Headache Medicines, Ergot Derivative-Containing (Systemic)

Brand name(s): Belcomp-PB

Before Using This Medicine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For these headache medicines, the following should be considered:

Allergies-Tell your doctor if you have ever had any unusual or allergic reaction to atropine, belladonna, pentobarbital or other barbiturates, caffeine, dimenhydrinate, diphenhydramine, or an ergot medicine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy-Use of dihydroergotamine or ergotamine by pregnant women may cause serious harm, including death of the fetus and miscarriage. Therefore, these medicines should not be used during pregnancy.

Breast-feeding-

• For dihydroergotamine and ergotamine: These medicines pass into the breast milk and may cause unwanted effects, such as vomiting, diarrhea, weak pulse, changes in blood pressure, or convulsions (seizures) in nursing babies. Large amounts of these medicines may also decrease the flow of breast milk.
• For caffeine: Caffeine passes into the breast milk. Large amounts of it may cause the baby to appear jittery or to have trouble in sleeping.
• For belladonna alkaloids, dimenhydrinate, and diphenhydramine: These medicines have drying effects. Therefore, it is possible that they may reduce the amount of breast milk in some people. Dimenhydrinate passes into the breast milk.
• For pentobarbital: Pentobarbital passes into the breast milk. Large amounts of it may cause unwanted effects such as drowsiness in nursing babies.

Be sure that you discuss these possible problems with your doctor before taking any of these medicines.

Children-

• For dihydroergotamine and ergotamine: These medicines are used to relieve severe, throbbing headaches in children 6 years of age or older. They have not been shown to cause different side effects or problems in children than they do in adults. However, these medicines can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.
• For belladonna alkaloids: Young children, especially children with spastic paralysis or brain damage, may be especially sensitive to the effects of belladonna alkaloids. This may increase the chance of side effects during treatment.
• For dimenhydrinate, diphenhydramine, and pentobarbital : Although these medicines often cause drowsiness, some children become excited after taking them.

Older adults-

• For dihydroergotamine and ergotamine: The chance of serious side effects caused by decreases in blood flow is increased in elderly people receiving these medicines.
• For belladonna alkaloids, dimenhydrinate, diphenhydramine, and pentobarbital: Elderly people are more sensitive than younger adults to the effects of these medicines. This may increase the chance of side effects such as excitement, depression, dizziness, drowsiness, and confusion.

Other medicines-Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Many medicines can add to or decrease the effects of the belladonna alkaloids, caffeine, dimenhydrinate, diphenhydramine, or pentobarbital present in some of these headache medicines. Therefore, you should tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. This is especially important if any medicine you take causes excitement, trouble in sleeping, dryness of the mouth, dizziness, or drowsiness.

When you are taking dihydroergotamine or ergotamine, it is especially important that your health care professional know if you are taking any of the following:

• Cocaine or
• Epinephrine by injection [e.g., Epi-Pen] or
• Other ergot medicines (ergoloid mesylates [e.g., Hydergine], ergonovine [e.g., Ergotrate], methylergonovine [e.g., Methergine], methysergide [e.g., Sansert])-The chance of serious side effects caused by dihydroergotamine or ergotamine may be increased

• Itraconazole (e.g., Sporanox)
• Ketoconazole (e.g., Nizoral)
• Macrolide antibiotics (clarithromycin [e.g., Biaxin], erythromycin [e.g., Ery-Tab], troleandomycin [e.g., TAO])
• Protease inhibitors (indinavir [e.g., Crixivan], nelfinavir [e.g., Viracept], ritonavir [e.g., Norvir])-Use of any of these medicines with ergotamine can cause serious or life-threatening problems with blood circulation.

• 5-HT₁ agonists (almotriptan [e.g., Axert], eletriptan [e.g., Relpax], frovatriptan [e.g., Frova], naratriptan [e.g., Amerge], rizatriptan [e.g., Maxalt], sumatriptan [e.g., Imitrex], zolmitriptan [e.g., Zomig])-Use of these medicines may cause serious side effects if taken within 24 hours of an ergot-containing medicine.

Other medical problems-The presence of other medical problems may affect the use of these headache medicines. Make sure you tell your doctor if you have any other medical problems, especially:

• Agoraphobia (fear of open or public places) or
• Panic attacks or
• Stomach ulcer or
• Trouble in sleeping (insomnia)-Caffeine can make your condition worse

• Diarrhea-Rectal dosage forms (suppositories) will not be effective if you have diarrhea

• Difficult urination or
• Enlarged prostate or
• Glaucoma (not well controlled) or
• Heart or blood vessel disease or
• High blood pressure (not well controlled) or
• Infection or
• Intestinal blockage or other intestinal problems or
• Itching (severe) or
• Kidney disease or
• Liver disease or
• Mental depression or
• Overactive thyroid or
• Trauma from an accident (broken arm or leg)
• Urinary tract blockage-The chance of side effects may be increased

Also, tell your doctor if you need, or if you have recently had, an angioplasty (a procedure done to improve the flow of blood in a blocked blood vessel) or surgery on a blood vessel. The chance of serious side effects caused by dihydroergotamine or ergotamine may be increased.

Last Revised: 02/20/2004

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