Sumatriptan 6mg/0.5ml Vial For Inj
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
Category C
FDA Approved
Dec 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Sumatriptan injection is a medicine 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/sound.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. 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 authorized it. 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 begins. Before using this 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 Handling
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 the medication at room temperature, avoiding refrigeration or freezing.
Missed Doses
Since this medication is taken as needed, do not take it more frequently than prescribed by your doctor.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. 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 authorized it. 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 begins. Before using this 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 Handling
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 the medication at room temperature, avoiding refrigeration or freezing.
Missed Doses
Since this medication is taken as needed, do not take it more frequently than prescribed by your doctor.
Lifestyle & Tips
- Use at the first sign of a migraine or cluster headache, but not for prevention.
- Do not use more than 2 injections (12 mg) in 24 hours for migraine, and do not repeat for cluster headache within 24 hours.
- Avoid driving or operating machinery until you know how sumatriptan affects you, as it can cause dizziness or drowsiness.
- Inform your doctor about all other medications you are taking, especially antidepressants (SSRIs/SNRIs), other migraine medications, or MAO inhibitors.
- If you experience chest pain, shortness of breath, or severe dizziness after injection, seek immediate medical attention.
Available Forms & Alternatives
Available Strengths:
- Sumatriptan 100mg Tablets
- Sumatriptan 25mg Tablets
- Sumatriptan 50mg Tablets
- Sumatriptan 6mg/0.5ml Pf Inj2x0.5ml
- Sumatriptan 50mg Tablets
- Sumatriptan 6mg/0.5ml Vial For Inj
- Sumatriptan 6mg/0.5ml Pf Inj2x0.5ml
- Sumatriptan 25mg Tablets
- Sumatriptan 5mg Nasal Spray (6 Spr)
- Sumatriptan 4mg/0.5ml Inj 2x0.5ml
- Sumatriptan 4mg/0.5 Inj, 0.5ml
- Sumatriptan 6mg/0.5 Inj, 0.5ml
- Sumatriptan 5mg Nasal Spray(6 Spr)
- Sumatriptan 20mg Nasal Spray(6 Spr)
- Sumatriptan 5mg Nasal Spray(6 Spr)
- Sumatriptan 6mg/0.5ml Pf Inj2x0.5ml
Dosing & Administration
Adult Dosing
Standard Dose:
6 mg subcutaneous injection, may repeat once after 1 hour for migraine or 24 hours for cluster headache.
Dose Range:
6 - 12 mg
Condition-Specific Dosing:
migraine:
6 mg SC, may repeat once after 1 hour if needed. Max 12 mg in 24 hours.
cluster_headache:
6 mg SC. Max 12 mg in 24 hours. Do not repeat within 24 hours for cluster headache.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Safety and efficacy not established for migraine. For cluster headache, limited data suggest 6 mg SC may be used in adolescents (12-17 years) under strict medical supervision, but generally not recommended.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment generally required.
Moderate:
No dosage adjustment generally required.
Severe:
No dosage adjustment generally required.
Dialysis:
Not significantly removed by dialysis. No specific adjustment, but use with caution.
Hepatic Impairment:
Mild:
No dosage adjustment generally required.
Moderate:
Use with caution. Consider lower doses (e.g., 3 mg) if necessary.
Severe:
Contraindicated.
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 (especially those of the dura mater and pial arteries) and by inhibiting the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings.
Pharmacokinetics
Absorption:
Bioavailability:
97% (subcutaneous)
Tmax:
Approximately 12 minutes (subcutaneous)
FoodEffect:
Not applicable for injection.
Distribution:
Vd:
Approximately 2.4 L/kg
ProteinBinding:
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)
Pharmacodynamics
OnsetOfAction:
Approximately 10-15 minutes (subcutaneous)
PeakEffect:
Approximately 1 hour
DurationOfAction:
Up to 24 hours, but headache recurrence is common within 24 hours.
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 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
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 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 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
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 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:
- Severe chest pain, jaw pain, or neck tightness (could indicate heart problems)
- Sudden numbness or weakness on one side of the body, sudden severe headache, vision changes (signs of stroke)
- Signs of serotonin syndrome: agitation, confusion, rapid heart rate, fever, sweating, muscle stiffness, twitching, nausea, vomiting, diarrhea
- Severe allergic reactions (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Vision loss or changes
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 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 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. Ensure that it is safe to take this medication with your other medications and health conditions. 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 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 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. Ensure that it is safe to take this medication with your other medications and health conditions. 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
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 recommended 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 years old, or having a family history of early heart disease, or if you are a postmenopausal female, discuss these risks with your doctor.
Cardiovascular Risks
Rarely, this medication can cause severe and potentially life-threatening heart problems, including heart attack and abnormal heartbeat, within a few hours of administration. 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 Warnings
If you have a latex allergy, inform your doctor, as some products may contain latex.
