Imitrex 50mg Tablets

Manufacturer GLAXO SMITH KLINE Active Ingredient Sumatriptan Tablets(soo ma TRIP tan) Pronunciation soo ma TRIP tan
It is used to treat migraine 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
Not available
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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 is a medication used to treat acute migraine headaches. It works by narrowing blood vessels in the brain and affecting certain nerves, which helps to relieve migraine pain and other symptoms like nausea and sensitivity to light and sound. It is not for preventing migraines.
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How to Use This Medicine

Taking Your Medication

To get the most benefit from this medication, follow your doctor's instructions carefully. Read all the information provided and follow the instructions closely. If your headache doesn't 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, even if you used a different form of this medication for the first dose.

Take this medication with or without food. Swallow the tablet whole - do not chew, break, or crush it. Take the medication with a liquid as soon as possible after the headache starts.

Storing and Disposing of Your Medication

Store this medication at room temperature, away from refrigeration and freezing.

Missing a Dose

Since this medication is taken as needed, you don't need to worry about missing a dose. However, do not take this medication more frequently than directed by your doctor.
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Lifestyle & Tips

  • Take sumatriptan as soon as migraine symptoms start, but not before the headache begins (e.g., during aura).
  • Do not use sumatriptan to prevent migraines.
  • Do not take more than the prescribed dose or more than 200 mg in 24 hours.
  • Avoid driving or operating machinery until you know how sumatriptan affects you, as it can cause dizziness or drowsiness.
  • Limit alcohol intake, as it can worsen headaches or interact with the medication.
  • Identify and avoid migraine triggers (e.g., certain foods, stress, lack of sleep).

Dosing & Administration

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Adult Dosing

Standard Dose: 50 mg orally as a single dose. May repeat dose after 2 hours if migraine returns or partially responds. Max 200 mg in 24 hours.
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

migraine: 25 mg, 50 mg, or 100 mg orally at the first sign of migraine attack. If no response to the first dose, a second dose should not be taken for the same attack. If migraine returns or partially responds, a second dose may be taken after 2 hours. Maximum 200 mg in 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 for oral tablets).
Adolescent: Not established (Safety and efficacy not established in patients under 18 years for oral tablets).
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: Consider lower doses (e.g., 50 mg)
Moderate: Use with caution; consider lower doses (e.g., 50 mg).
Severe: Contraindicated due to increased sumatriptan levels.

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 binding to these receptors on intracranial blood vessels, leading to vasoconstriction, and on sensory trigeminal nerves, inhibiting the release of pro-inflammatory neuropeptides (e.g., substance P, calcitonin gene-related peptide). This action helps to reverse the vasodilation and neurogenic inflammation associated with migraine attacks.
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Pharmacokinetics

Absorption:

Bioavailability: 15%
Tmax: 2.5 hours
FoodEffect: Minimal effect on absorption or Cmax.

Distribution:

Vd: 2.4 L/kg
ProteinBinding: 14-21%
CnssPenetration: Limited

Elimination:

HalfLife: 2.5 hours
Clearance: Not available
ExcretionRoute: Renal (60% as metabolite, 3% unchanged), Fecal (40% as metabolite)
Unchanged: 3%
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Pharmacodynamics

OnsetOfAction: Approximately 30 minutes (for oral tablets)
PeakEffect: 2-4 hours
DurationOfAction: Approximately 4-6 hours

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
+ Fainting
+ Changes in eyesight
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 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
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
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 notice any of the following:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach
* Vomiting

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 or severe chest pain, tightness, or pressure (especially if it spreads to your jaw or shoulder)
  • Shortness of breath
  • Sudden numbness or weakness, especially on one side of the body
  • Sudden severe headache (different from your usual migraine)
  • Vision changes
  • Slurred speech
  • Signs of serotonin syndrome: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, diarrhea.
  • Severe stomach pain or bloody diarrhea (rare)
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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 triptan medications, 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. They will help you determine if it is safe to take this medication with your existing health conditions and medications. Do not initiate, stop, or modify 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 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, having a family history of early heart disease, or being a postmenopausal female, exercise caution and discuss your treatment with your doctor.

