Ergotamine and caffeine (Oral)

Ergotamine and caffeine combination is used to treat or prevent vascular headaches, such as migraine, migraine variants, or histaminic cephalalgia. It will not relieve pain from headaches that are not migraines.

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

It is very important for your doctor to check your progress at 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 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 take 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 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 (e.g., retroperitoneal fibrosis). Check with your doctor right away if you have ongoing or severe stomach pain, increased 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 (e.g., pleuropulmonary fibrosis).

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

In deciding to use a medicine, the risks of taking it must be weighed against the benefits. This is a decision you and your doctor will make. For this medicine, consider the following:

Allergies

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

Pediatric

There have not been appropriate studies on the effects of ergotamine and caffeine combination in children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how ergotamine and caffeine combination affects older adults.

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding. However, there are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In these cases, your doctor may adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

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 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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food since interactions may happen. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

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 using food, alcohol, or tobacco.

• Grapefruit Juice
• Tobacco

Other Medical Problems

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

• Allergy to aspirin—Use with caution. This medicine contains a yellow dye called tartrazine, which may cause allergic reactions (including asthma) in patients with this allergy.

• 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—Should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, 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 bluish color of the 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
• Dizziness or lightheadedness
• Feeling of constant movement of self or surroundings
• Sensation of spinning

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.

In the U.S.

• Cafergot

Available Dosage Forms:

• Tablet

Therapeutic Class: Ergot Alkaloid Combination

Chemical Class: Ergotamine

Use this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. If too much of this medicine is taken 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.

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 oral dosage form (tablets):For migraine headaches: Adults—2 tablets at the first sign of a migraine attack, followed by 1 tablet every 30 minutes if needed. Each tablet contains 1 milligram (mg) ergotamine and 100 mg caffeine. Do not use more than 6 tablets in a day or 10 tablets 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

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

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.