Sumatriptan 100mg Tablets

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 (e.g., substance P, calcitonin gene-related peptide) from trigeminal nerve endings.

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 immediate medical attention:

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
Rarely, allergic reactions can be fatal.
Signs of high blood pressure, including:
+ Severe headache or 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, appearing 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 notice any of the following symptoms, contact your doctor right away:

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

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.

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 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.
Recent use of other medications for migraines, including:
+ 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 before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.

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 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 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

Age-Related Considerations

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. Your doctor will discuss the benefits and risks of this medication with you.

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 questions or concerns you may have.

• Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs
• Ergotamine-containing medications or ergot-type drugs (e.g., dihydroergotamine) or within 24 hours of sumatriptan
• Other 5-HT1 agonists (triptans) or within 24 hours of sumatriptan
• Severe hepatic impairment
• Ischemic heart disease (angina pectoris, history of myocardial infarction, documented silent ischemia)
• Coronary artery vasospasm (Prinzmetal's angina)
• Uncontrolled hypertension
• Hemiplegic or basilar migraine
• History of stroke or transient ischemic attack (TIA)
• Peripheral vascular disease

• Selective Serotonin Reuptake Inhibitors (SSRIs) - risk of serotonin syndrome
• Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) - risk of serotonin syndrome

• St. John's Wort - theoretical risk of serotonin syndrome
• Cimetidine - may increase sumatriptan levels (minor effect)

• Chest pain or tightness (may indicate cardiac ischemia or vasospasm)
• Neck pain or tightness
• Jaw pain or tightness
• Tingling or numbness
• Dizziness or vertigo
• Flushing
• Serotonin syndrome symptoms (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, coordination problems, nausea, vomiting, diarrhea)
• Vision changes
• Weakness or numbness on one side of the body (stroke symptoms)

Category C. Use 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.

L3 (Moderately Safe). Sumatriptan is excreted into breast milk. Infant exposure is low. Consider waiting 8-12 hours after a dose before breastfeeding to minimize infant exposure.

Safety and efficacy have not been established for oral sumatriptan in pediatric patients under 18 years of age. Use is generally not recommended.

Use with caution in elderly patients (over 65 years) due to a higher likelihood of cardiovascular disease and decreased renal/hepatic function. Consider lower initial doses and monitor closely for adverse effects, especially cardiovascular events.

• Sumatriptan is for acute migraine treatment, not prevention.
• It should be taken at the first sign of a migraine attack, but not during the aura phase if no headache follows.
• Patients should be screened for cardiovascular risk factors before starting sumatriptan.
• Warn patients about potential 'triptan sensations' (e.g., chest tightness, neck pain, tingling) which are usually transient and not cardiac in origin, but require medical evaluation if severe or persistent.
• Avoid concomitant use with MAOIs, ergotamines, or other triptans.
• Counsel patients on the risk of serotonin syndrome when used with SSRIs/SNRIs.
• Medication overuse headache (MOH) can occur with frequent use (e.g., >10 days/month).

• Other triptans (e.g., Zolmitriptan, Rizatriptan, Eletriptan, Frovatriptan, Naratriptan, Almotriptan)
• CGRP receptor antagonists (gepants like Ubrogepant, Rimegepant)
• 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

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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.