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Imitrex 4mg Statdose System

Manufacturer GLAXO SMITH KLINE Active Ingredient Sumatriptan Injection(soo ma TRIP tan) Pronunciation soo-ma-TRIP-tan
It is used to treat migraine headaches. It is used to treat cluster 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
C
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FDA Approved
Dec 1992
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DEA Schedule
Not Controlled

Overview

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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 to relieve the pain and other symptoms of a headache attack. It is not for preventing headaches.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. 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.

Administering the Injection

The injection should be given under the skin as soon as possible after the attack has started. Before using this medication, make sure you understand how to administer it correctly. Read the package insert and instructions for use that come with your medication. If you have any questions, consult your doctor or pharmacist. It's also essential to know where to inject the medication. If you're unsure, consult your doctor.

Precautions and Safety Measures

Wash your hands before and after using the medication. Do not use the solution if it appears cloudy, is leaking, or contains particles. Also, do not use the solution if it has changed color. After use, dispose of the needle in a 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.

Storage and Disposal

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

Missed Doses

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

  • Use at the first sign of a migraine or cluster headache attack, but not during the aura phase if it precedes the headache.
  • Do not use for more headaches than prescribed to avoid medication overuse headache.
  • Avoid triggers for your headaches (e.g., certain foods, stress, lack of sleep).
  • Maintain a regular sleep schedule.
  • Stay hydrated.
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Available Forms & Alternatives

Available Strengths:

Generic Alternatives:

Dosing & Administration

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Adult Dosing

Standard Dose: 6 mg subcutaneously (SC) as a single dose
Dose Range: 4 - 6 mg

Condition-Specific Dosing:

migraine: Initial dose 4 mg or 6 mg SC. If headache returns, a second injection may be administered at least 1 hour after the first dose. Maximum dose is 12 mg in 24 hours.
clusterHeadache: 6 mg SC as a single dose. Maximum dose is 12 mg in 24 hours. Do not use for prophylaxis.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established in patients under 18 years of age)
Adolescent: Not established (Safety and efficacy not established in patients under 18 years of age)
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Dose Adjustments

Renal Impairment:

Mild: No dosage adjustment necessary
Moderate: No dosage adjustment necessary
Severe: No dosage adjustment necessary
Dialysis: No specific recommendations; sumatriptan is not significantly removed by dialysis.

Hepatic Impairment:

Mild: No dosage adjustment necessary
Moderate: Consider lower doses (e.g., 3 mg SC) and monitor for adverse effects. Maximum single dose 6 mg, maximum 24-hour dose 12 mg.
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 circulation, which are dilated during a migraine attack. It also inhibits the release of pro-inflammatory neuropeptides from trigeminal nerve endings.
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Pharmacokinetics

Absorption:

Bioavailability: 97% (SC)
Tmax: 12 minutes (SC)
FoodEffect: Not applicable for injection

Distribution:

Vd: 2.7 L/kg
ProteinBinding: 14-21%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 hours
Clearance: 1160 mL/min (total plasma clearance)
ExcretionRoute: Renal (60% as metabolite, 3% unchanged), Fecal (40% as metabolite)
Unchanged: Approximately 22% (oral), 3% (SC)
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Pharmacodynamics

OnsetOfAction: Approximately 10-15 minutes (SC)
PeakEffect: Approximately 12 minutes (SC)
DurationOfAction: Up to 24 hours, though headache recurrence is common within this period.

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
+ 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
+ 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
 Irritation at the injection site

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:

  • Chest pain, tightness, or heaviness (especially if radiating to arm or jaw)
  • Shortness of breath
  • Sudden severe stomach pain
  • Numbness or tingling in fingers or toes
  • Weakness or numbness on one side of the body
  • Sudden vision changes
  • Severe dizziness or fainting
  • Rash or hives
  • Swelling of face, lips, tongue, or throat
  • Signs of serotonin syndrome: agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, uncontrolled movements, shivering, 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 depression 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, 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 all your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
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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.

Precautions and Warnings

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. 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, or having a family history of early heart disease, or if you are a postmenopausal female, discuss these risks with your doctor.