If you are 65 years 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 decide that the benefits outweigh the risks. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.
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 recommended 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 years old, or having a family history of early heart disease, or if you are a postmenopausal female, discuss these risks with your doctor.
Cardiovascular Risks
Rarely, this medication can cause severe and potentially life-threatening heart problems, including heart attack and abnormal heartbeat, within a few hours of administration. 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 Warnings
If you have a latex allergy, inform your doctor, as some products may contain latex.
If you are 65 years 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 decide that the benefits outweigh the risks. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.
Overdose Information
Overdose Symptoms:
- Convulsions
- Tremor
- Inactivity
- Redness of the extremities
- Reduced breathing
- Cyanosis
- Limb weakness
- Injection site reactions
What to Do:
Call 1-800-222-1222 (Poison Control) or seek immediate medical attention. Monitor cardiac and respiratory function, and provide supportive care.
Drug Interactions
Contraindicated Interactions
- Monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI
- Ergotamine-containing medications or ergot-type drugs (e.g., dihydroergotamine) within 24 hours
- Other 5-HT1 agonists (e.g., other triptans) within 24 hours
Major Interactions
- Selective serotonin reuptake inhibitors (SSRIs)
- Serotonin-norepinephrine reuptake inhibitors (SNRIs)
Moderate Interactions
- St. John's Wort
Monitoring
Baseline Monitoring
Cardiovascular risk assessment (e.g., ECG, blood pressure)
Rationale: To rule out underlying cardiovascular disease, as sumatriptan can cause coronary vasospasm and is contraindicated in certain cardiac conditions.
Timing: Prior to initiation, especially in patients with risk factors for CAD.
Blood pressure
Rationale: To ensure controlled hypertension, as sumatriptan is contraindicated in uncontrolled hypertension.
Timing: Prior to initiation.
Routine Monitoring
Headache frequency and severity
Frequency: Each visit or as needed
Target: Reduction in headache burden
Action Threshold: Lack of efficacy, increasing frequency of use (risk of medication overuse headache).
Blood pressure
Frequency: Periodically, especially in patients with hypertension
Target: Within normal limits
Action Threshold: Significant increase in blood pressure.
Symptom Monitoring
- Chest pain or tightness
- Neck or jaw pain/tightness
- Shortness of breath
- Dizziness or vertigo
- Tingling or numbness
- Flushing
- Injection site reactions (pain, redness, swelling)
- Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea)
- Signs of medication overuse headache (increasing headache frequency or severity with frequent triptan use)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies show some developmental toxicity, but human data are limited.
Trimester-Specific Risks:
First Trimester:
Limited human data, animal studies show some risk.
Second Trimester:
Limited human data.
Third Trimester:
Limited human data.
Lactation
Sumatriptan is excreted into breast milk. A single subcutaneous dose of 6 mg results in low levels in breast milk. Infant exposure can be minimized by avoiding breastfeeding for 12 hours after sumatriptan administration.
Infant Risk:
Low risk, but potential for drowsiness or vomiting in infant. Consider pumping and discarding milk for 12 hours post-dose.
Pediatric Use
Safety and efficacy not established for migraine in pediatric patients. Not recommended for children under 18 years. Limited data for cluster headache in adolescents, generally not recommended.
Geriatric Use
Use with caution in patients over 65 years due to higher likelihood of underlying cardiovascular disease. Consider lower initial doses and careful monitoring. Contraindicated in patients with risk factors for undiagnosed coronary artery disease unless a cardiovascular evaluation has been performed.
Clinical Information
Clinical Pearls
- Sumatriptan injection is the fastest-acting triptan formulation, making it ideal for rapid relief of severe migraine or cluster headache attacks.
- It is particularly useful for patients with rapid onset of headache or those who experience nausea/vomiting that prevents oral medication use.
- Patients should be instructed on proper subcutaneous injection technique.
- Counsel patients on the potential for 'triptan sensations' (e.g., chest pressure, neck tightness) which are generally non-cardiac but can be alarming.
- Always screen for cardiovascular risk factors and contraindications before prescribing, especially in older patients or those with multiple risk factors.
- Warn patients about the risk of medication overuse headache if used too frequently.
Alternative Therapies
- Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan, almotriptan) in various formulations (oral, nasal spray, ODT)
- CGRP receptor antagonists (gepants like rimegepant, ubrogepant)
- Ditans (lasmiditan)
- NSAIDs (e.g., ibuprofen, naproxen)
- Acetaminophen
- Ergot alkaloids (e.g., ergotamine, dihydroergotamine - use with caution due to interactions)
- Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
Cost & Coverage
Average Cost:
Varies widely, typically $50-$150 per 6mg/0.5ml vial per 6mg/0.5ml vial
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 (brand)
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 happened.