Imitrex 4mg Statdose Refills

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 (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 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. This applies even if you used a different form of the 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 the medication. If you have any questions, consult your doctor or pharmacist.

Preparation and Administration

Before administering the injection, wash your hands thoroughly. Choose the correct injection site, and if you are unsure, consult your doctor.

Important Safety Precautions

Do not use the medication if the solution is cloudy, leaking, or contains particles. Also, do not use the medication if the solution has changed color.

Disposing of Used Needles and Supplies

After use, dispose of the needle in a sharps disposal container. Do not reuse needles or other supplies. When the container 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, away from refrigeration and 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 activities requiring mental alertness until you know how the medication affects you, as it can cause dizziness or drowsiness.
  • Inform your doctor about all other medications you are taking, especially antidepressants, other migraine medications, or herbal supplements like St. John's Wort.
  • Do not use if you have certain heart conditions, uncontrolled high blood pressure, or severe liver disease.

Dosing & Administration

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Adult Dosing

Standard Dose: 6 mg subcutaneously (SC) as a single dose. A 4 mg SC dose may be used for patients who do not tolerate 6 mg.
Dose Range: 4 - 6 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Safety and efficacy not established for 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, but sumatriptan is not significantly removed by dialysis.

Hepatic Impairment:

Mild: No dosage adjustment necessary.
Moderate: Use with caution. Consider lower doses (e.g., 3 mg SC).
Severe: Contraindicated 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-HT1) receptors, specifically 5-HT1B and 5-HT1D subtypes. It is believed to exert its antimigraine effects by causing vasoconstriction of intracranial blood vessels (which are dilated during a migraine attack), inhibiting the release of pro-inflammatory neuropeptides from trigeminal nerve endings, and interrupting pain signal transmission in the trigeminal system.
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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 (total plasma clearance)
ExcretionRoute: Renal (approximately 60% as inactive metabolite, 3% as unchanged drug), fecal (approximately 40% as inactive metabolite).
Unchanged: 3% (renal)
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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, 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

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 or pressure, especially if it spreads to your jaw or arm (could be heart attack)
  • Shortness of breath
  • Sudden weakness or numbness on one side of the body, slurred speech, or sudden vision changes (signs of stroke)
  • Severe stomach pain, bloody diarrhea (ischemic colitis)
  • Confusion, agitation, hallucinations, rapid heart rate, fever, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea (signs of serotonin syndrome)
  • 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.
* Use of ergotamine, methysergide, dihydroergotamine, or similar medications within the last 24 hours.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. Ensure that it is safe to take this medication with your existing medications and health conditions. Do not initiate, stop, or modify 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 potential interactions with other treatments.

Precautions and Warnings

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
Regular blood pressure checks are crucial, as this medication can cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure.
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.
Taking more of this medication than prescribed (higher dose, more frequent) may worsen your headaches. Use caution if you have risk factors for heart disease, such as:
+ High blood pressure
+ High cholesterol
+ Overweight
+ High blood sugar or diabetes
+ Cigarette smoking
+ Male older than 40 years of age
+ Family history of early heart disease
+ Female after menopause
Discuss these risks with your doctor.

Serious Heart-Related Risks

Rarely, this medication can cause severe and potentially life-threatening heart problems, such as heart attack and abnormal heartbeat, within a few hours of taking it. Seek immediate medical attention if you experience:
+ Chest, throat, neck, or jaw tightness, pain, pressure, or heaviness
+ Cold sweat
+ Shortness of breath
+ Rapid heartbeat
+ Abnormal 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.
* This medication is not approved for use in children. However, your doctor may decide that the benefits outweigh the risks. If your child is prescribed this medication, ask your doctor about the potential 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 respiratory rate
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Paralysis

What to Do:

Seek immediate medical attention or call 911. Contact a poison control center (1-800-222-1222). General supportive measures are recommended. Monitor cardiac and respiratory function for at least 24 hours.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs
  • Ergotamine-containing medications or ergot-type drugs (e.g., dihydroergotamine) within 24 hours
  • Other 5-HT1 agonists (e.g., other triptans) 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) (risk of serotonin syndrome)
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Moderate Interactions

  • Propranolol (may increase sumatriptan exposure, but generally not clinically significant)
  • Alcohol (may exacerbate headache or side effects)
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Minor Interactions

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

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment (e.g., ECG, blood pressure, medical history)

Rationale: To identify underlying cardiovascular disease, which is a contraindication or requires caution due to risk of vasospasm.

Timing: Prior to initiation of therapy, especially in patients with risk factors for CAD.

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Routine Monitoring

Blood pressure

Frequency: Periodically, especially if hypertension is a concern or develops.

Target: Normal limits

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

Headache frequency and severity

Frequency: Ongoing, with each use

Target: Reduction in headache symptoms

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

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Symptom Monitoring

  • Chest pain or tightness (especially if radiating to arm/jaw)
  • Shortness of breath
  • Palpitations
  • Dizziness or vertigo
  • Numbness or tingling
  • Weakness on one side of the body
  • Vision changes
  • Severe abdominal pain
  • Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, overactive reflexes, 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, but animal studies show some developmental toxicity at high doses.

Trimester-Specific Risks:

First Trimester: Limited human data, no clear signal of increased risk of major birth defects.
Second Trimester: Limited data, generally considered low risk.
Third Trimester: Limited data, generally considered low risk. Theoretical risk of premature labor or fetal distress due to vasoconstrictive effects, but not well-established.
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Lactation

Sumatriptan is excreted into breast milk. The amount ingested by the infant is small. Consider avoiding breastfeeding for 12 hours after a dose to minimize infant exposure.

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

Safety and efficacy not established in patients under 18 years of age. Not recommended for pediatric use.

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Geriatric Use

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

Clinical Information

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Clinical Pearls

  • Sumatriptan injection is often preferred for rapid relief of severe migraine or cluster headache due to its fast onset of action.
  • Patients should be instructed on proper self-injection technique.
  • Do not use sumatriptan for prevention of migraine or cluster headache; it is for acute treatment only.
  • Warn patients about the potential for 'triptan sensations' (e.g., chest pressure, tightness, tingling, flushing) which are usually transient and not indicative of cardiac ischemia, but require evaluation if severe or persistent.
  • Educate patients on the risk of medication overuse headache if used too frequently (e.g., more than 10 days per month).
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan) in various formulations (oral, nasal spray, ODT)
  • CGRP receptor antagonists (gepants like rimegepant, ubrogepant)
  • Serotonin 5-HT1F receptor agonists (ditans like lasmiditan)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting
  • Opioids (generally discouraged for migraine due to abuse potential and lack of specific efficacy)
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Cost & Coverage

Average Cost: Varies widely by pharmacy and specific refill pack size (e.g., 2-pack, 4-pack). Typically ranges from $100 - $300+. per 2-pack or 4-pack of 4mg/6mg pre-filled syringes/autoinjectors
Generic Available: Yes
Insurance Coverage: Often Tier 2 or Tier 3, may require prior authorization or step therapy for brand-name.
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.