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HEADACHE MEDICINES, ERGOT DERIVATIVE-CONTAINING (Systemic)

Some commonly used brand names are:

In the U.S.—

• Belcomp-PB ⁵
• Cafergot ³
• D.H.E. 45 ¹
• Ergocaff-PB ⁵
• Ergomar ²
• Migergot ³
• Migracet-PB ⁵
• Wigraine ³

In Canada—

• Cafergot ³
• D.H.E. ¹
• Ergodryl ⁸
• Gravergol ⁷

Category

• Antihypotensive
• Thrombosis prophylaxis adjunct
• Vascular headache suppressant

Description

Dihydroergotamine and ergotamine belong to the group of medicines known as ergot alkaloids. They are used to treat severe, throbbing headaches, such as migraine and cluster headaches. Dihydroergotamine and ergotamine are not ordinary pain relievers. They will not relieve any kind of pain other than throbbing headaches. Because these medicines can cause serious side effects, they are usually used for patients whose headaches are not relieved by acetaminophen, aspirin, or other pain relievers.

Dihydroergotamine and ergotamine may cause blood vessels in the body to constrict (become narrower). This effect can lead to serious side effects that are caused by a decrease in the flow of blood (blood circulation) to many parts of the body.

The caffeine present in many ergotamine-containing combinations helps ergotamine work better and faster by causing more of it to be quickly absorbed into the body. The belladonna alkaloids, dimenhydrinate, and diphenhydramine in some combinations help to relieve nausea and vomiting, which often occur together with the headaches. Dimenhydrinate, diphenhydramine, and pentobarbital also help the patient relax and even sleep. This also helps relieve headaches.

Dihydroergotamine is also used for other conditions, as determined by your doctor.

These medicines are available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Ergotamine
  • Sublingual tablets (U.S.)
• Ergotamine and Caffeine
  • Tablets (U.S. and Canada)
• Ergotamine, Caffeine, and Dimenhydrinate
  • Capsules (Canada)
• Ergotamine, Caffeine, and Diphenhydramine
  • Capsules (Canada)

• Parenteral
• Dihydroergotamine
  • Injection (U.S. and Canada)

• Rectal
• Ergotamine and Caffeine
  • Suppositories (U.S. and Canada)
• Ergotamine, Caffeine, Belladonna Alkaloids, and Pentobarbital
  • Suppositories (U.S.)

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.

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. These medicines should not be used with ergotamine.

• 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.

Proper Use of This Medicine

Use this medicine only as directed by your doctor. Do not use more of it, and do not use it more often, than directed . If the amount you are to use does not relieve your headache, check with your doctor. Taking too much dihydroergotamine or ergotamine, or taking it too often, may cause serious effects, especially in elderly patients. Also, if a headache medicine (especially ergotamine) is used too often for migraines, it may lose its effectiveness or even cause a type of physical dependence. If this occurs, your headaches may actually get worse.

This medicine works best if you:

• Use it at the first sign of headache or migraine attack. If you get warning signals of a coming migraine, take it before the headache actually starts .
• Lie down in a quiet, dark room until you are feeling better .

Your doctor may direct you to take another medicine to help prevent headaches. It is important that you follow your doctor"s directions, even if your headaches continue to occur . Headache-preventing medicines may take several weeks to start working. Even after they do start working, your headaches may not go away completely. However, your headaches should occur less often, and they should be less severe and easier to relieve. This can reduce the amount of dihydroergotamine, ergotamine, or pain relievers that you need. If you do not notice any improvement after several weeks of headache-preventing treatment, check with your doctor.

For patients using dihydroergotamine :

• Dihydroergotamine is given only by injection. Your health care professional will teach you how to inject yourself with the medicine. Be sure to follow the directions carefully. Check with your health care professional if you have any problems using the medicine.

For patients using the sublingual (under-the-tongue) tablets of ergotamine :

• To use—Place the tablet under your tongue and let it remain there until it disappears. The sublingual tablet should not be chewed or swallowed, because it works faster when it is absorbed into the body through the lining of the mouth. Do not eat, drink, or smoke while the tablet is under your tongue.

