 5mg Tablets

Manufacturer MERCK SHARP & DOHME Active Ingredient Rizatriptan Tablets(rye za TRIP tan) Pronunciation RYE-za-TRIP-tan
It is used to treat migraine headaches.
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Drug Class
Antimigraine agent
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Pharmacologic Class
Selective serotonin (5-HT1B/1D) receptor agonist
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Pregnancy Category
Category C
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FDA Approved
Jun 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Rizatriptan is a medication used to treat acute migraine headaches with or without aura. It works by narrowing blood vessels in the brain and reducing substances that cause headache pain, nausea, and sensitivity to light and sound.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines.

Administration Guidelines

You can take this medication with or without food.
It's best to take it as soon as possible after your headache symptoms start.

Dosage Instructions for Adults

If your headache doesn't improve after the first dose, consult your doctor.
If your headache recurs, you may take a second dose if your doctor has advised you to do so. However, be sure to wait at least 2 hours after the initial dose before taking the second dose.

Dosage Instructions for Children

If your child's headache doesn't improve, improves but then returns, or if they only experience partial relief, consult your doctor before administering another dose.

Storage and Disposal

Store this medication at room temperature in a dry location, avoiding bathrooms.

Missed Dose

* Since this medication is taken as needed, you don't need to worry about missing a dose. However, do not take it more frequently than recommended by your doctor.
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Lifestyle & Tips

  • Take at the first sign of a migraine headache, but not for prevention.
  • Do not take more than 30 mg in 24 hours.
  • Avoid triggers that can cause migraines (e.g., certain foods, stress, lack of sleep, strong smells).
  • Maintain a regular sleep schedule.
  • Manage stress through relaxation techniques or exercise.
  • Limit caffeine intake, or maintain consistent intake to avoid withdrawal headaches.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg or 10 mg orally, once. If migraine recurs, a second dose may be taken after at least 2 hours. Maximum 30 mg in 24 hours.
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

withPropranolol: 5 mg orally, once. Maximum 15 mg in 24 hours.
initialDose: Consider 5 mg for patients not tolerating 10 mg.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 6 years. For children 6-17 years, an orally disintegrating tablet (ODT) formulation is available, dosed by weight (e.g., 5 mg for 20-39 kg, 10 mg for â‰Ĩ40 kg). Maxalt 5mg Tablets are not the ODT formulation.
Adolescent: For adolescents 12-17 years, 5 mg or 10 mg orally, once. If migraine recurs, a second dose may be taken after at least 2 hours. Maximum 30 mg in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment necessary.
Moderate: No dose adjustment necessary.
Severe: Use with caution. Limited data available.
Dialysis: Not available

Hepatic Impairment:

Mild: No dose adjustment necessary.
Moderate: Consider 5 mg dose. Use with caution.
Severe: Contraindicated due to increased plasma concentrations and half-life.
Confidence: Medium

Pharmacology

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Mechanism of Action

Rizatriptan is a selective agonist for 5-hydroxytryptamine1B/1D (5-HT1B/1D) receptors. Its therapeutic action in migraine is thought to be mediated by selective cranial vasoconstriction and inhibition of neuropeptide release from trigeminal afferents.
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Pharmacokinetics

Absorption:

Bioavailability: 40-45%
Tmax: 1-1.5 hours (for conventional tablets)
FoodEffect: Food delays Tmax by approximately 1 hour but does not significantly affect bioavailability.

Distribution:

Vd: 110-140 L
ProteinBinding: Approximately 14%
CnssPenetration: Limited

Elimination:

HalfLife: 2-3 hours
Clearance: Approximately 1000 mL/min (renal and non-renal)
ExcretionRoute: Renal (approximately 82%), Fecal (approximately 12%)
Unchanged: Approximately 17% (renal)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes to 2 hours
PeakEffect: 1-2 hours
DurationOfAction: Up to 24 hours (for migraine relief, though half-life is shorter)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting or changes in eyesight
Loss of eyesight (which can be long-lasting)
Abnormal sensations, such as burning, numbness, or tingling
Severe stomach upset or vomiting
Severe stomach pain or bloody diarrhea
Feeling of heaviness or tightness in the leg muscles
Feeling cold
Serotonin syndrome, a potentially life-threatening condition, which may cause:
+ Agitation
+ Changes in balance or coordination
+ Confusion
+ Hallucinations
+ Fever
+ Fast or abnormal heartbeat
+ Flushing
+ Muscle twitching or stiffness
+ Seizures
+ Shivering or shaking
+ Excessive sweating
+ Severe diarrhea, stomach upset, or vomiting
+ Severe headache
Heart problems, including:
+ Heart attack
+ Abnormal heartbeat
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweats
+ Shortness of breath
+ Fast or abnormal heartbeat
+ Severe dizziness or fainting
Brain blood vessel problems, including:
+ Stroke
+ Weakness on one side of the body
+ Difficulty speaking or thinking
+ Changes in balance or coordination
+ Drooping on one side of the face
+ Changes in eyesight

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. If you experience any of the following side effects, contact your doctor for advice:

Dizziness
Drowsiness
Fatigue
Weakness
Stomach upset

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Chest pain, jaw pain, or neck tightness (could be heart-related, seek immediate medical attention)
  • Sudden numbness or weakness on one side of the body, sudden severe headache, problems with vision, speech, or balance (signs of stroke, seek immediate medical attention)
  • Severe abdominal pain, bloody diarrhea (signs of ischemic colitis, seek medical attention)
  • Symptoms of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea (seek immediate medical attention)
  • Allergic reaction: rash, hives, swelling of face/lips/tongue/throat, difficulty breathing (seek immediate medical attention)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
If you have high blood pressure.
A history of certain health problems, including:
+ Chest pain or pressure
+ Diseased arteries in the legs or arms
+ Heart attack
+ Heart disease
+ Poor blood flow in the heart, brain, bowel, or kidney
+ Stroke or transient ischemic attack (TIA)
+ Certain types of migraines, such as hemiplegic or basilar migraines
+ Abnormal heartbeat, including Wolff-Parkinson-White syndrome
If you are taking propranolol.
If you have taken certain antidepressant medications, such as isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can cause severe high blood pressure.
If you have taken any of the following medications in the last 24 hours:
+ Almotriptan
+ Eletriptan
+ Frovatriptan
+ Naratriptan
+ Sumatriptan
+ Zolmitriptan
* If you have taken ergotamine, methysergide, dihydroergotamine, or similar medications in the last 24 hours.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Until you understand how this drug affects you, avoid operating a vehicle or engaging in activities that require alertness.

Monitor your blood pressure regularly, as prescribed by your doctor, since this medication can cause high blood pressure.

Note that this medication is not intended to prevent or reduce the frequency of migraine headaches. If you experience a headache that is unusual or differs from your typical migraine symptoms, consult your doctor before taking this medication.

Be cautious not to exceed the prescribed dose or frequency, as taking more of this medication than directed can worsen your headaches.

If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, having high blood sugar or diabetes, smoking cigarettes, being a male over 40 years old, having a family history of early heart disease, or being a postmenopausal female, exercise caution and discuss your individual situation with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, consult your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Hypertension
  • Coronary artery vasospasm
  • Ischemic cardiac symptoms
  • Transient ischemic attacks
  • Stroke
  • Serotonin syndrome

What to Do:

There is no specific antidote for rizatriptan overdose. Treatment should be symptomatic and supportive. Monitor patients for at least 12 hours or while symptoms persist. Consider activated charcoal if ingestion is recent. Contact a poison control center (e.g., 1-800-222-1222) for specific guidance.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrently or within 2 weeks of discontinuing MAOI)
  • Other 5-HT1 agonists (triptans)
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine, methysergide) (concurrently or within 24 hours)
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Major Interactions

  • Propranolol (increases rizatriptan plasma concentrations; reduce rizatriptan dose to 5 mg)
  • Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (increased risk of serotonin syndrome)
  • St. John's Wort (potential for serotonin syndrome)
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Moderate Interactions

  • Cimetidine (may increase rizatriptan levels, monitor for adverse effects)

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment

Rationale: To identify underlying cardiovascular disease, as triptans are contraindicated in patients with ischemic heart disease or uncontrolled hypertension.

