"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ERGOTAMINE/CAFFEINE - ORAL
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.
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