Imitrex 6mg Statdose System
It is used to treat migraine headaches. It is used to treat cluster headaches.
Drug Class
Antimigraine agent
Pharmacologic Class
Selective Serotonin (5-HT1B/1D) Receptor Agonist
Pregnancy Category
C
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sumatriptan injection is a medication used to treat acute migraine headaches and cluster headaches. It works by narrowing blood vessels in the brain and affecting certain nerves, which helps relieve headache pain and other symptoms like nausea and sensitivity to light and sound. It is given as an injection under the skin, usually in the arm or thigh.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. If your headache doesn't 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. Make sure you understand how many hours to wait before taking another dose, even if you used a different form of the medication for the first dose.
Administering the Injection
The injection should be given under the skin as soon as possible after the headache starts. Before using the medication, make sure you understand how to administer it correctly. Read the package insert and instructions for use that come with the medication. If you have any questions, consult your doctor or pharmacist. It's also essential to know the correct injection site. If you're unsure, consult your doctor.
Precautions and Safety
Before and after using the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Also, do not use the medication if the solution has changed color. After use, dispose of the needle in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding refrigeration or freezing.
Missing a Dose
Since this medication is taken as needed, do not take it more frequently than advised by your doctor.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. If your headache doesn't 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. Make sure you understand how many hours to wait before taking another dose, even if you used a different form of the medication for the first dose.
Administering the Injection
The injection should be given under the skin as soon as possible after the headache starts. Before using the medication, make sure you understand how to administer it correctly. Read the package insert and instructions for use that come with the medication. If you have any questions, consult your doctor or pharmacist. It's also essential to know the correct injection site. If you're unsure, consult your doctor.
Precautions and Safety
Before and after using the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Also, do not use the medication if the solution has changed color. After use, dispose of the needle in a designated needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow local regulations for disposal. If you have any questions, consult your doctor or pharmacist.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding refrigeration or freezing.
Missing a Dose
Since this medication is taken as needed, do not take it more frequently than advised by your doctor.
Lifestyle & Tips
- Use sumatriptan only for acute headache attacks, not for prevention.
- Do not use more than 2 injections (12 mg) in a 24-hour period.
- Avoid driving or operating machinery until you know how sumatriptan affects you, as it can cause dizziness or drowsiness.
- Identify and avoid migraine triggers (e.g., certain foods, stress, lack of sleep).
- Maintain a regular sleep schedule and healthy lifestyle.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
6 mg subcutaneous (SC) injection
Dose Range:
6 - 6 mg
Condition-Specific Dosing:
migraine:
6 mg SC at onset of migraine symptoms. May repeat once after 1 hour if symptoms return or only partial response, not to exceed 12 mg in any 24-hour period.
cluster_headache:
6 mg SC at onset of cluster headache symptoms. May repeat once after 1 hour if symptoms return or only partial response, not to exceed 12 mg in any 24-hour period.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Dialysis:
No specific recommendations; sumatriptan is not significantly removed by dialysis.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
Use with caution. Consider lower doses (e.g., 3 mg SC) and monitor for adverse effects.
Severe:
Contraindicated due to impaired metabolism and increased exposure.
Pharmacology
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 involved in migraine, and by inhibiting the release of pro-inflammatory neuropeptides from trigeminal nerve endings.
Pharmacokinetics
Absorption:
Bioavailability:
97% (subcutaneous)
Tmax:
12 minutes (subcutaneous)
FoodEffect:
Not applicable for injection.
Distribution:
Vd:
2.4 L/kg
ProteinBinding:
14-21%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 2 hours
Clearance:
1160 mL/min (total plasma clearance)
ExcretionRoute:
Renal (60% as metabolite, 2% unchanged), Fecal (40% as metabolite)
Unchanged:
2% (renal)
Pharmacodynamics
OnsetOfAction:
10-15 minutes (subcutaneous)
PeakEffect:
1-2 hours
DurationOfAction:
Up to 24 hours (though headache may recur, requiring a second dose)
Safety & Warnings
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
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
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
Irritation at the injection site
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.
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
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
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
Irritation at the injection site
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.
Seek Immediate Medical Attention If You Experience:
- Sudden or severe chest pain, tightness, or pressure (especially if it spreads to your jaw or arm)
- Shortness of breath
- Weakness or numbness on one side of your body
- Sudden vision changes
- Severe stomach pain or bloody diarrhea
- Signs of an allergic reaction (hives, difficulty breathing, swelling of your face/lips/tongue/throat)
- Symptoms of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, muscle stiffness, sweating, nausea, vomiting, diarrhea)
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. 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.
Recent use of other medications for migraines, 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 you have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without consulting 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. 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.
Recent use of other medications for migraines, 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 you have. This will help ensure your safety while taking this medication. Do not start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions 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 potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in 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.
Medication Purpose and Usage
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 and follow your doctor's instructions carefully.
Heart Disease Risks
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, discuss these risks with your doctor.
Serious Heart Problems
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 any of the following symptoms:
- Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
- Cold sweat
- Shortness of breath
- Rapid heartbeat
- Abnormal heartbeat
- Severe dizziness or fainting
Latex Allergy
If you have a latex allergy, inform your doctor, as some products may contain latex.
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 with you.
Use in Children
This medication is not approved for use in children. However, your doctor may decide that the benefits of taking this medication 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.
