Maxalt 10mg Tablets

Manufacturer ORGANON 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 migraine headaches. It works by narrowing blood vessels in the brain and reducing substances that cause pain, nausea, and other migraine symptoms. It is not for preventing migraines, but for treating them once they start.
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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 to you and follow the instructions closely.

Administration Instructions

You can take this medication with or without food.
Take the medication as soon as possible after the onset of an attack.
For adults:
+ If your headache does not 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 first dose before taking the second dose.
For children:
+ If your child's headache does not improve, improves but then recurs, or if your child experiences only partial relief, consult the doctor before administering another dose.

Storage and Disposal

Store the medication at room temperature in a dry place.
Avoid storing the medication in a bathroom.

Missed Dose Instructions

Since this medication is taken as needed, you do not need to worry about missing a dose. However, do not take the medication more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take rizatriptan as soon as migraine symptoms begin, but not before.
  • Do not take more than the prescribed dose or more than 30 mg in 24 hours (or 15 mg if taking propranolol).
  • Do not use for more than 10 days per month to avoid medication overuse headache.
  • Avoid migraine triggers (e.g., certain foods, stress, lack of sleep, strong smells).
  • Rest in a quiet, dark room after taking the medication.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg orally as a single dose. May repeat dose after 2 hours if migraine recurs or partially responds. Maximum 30 mg in 24 hours.
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

Initial Dose: 5 mg or 10 mg
Repeat Dose: If migraine recurs or partially responds, a second dose may be taken 2 hours after the first. Maximum 30 mg in 24 hours.
Concomitant Propranolol Use: Initial dose 5 mg, maximum 15 mg in 24 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 6 years. For children 6 to 17 years: 5 mg for body weight < 40 kg, 10 mg for body weight â‰Ĩ 40 kg. May repeat dose after 2 hours if migraine recurs or partially responds. Maximum 10 mg in 24 hours for < 40 kg, 20 mg in 24 hours for â‰Ĩ 40 kg.
Adolescent: For adolescents 12 to 17 years: 5 mg or 10 mg orally as a single dose. May repeat dose after 2 hours if migraine recurs or partially responds. Maximum 30 mg in 24 hours. (Same as adult dosing for this age group, but specific pediatric guidelines often recommend starting lower for younger adolescents).
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: Use with caution. Not studied in patients with severe renal impairment (CrCl < 15 mL/min).
Dialysis: Not recommended due to lack of data.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: Consider 5 mg initial dose. Maximum 15 mg in 24 hours.
Severe: Contraindicated due to increased plasma concentrations and lack of data.

Pharmacology

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Mechanism of Action

Rizatriptan is a selective agonist for serotonin 5-hydroxytryptamine1B (5-HT1B) and 5-hydroxytryptamine1D (5-HT1D) receptors. Its therapeutic action in migraine is thought to be mediated by vasoconstriction of intracranial blood vessels, which become dilated during a migraine attack, and by inhibition of neuropeptide release from trigeminal afferents, thereby reducing inflammation and pain transmission.
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Pharmacokinetics

Absorption:

Bioavailability: 40-65%
Tmax: 1-1.5 hours (tablets), 1.6-2.5 hours (orally disintegrating tablets)
FoodEffect: Food delays Tmax by approximately 1 hour but does not significantly affect bioavailability.

Distribution:

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

Elimination:

HalfLife: 2-3 hours
Clearance: Approximately 1000 mL/min
ExcretionRoute: Approximately 82% renally (17% as unchanged drug, 65% as metabolite), 12% in feces.
Unchanged: 17%
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Pharmacodynamics

OnsetOfAction: Within 30 minutes to 2 hours
PeakEffect: 1-2 hours
DurationOfAction: Up to 24 hours (though pain relief may be shorter, requiring a second dose)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble 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
+ Passing out
+ 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
+ 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 sweat
+ Shortness of breath
+ Fast or abnormal heartbeat
+ Severe dizziness or passing out
Brain blood vessel problems, including:
+ Stroke
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Changes in balance
+ 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 contact your doctor or seek medical attention if you experience any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Upset stomach

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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:

  • Sudden or severe chest pain, jaw pain, or arm pain (call 911 immediately, could be heart attack)
  • Sudden numbness or weakness on one side of the body, sudden severe headache, sudden vision changes, trouble speaking (could be stroke)
  • Severe stomach pain, bloody diarrhea (could be ischemic colitis)
  • Signs of serotonin syndrome: agitation, confusion, hallucinations, fast heartbeat, sweating, shivering, severe muscle stiffness or 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 and medications 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 depression 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
+ Ergotamine
+ Methysergide
+ Dihydroergotamine
+ Any other ergotamine-like medications

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. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe treatment.
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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 driving and other activities that require alertness.

Monitor your blood pressure regularly, as prescribed by your doctor, since this medication can cause high blood pressure. However, please note that this drug is not intended to prevent or reduce the frequency of migraine headaches.

If you experience a headache that is different from your typical migraine, consult your doctor before taking this medication. Be aware that taking a higher dose or using this medication more frequently than directed by your doctor may worsen your headaches.

