Imitrex 20mg 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
May 1998
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Sumatriptan nasal spray is a medication used to treat migraine headaches. It works by narrowing blood vessels in the brain and affecting certain nerves, which helps to relieve migraine pain and other symptoms like nausea and sensitivity to light and sound. It should be used at the first sign of a migraine attack, but not to prevent migraines.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all the information provided. Take this medication as directed, and if your headache does not improve after the first dose, consult 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 advised you to do so. Be sure to wait the recommended number of hours before taking another dose, even if you used a different form of this medication for the first dose.

Important Administration Instructions

Do not take this medication by mouth; it is for nasal use only.
Avoid getting the medication in your mouth or eyes, as it may cause burning.
Use this medication as soon as possible after the onset of an attack.
Sit down before using the medication.
* Blow your nose before administering the dose.

Storage and Disposal

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

Missed Dose Instructions

Since this medication is taken as needed, do not take it more frequently than advised by your doctor.
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Lifestyle & Tips

  • Use at the first sign of a migraine headache, but not for prevention.
  • Do not use if you have certain heart conditions, uncontrolled high blood pressure, or a history of stroke.
  • Avoid driving or operating machinery until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • Avoid alcohol during a migraine attack as it can worsen symptoms or interact with medication.
  • Identify and avoid 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: 20 mg administered as a single dose into one nostril. May repeat once after 2 hours if partial response, for a maximum of 40 mg in a 24-hour period.
Dose Range: 20 - 40 mg

Condition-Specific Dosing:

migraine_with_or_without_aura: 20 mg single dose, may repeat once after 2 hours (max 40 mg/24 hours).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established for children under 12 years of age).
Adolescent: For adolescents 12-17 years, 10 mg or 20 mg single dose. Max 40 mg/24 hours. Use with caution and only if benefits outweigh risks due to limited data.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: No specific dose adjustment required, but use with caution due to potential for increased exposure.
Dialysis: Not significantly removed by dialysis. Use with caution.

Hepatic Impairment:

Mild: No specific dose adjustment required.
Moderate: Consider lower initial doses (e.g., 10 mg nasal spray) and monitor for adverse effects. Max 20 mg/24 hours.
Severe: Contraindicated due to impaired metabolism and increased exposure.

Pharmacology

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Mechanism of Action

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B/1D) receptors. It is believed to exert its antimigraine effect by causing vasoconstriction of intracranial blood vessels, particularly those of the carotid arterial circulation, and by inhibiting the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 17% (range 8-25%) via nasal administration.
Tmax: 1 to 1.5 hours (nasal spray).
FoodEffect: Not significantly affected by food.

Distribution:

Vd: Approximately 2.4 L/kg.
ProteinBinding: 14-21%.
CnssPenetration: Limited (low penetration).

Elimination:

HalfLife: Approximately 2 hours.
Clearance: Approximately 1160 mL/min (total plasma clearance).
ExcretionRoute: Renal (major metabolite), some fecal.
Unchanged: Approximately 3% of the administered dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Within 15-30 minutes (nasal spray).
PeakEffect: 1 to 1.5 hours.
DurationOfAction: Up to 24 hours (though headache relief may wane sooner, requiring a second dose).

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 experience 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 or dizziness
+ Passing out
+ Changes in eyesight
Seizures
Loss of eyesight (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
+ 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
Change in balance
Confusion
Hallucinations
Fever
Fast or abnormal heartbeat
Flushing
Muscle twitching or stiffness
Seizures
Shivering or shaking
Excessive sweating
Severe diarrhea
Upset stomach
Throwing up
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
Change 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're bothered by any of the following:

Feeling dizzy, sleepy, tired, or weak
Flushing
Feeling of warmth
Upset stomach or throwing up
Changes in taste
Burning
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:

  • Sudden or severe chest pain, tightness, or pressure (especially if radiating to arm, back, neck, jaw, or stomach)
  • Shortness of breath
  • Weakness or numbness on one side of the body
  • Slurred speech
  • Sudden severe headache (different from your usual migraine)
  • Vision changes (e.g., temporary blindness)
  • Signs of serotonin syndrome: agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, fever, nausea, vomiting, diarrhea
  • Signs of allergic reaction: rash, hives, swelling of face/lips/tongue, difficulty breathing
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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 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.
Concurrent use of another medication that contains the same active ingredient.
Use of other medications for migraines, 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.
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Precautions & Cautions

Important Information for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure your safety and prevent any potential interactions with other treatments.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert. This will help prevent accidents and ensure your safety.

Monitoring Blood Pressure
High blood pressure has been reported in patients taking this medication. Follow your doctor's instructions for regular blood pressure checks to monitor your condition.

Important Usage Information
This medication is not intended to prevent or reduce the frequency of migraine headaches. If you experience a headache that is different from your usual migraine headaches, consult your doctor before taking this medication.

