What is the most important information I should know about caffeine and ergotamine?
This medication can harm an unborn baby or cause birth defects. Do not use if you are pregnant.
You should not use caffeine and ergotamine if you have coronary heart disease, high blood pressure, circulation problems, liver or kidney disease, or a serious infection called sepsis.
Some medicines can cause a dangerous decrease in blood flow when used with caffeine and ergotamine. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects.
Tell your doctor about all medicines you use, and those you start or stop using, especially: atazanavir, boceprevir, clarithromycin, delavirdine, fosamprenavir, imatinib, indinavir, isoniazid, itraconazole, ketoconazole, nefazodone, nelfinavir, nicardipine, posaconazole, quinidine, ritonavir, saquinavir, telaprevir, telithromycin, or voriconazole.
What is caffeine and ergotamine?
Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).
Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.
Caffeine and ergotamine is a combination medicine used to treat or prevent a migraine type headache.
This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.
Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.
Caffeine and ergotamine may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using caffeine and ergotamine ?
You should not use this medicine if you are allergic to caffeine or ergotamine, if you are pregnant, or if you have:
- coronary heart disease;
- high blood pressure;
- blood circulation problems;
- liver disease;
- kidney disease; or
- a serious infection called sepsis.
Some medicines can cause a dangerous decrease in blood flow when used with caffeine and ergotamine. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Your doctor may need to change your treatment plan if you use any of the following drugs:
- imatinib;
- isoniazid;
- nefazodone;
- an antibiotic--clarithromycin, telithromycin;
- antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
- heart medication--nicardipine, quinidine;
- hepatitis C medications--boceprevir, telaprevir; or
- HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.
FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medication.
Caffeine and ergotamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
How should I use caffeine and ergotamine?
Follow all directions on your prescription label. Never use more than your recommended dose. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. This medicine is not for daily use.
To use caffeine and ergotamine tablets:
- Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.
- If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed.
- If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.
If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.
Do not take a rectal suppository by mouth. It is for use only in your rectum.
Wash your hands before and after inserting the rectal suppository.
To use caffeine and ergotamine rectal suppositories:
- Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun.
- Remove the wrapper before inserting the suppository. Avoid handling the suppository too long or it will melt in your hands.
- Lie on your back with your knees up toward your chest. Gently insert the suppository into your rectum about 1 inch.
- For best results, stay lying down for a few minutes. The suppository will melt quickly and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after using the suppository.
- If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.
If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days.
Do not share this medication with another person, even if they have the same symptoms you have.
Store at room temperature away from moisture and heat.
What happens if I miss a dose?
Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.
Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week.
Do not use more than 2 suppositories per headache or 5 suppositories per week.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.
What should I avoid while using caffeine and ergotamine?
Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:
- dihydroergotamine, ergonovine, or methylergonovine; or
- almotriptan, eletriptan, frovatriptan, naratriptan, sumatriptan, rizatriptan, or zolmitriptan.
Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to unwanted side effects. Avoid the use of grapefruit products while taking caffeine and ergotamine.
What are the possible side effects of caffeine and ergotamine?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using caffeine and ergotamine and call your doctor at once if you have:
- weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes;
- painful sores on your rectum after using the rectal suppositories;
- sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
- fast or slow heart rate;
- leg weakness, muscle pain in your arms or legs;
- severe pain in your stomach or lower back;
- little or no urinating;
- chest discomfort, dry cough or hack, feeling short of breath on exertion; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).
Common side effects may include:
- dizziness, spinning sensation;
- weakness;
- nausea, vomiting; or
- mild itching or swelling.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect caffeine and ergotamine?
Tell your doctor about all medicines you use, and those you start or stop using during your treatment with caffeine and ergotamine, especially:
- aprepitant;
- cimetidine;
- cyclosporine;
- haloperidol;
- imatinib;
- nicotine;
- an antibiotic--ciprofloxacin, doxycycline, erythromycin, metronidazole, norfloxacin, tetracycline;
- antifungal medication--clotrimazole, fluconazole, voriconazole;
- an antidepressant--desipramine, fluoxetine, fluvoxamine, sertraline;
- diet pills, stimulants, or ADHD medication;
- heart or blood pressure medication--amiodarone, diltiazem, dronedarone, lidocaine, propranolol, verapamil;
- HIV/AIDS medication--atazanavir, fosamprenavir, efavirenz, darunavir when given with ritonavir, saquinavir; or
- medicines to treat asthma, colds or allergies.
This list is not complete. Other drugs may interact with caffeine and ergotamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Where can I get more information?
Your pharmacist can provide more information about caffeine and ergotamine.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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