For patients using rectal suppository forms of a headache medicine :

• If the suppository is too soft to use, chill it in the refrigerator for 30 minutes or run cold water over it before removing the foil wrapper.
• If you have been directed to use part of a suppository, you should divide the suppository into pieces that all contain the same amount of medicine. To do this, use a sharp knife and carefully cut the suppository lengthwise (from top to bottom) into pieces that are the same size. The suppository will be easier to cut if it has been kept in the refrigerator.
• To insert the suppository—First remove the foil wrapper and moisten the suppository with cold water. Lie down on your side and use your finger to push the suppository well up into the rectum.

Dosing—The dose of these headache medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

• For dihydroergotamine
• Adults: For relieving a migraine or cluster headache—1 mg. If your headache is not better, and no side effects are occurring, a second 1-mg dose may be used at least one hour later.
• Children 6 years of age and older: For relieving a migraine headache—It is not likely that a child will be receiving dihydroergotamine at home. If a child needs the medicine, the dose will have to be determined by the doctor.

• For ergotamine
• Some headache medicines contain only ergotamine. Some of them contain other medicines along with the ergotamine. The number of tablets, capsules, or suppositories that you need for each dose depends on the amount of ergotamine in them. The size of each dose, and the number of doses that you take, also depends on the reason you are taking the medicine and on how you react to the medicine.
• For oral (capsule or tablet) and sublingual (under-the-tongue tablet) dosage forms:
  • Adults:
    • For relieving a migraine or cluster headache—1 or 2 mg of ergotamine. If your headache is not better, and no side effects are occurring, a second dose and even a third dose may be taken; however the doses should be taken at least 30 minutes apart. People who usually need more than one dose of the medicine, and who do not get side effects from it, may be able to take a larger first dose of not more than 3 mg of ergotamine. This may provide better relief of the headache with only one dose. The medicine should not be taken more often than 2 times a week, at least five days apart .
    • For preventing cluster headaches—The dose of ergotamine, and the number of doses you need every day, will depend on how many headaches you usually get each day. For some people, 1 or 2 mg of ergotamine once a day may be enough. Other people may need to take 1 or 2 mg of ergotamine 2 or 3 times a day.
    • For all uses— Do not take more than 6 mg of ergotamine a day in the form of capsules or tablets .
  • Children 6 years of age and older: For relieving migraine headaches—1 mg of ergotamine. If the headache is not better, and no side effects are occurring, a second dose and even a third dose may be taken; however, the doses should be taken at least 30 minutes apart. Children should not take more than 3 mg of ergotamine a day in the form of capsules or tablets. Also, this medicine should not be taken more often than 2 times a week, at least five days apart .
• For rectal suppository dosage forms:
  • Adults: For relieving migraine or cluster headaches—Usually 1 mg of ergotamine, but the dose may range from half of this amount to up to 2 mg. If your headache is not better, and no side effects are occurring, a second dose and even a third dose may be used; however the doses should be taken at least 30 minutes apart. People who usually need more than one dose of the medicine, and who do not get side effects from it, may be able to use a larger first dose of not more than 3 mg. This may provide better relief of the headache with only one dose. Adults should not use more than 4 mg of ergotamine a day in suppository form. Also, this medicine should not be used more often than 2 times a week, at least five days apart .
  • Children 6 years of age and older: For relieving migraine headaches—One-half or 1 mg of ergotamine. Children should not receive more than 1 mg a day of ergotamine in suppository form. Also, this medicine should not be used more often than 2 times a week, at least five days apart .

