Sumatriptan 20mg Nasal Spray(6 Spr)

Manufacturer PRASCO LABORATORIES 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 (Triptan)
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Pregnancy Category
Category C
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FDA Approved
Mar 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 acute migraine headaches. It works by narrowing blood vessels in the brain and affecting certain nerves, which helps relieve migraine pain and other symptoms like nausea and sensitivity to light and sound. It is not for preventing 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, even 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, and avoid getting it in your eyes or mouth, as it may cause burning. Use this medication as soon as possible after the onset of a 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 prescribed 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 severe liver disease.
  • Avoid using within 24 hours of other triptans or ergotamine-containing medications.
  • Inform your doctor about all medications you are taking, especially antidepressants (SSRIs/SNRIs), as there is a risk of serotonin syndrome.
  • Lie down in a quiet, dark room after taking the medication to help with symptom relief.
  • Avoid driving or operating machinery if you experience dizziness or drowsiness.

Dosing & Administration

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Adult Dosing

Standard Dose: 20 mg (or 10 mg) administered as a single dose into one nostril. May repeat dose once after 2 hours if migraine symptoms return or only partial response, not to exceed 40 mg in any 24-hour period.
Dose Range: 10 - 40 mg

Condition-Specific Dosing:

initial_dose: 10 mg or 20 mg
repeat_dose_interval: After 2 hours
max_daily_dose: 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 patients under 18 years of age)
Adolescent: Not established (Safety and efficacy not established for patients under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment generally required.
Moderate: No dosage adjustment generally required.
Severe: No dosage adjustment generally required, but use with caution due to potential for increased exposure.
Dialysis: Not specifically studied, but sumatriptan is not significantly removed by dialysis. Use with caution.

Hepatic Impairment:

Mild: No dosage adjustment generally required.
Moderate: Use with caution; consider lower doses (e.g., 10 mg initial dose) and monitor for adverse effects. Avoid in severe hepatic impairment.
Severe: Contraindicated.

Pharmacology

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Mechanism of Action

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B and 5-HT1D) receptors. It is believed to exert its antimigraine effect by causing vasoconstriction of intracranial blood vessels, which are dilated during a migraine attack, and by inhibiting the release of pro-inflammatory neuropeptides from trigeminal nerve endings.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 17% (nasal spray)
Tmax: Approximately 1-1.5 hours (nasal spray)
FoodEffect: Not significantly affected by food.

Distribution:

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

Elimination:

HalfLife: Approximately 2 hours
Clearance: Approximately 1160 mL/min (total plasma clearance)
ExcretionRoute: Renal (approximately 60% as inactive metabolite, 3% as unchanged drug); Fecal (approximately 40% as inactive metabolite)
Unchanged: Approximately 3% (renal)
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Pharmacodynamics

OnsetOfAction: Within 15-30 minutes (nasal spray)
PeakEffect: Approximately 1-1.5 hours (nasal spray)
DurationOfAction: Up to 24 hours (though repeat dose may be needed after 2 hours)

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
Rarely, 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
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
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
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 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

If you have any 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, jaw pain, or arm pain (could indicate heart problems - seek immediate medical attention)
  • Shortness of breath
  • Weakness or numbness on one side of the body
  • Slurred speech
  • Sudden vision changes
  • Severe stomach pain or bloody diarrhea
  • Symptoms of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea (seek immediate medical attention)
  • Severe allergic reactions (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, 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 heart rhythms, like Wolff-Parkinson-White syndrome
Recent use of certain depression 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.
Current use of another medication that contains the same active ingredient.
Recent use of other medications, including:
+ 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 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 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.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other activities that require you to be alert.

Monitoring Blood Pressure
High blood pressure is a potential side effect of this medication. Follow your doctor's instructions for regular blood pressure checks.

Important Note on Migraine Treatment
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 Headache Worsening
Taking more of this medication than prescribed (higher dose, more frequent) may worsen your headaches. Use caution and follow your doctor's instructions.

Heart Disease Risks
If you have risk factors for heart disease, such as high blood pressure, high cholesterol, being overweight, 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, discuss these risks with your doctor.

