Imitrex 5mg Nasal Spray (6 Doses)

Manufacturer GLAXO SMITH KLINE Active Ingredient Sumatriptan Nasal Spray(soo ma TRIP tan) Pronunciation SOO-ma-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
Oct 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Imitrex Nasal Spray contains sumatriptan, a medicine used to treat migraine headaches. It works by narrowing blood vessels in the brain and reducing substances that cause pain, nausea, and sensitivity to light and sound during a migraine attack. It should be used as soon as migraine symptoms start, but not to prevent migraines.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from this medication, use it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. If your headache does not improve after the first dose, consult with your doctor. If your headache improves but then returns, or if you only experience partial relief, you may take a second dose if your doctor has instructed you to do so. Be sure to understand how many hours you should wait before taking another dose, including if you used a different form of this medication for the first dose.

Important Administration Instructions

This medication is for nasal use only. Do not take it by mouth. Avoid getting it in your mouth or eyes, as it may cause burning. Use this medication as soon as possible after the onset of your headache attack. Before using, sit down and blow your nose to ensure proper administration.

Storage and Disposal

Store this medication at room temperature, avoiding refrigeration or freezing.

Missed Dose Instructions

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

  • Identify and avoid personal migraine triggers (e.g., stress, certain foods, lack of sleep, strong smells).
  • Maintain a regular sleep schedule.
  • Stay hydrated.
  • Practice stress-reduction techniques (e.g., meditation, yoga).
  • Limit caffeine and alcohol intake.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg or 10 mg as a single dose. May repeat once after 2 hours if needed.
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

Maximum daily dose: 20 mg in 24 hours
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established in children under 12 years)
Adolescent: 10 mg as a single dose for patients 12 to 17 years of age. May repeat once after 2 hours if needed. Maximum 20 mg in 24 hours.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed, use with caution.
Moderate: No specific adjustment needed, use with caution.
Severe: No specific adjustment needed, use with caution.
Dialysis: No specific recommendations, use with caution.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: Contraindicated due to increased sumatriptan levels.

Pharmacology

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Mechanism of Action

Sumatriptan is a selective 5-hydroxytryptamine1 (5-HT1B/1D) receptor agonist. It is believed to exert its antimigraine effect by causing vasoconstriction of intracranial blood vessels, inhibiting the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings, and inhibiting pain signal transmission in the trigeminal nucleus caudalis.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 17% (nasal)
Tmax: 1 to 1.5 hours (nasal)
FoodEffect: Not clinically significant for nasal spray

Distribution:

Vd: 2.4 L/kg
ProteinBinding: 14% to 21%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 hours
Clearance: Approximately 1160 mL/min
ExcretionRoute: Renal (60% as inactive indole acetic acid metabolite, 3% unchanged), Fecal (40% as metabolite)
Unchanged: 3%
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Pharmacodynamics

OnsetOfAction: Approximately 15 minutes (nasal)
PeakEffect: 1 to 2 hours
DurationOfAction: 2 to 4 hours (symptom relief can last longer)

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 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
Note: In rare cases, allergic reactions can be fatal.
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Seizures
Loss of eyesight (which can be long-lasting)
Abnormal sensations, such as:
+ Burning
+ Numbness
+ Tingling
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Gastrointestinal issues, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Cramps and pain in legs or hips
+ Feeling of 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 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 if you notice any of the following:

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

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe chest pain, pressure, or tightness (especially if radiating to arm, back, neck, or jaw)
  • Shortness of breath
  • Sudden weakness or numbness on one side of the body
  • Sudden severe headache different from usual migraine
  • Vision changes (e.g., sudden loss of vision)
  • Severe dizziness or fainting
  • Signs of an allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Signs of serotonin syndrome (e.g., agitation, confusion, hallucinations, rapid heart rate, fever, sweating, muscle stiffness or twitching, loss of coordination, severe nausea, vomiting, or diarrhea)
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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:

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 heartbeat, such as Wolff-Parkinson-White syndrome
Recent use of certain antidepressant medications, including isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking 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
+ 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 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

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 taking the medication. Seek immediate medical attention if you experience:
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweats
+ Shortness of breath
+ Rapid or irregular heartbeat
+ Severe dizziness or fainting
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy, Breastfeeding, and Pediatric Use

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks of this medication for you and your baby.
* 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.
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Overdose Information

Overdose Symptoms:

  • Convulsions
  • Tremor
  • Inactivity
  • Redness of extremities
  • Reduced respiration
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Paralysis

What to Do:

There is no specific antidote for sumatriptan overdose. Treatment should be supportive and symptomatic. Monitor cardiac and respiratory function for at least 12 hours. Call 1-800-222-1222 (Poison Control Center) immediately.

