Ergotamine and caffeine (Rectal)

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 from headaches other than migraines.

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

It is very important for your doctor to check your progress during regular visits. This will help your doctor see if the medicine is working properly and decide if you should keep using it.

Using this medicine could harm your unborn baby. Use an effective form of birth control to prevent pregnancy. Tell your doctor right away if you think you might be pregnant.

Do not use this medicine 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 take more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken too much of this medicine, get emergency help immediately. Signs of an overdose include: blurred vision, change in consciousness, dizziness, faintness, or lightheadedness when getting up suddenly from lying down, 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 (for example, retroperitoneal fibrosis). Check with your doctor right away if you have ongoing or severe stomach pain, increased frequency of urination, ongoing loss of appetite, lower back pain, ongoing 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 (for example, pleuropulmonary fibrosis).

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

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. For this medicine, please consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on how age affects the use of ergotamine and caffeine combination suppository in children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how age affects the use of ergotamine and caffeine combination suppository in older patients.

Breast Feeding

Studies suggest that this medicine poses minimal risk to infants when used during breastfeeding.

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while you are using this medicine. The following interactions have been selected based on 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 necessary 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
• Daridorexant
• 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 increase the risk of certain side effects, but using both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been selected based on 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 provide special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice
• Tobacco

Other Medical Problems

Having other medical problems may affect how this medicine works. Make sure to tell your doctor if you have any other medical issues, especially:

• Heart or blood vessel disease (e.g., coronary heart disease, peripheral vascular disease) or
• Hypertension (high blood pressure) or
• Severe infection (e.g., sepsis) or
• Kidney disease or
• Liver disease—This medicine should not be used in patients with these conditions.

Along with its needed effects, this medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, you 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 bluish color of the skin on 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. Your health care professional may also 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 health care professional.

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

In Canada

• Cafergot

Available Dosage Forms:

• Suppository

Therapeutic Class: Ergot Alkaloid Combination

Chemical Class: Ergotamine

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.