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Sumatriptan 4mg/0.5 Inj, 0.5ml

Manufacturer PRASCO LABORATORIES 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
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 headache pain and other symptoms like nausea and sensitivity to light and sound.
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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 instructed 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.

This medication is administered via injection under the skin as soon as possible after the onset of the attack. Before using this medication, make sure you understand how to administer it correctly. Read the package insert and instructions for use that come with this medication. If you have any questions, 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 appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.

After use, dispose of needles and other sharp objects 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.

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 recommended by your doctor.
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Lifestyle & Tips

  • Administer the injection as soon as migraine or cluster headache symptoms begin, but not before the headache starts (for prevention).
  • Do not use for more headaches than prescribed. Overuse can lead to medication overuse headache.
  • Avoid driving or operating machinery until you know how sumatriptan affects you, as it can cause dizziness or drowsiness.
  • Avoid alcohol during a migraine attack as it can worsen symptoms or interact with medications.
  • Maintain a regular sleep schedule, manage stress, and identify/avoid migraine triggers (e.g., certain foods, strong smells, bright lights).
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Available Forms & Alternatives

Available Strengths:

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: 6 mg SC. If partial response or recurrence, a second 6 mg dose may be given after 1 hour. Max 12 mg in 24 hours.
cluster_headache: 6 mg SC. Max 12 mg in 24 hours. (Note: Sumatriptan injection is indicated for acute treatment of cluster headache episodes.)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established for migraine in patients under 18 years of age. Not recommended for cluster headache in pediatric patients.)
Adolescent: Not established (Safety and efficacy not established for migraine in patients under 18 years of age.)
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment generally needed.
Moderate: No dose adjustment generally needed.
Severe: No dose adjustment generally needed, but use with caution due to potential for accumulation of metabolites.
Dialysis: Not specifically studied, but unlikely to be significantly removed by dialysis due to high protein binding and metabolism.

Hepatic Impairment:

Mild: No dose adjustment generally needed.
Moderate: Use with caution. Consider lower doses (e.g., 3 mg SC) and monitor for adverse effects.
Severe: Contraindicated in severe hepatic impairment due to reduced clearance and increased plasma concentrations.

Pharmacology

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Mechanism of Action

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

Absorption:

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

Distribution:

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

Elimination:

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

OnsetOfAction: Approximately 10-15 minutes (subcutaneous)
PeakEffect: Approximately 1 hour
DurationOfAction: Up to 24 hours (for migraine relief, though half-life is shorter, clinical effect can persist)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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 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 problems, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Leg cramps and pain
+ 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 or 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 have any concerns. Common side effects include:

Dizziness
 Drowsiness
Fatigue
 Weakness
Flushing
 Feeling of warmth
Upset stomach or vomiting
 Irritation at the injection site

If you experience any side effects that bother you or do not go away, contact your doctor for advice. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Sudden or severe chest pain, jaw pain, or neck tightness (especially if new or worsening)
  • Shortness of breath
  • Weakness or numbness on one side of the body
  • Sudden severe headache (different from usual migraine)
  • Vision changes
  • Signs of an allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Symptoms of serotonin syndrome (agitation, confusion, rapid heart rate, fever, muscle stiffness, sweating, diarrhea)
  • Coldness, numbness, or pain in fingers or toes
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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 the following health problems:
+ Chest pain or pressure
+ Diseased arteries in the legs or arms
+ Heart attack
+ Heart disease
+ Poor blood flow in the heart, brain, bowel, or kidney
+ Stroke or transient ischemic attack (TIA)
+ Certain types of migraines, such as hemiplegic or basilar migraines
+ Abnormal heart rhythms, like Wolff-Parkinson-White syndrome
 Recent use of certain antidepressant medications, such as isocarboxazid, phenelzine, or tranylcypromine, within the last 14 days. Taking this medication within 14 days of these drugs can cause severe high blood pressure.
Concurrent use of another medication containing the same active ingredient.
 Use of other medications for migraines, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, within the last 24 hours.
* Use of ergotamine, methysergide, dihydroergotamine, or similar medications within the last 24 hours.

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

Precautions and Safety Measures

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
 Regularly monitor your blood pressure as advised by your doctor, as 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 unusual or 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 risks 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 taking it. Seek immediate medical attention if you experience symptoms such as:
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweats
+ Shortness of breath
+ Rapid or irregular heartbeat
+ Severe dizziness or fainting
If you have a latex allergy, inform your doctor, as some products may contain latex.

Age-Related Considerations

 If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
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, consult your doctor about the potential benefits and risks.