Cardiovascular Risks

Rare but serious heart problems, including heart attack and abnormal heartbeat, have occurred within a few hours of taking this 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

Additional Considerations

 If you have a latex allergy, inform your doctor, as some products may contain latex.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
 Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor.

Pediatric Use

* This medication is not approved for use in children. However, your doctor may determine that the benefits outweigh the risks. If your child has been prescribed this medication, consult with your doctor to understand the benefits and risks, and discuss any questions or concerns you may have.
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Overdose Information

Overdose Symptoms:

  • Convulsions
  • Tremor
  • Inactivity
  • Erythema of the extremities
  • Reduced respiration
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Salivation
  • Lacrimation

What to Do:

Seek immediate medical attention. There is no specific antidote. General supportive measures should be employed. Monitor cardiac and respiratory function. Call 911 or Poison Control at 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • MAO-A inhibitors (concurrent use or within 2 weeks of discontinuation)
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine, methysergide) (concurrent use or within 24 hours)
  • Other 5-HT1 agonists (e.g., other triptans) (concurrent use or within 24 hours)
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome)
  • Tricyclic Antidepressants (TCAs) (theoretical risk of serotonin syndrome)
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Moderate Interactions

  • St. John's Wort (theoretical risk of serotonin syndrome)
  • Cimetidine (may increase sumatriptan exposure, though not clinically significant for injection)

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment

Rationale: To rule out underlying cardiovascular disease (e.g., ischemic heart disease, Prinzmetal's angina, uncontrolled hypertension) due to potential for coronary vasospasm.

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

Blood pressure

Rationale: To ensure hypertension is controlled, as sumatriptan can cause transient increases in blood pressure.

Timing: Prior to first dose.

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Routine Monitoring

Blood pressure

Frequency: Periodically, especially if patient has hypertension.

Target: Within normal limits or patient's controlled range.

Action Threshold: Significant or sustained elevation; consider discontinuation or alternative.

Headache frequency and severity

Frequency: Ongoing, with each use.

Target: Reduction in headache severity and frequency.

Action Threshold: Lack of efficacy, increasing frequency of use (risk of medication overuse headache).

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Symptom Monitoring

  • Chest pain or tightness (may indicate coronary vasospasm)
  • Shortness of breath
  • Palpitations
  • Dizziness or vertigo
  • Numbness or tingling
  • Weakness on one side of the body
  • Vision changes
  • Severe headache (worsening or new type)
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)

Special Patient Groups

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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. Animal studies show some developmental toxicity at high doses.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear evidence of increased risk of major birth defects.
Second Trimester: Limited data, generally considered low risk.
Third Trimester: Limited data, generally considered low risk.
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Lactation

Sumatriptan is excreted into human milk. Infant exposure is low. Consider avoiding breastfeeding for 12 hours after a dose to minimize infant exposure.

Infant Risk: L3 (Moderate concern; there are no controlled studies in breastfeeding women, but the risk of adverse effects to a breastfed infant appears to be low based on limited data and short half-life.)
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Pediatric Use

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

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Geriatric Use

Use with caution in elderly patients (over 65 years) due to a greater likelihood of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Consider lower initial doses and monitor for adverse effects, especially cardiovascular events.

Clinical Information

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Clinical Pearls

  • Sumatriptan injection is often preferred for rapid relief of severe migraine or cluster headache, especially when oral medications are ineffective or contraindicated (e.g., nausea/vomiting).
  • Ensure patients understand proper injection technique for the Statdose system.
  • Advise patients to lie down in a quiet, dark room after administration for optimal effect.
  • Counsel patients on the importance of not exceeding the maximum daily dose to avoid medication overuse headache.
  • Always screen for cardiovascular risk factors before prescribing, as triptans can cause coronary vasospasm.
  • Do not use for basilar or hemiplegic migraine, as these are contraindications.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan, almotriptan)
  • CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
  • Ditans (e.g., lasmiditan)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • Anti-emetics (e.g., metoclopramide, prochlorperazine) (often used adjunctively)
  • Opioids (generally not recommended for migraine due to abuse potential and risk of medication overuse headache)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$150 per 4mg/6mg pre-filled syringe per single dose
Generic Available: Yes
Insurance Coverage: Tier 2 or 3 (often requires prior authorization or step therapy for brand, generic usually preferred)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.