Sumatriptan 5mg Nasal Spray (6 Spr)

Sumatriptan is a selective 5-hydroxytryptamine1 (5-HT1B/1D) receptor agonist. It is believed to exert its antimigraine effect by binding to 5-HT1B and 5-HT1D receptors on intracranial blood vessels and sensory nerves. This leads to vasoconstriction of cranial arteries, inhibition of neuropeptide release (e.g., CGRP) from trigeminal nerve endings, and interruption of pain signal 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 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
Note: In rare cases, allergic reactions can be fatal.
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Seizures
Loss of vision (which can be long-lasting)
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Discoloration of the skin, lips, nail beds, fingers, or toes (blue or gray)
Gastrointestinal issues, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Leg cramps and pain
+ Heaviness or tightness in the leg muscles
+ Feeling cold
+ Burning or aching pain in the feet or toes

Serotonin Syndrome: A Potentially Life-Threatening Condition

There is a risk of developing serotonin syndrome, a severe and potentially deadly condition, especially when taking certain other medications. If you experience any of the following symptoms, contact your doctor immediately:

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
Vomiting
Severe headache

Brain Blood Vessel Problems: A Rare but Serious Risk

In rare cases, this medication can cause brain blood vessel problems, including stroke. If you experience any of the following symptoms, contact your doctor immediately:

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

While many people may not experience any side effects or only minor ones, it is essential to be aware of the following possible side effects:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach
Vomiting
Changes in taste
Burning sensation
Nose or throat irritation

If you are concerned about any side effects or have questions, 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:

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.
Certain health conditions, including:
+ High blood pressure
+ Liver disease
A history of specific health problems, such as:
+ 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, including hemiplegic or basilar migraines
+ Abnormal heart rhythms, such as Wolff-Parkinson-White syndrome
Recent use of certain antidepressant medications, including isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Using this medication within 14 days of these drugs can cause severe high blood pressure.
Current use of another medication that contains the same active ingredient as this drug.
Use of other medications for migraine or headache, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, within the last 24 hours.
* Use of ergotamine, methysergide, dihydroergotamine, or similar medications within 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. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

Precautions and Safety Measures

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
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 different from your typical migraine, consult your doctor before taking this medication.
Be cautious not to exceed the prescribed dose or frequency, as this may worsen your headaches.

Special Considerations

If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, having high blood sugar or diabetes, smoking, 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 treatment with your doctor.
Rarely, this medication can cause severe and potentially life-threatening heart problems, including heart attack and abnormal heartbeat, within a few hours of administration. Seek immediate medical attention if you experience symptoms such as:
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweats
+ Shortness of breath
+ Rapid or irregular heartbeat
+ Severe dizziness or fainting

Age-Related Considerations

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

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication with you.

Pediatric Use

* This medication is not approved for use in children. However, your doctor may decide that the benefits of treatment outweigh the risks. If your child has been prescribed this medication, consult your doctor for information about the benefits and risks, and discuss any questions or concerns you may have.

• Monoamine Oxidase Inhibitors (MAOIs) (within 2 weeks of use)
• Ergot-containing drugs (e.g., ergotamine, dihydroergotamine) (within 24 hours)
• Other 5-HT1 agonists (triptans) (within 24 hours)

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

• Beta-blockers (may increase sumatriptan levels slightly, but generally not clinically significant)
• Cimetidine (may increase sumatriptan levels, but generally not clinically significant)

• Chest pain or tightness (especially if radiating to arm/jaw)
• Shortness of breath
• Palpitations
• Sudden severe headache (different from usual migraine)
• Weakness or numbness on one side of the body
• Vision changes
• Slurred speech
• Confusion or agitation (signs of serotonin syndrome)
• Fever, sweating, shivering, muscle rigidity (signs of serotonin syndrome)

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some developmental toxicity at high doses. Limited human data suggest no increased risk of major birth defects, but data are insufficient to rule out a risk.

Sumatriptan is excreted into breast milk. The amount is small, and infant exposure is low. Infant adverse effects are unlikely. To minimize infant exposure, breastfeeding can be delayed for 12 hours after a dose.

Safety and efficacy have not been established in pediatric patients under 18 years of age. Use is generally not recommended.

Use with caution in elderly patients (over 65 years) due to a higher likelihood of underlying cardiovascular disease and potential for decreased renal function. Consider lower starting doses and careful monitoring.

• Sumatriptan nasal spray is effective for acute migraine and cluster headache, offering a non-oral route for patients with nausea/vomiting or rapid onset needs.
• It should be used at the first sign of a headache, but not during the aura phase if present, and not for prevention.
• Patients should be screened for cardiovascular risk factors before initiating triptan therapy.
• Counsel patients on the potential for chest/throat tightness or pressure, which is usually non-cardiac but should be reported if severe or persistent.
• Warn patients about the risk of medication overuse headache if used too frequently (e.g., more than 10 days per month).
• Ensure patients understand the contraindications, especially with MAOIs and ergotamines, and the risk of serotonin syndrome with SSRIs/SNRIs.

• Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan) - available in various formulations (oral, ODT, nasal spray, injectable)
• CGRP receptor antagonists (gepants like rimegepant, ubrogepant) - oral acute treatment
• Serotonin 5-HT1F receptor agonists (ditans like lasmiditan)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Combination analgesics (e.g., Excedrin Migraine)
• Ergot alkaloids (e.g., dihydroergotamine nasal spray)
• Anti-emetics (e.g., ondansetron, metoclopramide) 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 details. 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 information about the medication taken, the amount, and the time it happened.