Pregnancy and Breastfeeding

 Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

There is no specific antidote for sumatriptan overdose. Treatment should be symptomatic and supportive. Monitor patients for at least 12 hours or while symptoms persist. Call 1-800-222-1222 (Poison Control Center) immediately for advice.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI (risk of serotonin syndrome)
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine) or within 24 hours of sumatriptan (risk of prolonged vasospastic reactions)
  • Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan (risk of prolonged vasospastic reactions and additive serotonergic effects)
  • Severe hepatic impairment
  • Ischemic heart disease (e.g., angina pectoris, history of myocardial infarction, documented silent ischemia)
  • Coronary artery vasospasm (Prinzmetal's angina)
  • Wolff-Parkinson-White Syndrome or other cardiac accessory conduction pathway disorders
  • History of stroke or transient ischemic attack (TIA)
  • Peripheral vascular disease
  • Uncontrolled hypertension
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs): Increased risk of serotonin syndrome. Monitor patients.
  • St. John's Wort: Potential for increased risk of serotonin syndrome.
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Moderate Interactions

  • Cimetidine: May increase sumatriptan exposure (minor clinical significance for injection).
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Confidence Interactions

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment

Rationale: To identify patients with underlying cardiovascular disease or risk factors for whom sumatriptan is contraindicated or requires careful consideration.

Timing: Prior to initiating therapy.

Blood pressure

Rationale: To ensure hypertension is controlled, as sumatriptan is contraindicated in uncontrolled hypertension.

Timing: Prior to initiating therapy.

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Routine Monitoring

Blood pressure

Frequency: Periodically, especially in patients with controlled hypertension.

Target: Individualized, typically <130/80 mmHg

Action Threshold: Significant increase or uncontrolled hypertension; consider discontinuation or alternative.

Symptoms of serotonin syndrome

Frequency: Ongoing, especially if co-administered with SSRIs/SNRIs.

Target: Absence of symptoms

Action Threshold: Agitation, hallucinations, rapid heart rate, fever, overactive reflexes, nausea, vomiting, diarrhea; discontinue sumatriptan and supportive care.

Symptoms of vasospasm/ischemia

Frequency: Ongoing

Target: Absence of symptoms

Action Threshold: Chest pain, tightness, jaw/neck pain, shortness of breath, abdominal pain, peripheral ischemia (cold, numb extremities); discontinue and evaluate.

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Symptom Monitoring

  • Chest pain or tightness (can be non-cardiac, but requires evaluation)
  • Jaw or neck pain/tightness
  • Shortness of breath
  • Abdominal pain
  • Numbness, tingling, or flushing sensation
  • Dizziness or vertigo
  • Weakness
  • Vision changes
  • Symptoms of serotonin syndrome (agitation, confusion, rapid heart rate, fever, muscle rigidity, sweating, diarrhea)
  • Symptoms of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)

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 human data, animal studies show some risk at high doses. Use only if clearly needed.
Second Trimester: Limited human data, animal studies show some risk at high doses. Use only if clearly needed.
Third Trimester: Limited human data, animal studies show some risk at high doses. Use only if clearly needed. Potential for vasoconstrictive effects on the fetus or uterus.
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Lactation

Sumatriptan is excreted into human breast milk. Infant exposure is low, but potential for adverse effects exists. Advise mothers to pump and discard breast milk for 12 hours after sumatriptan administration to minimize infant exposure.

Infant Risk: L3 (Moderately safe; some data suggests excretion into milk, but adverse effects in breastfed infants are unlikely with typical doses. Consider discarding milk for 12 hours.)
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Pediatric Use

Safety and efficacy have not been established for the treatment of migraine in pediatric patients under 18 years of age. Not recommended for cluster headache in pediatric patients.

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Geriatric Use

Use with caution in elderly patients (â‰Ĩ65 years) due to a greater likelihood of decreased renal, hepatic, or cardiac function, and of concomitant disease or other drug therapy. Consider lower initial doses and careful monitoring, especially for cardiovascular events.

Clinical Information

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Clinical Pearls

  • Sumatriptan injection is for acute treatment of migraine and cluster headache, not for prevention.
  • Do not administer intravenously due to potential for coronary vasospasm.
  • Ensure proper patient selection by screening for cardiovascular risk factors before prescribing.
  • Patients may experience transient symptoms like chest pressure, jaw tightness, or tingling after injection; these are usually not cardiac in origin but should be evaluated if severe or persistent.
  • Not indicated for hemiplegic or basilar migraine.
  • Instruct patients on proper subcutaneous injection technique if self-administering.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan)
  • CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine - generally less preferred due to side effect profile)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Anti-emetics (e.g., metoclopramide, prochlorperazine - often used as adjuncts)
  • Opioids (generally discouraged for migraine due to risk of medication overuse headache and dependence)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$150 per 4mg/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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.