Rizatriptan ODT 5mg Tablets

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 (via 5-HT1B receptors on intracranial blood vessels) and inhibition of neuropeptide release from trigeminal afferents (via 5-HT1D receptors on presynaptic nerve terminals). It does not have significant affinity for 5-HT2, 5-HT3, alpha1-, alpha2-, or beta-adrenergic, dopamine1, dopamine2, muscarinic, or benzodiazepine receptors.

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
+ 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
+ Throwing up
+ 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 throwing up
+ Severe headache
Heart problems, including:
+ Heart attack
+ Abnormal heartbeat
+ Symptoms such as:
- Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
- Cold sweat
- Shortness of breath
- Fast heartbeat
- Abnormal heartbeat
- Severe dizziness or passing out
Brain blood vessel problems, including:
+ Stroke
+ Symptoms such as:
- 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 Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Feeling dizzy, sleepy, tired, or weak
Upset stomach

Reporting Side Effects

This is not an exhaustive list of potential 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, 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 specific 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 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. This will help ensure that it is safe to take this medication with your existing treatments and health conditions. Never 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. 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 more of this drug than prescribed (higher dose, more frequent) 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 post-menopausal female. Discuss your individual situation with your doctor.

If you have phenylketonuria (PKU), consult your doctor, as some products contain phenylalanine. Additionally, 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, inform your doctor to discuss the potential benefits and risks to both you and your baby.

• Monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing MAOI therapy (risk of serotonin syndrome, hypertensive crisis).
• Ergot-type medications (e.g., ergotamine, dihydroergotamine, methysergide) or within 24 hours of taking rizatriptan (risk of prolonged vasospastic reactions).
• Other 5-HT1 agonists (triptans) or within 24 hours of taking rizatriptan (risk of prolonged vasospastic reactions and additive cardiovascular effects).

• Propranolol: Increases rizatriptan plasma concentrations (AUC and Cmax) by 70-80%. Reduce rizatriptan dose to 5 mg if co-administered, max 10 mg/24 hours.
• Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs): Risk of serotonin syndrome (rare but serious).

• St. John's Wort: Potential for increased risk of serotonin syndrome.
• Cimetidine: May slightly increase rizatriptan levels, but generally not clinically significant.

• Oral contraceptives: No significant interaction.

• Chest pain, tightness, pressure, or heaviness (may radiate to jaw/neck/arm)
• Shortness of breath
• Palpitations
• Dizziness, lightheadedness, fainting
• Numbness or tingling in extremities
• Weakness on one side of the body
• Slurred speech
• Vision changes
• Severe abdominal pain, bloody diarrhea (ischemic colitis)
• Signs of serotonin syndrome: mental status changes (agitation, hallucinations, coma), autonomic instability (tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (hyperreflexia, incoordination), gastrointestinal symptoms (nausea, vomiting, diarrhea).

Rizatriptan is Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some evidence of developmental toxicity at doses higher than human therapeutic doses.

Rizatriptan is excreted into breast milk in small amounts. The amount transferred to the infant is low, and adverse effects are unlikely. However, caution is advised. Consider waiting 12-24 hours after a dose before breastfeeding to minimize infant exposure.

Approved for acute treatment of migraine with aura or without aura in adolescents 6 to 17 years of age. Dosing is weight-based for this age group. Safety and effectiveness in children younger than 6 years have not been established.

Use with caution in patients over 65 years of age due to a higher likelihood of underlying cardiovascular disease and increased sensitivity to adverse effects. A lower starting dose (5 mg) may be considered, and careful cardiovascular assessment is recommended.

• Rizatriptan ODT (Orally Disintegrating Tablet) can be taken without water, making it convenient for patients experiencing nausea or who do not have access to water.
• Instruct patients to place the ODT on the tongue, allow it to dissolve, and then swallow with saliva.
• This medication is for acute migraine treatment, not for prevention. It should be taken at the onset of a migraine headache, not during the aura phase if it precedes the headache.
• Counsel patients on the importance of not exceeding the maximum daily dose (30 mg in 24 hours for adults, 10 mg in 24 hours for adolescents) to avoid medication overuse headache and other adverse effects.
• Always screen patients for cardiovascular risk factors before prescribing triptans, especially those with a history of CAD, stroke, or uncontrolled hypertension.

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

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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.