Ergotamine Tartrate/caffeine Tabs

Ergotamine is an alpha-adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. It is also a partial agonist/antagonist at serotonergic (5-HT1B/1D) and dopaminergic receptors. These actions lead to vasoconstriction, particularly of dilated cranial blood vessels, which is thought to be the primary mechanism for its antimigraine effect. Caffeine is a CNS stimulant that enhances the absorption of ergotamine and has intrinsic analgesic properties, possibly by blocking adenosine receptors.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Chest pain or pressure
Slow heartbeat
Swelling
Dizziness or fainting
Muscle pain or weakness
Changes in skin color, such as pale, blue, gray, purple, or red hands, feet, or other areas
Numbness, pain, tingling, or cold feeling in the hands or feet
Sores or wounds on the fingers or toes
Pain in the calf, thigh, or buttock that worsens with activity and improves with rest
Heart valve problems, which can cause:
+ Fast or abnormal heartbeat
+ Shortness of breath
+ Swelling in the arms or legs
+ Sudden weight gain

Other Possible 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 discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

* Upset stomach or vomiting

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. 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. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Blood vessel disease
+ Heart disease
+ High blood pressure
+ Kidney disease
+ Liver disease
+ Severe infections
If you have taken any of the following medications in the last 24 hours:
+ Almotriptan
+ Eletriptan
+ Frovatriptan
+ Naratriptan
+ Rizatriptan
+ Sumatriptan
+ Zolmitriptan
If you are pregnant or think you might be pregnant. Note that this medication is not recommended during pregnancy.
* If you are breastfeeding or plan to breastfeed.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.

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.

If you consume grapefruit juice or eat grapefruit regularly, discuss this with your doctor, as it may interact with the medication.

Safe Use Guidelines

This medication is not intended for daily, routine use. Consult with your doctor to discuss the appropriate usage.

To minimize the risk of severe side effects, adhere to the following guidelines:

Do not exceed the dosage prescribed by your doctor.
Do not use the medication more frequently or for a longer duration than recommended.
* Deviating from these guidelines may increase the risk of adverse effects.

Special Precautions

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 these factors with your doctor.

Interactions with Other Substances

Limit your consumption of caffeine-containing products (e.g., tea, coffee, cola) and chocolate, as combining them with this medication may cause nervousness, shakiness, and a rapid heartbeat.

Allergy Warning

If you are allergic to tartrazine (FD&C Yellow No. 5), a component found in some products, consult with your doctor.

Pregnancy and Breastfeeding

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately.

Pediatric Use

This medication is not approved for use in children. However, your doctor may determine that the benefits of using this medication outweigh the risks for your child. If your child has been prescribed this medication, ask your doctor about the potential benefits and risks, and discuss any concerns you may have.

• Potent CYP3A4 inhibitors (e.g., protease inhibitors like ritonavir, nelfinavir, indinavir; macrolide antibiotics like erythromycin, clarithromycin, troleandomycin; azole antifungals like ketoconazole, itraconazole, voriconazole)
• Other vasoconstrictors (e.g., sumatriptan, zolmitriptan, other triptans, other ergot alkaloids, dopamine, epinephrine, norepinephrine)
• Beta-blockers (non-selective)

• Nitrates (may reduce anti-anginal effect)
• SSRIs/SNRIs (potential for serotonin syndrome, though less common with ergotamines)
• Cimetidine (increases caffeine levels)
• Disulfiram (increases caffeine levels)

• Oral contraceptives (may increase caffeine levels)
• Fluoroquinolones (e.g., ciprofloxacin, enoxacin - increase caffeine levels)
• Theophylline (additive CNS stimulation)
• Alcohol (may exacerbate GI side effects)

• Smoking (induces CYP1A2, decreases caffeine levels)
• Grapefruit juice (weak CYP3A4 inhibitor, avoid large quantities)

• Numbness or tingling in fingers and toes
• Pain in arms, legs, or lower back
• Muscle weakness
• Cold or pale hands and feet
• Chest pain
• Bradycardia or tachycardia
• Nausea, vomiting (beyond migraine symptoms)
• Diarrhea
• Localized edema
• Itching
• Headache (medication overuse headache)

Contraindicated in pregnancy (Category X). Ergotamine has oxytocic effects and can cause uterine contractions, potentially leading to fetal harm or abortion. It also causes vasoconstriction, which could compromise placental blood flow.

Contraindicated during lactation (L5). Ergotamine is excreted in breast milk and can cause ergotism (vomiting, diarrhea, convulsions, unstable blood pressure) in the nursing infant. It can also suppress lactation.

Not recommended for pediatric patients due to lack of established safety and efficacy, and potential for serious adverse effects.

Use with caution in elderly patients due to increased risk of peripheral vascular disease, coronary artery disease, and hypertension. Lower doses and careful monitoring for signs of ergotism are advised. Contraindicated in patients with severe cardiovascular disease.

• Ergotamine/caffeine is an abortive medication for acute migraine or cluster headaches, not for prophylaxis.
• Strict adherence to dosing limits (max 6 tablets/attack, 10 tablets/week) is crucial to prevent ergotism and medication overuse headache.
• Patients should be thoroughly educated on the signs and symptoms of ergotism and instructed to seek immediate medical attention if they occur.
• Concomitant use with potent CYP3A4 inhibitors is absolutely contraindicated due to the risk of severe, life-threatening vasospasm.
• Consider alternative treatments (e.g., triptans) for patients with cardiovascular risk factors or those on interacting medications.
• Medication overuse headache (MOH) is a significant risk with frequent use; patients should be advised to limit use and seek medical advice if headaches become more frequent or severe.

• Triptans (e.g., sumatriptan, zolmitriptan, rizatriptan, eletriptan, frovatriptan, naratriptan)
• CGRP receptor antagonists (e.g., rimegepant, ubrogepant)
• Ditans (e.g., lasmiditan)
• NSAIDs (e.g., ibuprofen, naproxen, diclofenac)
• Acetaminophen
• Anti-emetics (e.g., metoclopramide, prochlorperazine) often used adjunctively
• Opioids (generally not recommended for migraine due to abuse potential and lack of efficacy)

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 this 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.