Sumatriptan 4mg/0.5ml Inj 2x0.5ml

Sumatriptan is a selective agonist for 5-hydroxytryptamine1 (5-HT1B and 5-HT1D) receptors. It is believed to exert its antimigraine effect by causing vasoconstriction of intracranial blood vessels, particularly those of the carotid arterial circulation, and by inhibiting the release of pro-inflammatory neuropeptides from trigeminal nerve endings.

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

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
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
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 has been associated with 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

While many people may not experience any side effects or only minor ones, it's essential to be aware of the following possible side effects:

Dizziness
Drowsiness
Fatigue
Weakness
Flushing
Feeling of warmth
Upset stomach
Vomiting
Irritation at the injection site

If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help.

Reporting Side Effects

If you have questions about side effects or want to report any, you can:

Contact your doctor for medical advice
Call the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website 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.
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 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 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.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and engaging in activities that require you to be alert. This will help prevent accidents and ensure your safety.

Monitoring Blood Pressure
High blood pressure has been reported in patients taking this medication. Follow your doctor's instructions for regular blood pressure checks to monitor your condition.

Important Usage Information
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.

Dosage and Administration
Taking more of this medication than prescribed by your doctor (a higher dose or more frequent doses) may worsen your headaches. Use caution when taking this medication, especially if you have risk factors for heart disease, such as:

High blood pressure
High cholesterol
Overweight or obesity
High blood sugar or diabetes
Cigarette smoking
Male older than 40 years of age
Family history of early heart disease
Female after menopause

Discuss your individual risk factors with your doctor.

Cardiovascular Risks
Rare but serious 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

Latex Allergy
If you have a latex allergy, inform your doctor, as some products may contain latex.

Special Considerations

Older Adults (65 and 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 taking this medication with you.
Children: 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 benefits and risks, and discuss any questions or concerns you may have.

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

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

• Propranolol - may increase sumatriptan exposure (clinical significance generally minor)
• Cimetidine - may increase sumatriptan exposure

• Chest pain or tightness
• Shortness of breath
• Numbness or tingling in extremities
• Flushing or warmth
• Dizziness or vertigo
• Vision changes
• Signs of serotonin syndrome (agitation, hallucinations, rapid heart rate, fever, sweating, muscle rigidity, twitching, coordination loss, nausea, vomiting, diarrhea)
• Signs of allergic reaction (rash, hives, swelling of face/lips/tongue/throat, difficulty breathing)

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.

L3 (Moderately safe). Sumatriptan is excreted into breast milk. The amount ingested by an infant is small. Consider pumping and discarding breast milk for 12 hours after a dose to minimize infant exposure.

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

Use with caution in elderly patients (≥65 years) due to a greater likelihood of underlying cardiovascular disease and increased sensitivity to adverse effects. Consider lower initial doses and careful monitoring.

• Sumatriptan injection is typically used for acute treatment of migraine or cluster headache, especially when rapid onset of action is desired or when oral medications are ineffective or poorly tolerated (e.g., with severe nausea/vomiting).
• Not for the prophylactic treatment of migraine or cluster headache.
• Contraindicated in patients with a history of ischemic heart disease, uncontrolled hypertension, cerebrovascular events, or peripheral vascular disease.
• The first dose should be administered under medical supervision in patients with risk factors for coronary artery disease (e.g., hypertension, hypercholesterolemia, obesity, diabetes, smoking, strong family history of CAD, postmenopausal women, men over 40 years of age).
• Do not use for hemiplegic or basilar migraine.
• Patients should be advised to report any symptoms of chest pain, shortness of breath, or other cardiovascular symptoms immediately.

• Other triptans (e.g., zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan - available in various formulations like oral, nasal spray, ODT)
• CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
• NSAIDs (e.g., ibuprofen, naproxen)
• Acetaminophen
• Ergot alkaloids (e.g., ergotamine, dihydroergotamine - less commonly used due to side effects)
• Antiemetics (e.g., metoclopramide, prochlorperazine - often used adjunctively)
• Opioids (generally discouraged for migraine due to risk of medication overuse headache and dependence)

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.