Exercise caution 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. Discuss these risks with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects. Additionally, 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 (high blood pressure)
  • Coronary artery vasospasm (chest pain, heart attack symptoms)
  • Other serious cardiovascular events
  • Neurological symptoms (e.g., ataxia, tremors, convulsions)

What to Do:

Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention immediately. Treatment is symptomatic and supportive. Monitor ECG and blood pressure.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs (risk of serotonin syndrome, hypertensive crisis)
  • Other 5-HT1 agonists (triptans) (risk of additive cardiovascular effects)
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine, methysergide) or within 24 hours of discontinuing (risk of prolonged vasospastic reactions)
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Major Interactions

  • Propranolol (increases rizatriptan plasma concentrations; requires dose adjustment of rizatriptan)
  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome)
  • Cimetidine (increases rizatriptan plasma concentrations; requires dose adjustment of rizatriptan)

Monitoring

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Baseline Monitoring

Cardiovascular Risk Assessment

Rationale: To identify underlying cardiovascular disease (e.g., ischemic heart disease, cerebrovascular disease, peripheral vascular disease) for which triptans are contraindicated.

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).

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Routine Monitoring

Efficacy (migraine relief)

Frequency: With each dose

Target: Significant reduction or elimination of migraine pain and associated symptoms.

Action Threshold: If no relief after initial dose, do not take a second dose for the same attack. If partial relief or recurrence, consider second dose after 2 hours.

Adverse Effects (e.g., chest pain, neck/jaw tightness, paresthesias, dizziness)

Frequency: With each dose and during treatment

Target: Absence or mild, transient nature of typical triptan sensations.

Action Threshold: Severe or persistent chest pain, shortness of breath, or other concerning symptoms warrant immediate medical evaluation to rule out cardiac ischemia.

Symptoms of Serotonin Syndrome

Frequency: Monitor, especially with concomitant serotonergic drugs

Target: Absence of mental status changes, autonomic instability, neuromuscular abnormalities, or gastrointestinal symptoms.

Action Threshold: Discontinue rizatriptan and concomitant serotonergic agents immediately if symptoms occur.

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Symptom Monitoring

  • Chest pain, tightness, pressure, or heaviness in the chest, throat, neck, or jaw (could indicate cardiac ischemia)
  • Shortness of breath
  • Weakness or numbness of an arm or leg, or one side of the body (could indicate stroke)
  • Sudden severe headache (could indicate subarachnoid hemorrhage)
  • Vision changes
  • Dizziness, drowsiness
  • Tingling or numbness (paresthesias)
  • Nausea, vomiting
  • Signs of serotonin syndrome: agitation, hallucinations, rapid heart beat, fever, sweating, shivering, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea.

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Animal studies show adverse effects, but no adequate and well-controlled studies in pregnant women. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of certain birth defects based on animal data, but human data is limited and conflicting.
Second Trimester: Limited data, generally considered lower risk than first trimester for structural defects.
Third Trimester: Potential for premature labor or fetal distress due to vasoconstrictive effects, especially near term. Avoid use unless clearly needed.
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Lactation

L3 (Moderately Safe). Rizatriptan is excreted into breast milk. The amount is small, and adverse effects in breastfed infants are unlikely but possible. Monitor infant for drowsiness, poor feeding, or irritability. Consider waiting 8-12 hours after a dose before breastfeeding to minimize infant exposure.

Infant Risk: Low to moderate risk. Potential for drowsiness or other mild effects, but generally considered compatible with breastfeeding with caution.
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Pediatric Use

Approved for acute treatment of migraine in patients 6 to 17 years of age. Dosing is weight-based for children 6-17 years. Safety and efficacy not established in children under 6 years. Close monitoring for adverse effects is crucial.

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Geriatric Use

Use with caution. Elderly patients (over 65 years) may be more sensitive to the effects of triptans and may have a higher risk of cardiovascular disease. Consider a lower initial dose (5 mg) and monitor closely 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 attack, but not during the aura phase if it precedes the headache.
  • It is not for prevention of migraines or for treating cluster headaches.
  • Patients should be screened for cardiovascular risk factors before starting triptan therapy.
  • Advise patients to report any chest pain, shortness of breath, or other concerning symptoms immediately.
  • Counsel patients on the risk of serotonin syndrome when co-administered with SSRIs, SNRIs, or other serotonergic drugs.
  • Medication overuse headache (MOH) is a risk with frequent use (more than 10 days per month). Educate patients on this risk and encourage limiting use.
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Alternative Therapies

  • Other Triptans (e.g., Sumatriptan, Zolmitriptan, Eletriptan, Frovatriptan, Naratriptan, Almotriptan)
  • CGRP Receptor Antagonists (e.g., Rimegepant, Ubrogepant)
  • NSAIDs (e.g., Ibuprofen, Naproxen)
  • Acetaminophen
  • Ergotamines (e.g., Ergotamine/Caffeine)
  • Anti-emetics (e.g., Metoclopramide, Prochlorperazine) for associated nausea/vomiting
  • Non-pharmacological treatments (e.g., rest in a dark, quiet room, cold compress)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 9 tablets (generic)
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 condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to discuss them with 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.