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 potential interactions with other treatments.
Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in 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.
Medication Purpose and Usage
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 and follow your doctor's instructions carefully.
Heart Disease Risks
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, discuss these risks with your doctor.
Serious Heart Problems
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 any of the following symptoms:
- Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
- Cold sweat
- Shortness of breath
- Rapid heartbeat
- Abnormal heartbeat
- Severe dizziness or fainting
Latex Allergy
If you have a latex allergy, inform your doctor, as some products may contain latex.
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 with you.
Use in Children
This medication is not approved for use in children. However, your doctor may decide that the benefits of taking this medication 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.
Overdose Information
Overdose Symptoms:
- Convulsions (seizures)
- Tremor
- Inactivity
- Redness of the 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. Treatment is supportive and symptomatic.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI (risk of sumatriptan toxicity)
- Ergot-type medications (e.g., ergotamine, dihydroergotamine) or within 24 hours of sumatriptan (risk of prolonged vasospastic reactions)
- Other 5-HT1 agonists (e.g., other triptans) or within 24 hours of sumatriptan (risk of additive vasoconstrictor effects)
Major Interactions
- Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome)
- Tricyclic Antidepressants (TCAs) (risk of serotonin syndrome)
Moderate Interactions
- Propranolol (may increase sumatriptan Cmax and AUC, though not considered clinically significant for SC sumatriptan)
Monitoring
Baseline Monitoring
Cardiovascular risk assessment (e.g., blood pressure, ECG if indicated)
Rationale: To identify underlying cardiovascular disease, as sumatriptan can cause coronary vasospasm and is contraindicated in certain cardiovascular conditions.
Timing: Prior to initiating therapy, especially in patients with risk factors for CAD.
Routine Monitoring
Headache frequency and severity
Frequency: Ongoing, as needed
Target: Reduction in headache symptoms
Action Threshold: Lack of efficacy or increasing headache frequency may indicate medication overuse headache or need for alternative therapy.
Blood pressure
Frequency: Periodically, especially in patients with hypertension
Target: Within normal limits or patient's target range
Action Threshold: Significant increase in blood pressure.
Symptoms of serotonin syndrome
Frequency: Ongoing, especially if co-administered with SSRIs/SNRIs
Target: Absence of symptoms
Action Threshold: Agitation, hallucinations, tachycardia, labile blood pressure, hyperthermia, hyperreflexia, incoordination, nausea, vomiting, diarrhea.
Symptom Monitoring
- Chest pain or tightness (especially if severe or radiating)
- Shortness of breath
- Palpitations
- Numbness or tingling
- Weakness on one side of the body
- Vision changes
- Severe dizziness or fainting
- Signs of allergic reaction (rash, hives, swelling)
- Symptoms of serotonin syndrome (agitation, confusion, rapid heart rate, fever, muscle rigidity, sweating, diarrhea)
Special Patient Groups
Pregnancy
Use 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 show some developmental toxicity.
Trimester-Specific Risks:
First Trimester:
Limited human data, no clear evidence of increased risk of major birth defects. Animal studies show some embryolethality and teratogenicity at high doses.
Second Trimester:
Limited data, generally considered low risk based on available information.
Third Trimester:
Limited data, generally considered low risk based on available information. Potential for vasoconstrictive effects on the fetus is a theoretical concern.
Lactation
Sumatriptan is excreted into human breast milk. Advise lactating women to consider pumping and discarding breast milk for 12 hours after sumatriptan administration to minimize infant exposure.
Infant Risk:
Low risk of adverse effects in breastfed infants based on limited data, but potential for exposure exists. Monitor infant for drowsiness, irritability, or feeding changes.
Pediatric Use
Safety and efficacy have not been established in pediatric patients for the treatment of migraine or cluster headache. Not recommended for use in patients under 18 years of age.
Geriatric Use
Use with caution in elderly patients (over 65 years of age) due to a higher likelihood of underlying cardiovascular disease and potential for increased sensitivity to the drug's effects. Consider lower initial doses and careful monitoring.
Clinical Information
Clinical Pearls
- Sumatriptan injection is typically used when a rapid onset of action is desired, or when oral formulations are ineffective or not tolerated (e.g., due to severe nausea/vomiting).
- It is crucial to rule out underlying cardiovascular disease before prescribing sumatriptan, especially in patients with risk factors.
- Not indicated for the prophylactic treatment of migraine or cluster headache.
- Not for use in patients with hemiplegic or basilar migraine.
- Patients should be advised to administer the injection as soon as migraine or cluster headache symptoms begin, but it can be effective at any stage of the attack.
- Risk of medication overuse headache (MOH) with frequent use; educate patients on this risk.
Alternative Therapies
- Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan) - available in various formulations (oral, nasal spray, ODT)
- CGRP receptor antagonists (e.g., rimegepant, ubrogepant) - for acute migraine
- Ditans (e.g., lasmiditan) - for acute migraine
- NSAIDs (e.g., ibuprofen, naproxen)
- Acetaminophen
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - for acute migraine/cluster headache (less commonly used due to side effects)
- Oxygen (for cluster headache)
Cost & Coverage
Average Cost:
Varies widely, typically $50-$150+ per 6mg pre-filled syringe
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 (for generic)
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 discuss them with 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 taken, the amount, and the time it occurred.