Pronunciation:

er-GOT-a-meen TAR-trate, KAF-een

Brand Names:

• Cafergot

Dosage Forms:

• Suppository

Classifications:

Therapeutic—

Ergot Alkaloid Combination

Chemical—

Ergotamine

Uses of This Medicine:

Ergotamine and caffeine combination suppository is used to treat or prevent vascular headaches, including migraine, migraine variants, or histaminic cephalalgia. It will not relieve pain other than from migraine headaches.

This medicine is available only with your doctor's prescription.

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ergotamine and caffeine combination suppository in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of ergotamine and caffeine combination suppository in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Almotriptan
• Amprenavir
• Atazanavir
• Boceprevir
• Clarithromycin
• Cobicistat
• Conivaptan
• Darunavir
• Delavirdine
• Dopamine
• Eletriptan
• Erythromycin
• Fosamprenavir
• Frovatriptan
• Idelalisib
• Indinavir
• Itraconazole
• Ketoconazole
• Letermovir
• Levoketoconazole
• Lopinavir
• Mifepristone
• Naratriptan
• Nefazodone
• Nelfinavir
• Nirmatrelvir
• Posaconazole
• Riociguat
• Ritonavir
• Rizatriptan
• Saquinavir
• Sumatriptan
• Telaprevir
• Telithromycin
• Tipranavir
• Troleandomycin
• Viloxazine
• Voriconazole
• Zolmitriptan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Adagrasib
• Alefacept
• Asciminib
• Avacopan
• Azithromycin
• Belzutifan
• Berotralstat
• Capmatinib
• Ceritinib
• Crizotinib
• Dabrafenib
• Eluxadoline
• Enzalutamide
• Erdafitinib
• Fedratinib
• Fexinidazole
• Fluconazole
• Fluvoxamine
• Fosnetupitant
• Givosiran
• Imatinib
• Iobenguane I 131
• Ivacaftor
• Lanreotide
• Lefamulin
• Lenacapavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mitotane
• Mobocertinib
• Netupitant
• Octreotide
• Omaveloxolone
• Palbociclib
• Pazopanib
• Peginterferon Alfa-2b
• Phenobarbital
• Pirtobrutinib
• Pixantrone
• Primidone
• Propatyl Nitrate
• Ranolazine
• Ribociclib
• Ritlecitinib
• Selpercatinib
• Sibutramine
• Sotorasib
• Taurursodiol
• Tocilizumab
• Trofinetide
• Tucatinib
• Voxelotor

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Nevirapine
• Propranolol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice
• Tobacco

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease (eg, coronary heart disease, peripheral vascular disease) or
• Hypertension (high blood pressure) or
• Infection (eg, sepsis), severe or
• Kidney disease or
• Liver disease—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. If too much of this medicine is used for a long time, it may become habit-forming (causing serious unwanted effects).

This medicine works best if you take it at the first sign of a migraine headache.

To use the suppository:

• Never take rectal suppositories by mouth.
• Do not cut or break the suppository.
• Remove one suppository from the strip of suppositories. Hold suppository upright and carefully remove the foil wrapper.
• Wash your hands with soap and water before and after using this medicine. Remove the foil or wrapper from the suppository before inserting it.
• Do not keep the suppository in your hand too long or it may begin to melt.
• To make the suppository easier to insert, you may use a lubricating gel such as K-Y® Jelly, but do not use petroleum jelly (Vaseline®).
• Insert suppository (pointed end first) completely into rectum with gentle pressure.
• Keep lying down for about 15 minutes to keep the suppository from coming out before it melts. Then, wash your hands again.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For rectal dosage form (suppository):
  • For migraine headaches:
    • Adults—1 suppository inserted into your rectum at the first sign of a migraine attack, followed by another suppository after 1 hour if needed. Each suppository contains 2 milligrams (mg) ergotamine and 100 mg caffeine. Do not use more than 2 suppositories in a day or 5 suppositories in a week.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

You may store the suppositories in the refrigerator, but do not freeze them.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

Using this medicine could harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Tell your doctor right away if you think you have become pregnant.

Do not use this medicine together with clarithromycin (Biaxin®), erythromycin (Erythrocin®), indinavir (Crixivan®), itraconazole (Sporanox®), ketoconazole (Nizoral®), nelfinavir (Viracept®), ritonavir (Norvir®), or troleandomycin (Tao®).

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Signs of an overdose include: blurred vision, change in consciousness, dizziness, faintness, or lightheadedness when getting up suddenly from a lying position, headache, nervousness, numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds, loss of consciousness, pale, clammy skin, pounding in the ears, sweating, unusual tiredness or weakness, or vomiting.

This medicine may cause stomach problems (eg, retroperitoneal fibrosis). Check with your doctor right away if you have continuing or severe stomach pain, increased frequency of urination, continuing loss of appetite, lower back pain, continuing or severe nausea and vomiting, or weakness.

Check with your doctor right away if you have chest pain or tightness, or trouble breathing. These may be symptoms of a lung problem (eg, pleuropulmonary fibrosis).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

Chest pain, discomfort, or tightness

cold, pale, or a bluish color skin of the fingers or toes

continuing loss of appetite

continuing or severe nausea and vomiting

continuing or severe stomach pain

increased frequency of urination

irregular heartbeat

itching skin

lower back pain

numbness or tingling of the fingers or toes

pain in the fingers or toes

pain in arms legs, or lower back, especially pain in calves or heels upon exertion

sweating

swelling of hands, ankles, feet, or lower legs

weakness

weak or absent pulses in the legs

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Blurred vision

change or loss of consciousness

cold clammy skin

decreased awareness or responsiveness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

headache

nervousness

numbness, tingling, pain, and bluish color of the fingernails, lips, skin, palms, or nail beds

pounding in the ears

seizures

severe sleepiness

slow or fast heartbeat

sweating

unusual tiredness or weakness

vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty in moving bowels

dizziness or lightheadedness

feeling of constant movement of self or surroundings

irregular bowel movements

rectal discomfort

sensation of spinning

stomach pain

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.