Storage—To store this medicine:

• Keep out of the reach of children since overdose is especially dangerous in children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Suppositories should be stored in a cool place, but not allowed to freeze. Some manufacturers recommend keeping them in a refrigerator; others do not. Follow the directions on the package. However, cutting the suppository into smaller pieces, if you need to do so, will be easier if the suppository is kept in the refrigerator.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Check with your doctor :

• If your migraine headaches are worse than they were before you started using this medicine, or your headache medicine stops working as well as it did when you first started using it. This may mean that you are in danger of becoming dependent on the headache medicine. Do not try to get better relief by increasing the dose .
• If your migraine headaches are occurring more often than they did before you started using this medicine. This is especially important if a new headache occurs within 1 day after you took your last dose of headache medicine, or if you are having headaches every day. This may mean that you are dependent on the headache medicine. Continuing to take this medicine will cause even more headaches later on . Your doctor can give you advice on how to relieve the headaches.

Drinking alcoholic beverages can make headaches worse or cause new headaches to occur. People who suffer from severe headaches should probably avoid alcoholic beverages, especially during a headache.

Smoking or nicotine replacement therapy products may increase some of the harmful effects of dihydroergotamine or ergotamine. It is best to avoid smoking or the use of nicotine replacement therapy products for several hours after taking these medicines.

Dihydroergotamine and ergotamine may make you more sensitive to cold temperatures, especially if you have blood circulation problems. They tend to decrease blood flow in the skin, fingers, and toes. Dress warmly during cold weather and be careful during prolonged exposure to cold temperatures. This is especially important for older patients, who are more likely than younger adults to already have problems with their circulation.

If you have a serious infection or illness of any kind, check with your doctor before using this medicine, since you may be more sensitive to its effects.

For patients taking one of the combination medicines that contains caffeine :

• Caffeine may interfere with the results of a test that uses dipyridamole (e.g., Persantine) to help find out how well your blood is flowing through certain blood vessels. You should not have any caffeine for at least 12 hours before the test.

Caffeine may also interfere with some other laboratory tests. Before having any other laboratory tests, tell the person in charge if you have taken a medicine that contains caffeine.

For patients taking one of the combination medicines that contains belladonna alkaloids, dimenhydrinate, diphenhydramine, or pentobarbital :

• These medicines may cause some people to have blurred vision or to become drowsy, dizzy, lightheaded, or less alert than they are normally. These effects may be especially severe if you also take CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness) together with one of these combination medicines. Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; and antiemetics (medicines that prevent or relieve nausea or vomiting). If you are not able to lie down for a while, make sure you know how you react to this medicine or combination of medicines before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well .
• Belladonna alkaloids, dimenhydrinate, and diphenhydramine may cause dryness of the mouth, nose, and throat. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute.
• Belladonna alkaloids may interfere with certain laboratory tests that check the amount of acid in your stomach. They should not be taken for 24 hours before the test.
• Dimenhydrinate and diphenhydramine may interfere with skin tests that show whether you are allergic to certain substances. They should not be taken for 3 days before the test.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects may occur that usually do not need medical attention. These side effects may go away after a little while. However, check with your doctor if any of the following side effects continue or are bothersome:

After you stop taking this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were taking and how long you took it. During this time check with your doctor if your headaches begin again or worsen.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not specifically included in product labeling, dihydroergotamine is sometimes used together with another medicine (heparin) to help prevent blood clots that may occur after certain kinds of surgery. It is also used to prevent or treat low blood pressure in some patients.

For patients receiving this medicine for preventing blood clots :

• You may need to receive this medicine two or three times a day for several days in a row. This may increase the chance of problems caused by decreased blood flow. Your health care professional will be following your progress, to make sure that this medicine is not causing problems with blood circulation.

For patients using this medicine to prevent or treat low blood pressure :

• Take this medicine every day as directed by your doctor.
• The dose of dihydroergotamine will depend on whether the medicine is going to be injected under the skin or into a muscle, and, sometimes, on the weight of the patient. For these reasons, the dose will have to be determined by your doctor.
• Your doctor will need to check your progress at regular visits, to make sure that the medicine is working properly without causing side effects.
• This medicine is less likely to cause problems with blood circulation in patients with low blood pressure than it is in patients with normal or high blood pressure.
• In patients being treated for low blood pressure, an increase in blood pressure is the wanted effect, not a side effect that may need medical attention.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 02/20/2004

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