Rare but Serious Heart Problems
In rare cases, 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 sweat
- Shortness of breath
- Rapid heartbeat
- Abnormal heartbeat
- Severe dizziness or fainting

Special Considerations for Older Adults
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 for you and your baby.

Use in Children
This medication is not approved for use in children. However, your doctor may decide that 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:

  • Severe drowsiness
  • Dizziness
  • Nausea
  • Vomiting
  • Convulsions
  • Tremor
  • Redness or flushing
  • Weakness
  • Lack of coordination
  • Breathing problems
  • Cyanosis (bluish skin)

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 MAOI therapy
  • Ergotamine-containing medications or ergot-type drugs (e.g., dihydroergotamine) within 24 hours
  • Other 5-HT1 agonists (triptans) within 24 hours
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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 - theoretical risk of serotonin syndrome
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Moderate Interactions

  • Cimetidine - may increase sumatriptan exposure (minor effect, not clinically significant for most)
  • Propranolol - no significant interaction
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Minor Interactions

  • Alcohol - no direct interaction, but may exacerbate migraine or side effects

Monitoring

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Baseline Monitoring

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

Rationale: Sumatriptan can cause coronary vasospasm and is contraindicated in certain cardiovascular conditions.

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

Blood pressure

Rationale: Sumatriptan can cause transient increases in blood pressure.

Timing: Prior to initiation, especially in patients with hypertension.

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Routine Monitoring

Migraine frequency, severity, and response to treatment

Frequency: Ongoing, with each migraine episode

Target: Reduction in headache pain and associated symptoms

Action Threshold: Lack of efficacy, increasing frequency of use, or development of medication overuse headache.

Blood pressure

Frequency: Periodically, especially in patients with hypertension

Target: Within patient's target range

Action Threshold: Sustained or significant elevation.

Symptoms of serotonin syndrome (e.g., mental status changes, autonomic instability, neuromuscular abnormalities)

Frequency: During concomitant use with SSRIs/SNRIs or other serotonergic drugs

Target: Absence of symptoms

Action Threshold: Presence of any symptoms suggestive of serotonin syndrome.

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Symptom Monitoring

  • Chest pain or tightness (evaluate for cardiac origin)
  • Shortness of breath
  • Jaw or neck tightness/pressure
  • Numbness or tingling (paresthesia)
  • Dizziness or vertigo
  • Nausea or vomiting
  • Nasal irritation or taste disturbance
  • Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart beat, fever, overactive reflexes, nausea, vomiting, diarrhea, incoordination)
  • Vision changes

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some developmental toxicity at high doses, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies suggest potential risk at high doses.
Second Trimester: Limited human data.
Third Trimester: Limited human data.
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Lactation

Sumatriptan is excreted into breast milk. Caution should be exercised when sumatriptan is administered to a nursing woman. Consider temporary interruption of breastfeeding for 12 hours after a dose to minimize infant exposure.

Infant Risk: Low risk; relative infant dose is low. Monitor infant for drowsiness or feeding changes.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients under 18 years of age. Not recommended for this age group.

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Geriatric Use

Use with caution in patients over 65 years of age due to a greater likelihood of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Consider starting with the lowest effective dose (e.g., 10 mg nasal spray).

Clinical Information

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Clinical Pearls

  • Sumatriptan nasal spray is for acute treatment of migraine attacks, not for prevention.
  • Instruct patients on proper nasal spray technique to ensure optimal absorption.
  • Advise patients to take the medication as soon as migraine symptoms appear, but not during the aura phase if it precedes the headache.
  • Patients should be screened for cardiovascular risk factors before starting sumatriptan.
  • Warn patients about the potential for medication overuse headache if used too frequently (e.g., >10 days/month).
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan - oral, ODT, nasal, injectable forms)
  • Non-steroidal anti-inflammatory drugs (NSAIDs)
  • Acetaminophen
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • CGRP receptor antagonists (gepants, e.g., ubrogepant, rimegepant)
  • Serotonin 5-HT1F receptor agonists (ditans, e.g., lasmiditan)
  • Anti-emetics (for associated nausea/vomiting)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., $50-$200+ for 6 sprays) per 6 sprays (20mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 for generic, Tier 3 or higher for brand
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.