GENERIC NAME: ERGOTAMINE/CAFFEINE - ORAL (er-GOT-a-meen/KAF-een)
WARNING: This medication has rarely caused a serious lack of blood flow to the arms/hands, or to the feet, or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of ergotamine from your body. Examples include boceprevir, mifepristone, telaprevir, telithromycin, certain antidepressants (such as nefazodone), azole antifungals (such as ketoconazole, itraconazole), macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV protease inhibitors (such as ritonavir, nelfinavir, indinavir), HIV NNRTIs (such as delavirdine, efavirenz), a certain combination HIV medication (elvitegravir/cobicistat/emtricitabine/tenofovir), SSRIs (such as fluoxetine, paroxetine, fluvoxamine), among others.
USES: This combination medication is used to treat or prevent certain types of headaches (vascular headaches including migraine and cluster headaches). Headache pain can sometimes be caused by widened blood vessels in the head. Ergotamine works by narrowing these widened blood vessels. Caffeine increases the absorption of ergotamine and also narrows widened blood vessels.
HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 2 tablets at the first sign of headache, followed by 1 tablet every half hour until the headache is relieved. Do not take more than 6 tablets per headache attack or 10 tablets in a 7-day period.If your doctor has prescribed this medication to help prevent certain types of headaches (such as cluster headaches), take this medication exactly as directed by your doctor, usually for short-term treatment (2 to 3 weeks).The dosage is based on your medical condition and response to treatment. This medication works best if it is taken at the first sign of the headache. If you wait until the headache has worsened, the medication may not work as well.If you have a higher risk for heart problems (see Precautions), your doctor may perform a heart exam before you start taking this medication. He/she may also direct you to take your first dose of this medication in the office/clinic to monitor for serious side effects (such as chest pain). Talk to your doctor for details.This medication is usually taken only as needed. It is not meant for long-term daily use.Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.Overuse of drugs to treat sudden migraine attacks can sometimes lead to worsening of headache (medication overuse headache) or rebound headache. Therefore, do not use this medication more often or for longer than prescribed. Tell your doctor if you need to use this medication more often, if the medication is not working as well, or if you have more frequent or worse headaches. Your doctor may need to change your medication and/or add another medication to help prevent headaches.
SIDE EFFECTS: Nausea, vomiting, upset stomach, restlessness, trouble sleeping, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: slow/fast/irregular heartbeat, numbness/tingling in fingers/toes, blue fingers/toes/nails, cold hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, decrease in the amount of urine.Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, confusion, slurred speech, vision changes, weakness on one side of the body.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to ergotamine or caffeine; or to other ergot alkaloids (such as dihydroergotamine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood circulation problems (for example, in your legs, arms/hands, or stomach), certain types of headaches (hemiplegic or basilar migraine), heart problems (such as chest pain, irregular heartbeat, previous heart attack), kidney disease, liver disease, stroke or "mini-stroke" (transient ischemic attack).Certain conditions can increase your risk for heart problems. Tell your doctor if you have any of these conditions, including: high blood pressure, high cholesterol, diabetes, family history of heart disease, overweight, postmenopausal (women), age more than 40 years (men).This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Remember that alcohol may cause headaches.Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems and decreased blood flow to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of at least two reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: See also Warning section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.If you also take "triptan" migraine drugs (such as sumatriptan, rizatriptan), you will need to separate your triptan dose from your dose of this medication to lessen the chance of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.Check the labels on all your medicines (especially cough-and-cold products, diet aids, other headache products) because they may contain caffeine or other ingredients that could increase your heart rate or blood pressure. Certain beverages (such as coffee, colas, energy drinks) may also contain caffeine. Ask your pharmacist about using those products safely.This medication may interfere with certain medical/laboratory tests (including dipyridamole-thallium imaging tests, urine catecholamine/5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: nausea/vomiting, numbness/tingling in the fingers/toes, chest pain, muscle pain/weakness.
NOTES: Do not share this medication with others.Certain foods, beverages, or food additives (such as red wine, cheese, chocolate, monosodium glutamate) as well as lifestyle patterns such as irregular eating/sleeping habits or stress may bring on a migraine headache. Avoiding these "triggers" may help lessen migraine attacks. Consult your doctor for more details.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.
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