MIGERGOT® (ergotamine tartrate & caffeine suppositories)

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MIGERGOT® (ergotamine tartrate and caffeine suppositories)?

Serious and/or life-threatening reductions in blood flow to the brain or extremities have been reported due to interactions between the active ingredients in MIGERGOT (ergotamine tartrate and caffeine) and protease inhibitors and macrolide antibiotics. These medications should not be taken together.

Uses of MIGERGOT
MIGERGOT is a prescription medicine used in adults for treating or preventing a migraine headache.
MIGERGOT is not a pain medicine and should not be used to treat other types of headaches.

Do not take MIGERGOT 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
    As there are serious drug interactions with MIGERGOT
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed as MIGERGOT may affect your unborn child or nursing infant.
  • 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 MIGERGOT

How to take MIGERGOT:

  • MIGERGOT is a rectal suppository. Do not take MIGERGOT orally.
  • One suppository of MIGERGOT should be taken at the first sign of a migraine attack. If you do not experience relief from the first dose, a second dose may be taken no sooner than 60 minutes after the first dose.
  • The use of MIGERGOT should not exceed dosing guidelines and should not be used on a daily basis.
    • Do not take more than 2 suppositories for any single migraine attack.
    • Do not take more than 5 suppositories during any 7-day period.

Contact your doctor immediately if you experience these symptoms while taking MIGERGOT:

  • 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

There are possible side effects with MIGERGOT:
Side effects of MIGERGOT may include nausea and vomiting, rectal or anal ulcer (from overuse of suppositories), sensation of tingling or limbs “falling asleep”, numbness, weakness, dizziness, swelling and itching. 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.

The risk information provided here is not comprehensive. To learn more, talk about MIGERGOT with your health care provider or pharmacist.

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 the Horizon Pharma Medical Information Department toll-free at 1-866-479-6742 or medicalinformation@horizonpharma.com.

Please see the Prescribing Information, including Boxed Warning, for more information.