Sumatriptan 50mg Tablets

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B/1D) 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.

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
Rarely, 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
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Gastrointestinal problems, 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
Throwing up
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
Sleepiness
Tiredness
Weakness
Flushing
Feeling of warmth
Upset stomach
* Throwing up

If you have any 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, including:
+ 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 depression 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.
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 other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.

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.
Regular blood pressure checks are crucial, as this medication can cause high blood pressure. Follow your doctor's instructions for monitoring your 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. 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.

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:
+ 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, plan to become pregnant, or are 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 outweigh the risks. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.

• Monoamine Oxidase Inhibitors (MAOIs) or within 2 weeks of discontinuing MAOIs (risk of increased sumatriptan exposure and serotonin syndrome)
• Ergot-containing 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 additive vasoconstrictor effects)
• Severe hepatic impairment

• Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs) (risk of serotonin syndrome)
• Tricyclic Antidepressants (TCAs) (potential for serotonin syndrome, though less common than with SSRIs/SNRIs)

• St. John's Wort (potential for serotonin syndrome)
• Cimetidine (may increase sumatriptan exposure, though not clinically significant for most patients)

• Chest pain, tightness, or pressure (especially if new or worsening)
• Shortness of breath
• Jaw or neck pain/tightness
• Tingling, numbness, or weakness in extremities
• Abdominal pain, bloody diarrhea (ischemic colitis)
• Vision changes
• Dizziness, lightheadedness
• Signs of serotonin syndrome: mental status changes (agitation, hallucinations, coma), autonomic instability (tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (hyperreflexia, incoordination), gastrointestinal symptoms (nausea, vomiting, diarrhea)
• Signs of medication overuse headache (increasing headache frequency or severity)

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 adverse effects at high doses. Generally, non-pharmacological measures or safer alternatives are preferred if possible.

L2 (Safer). Sumatriptan is excreted into breast milk in small amounts. Infant exposure is low. Monitor the infant for drowsiness, irritability, or poor feeding. Consider waiting 8-12 hours after a dose before breastfeeding to minimize infant exposure.

Not recommended for children under 12 years of age for oral tablets due to lack of established safety and efficacy. For adolescents (12-17 years), oral tablets are generally not recommended, though other formulations (nasal spray, subcutaneous) have specific indications and dosing.

Use with caution in elderly patients (over 65 years) due to a higher likelihood of underlying cardiovascular disease and increased sensitivity to adverse effects. A thorough cardiovascular evaluation is recommended before initiating therapy.

• Sumatriptan is for acute migraine treatment, not prevention. It should be taken at the onset of migraine symptoms.
• Do not use if there is any suspicion of underlying cardiovascular disease, uncontrolled hypertension, or basilar/hemiplegic migraine.
• Counsel patients on the risk of serotonin syndrome, especially if they are also taking SSRIs, SNRIs, or other serotonergic drugs.
• Advise patients to wait at least 24 hours after taking sumatriptan before using ergotamine-containing medications or other triptans, and vice versa.
• Medication overuse headache (MOH) is a significant risk with frequent use; educate patients on limiting use to 2-3 days per week.

• Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Combination analgesics (e.g., Excedrin Migraine)
• CGRP receptor antagonists (e.g., ubrogepant, rimegepant)
• Ditans (e.g., lasmiditan)
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine - generally less preferred due to side effects and interactions)

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.