Serious Heart-Related Risks

Rarely, 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 sweats
+ Shortness of breath
+ Rapid or irregular heartbeat
+ Severe dizziness or fainting

Special Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor.
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 respiratory rate
  • Cyanosis
  • Ataxia
  • Mydriasis
  • Paralysis

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

Drug Interactions

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Contraindicated Interactions

  • Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs (increased sumatriptan exposure)
  • Ergot-type medications (e.g., ergotamine, dihydroergotamine) or within 24 hours of sumatriptan (additive vasospastic effects)
  • Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan (additive vasospastic effects)
  • Severe hepatic impairment
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Major Interactions

  • Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome)
  • St. John's Wort (risk of serotonin syndrome)
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Moderate Interactions

  • Propranolol (may increase sumatriptan exposure, though not clinically significant for most patients)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Cardiovascular risk assessment (history of CAD, uncontrolled hypertension, risk factors for CAD)

Rationale: Sumatriptan can cause coronary vasospasm and other serious cardiovascular events.

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 initiation and periodically during treatment.

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Routine Monitoring

Efficacy of migraine relief

Frequency: With each migraine attack treated

Target: Significant reduction or elimination of migraine symptoms

Action Threshold: Lack of efficacy after appropriate dosing may warrant consideration of alternative treatments.

Adverse effects (e.g., chest tightness, tingling, dizziness, neck pain)

Frequency: With each dose

Target: Absence or tolerability of side effects

Action Threshold: Intolerable or severe adverse effects require discontinuation and medical evaluation.

Frequency of sumatriptan use

Frequency: Periodically (e.g., every 3-6 months)

Target: Not exceeding 10 days of use per month

Action Threshold: Use on 10 or more days per month increases risk of medication overuse headache; consider preventive therapy.

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Symptom Monitoring

  • Chest pain or tightness
  • Shortness of breath
  • Palpitations
  • Severe headache (worsening or new type)
  • Numbness or tingling
  • Weakness on one side of the body
  • Vision changes
  • Confusion
  • Agitation
  • Hallucinations
  • Rapid heart rate
  • Fever
  • Loss of coordination
  • Severe nausea/vomiting

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. 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: Not available
Third Trimester: Not available
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Lactation

Sumatriptan is excreted into breast milk. Infant exposure is low. Consider pumping and discarding breast milk for 12 hours after a dose to minimize infant exposure, especially if the infant is a neonate or has underlying health issues.

Infant Risk: Low risk, but potential for drowsiness or vomiting in the infant.
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Pediatric Use

Oral tablets are not recommended for patients under 18 years of age due to lack of established efficacy and safety. Nasal spray and subcutaneous injection forms have specific pediatric indications for adolescents.

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Geriatric Use

Use with caution in patients over 65 years due to a higher likelihood of underlying cardiovascular disease and increased sensitivity to adverse effects. Consider lower initial doses and careful monitoring.

Clinical Information

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Clinical Pearls

  • Sumatriptan is for acute treatment of migraine, not for prevention.
  • It should be taken at the first sign of migraine symptoms, but not during the aura phase if the headache has not started.
  • Do not use if the headache is atypical or if there are signs of a more serious neurological event (e.g., hemiplegic or basilar migraine).
  • Patients with cardiovascular risk factors should undergo a cardiovascular evaluation before starting sumatriptan.
  • Risk of medication overuse headache (MOH) if used frequently (e.g., 10 or more days per month).
  • Patients should be advised about the potential for serotonin syndrome when co-administered with SSRIs/SNRIs.
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Alternative Therapies

  • Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan)
  • CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
  • Ditans (e.g., lasmiditan)
  • NSAIDs (e.g., ibuprofen, naproxen)
  • Acetaminophen
  • Ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • Anti-emetics (for associated nausea/vomiting)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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.