Drug Interactions

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Contraindicated Interactions

  • Monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing MAOI therapy
  • Ergotamine-containing drugs or ergot-type drugs (e.g., dihydroergotamine) within 24 hours
  • Other 5-HT1 agonists (e.g., other triptans) within 24 hours
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Major Interactions

  • Selective serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) - increased risk of serotonin syndrome
  • St. John's Wort - increased risk of serotonin syndrome
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Moderate Interactions

  • Propranolol - may slightly increase sumatriptan Cmax and AUC, but generally not clinically significant

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment

Rationale: To identify patients at risk for coronary artery disease (CAD) or other underlying cardiovascular conditions, as sumatriptan can cause coronary vasospasm.

Timing: Before initiating therapy, especially in patients with risk factors (e.g., hypertension, hypercholesterolemia, diabetes, smoking, obesity, strong family history of CAD, postmenopausal women, males over 40 years).

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Routine Monitoring

Efficacy (headache relief, associated symptoms)

Frequency: During and after each dose

Target: Significant reduction or resolution of migraine symptoms

Action Threshold: Lack of efficacy after appropriate dosing may warrant consideration of alternative treatments.

Adverse effects (e.g., chest pain, paresthesias, dizziness, serotonin syndrome symptoms)

Frequency: During and after each dose

Target: Absence of severe or persistent adverse effects

Action Threshold: Presence of severe chest pain, shortness of breath, or signs of serotonin syndrome requires immediate medical attention and discontinuation.

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Symptom Monitoring

  • Chest pain or tightness (especially if severe or radiating)
  • Shortness of breath
  • Jaw or neck tightness/pressure
  • Tingling, numbness, or paresthesias
  • Dizziness or vertigo
  • Weakness or numbness on one side of the body
  • Vision changes
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Limited human data, but no clear evidence of teratogenicity from available studies. A pregnancy registry for sumatriptan was maintained, but is now closed.

Trimester-Specific Risks:

First Trimester: Limited data, no consistent pattern of major birth defects observed.
Second Trimester: Limited data, no consistent pattern of major birth defects observed.
Third Trimester: Limited data, no consistent pattern of major birth defects observed.
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Lactation

Sumatriptan is excreted into breast milk. Infant exposure is low. To minimize infant exposure, consider waiting 8-12 hours after a dose before breastfeeding.

Infant Risk: L3 (Moderately Safe) - Adverse effects in breastfed infants are unlikely based on low levels in milk and short half-life. Monitor infant for drowsiness or poor feeding.
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Pediatric Use

Approved for acute treatment of migraine with or without aura in adolescents 12 to 17 years of age. Safety and efficacy have not been established in children under 12 years of age.

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Geriatric Use

Use with caution due to the higher incidence of cardiovascular disease and potential for decreased renal and hepatic function in this population. Consider lower starting doses and careful monitoring.

Clinical Information

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Clinical Pearls

  • Sumatriptan nasal spray is a good option for patients who experience significant nausea and vomiting with their migraines, or who cannot tolerate oral medications.
  • It should be administered as soon as migraine symptoms begin, but it is also effective if taken later during the attack.
  • Do not use sumatriptan for basilar or hemiplegic migraine, as these types of migraines may be associated with increased risk of cerebrovascular events.
  • Patients should be screened for cardiovascular risk factors before initiating triptan therapy, especially if they have risk factors for undiagnosed CAD.
  • Advise patients about common 'triptan sensations' (e.g., chest pressure, jaw tightness, tingling, flushing) which are usually not cardiac in origin but can be alarming. These sensations are generally mild and transient.
  • Ensure proper nasal spray technique is demonstrated and understood by the patient for optimal absorption and efficacy.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan, almotriptan - available in various formulations including oral, ODT, nasal spray, subcutaneous injection)
  • CGRP receptor antagonists (gepants like rimegepant, ubrogepant)
  • 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 or injection)
  • Anti-emetics (for associated nausea/vomiting)
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Cost & Coverage

Average Cost: Varies widely, typically $300-$600+ per 6 doses
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 for brand; Tier 1 for generic
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General Drug Facts

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 this 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, including the amount taken and the time it happened, to facilitate prompt and effective treatment.