Rizatriptan 10mg Tablets

Manufacturer AUROBINDO 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. 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 or treating other types of headaches.
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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 Guidelines

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

Dosage Instructions for Adults

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

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 giving another dose.

Storage and Disposal

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

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 your doctor has prescribed.
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Lifestyle & Tips

  • Take at the first sign of a migraine headache, but not during the aura phase if it precedes the headache.
  • Do not use for more headaches than prescribed to avoid medication overuse headache.
  • Avoid known migraine triggers (e.g., certain foods, stress, lack of sleep).
  • Ensure adequate rest and hydration.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg orally as a single dose. If headache recurs, a second dose may be taken 2 hours after the first. Maximum 30 mg in 24 hours.
Dose Range: 10 - 30 mg

Condition-Specific Dosing:

withPropranolol: 5 mg orally as a single dose. If headache recurs, a second dose may be taken 2 hours after the first. 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.
Adolescent: For patients 6 to 17 years of age: For patients weighing 20 kg to less than 40 kg, the recommended dose is 5 mg. For patients weighing 40 kg or more, the recommended dose is 10 mg. Only one dose should be given in a 24-hour period.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No dose adjustment necessary.
Moderate: Consider 5 mg dose, maximum 15 mg in 24 hours.
Severe: Not recommended due to increased plasma concentrations.

Pharmacology

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Mechanism of Action

Rizatriptan is a selective agonist for serotonin 5-hydroxytryptamine1B (5-HT1B) and 5-HT1D receptors. Its therapeutic action in migraine is thought to be due to selective cranial blood vessel constriction (via 5-HT1B receptors) and inhibition of neuropeptide release from trigeminal afferents (via 5-HT1D receptors), thereby reducing inflammation and pain transmission.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 40-45%
Tmax: 1.0-1.5 hours (oral tablet); 1.6-2.5 hours (orally disintegrating tablet)
FoodEffect: Delays Tmax by approximately 1 hour but does not significantly affect AUC.

Distribution:

Vd: Approximately 110 L
ProteinBinding: Approximately 14%
CnssPenetration: Yes

Elimination:

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

OnsetOfAction: Within 30 minutes to 2 hours
PeakEffect: Approximately 2 hours
DurationOfAction: Up to 24 hours (though half-life is short, clinical effect can persist)

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 when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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 sweats
+ 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any others that bother you or do not go away, contact your doctor:

Feeling dizzy, sleepy, tired, or weak
* Upset stomach

Reporting Side Effects

This is not a complete 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, or neck tightness (seek immediate medical attention).
  • Shortness of breath.
  • Weakness or numbness on one side of the body, slurred speech, or sudden vision changes (signs of stroke, seek immediate medical attention).
  • Severe dizziness, agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, or uncontrolled movements (signs of serotonin syndrome, seek immediate medical attention).
  • Allergic reactions such as rash, hives, swelling of the face, lips, tongue, or 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. 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. Ensure that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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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. Additionally, be aware that taking more of this drug than prescribed (either a higher dose or more frequent doses) 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. Pregnant women, those planning to become pregnant, or breastfeeding mothers should consult their doctor to discuss the potential benefits and risks to both themselves and their baby.
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Overdose Information

Overdose Symptoms:

  • Hypertension
  • Coronary artery vasospasm
  • Ischemia
  • Myocardial infarction
  • Cerebral ischemia
  • Serotonin syndrome

What to Do:

Call 911 or your local emergency number immediately. Contact a poison control center at 1-800-222-1222. 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 MAOI therapy (risk of severe hypertension and serotonin syndrome).
  • Other 5-HT1 agonists (e.g., sumatriptan, zolmitriptan) (risk of additive cardiovascular effects).
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine) or within 24 hours of using ergot-type medications (risk of prolonged vasospastic reactions).
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (increased risk of serotonin syndrome).
  • Propranolol (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, as triptans can cause coronary vasospasm.

Timing: Prior to initiating therapy, especially in patients with risk factors for coronary artery disease.

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Routine Monitoring

Efficacy of headache relief

Frequency: With each use

Target: Significant reduction or resolution of migraine symptoms

Action Threshold: Lack of efficacy after appropriate dosing may warrant re-evaluation of diagnosis or treatment plan.

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

Frequency: With each use

Target: Absence or mild, transient nature of effects

Action Threshold: Persistent, severe, or atypical symptoms (especially chest pain) require immediate medical evaluation.

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Symptom Monitoring

  • Chest pain, jaw/neck tightness, or pressure (could indicate cardiac ischemia)
  • Shortness of breath
  • Weakness or numbness on one side of the body
  • Slurred speech
  • Vision changes
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, coordination problems, nausea, vomiting, diarrhea)
  • Symptoms of medication overuse headache (increased frequency or severity of headaches)

Special Patient Groups

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Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data suggest no increased risk of major birth defects, but animal studies show some adverse effects at high doses.

Trimester-Specific Risks:

First Trimester: Limited data, no clear evidence of increased risk of major birth defects.
Second Trimester: Limited data, no clear evidence of increased risk.
Third Trimester: Limited data, no clear evidence of increased risk. Consider potential for vasoconstrictive effects on the fetus.
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Lactation

L3 (Moderately Safe). Rizatriptan is excreted into breast milk in small amounts. Monitor breastfed infants for signs of drowsiness, poor feeding, or other adverse effects. Consider waiting 12-24 hours after a dose before breastfeeding to minimize infant exposure.

Infant Risk: Low to moderate. Potential for drowsiness, irritability, or gastrointestinal upset in the infant, though unlikely with typical doses.
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Pediatric Use

Approved for acute treatment of migraine in adolescents 6 to 17 years of age. Dosing is weight-based. Safety and effectiveness in children younger than 6 years have not been established.

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Geriatric Use

Use with caution. Consider a lower starting dose (5 mg) and limit total daily dose to 15 mg in patients over 65 years due to potential for decreased clearance and increased sensitivity to adverse effects, particularly cardiovascular events.

Clinical Information

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Clinical Pearls

  • Rizatriptan is available as a conventional tablet and an orally disintegrating tablet (MLT), which can be beneficial for patients with nausea or difficulty swallowing.
  • Instruct patients to take rizatriptan at the onset of migraine headache, not during the aura phase if it precedes the headache.
  • Counsel patients on the importance of not exceeding the maximum recommended dose within 24 hours to avoid medication overuse headache and other adverse effects.
  • Always screen patients for cardiovascular risk factors before initiating triptan therapy.
  • Advise patients to seek immediate medical attention for any chest pain, shortness of breath, or neurological symptoms after taking rizatriptan.
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Alternative Therapies

  • Other triptans (e.g., sumatriptan, zolmitriptan, eletriptan, frovatriptan, naratriptan, almotriptan)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
  • Ditans (e.g., lasmiditan)
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine - generally less preferred due to side effect profile)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't 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 overdose, be prepared to provide details about the medication taken, the amount, and the time it occurred.