Rizatriptan ODT 10mg Tablets

Rizatriptan is a selective agonist for serotonin 5-HT1B and 5-HT1D receptors. Its therapeutic action in migraine is thought to be due to agonism of 5-HT1B/1D receptors on intracranial blood vessels, leading to vasoconstriction of dilated intracranial arteries, and inhibition of neuropeptide release from trigeminal afferents, thereby reducing neurogenic inflammation and pain transmission.

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 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
+ Tingling
Severe stomach problems, including:
+ Upset stomach
+ Vomiting
+ Stomach pain
+ Bloody diarrhea
Muscle symptoms, such as:
+ 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, upset stomach, 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, such as:
+ 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 help if you notice any of the following:

Feeling dizzy, sleepy, tired, or weak
Upset stomach
* Other side effects that bother you or do not go away

Reporting 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.

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. Be sure to 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
+ Ergotamine
+ Methysergide
+ Dihydroergotamine
+ Any other medications similar to these

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. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

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

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 cautious not to exceed the dosage or frequency of this medication as prescribed by your doctor, as taking more than recommended may 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 post-menopausal female, discuss these risks with your doctor.

If you have phenylketonuria (PKU), consult your doctor, as some products contain phenylalanine.

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, discuss the potential benefits and risks of this medication with your doctor to make an informed decision regarding you and your baby.

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

• Propranolol (increases rizatriptan plasma concentrations; requires dose adjustment of rizatriptan)

• Selective Serotonin Reuptake Inhibitors (SSRIs) (increased risk of serotonin syndrome)
• Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (increased risk of serotonin syndrome)

• St. John's Wort (potential for increased serotonin syndrome risk)

• Chest pain or tightness
• Neck pain or tightness
• Jaw pain or tightness
• Tingling or numbness (paresthesias)
• Dizziness
• Fatigue
• Flushing
• Nausea
• Vomiting
• Diarrhea
• Muscle rigidity
• Agitation or restlessness
• Confusion
• Rapid heart rate
• High blood pressure
• Fever
• Hallucinations
• Loss of coordination

Rizatriptan is Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Rizatriptan is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. However, LactMed suggests a low risk to the infant but advises monitoring for drowsiness or poor feeding. Consider waiting 12-24 hours after a dose before breastfeeding to minimize infant exposure.

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.

Use with caution in elderly patients (over 65 years of age) due to a higher likelihood of concomitant cardiovascular disease and potential for increased sensitivity to the drug's effects. No specific dose adjustment is generally required unless hepatic or renal impairment is present, but lower initial doses may be considered.

• Rizatriptan ODT is designed to dissolve on the tongue and can be taken without water, which is convenient for patients experiencing nausea or who do not have access to water.
• It is an acute migraine treatment and should not be used for migraine prophylaxis or for cluster headaches.
• Patients should be screened for cardiovascular risk factors before initiating triptan therapy, especially those with a history of heart disease, stroke, or uncontrolled hypertension.
• Advise patients to report any chest pain, shortness of breath, or other concerning symptoms immediately after taking the medication.
• Counsel patients on the risk of serotonin syndrome when co-administered with SSRIs, SNRIs, or other serotonergic agents.

• Other Triptans (e.g., Sumatriptan, Zolmitriptan, Eletriptan, Frovatriptan, Naratriptan, Almotriptan)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
• CGRP receptor antagonists (e.g., Ubrogepant, Rimegepant)
• Ditans (e.g., Lasmiditan)
• Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting

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.