References: 1. Ergomar® Prescribing Information. TerSera Therapeutics LLC; 2016. 2. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1-211. 3. Fanciullacci M. When cluster headache was called histaminic cephalalgia (Horton’s headache). J Headache Pain. 2006;7:231-234. 4. Cluster vs. Episodic Migraine Page. Michigan Headache & Neurological Institute Web site. https://www.mhni.com/headache-pain-faq/cluster-headaches/cluster-vs-migraine. Accessed June 29, 2017. 5. Weaver-Agostoni J. Cluster headache. Am Fam Physician. 2013;88(2):122-128. 6. Migraine Information Page. National Institute of Neurological Disorders and Stroke Web site. https://www.ninds.nih.gov/Disorders/All-Disorders/Migraine-Information-Page. Accessed January 17, 2017. 7. Winsor T. Plethysmographic comparison of sublingual and intramuscular ergotamine. Clin Pharmacol Ther. 1981;29(1):94-99. 8. Sayeed VA, Ashraf M. Considerations in developing sublingual tablets—an overview. Pharma Technology. 2014;38(11).
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Ergomar® Sublingual Tablets, 2 mg (Ergotamine Tartrate Sublingual Tablets, USP)?
Serious and/or life-threatening reductions in blood flow to the brain or extremities have been reported due to interactions between the active ingredient in Ergomar (ergotamine tartrate) and protease inhibitors and macrolide antibiotics. Do not take Ergomar if you take protease inhibitors or macrolide antibiotics.
Before starting Ergomar, you should know that:
Ergomar is a prescription medicine used in adults for treating or preventing a migraine or cluster headache. Ergomar is not a pain medicine and should not be used to treat other types of headaches.
Do not take Ergomar if you are taking medicines called CYP 3A4 inhibitors (such as certain medicines for infections, certain HIV medicines, and some antibiotics). Serious side effects may occur when these kinds of medicines are used at the same time as Ergomar.
There have been a few reports of patients on ergotamine tartrate (the active ingredient of Ergomar) and caffeine therapy experiencing a buildup of excess tissue in the space behind the stomach and intestine or in the lungs. In rare cases, long-term use of ergotamine tartrate plus caffeine has caused thickening of the valves of the heart. Do not take Ergomar on a daily basis.
Do not take Ergomar with other medicines that cause the blood vessels to become narrow (vasoconstrictors).
Do not smoke if you take Ergomar.
Do not take more Ergomar than your healthcare professional recommends. (see How to take Ergomar)
In rare cases, patients have experienced withdrawal symptoms (including rebound headache) when stopping ergotamine, particularly after taking it over long periods of time.
There have been reports of drug abuse and psychological dependence in patients who take ergotamine tartrate.
Do not take Ergomar if you:
- Are taking certain anti-HIV medications known as protease inhibitors such as ritonavir, nelfinavir or indinavir
- Are taking a macrolide antibiotic such as erythromycin, clarithromycin or troleandomycin
- Are taking anti-fungal medications such as ketoconazole or itraconazole
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
- Have high blood pressure or if you have any disease affecting your heart, arteries, or blood circulation
- Have liver or kidney disease
- Are allergic to any of the ingredients in Ergomar
How to take Ergomar:
For best results, Ergomar should be taken at the first sign of a migraine attack.
- One Ergomar 2 mg tablet should be placed under the tongue. Allow tablet to dissolve and wait several minutes before eating or drinking
- If needed, another tablet may be taken no sooner than 30 minutes following each dose
- You should not take more than three tablets in any 24-hour period
- You should not take more than five tablets (10 mg) in any one week (7 days)
- Ergomar should not be used on a daily basis
There are possible side effects when taking Ergomar. Contact your healthcare professional immediately if you experience:
- Blue-colored skin, numbness or tingling in the fingers or toes
- Muscle pain in the arms and legs
- Weakness in the legs
- Chest pain
- Temporary speeding or slowing of the heart rate
- Swelling or itching
Other side effects of Ergomar may include nausea, vomiting, and dizziness. This is not a complete list of all possible side effects. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
This summarizes the most important information to know about Ergomar. Ask your healthcare professional if you have any questions or want more information.
Please see the Prescribing Information, including Boxed Warning, for more information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also contact TerSera Therapeutics at 1-888-374-6627 or firstname.lastname@example.org.
Do you suffer
- Are you dissatisfied with the therapies you have been prescribed to treat your migraine or cluster headaches?
- Have you been told to avoid caffeine or the sweetener aspartame?
- Do you have trouble swallowing pills or capsules?
- Have you been unable to get your migraine or cluster headache prescription due to unavailability or insurance issues?
- Would you prefer to take a tablet that dissolves under your tongue than your current treatment?
If you answered yes to one or more of these questions, ask your healthcare provider if Ergomar might be right for you.
Please see Important Safety Information and Full Prescribing Information, including Boxed Warning.