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Sumatriptan 6mg/0.5 Inj, 0.5ml

Manufacturer PRASCO 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; Triptan
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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 medicine used to treat acute migraine headaches and cluster headaches. It works by narrowing blood vessels in the brain and reducing substances that cause pain, nausea, and other migraine symptoms. It is given as an injection under the skin, usually in the arm or thigh.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take this medication as directed by your doctor, and carefully follow all instructions.

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 understand how many hours you should wait before taking another dose. This applies even if you used a different form of this medication for the first dose.

The injection should be administered under the skin as soon as possible after the attack begins. Before using this medication, make sure you understand how to administer it. Read the package insert and instructions for use that come with this medication. If you have questions about using this medication, consult your doctor or pharmacist.

Before administering the injection, ensure you know the correct injection site. If you are unsure, consult your doctor. Wash your hands before and after use. Do not use the medication if the solution is cloudy, leaking, or contains particles. Also, do not use the solution if it has changed color.

After use, dispose of needles 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 this medication at room temperature, avoiding refrigeration or freezing.

Missed Dose

This medication is taken as needed. Do not take it more frequently than advised by your doctor.
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Lifestyle & Tips

  • Avoid triggers: Identify and avoid factors that trigger your headaches (e.g., certain foods, stress, lack of sleep).
  • Maintain a regular sleep schedule.
  • Manage stress through relaxation techniques.
  • Stay hydrated.
  • Limit alcohol and caffeine intake.
  • Do not use for prevention; only for acute treatment of a headache that has already started.
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Available Forms & Alternatives

Available Strengths:

Dosing & Administration

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Adult Dosing

Standard Dose: 6 mg subcutaneously as a single dose
Dose Range: 6 - 12 mg

Condition-Specific Dosing:

migraine: 6 mg SC. May repeat once after 1 hour if needed. Maximum 12 mg in 24 hours.
cluster_headache: 6 mg SC. Maximum 12 mg in 24 hours.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for acute treatment of migraine or cluster headache.
Adolescent: Not established for acute treatment of migraine or cluster headache.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No dose adjustment necessary.
Moderate: Use with caution; consider lower doses.
Severe: Contraindicated due to impaired metabolism and increased plasma concentrations.

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 and by inhibiting the release of pro-inflammatory neuropeptides from trigeminal nerve endings.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: 170 L
ProteinBinding: 14-21%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 2 hours
Clearance: 1160 mL/min (total plasma clearance)
ExcretionRoute: Renal (major), some fecal
Unchanged: Approximately 22% (renal)
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Pharmacodynamics

OnsetOfAction: Approximately 10 minutes (subcutaneous)
PeakEffect: Approximately 12 minutes (subcutaneous)
DurationOfAction: Up to 24 hours (though headache recurrence is common)

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
+ 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

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden, severe chest pain, tightness, or pressure (especially if it spreads to the jaw or arm)
  • Shortness of breath
  • Weakness or numbness on one side of the body
  • Sudden vision changes
  • Slurred speech
  • Severe stomach pain or bloody diarrhea
  • Signs of serotonin syndrome: agitation, confusion, rapid heart rate, sweating, muscle stiffness, twitching, uncontrolled movements, fever, nausea, vomiting, 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. Be sure to 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.
 Use of other medications for migraine or headache, such as:
+ 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.
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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.

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 prescribed dose or frequency, as this may worsen your headaches.

Special Considerations

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, exercise caution and discuss your treatment with your doctor.
 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; or 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 of treatment outweigh the risks. If your child has been prescribed this medication, consult your doctor for information about the benefits and risks, and discuss any concerns you may have.
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Overdose Information

Overdose Symptoms:

  • Convulsions
  • Tremor
  • Inactivity
  • Redness of the extremities
  • Reduced activity
  • Respiratory depression
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Paralysis

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. Contact a poison control center (1-800-222-1222 in the US). Supportive treatment should be given as required. Monitor for at least 12 hours due to the possibility of recurrence of symptoms.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs
  • Ergot-containing drugs (e.g., ergotamine, dihydroergotamine) or within 24 hours of sumatriptan
  • Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan
  • Severe hepatic impairment
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) - increased risk of serotonin syndrome
  • Tricyclic Antidepressants (TCAs) - theoretical risk of serotonin syndrome

Monitoring

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Baseline Monitoring

Cardiovascular assessment (history of ischemic heart disease, uncontrolled hypertension, cerebrovascular disease)

Rationale: To identify patients at risk for serious cardiovascular events, as sumatriptan can cause coronary vasospasm.

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

Blood pressure

Rationale: Sumatriptan can cause transient increases in blood pressure.

Timing: Prior to initiating therapy.

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Routine Monitoring

Blood pressure

Frequency: Periodically, especially if hypertension is a concern.

Target: Individualized based on patient's health status.

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

ECG (Electrocardiogram)

Frequency: As clinically indicated, especially in patients with cardiovascular risk factors or symptoms.

Target: Normal sinus rhythm, no ischemic changes.

Action Threshold: Signs of ischemia or arrhythmia; discontinue sumatriptan and investigate.

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Symptom Monitoring

  • Chest pain, tightness, or pressure (can be cardiac or non-cardiac)
  • Shortness of breath
  • Jaw or neck pain
  • Numbness or tingling
  • Weakness on one side of the body
  • Vision changes
  • Severe headache (worsening or new symptoms)
  • 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

Category C. 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 at high doses.

Trimester-Specific Risks:

First Trimester: Limited data, no clear evidence of increased risk of major birth defects.
Second Trimester: Limited data.
Third Trimester: Limited data. Theoretical risk of uterine contractions or fetal vascular effects, but not well-established clinically.
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Lactation

Sumatriptan is excreted into breast milk. The American Academy of Pediatrics considers sumatriptan to be compatible with breastfeeding. To minimize infant exposure, mothers may consider pumping and discarding breast milk for 12 hours after a dose.

Infant Risk: Low risk of adverse effects in breastfed infants. Monitor for drowsiness or feeding difficulties.
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Pediatric Use

Safety and effectiveness in pediatric patients (under 18 years of age) for acute treatment of migraine or cluster headache have not been established. Not recommended for this population.

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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 decreased renal function. Consider lower initial doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Sumatriptan injection is intended for acute treatment of migraine or cluster headache, not for prevention.
  • Do not use if there is a history of ischemic heart disease, uncontrolled hypertension, hemiplegic or basilar migraine, or severe hepatic impairment.
  • Patients should be instructed on proper self-injection technique.
  • Advise patients to administer the dose as soon as migraine or cluster headache symptoms appear, but it can be effective at any stage of the attack.
  • Risk of medication overuse headache (MOH) with frequent use. Limit use to no more than 10 days per month.
  • Transient symptoms such as chest pain, tightness, or pressure, flushing, tingling, and dizziness are common after administration and are usually not cardiac in origin, but patients should be advised to report any concerning symptoms.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan) - oral, nasal spray, or ODT formulations.
  • CGRP receptor antagonists (e.g., ubrogepant, rimegepant) - oral.
  • NSAIDs (e.g., ibuprofen, naproxen, diclofenac) - oral.
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) - nasal spray, injection, oral.
  • Anti-emetics (e.g., metoclopramide, prochlorperazine) - often used adjunctively for nausea/vomiting.
  • Oxygen (for cluster headache).
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 6mg/0.5ml syringe per 6mg/0.5ml pre-filled syringe
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 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 happened.