Timing: Prior to initiating therapy, especially in patients with risk factors (e.g., hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, postmenopausal women, men over 40 years).

Blood pressure

Rationale: To ensure hypertension is controlled, as triptans can cause transient increases in blood pressure.

Timing: Prior to initiating therapy.

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Routine Monitoring

Migraine frequency and severity

Frequency: Regularly, as needed

Target: Reduction in migraine attacks and severity

Action Threshold: Lack of efficacy or increasing frequency may warrant re-evaluation of diagnosis or treatment plan.

Cardiovascular symptoms (e.g., chest pain, shortness of breath)

Frequency: With each dose and ongoing

Target: Absence of symptoms

Action Threshold: Any new or worsening cardiovascular symptoms require immediate medical evaluation and discontinuation of the drug.

Symptoms of Serotonin Syndrome (e.g., agitation, hallucinations, rapid heart rate, fever, muscle rigidity, nausea, vomiting, diarrhea)

Frequency: Ongoing, especially when co-administered with SSRIs/SNRIs

Target: Absence of symptoms

Action Threshold: Development of any symptoms requires immediate medical attention and discontinuation of rizatriptan and other serotonergic agents.

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Symptom Monitoring

  • Chest pain or tightness
  • Jaw or neck tightness
  • Dizziness
  • Fatigue
  • Somnolence
  • Nausea
  • Dry mouth
  • Paresthesia
  • Flushing
  • Serotonin syndrome symptoms (agitation, confusion, rapid heart rate, fever, muscle rigidity, tremors, sweating, diarrhea)

Special Patient Groups

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Pregnancy

Rizatriptan is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown adverse effects at high doses.

Trimester-Specific Risks:

First Trimester: Limited human data. Animal studies suggest potential for developmental toxicity at high doses.
Second Trimester: Limited human data. Use only if clearly needed.
Third Trimester: Limited human data. Use only if clearly needed.
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Lactation

Rizatriptan is excreted into breast milk in rats. It is unknown whether it is excreted in human milk. Caution should be exercised when rizatriptan is administered to a nursing woman. Consider pumping and discarding milk for 12-24 hours after a dose.

Infant Risk: Low to moderate risk. Monitor infant for drowsiness, poor feeding, or other adverse effects.
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Pediatric Use

Not recommended for children under 6 years of age. For children 6-17 years, an orally disintegrating tablet (ODT) formulation is available and dosed by weight. Maxalt 5mg Tablets (conventional tablets) are generally not the preferred formulation for younger pediatric patients.

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Geriatric Use

Use with caution in patients over 65 years due to a higher likelihood of underlying cardiovascular disease and potential for increased sensitivity to the drug's effects. A lower starting dose (5 mg) may be considered. Monitor for adverse cardiovascular events.

Clinical Information

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Clinical Pearls

  • Rizatriptan is most effective when taken at the first sign of a migraine headache, but not during the aura phase if it precedes the headache.
  • It is not for migraine prevention; it is for acute treatment only.
  • Patients should be screened for cardiovascular risk factors before starting triptan therapy.
  • Advise patients to report any chest pain, jaw pain, or neck tightness immediately.
  • Warn patients about the risk of serotonin syndrome, especially if they are also taking SSRIs or SNRIs.
  • The orally disintegrating tablet (Maxalt-MLT) can be taken without water, which may be convenient for some patients.
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Alternative Therapies

  • Other Triptans (e.g., sumatriptan, zolmitriptan, eletriptan, frovatriptan, naratriptan, almotriptan)
  • CGRP Receptor Antagonists (gepants like rimegepant, ubrogepant, zavegepant)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Ergotamines (e.g., ergotamine/caffeine)
  • Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
  • Opioids (generally discouraged for migraine due to risk of medication overuse headache and dependence)
  • Barbiturate combinations (e.g., butalbital/acetaminophen/caffeine)
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Cost & Coverage

Average Cost: $15 - $50 per 30 tablets (generic rizatriptan 10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic), Tier 3 or higher (for brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.