Sumatriptan 25mg Tablets

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B and 5-HT1D) 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.

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 has been associated with 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

As with any medication, you may experience side effects. While many people have no side effects or only minor ones, it's essential to contact your doctor if you experience 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 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.
Current use of another medication that contains the same active ingredient as this drug.
Recent use of other triptan medications, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, or zolmitriptan, within the last 24 hours.
* Recent use of 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, or being a male over 40 years old or a postmenopausal female, exercise caution and discuss your risks with your doctor.

Cardiovascular Risks

Rare but severe and potentially life-threatening heart problems, including heart attack and abnormal heartbeat, have occurred within a few hours of taking this 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, 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 outweigh the risks. If your child has been prescribed this medication, consult your doctor about the benefits and risks, and ask any questions you may have.

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

• Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin Norepinephrine Reuptake Inhibitors (SNRIs): Increased risk of serotonin syndrome (monitor closely)
• St. John's Wort: Increased risk of serotonin syndrome

• Propranolol: May increase sumatriptan exposure (clinical significance generally minor, but monitor)
• Cimetidine: May increase sumatriptan exposure (clinical significance generally minor, but monitor)

• Chest pain, tightness, or pressure (may radiate to jaw or arm)
• Shortness of breath
• Throat or neck tightness
• Tingling, numbness, or paresthesia
• Dizziness or vertigo
• Weakness or fatigue
• Serotonin syndrome symptoms (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, loss of coordination, nausea, vomiting, diarrhea)
• Vision changes
• Severe abdominal pain or bloody diarrhea (ischemic colitis)

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Limited human data are available. Animal studies have shown some developmental toxicity at high doses.

Sumatriptan is excreted into breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Advise mothers to pump and discard breast milk for 12 hours after sumatriptan administration to minimize infant exposure.

Not recommended for children under 12 years of age due to lack of established safety and efficacy. For adolescents (12-17 years), use with caution; some formulations (e.g., nasal spray) have specific pediatric indications, but oral tablets are generally not first-line for this age group.

Use with caution in elderly patients (over 65 years) due to a potentially greater likelihood of cardiovascular disease and reduced hepatic function. Consider a lower starting dose (e.g., 25 mg) and monitor closely for adverse effects.

• Sumatriptan is for acute treatment of migraine attacks, not for prevention.
• Take at the first sign of migraine headache, but not during the aura phase if no headache is present.
• Do not use if there is any suspicion of underlying cardiovascular disease without prior cardiovascular evaluation.
• Patients should be advised to report any chest pain, shortness of breath, or other symptoms suggestive of cardiac ischemia immediately.
• Risk of medication overuse headache (MOH) if used too frequently (e.g., 10 or more days per month).

• Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan)
• CGRP receptor antagonists (gepants like ubrogepant, rimegepant)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine - generally less preferred due to side effects)
• Anti-emetics (e.g., metoclopramide, prochlorperazine) for associated nausea/vomiting

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 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 happened.