Dosage and Administration
Taking more of this medication than prescribed by your doctor (higher dose, more frequent) may worsen your headaches. Use caution when taking this medication, especially if you have risk factors for heart disease, such as:

High blood pressure
High cholesterol
Overweight
High blood sugar or diabetes
Cigarette smoking
Male older than 40 years of age
Family history of early heart disease
Female after menopause

Discuss your individual risk factors with your doctor.

Rare but Serious Heart Problems
In rare cases, this medication can cause serious 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 any of the following symptoms:

Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
Cold sweat
Shortness of breath
Fast heartbeat
Abnormal heartbeat
Severe dizziness or fainting

Special Considerations

Older Adults (65 and 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 taking this medication with you.
* Children: This medication is not approved for use in children. However, your doctor may prescribe it if the benefits outweigh the risks. If your child has been prescribed this medication, ask your doctor 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 respiratory rate
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Paralysis

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs (risk of serotonin syndrome).
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine, methysergide) or within 24 hours of sumatriptan (risk of prolonged vasospastic reactions).
  • Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan (risk of prolonged vasospastic reactions).
  • Severe hepatic impairment.
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome).
  • St. John's Wort (risk of serotonin syndrome).
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Moderate Interactions

  • Cimetidine (may increase sumatriptan exposure, though not clinically significant for most patients).
  • Propranolol (no significant interaction).

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment (e.g., history of ischemic heart disease, uncontrolled hypertension, cerebrovascular disease)

Rationale: Sumatriptan can cause coronary vasospasm and other cardiovascular events. It is contraindicated in patients with certain cardiovascular conditions.

Timing: Prior to initiating therapy, especially in patients with risk factors.

Blood pressure

Rationale: Sumatriptan can cause transient increases in blood pressure.

Timing: Prior to initiating therapy, and periodically during treatment if clinically indicated.

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Routine Monitoring

Efficacy (headache relief, associated symptoms)

Frequency: With each dose

Target: Significant reduction or resolution of migraine symptoms within 2 hours.

Action Threshold: If no relief after first dose, do not take a second dose for the same attack. If partial relief, a second dose may be considered after 2 hours.

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

Frequency: With each dose and during follow-up

Target: Absence or mild, transient nature of side effects.

Action Threshold: Severe or persistent chest pain, shortness of breath, or neurological symptoms warrant immediate medical evaluation.

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Symptom Monitoring

  • Chest pain, tightness, or pressure (can be cardiac or non-cardiac)
  • Neck or jaw pain/tightness
  • Shortness of breath
  • Dizziness or vertigo
  • Paresthesia (tingling, numbness)
  • Flushing
  • Weakness or fatigue
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, coordination problems, nausea, vomiting, diarrhea)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)

Special Patient Groups

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Pregnancy

Sumatriptan is classified as Pregnancy Category C. It should be used 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 have shown some developmental toxicity at high doses.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear evidence of increased risk of major birth defects. Animal studies show some developmental toxicity.
Second Trimester: Limited data, generally considered low risk if used intermittently.
Third Trimester: Limited data, theoretical risk of premature closure of ductus arteriosus (though less likely than with NSAIDs). Use with caution.
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Lactation

Sumatriptan is excreted into breast milk in small amounts. Amounts ingested by the infant are small and are not expected to cause adverse effects. To minimize infant exposure, breastfeeding can be delayed for 8-12 hours after a dose.

Infant Risk: Low risk (L3 - Moderately Safe, per LactMed).
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Pediatric Use

Not recommended for children under 12 years of age due to lack of established safety and efficacy. For adolescents (12-17 years), use with caution and only if benefits outweigh risks, as data are limited.

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Geriatric Use

Use with caution in elderly patients (over 65 years) due to a higher likelihood of underlying cardiovascular disease or other comorbidities. Consider lower initial doses and monitor closely for adverse cardiovascular events.

Clinical Information

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Clinical Pearls

  • Sumatriptan nasal spray is for acute treatment of migraine attacks, not for prevention.
  • Administer the dose into one nostril. Do not sniff hard after administration.
  • Do not use if the headache is atypical or different from usual migraine, as it may be a sign of a more serious condition.
  • Patients should be screened for cardiovascular risk factors before initiating sumatriptan therapy.
  • Advise patients to wait at least 24 hours before taking another triptan or ergot-type medication after sumatriptan, and vice versa.
  • Inform patients about the risk of serotonin syndrome, especially if taking SSRIs or SNRIs concurrently.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan)
  • CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
  • Ditans (e.g., lasmiditan)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Combination analgesics (e.g., Excedrin Migraine)
  • Anti-emetics (for associated nausea/vomiting)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$150 per dose for brand, less for generic. per 20mg nasal spray dose
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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.