Imitrex 6mg/0.5ml Vial For Inj

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; Cluster headache agent
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Pharmacologic Class
Selective Serotonin (5-HT1B/1D) Receptor Agonist
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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 reducing pain signals. It is not meant to prevent headaches, but to treat them once they have started.
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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, and 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.

Administering the Injection

This medication is given 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, and if you have any questions, consult your doctor or pharmacist. Identify the correct injection site, and if you are unsure, consult your doctor.

Precautions and Handling

Wash your hands before and after using this 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, and 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

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

  • Identify and avoid migraine triggers (e.g., certain foods, stress, lack of sleep).
  • Maintain a regular sleep schedule.
  • Manage stress through relaxation techniques.
  • Limit caffeine and alcohol intake.
  • Stay hydrated.

Dosing & Administration

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Adult Dosing

Standard Dose: 6 mg subcutaneously (SC) at the onset of migraine or cluster headache. May repeat once after 1 hour if needed.
Dose Range: 6 - 12 mg

Condition-Specific Dosing:

migraine: 6 mg SC, may repeat once after 1 hour (max 12 mg/24 hours)
cluster_headache: 6 mg SC, may repeat once after 1 hour (max 12 mg/24 hours)
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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 specific dose adjustment recommended
Moderate: No specific dose adjustment recommended
Severe: No specific dose adjustment recommended
Dialysis: Not specifically studied, but sumatriptan is primarily metabolized by MAO-A, not significantly renally cleared as unchanged drug. Use with caution.

Hepatic Impairment:

Mild: No specific dose adjustment recommended
Moderate: Use with caution; consider lower doses. Sumatriptan clearance may be reduced.
Severe: Contraindicated or use with extreme caution; significant reduction in clearance expected. Avoid if possible.

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 effects by causing vasoconstriction of intracranial blood vessels, particularly those 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 applicable for injection

Distribution:

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

Elimination:

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

OnsetOfAction: Approximately 10-15 minutes (subcutaneous)
PeakEffect: Approximately 1 hour
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, 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 vision
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 problems, including:
+ Diarrhea
+ Constipation
+ Severe stomach pain
+ Bloody diarrhea
Other symptoms, such as:
+ Belly pain after meals
+ Fever
+ Weight loss
+ Leg cramps or 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 Condition

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 vision

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're bothered by any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach or 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 pressure in the chest, jaw, or neck (could indicate heart problems)
  • Shortness of breath
  • Sudden weakness or numbness on one side of the body, or sudden vision changes (could indicate stroke)
  • Severe stomach pain or bloody diarrhea (could indicate ischemic colitis)
  • Signs of serotonin syndrome: agitation, hallucinations, rapid heart rate, fever, sweating, muscle stiffness or twitching, loss of coordination, nausea, vomiting, diarrhea (especially if taking antidepressants)
  • Severe allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
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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 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.
Concurrent use of another medication containing the same active ingredient.
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. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify the dose of any medication without consulting your doctor.
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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. This will help ensure your safety and prevent any 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 alertness. This will help prevent accidents and ensure your safety.

Monitoring Blood Pressure
High blood pressure is a possible side effect of this medication. Follow your doctor's instructions for regular blood pressure checks to monitor your condition.

Important Note on Migraine Treatment
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.

Correct Dosage and Usage
Taking more of this medication than prescribed by your doctor can worsen your headaches. Use this medication only as directed, and do not exceed the recommended dose or frequency.

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, or being a male over 40 years old or a female after menopause, exercise caution when taking this medication. Discuss your risks with your doctor.

Rare but Serious Heart Problems
In rare cases, 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 or irregular 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
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor.

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 for your child. If your child has been prescribed this medication, ask your doctor 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 extremities
  • Reduced respiration
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Paralysis

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) (concurrent use or within 2 weeks of discontinuing MAOI)
  • Ergot-type drugs (e.g., ergotamine, dihydroergotamine) (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) (increased risk of serotonin syndrome)
  • Other triptans (increased risk of vasoconstrictive reactions)
  • Ergot alkaloids (increased risk of prolonged vasospastic reactions)
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Moderate Interactions

  • St. John's Wort (potential for serotonin syndrome)
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Confidence Interactions

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment

Rationale: To identify patients with underlying cardiovascular disease (e.g., ischemic heart disease, uncontrolled hypertension, cerebrovascular disease) for whom sumatriptan is contraindicated or requires extreme caution.

Timing: Prior to initiating therapy

Blood pressure

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

Timing: Prior to initiating therapy

Liver function tests (LFTs)

Rationale: Sumatriptan is metabolized hepatically; assess baseline function, especially if hepatic impairment is suspected.

Timing: Prior to initiating therapy (if clinically indicated)

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Routine Monitoring

Headache frequency and severity

Frequency: Each visit or as needed

Target: Reduction in headache burden

Action Threshold: Lack of efficacy, increasing frequency, or development of medication overuse headache

Blood pressure

Frequency: Periodically, especially in patients with risk factors for hypertension

Target: Within normal limits

Action Threshold: Significant or sustained elevation

Signs/symptoms of serotonin syndrome

Frequency: With concurrent use of SSRIs/SNRIs or other serotonergic drugs

Target: Absence of symptoms

Action Threshold: Development of agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, nausea, vomiting, diarrhea

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Symptom Monitoring

  • Chest pain
  • Jaw or neck tightness/pressure
  • Shortness of breath
  • Palpitations
  • Numbness or tingling
  • Weakness on one side of the body
  • Vision changes
  • Severe abdominal pain
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Signs of serotonin syndrome (agitation, confusion, rapid heart rate, fever, sweating, muscle rigidity, tremors, twitching, 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 are available.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a possible, though small, increased risk of certain birth defects (e.g., pyloric stenosis, cardiovascular defects). Data are conflicting and not conclusive.
Second Trimester: Limited data, generally considered low risk based on available information.
Third Trimester: Limited data, generally considered low risk based on available information.
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Lactation

Sumatriptan is excreted into breast milk. Infant exposure is low. The American Academy of Pediatrics considers sumatriptan compatible with breastfeeding. To minimize infant exposure, consider pumping and discarding milk for 12-24 hours after a dose.

Infant Risk: Low risk (L3 - Moderately Safe)
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Pediatric Use

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

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Geriatric Use

Use with caution in elderly patients (â‰Ĩ65 years) due to a higher likelihood of underlying cardiovascular disease and potential for decreased renal or hepatic function. Consider starting with lower doses and monitor closely.

Clinical Information

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Clinical Pearls

  • Sumatriptan injection is for acute treatment of migraine or cluster headache, not for prevention.
  • Administer at the first sign of a migraine attack or cluster headache, but it can be effective even if taken later during the attack.
  • Do not use if there is a history of ischemic heart disease, uncontrolled hypertension, or cerebrovascular disease.
  • Patients should be advised about the potential for medication overuse headache if sumatriptan is used too frequently (e.g., >10 days/month).
  • Injection site reactions (pain, redness, swelling) are common but usually mild and transient.
  • Patients should be instructed on proper subcutaneous injection technique.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan, almotriptan)
  • CGRP receptor antagonists (e.g., ubrogepant, rimegepant, zavegepant)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Antiemetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine) (less commonly used due to side effects)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and formulation (e.g., pre-filled syringe vs. vial) per 6mg/0.5ml vial
Generic Available: Yes
Insurance Coverage: Typically Tier 2 or Tier 3, may require prior authorization depending on insurance plan.
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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 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. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.