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|Caffeine/Ergotamine Suppositories

Caffeine/Ergotamine Suppositories

Caffeine/Ergotamine Suppositories is used for:

Preventing and treating certain kinds of headaches (eg, migraines, migraine variants, "histaminic cephalalgia"). It may also be used for other conditions as determined by your doctor.

Caffeine/Ergotamine Suppositories is a combination of 2 vasoconstrictors. It works by constricting blood vessels in the lining of the brain, which helps to decrease the pain from migraine headaches.

Do NOT use Caffeine/Ergotamine Suppositories if:

• you are allergic to any ingredient in Caffeine/Ergotamine Suppositories
• you are pregnant or may become pregnant
• you are in labor
• you have blood vessel problems (eg, peripheral vascular disease), coronary heart disease, high blood pressure, liver or kidney problems, or severe infection (eg, sepsis)
• you are taking an azole antifungal (eg, itraconazole, ketoconazole, voriconazole), delavirdine, HIV protease inhibitors (eg, delavirdine, indinavir, nelfinavir, ritonavir), efavirenz, a ketolide antibiotic (eg, telithromycin), a macrolide antibiotic (eg, clarithromycin, erythromycin), or selective 5-HT agonists (eg, sumatriptan, eletriptan)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Caffeine/Ergotamine Suppositories:

Some medical conditions may interact with Caffeine/Ergotamine Suppositories. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are planning to become pregnant or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of blood problems (eg, porphyria), stroke, anxiety, trouble sleeping, or heart problems
• if you smoke

Some MEDICINES MAY INTERACT with Caffeine/Ergotamine Suppositories. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Clotrimazole, fluconazole, fluoxetine, fluvoxamine, metronidazole, nefazodone, saquinavir, or zileuton because side effects of Caffeine/Ergotamine Suppositories may be increased
• Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), beta-blockers (eg, propranolol), delavirdine, HIV protease inhibitors (eg, delavirdine, indinavir, nelfinavir, ritonavir), efavirenz, ketolide antibiotics (eg, telithromycin), macrolide antibiotics (eg, erythromycin, clarithromycin), or selective 5-HT agonists (eg, sumatriptan, eletriptan) because the risk of severe side effects, including irregular heartbeat or decreased oxygen to the extremities (eg, hands, feet) or brain, may be increased
• Pressor agents (eg, norepinephrine) or sympathomimetics (eg, pseudoephedrine, albuterol) because risk of side effects, including severe high blood pressure, may be increased
• Quinolones (eg, levofloxacin) because risk of side effects, such as nervousness, sleeplessness, and fast heartbeat, may be increased
• Theophylline because actions and side effects may be increased by Caffeine/Ergotamine Suppositories

This may not be a complete list of all interactions that may occur. Ask your health care provider if Caffeine/Ergotamine Suppositories may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Caffeine/Ergotamine Suppositories:

Use Caffeine/Ergotamine Suppositories as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Caffeine/Ergotamine Suppositories may be taken with or without food.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Caffeine/Ergotamine Suppositories in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• Caffeine/Ergotamine Suppositories is only to be used as needed for a migraine attack.
• Use Caffeine/Ergotamine Suppositories at the first sign of a headache. Remove the wrapper and moisten the suppository with cool water. Lie down on your side. Insert the pointed end of the suppository into the rectum, then use your finger to push it in completely. Wash your hands thoroughly after using Caffeine/Ergotamine Suppositories.
• If the suppository has softened because of a period of unavoidable exposure to heat, place in the refrigerator for about 15 minutes or chill in ice cold water before removing the wrapper.
• If the initial dose does not relieve your headache, an additional dose may be needed according to your doctor"s instructions. Do not use a dose of Caffeine/Ergotamine Suppositories within 1 hour of your last dose.
• Do not use more than 2 suppositories for a single migraine headache or more than 5 suppositories during any 7-day period without first checking with your doctor.
• If you miss a dose of Caffeine/Ergotamine Suppositories and you still have a headache, use it as soon as you remember. Do not use a dose of Caffeine/Ergotamine Suppositories within 1 hour of your last dose. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Caffeine/Ergotamine Suppositories.

Important safety information:

• Do NOT exceed the recommended dose or use Caffeine/Ergotamine Suppositories for longer than prescribed without checking with your doctor. Caffeine/Ergotamine Suppositories is not for long-term daily use.
• Do not use Caffeine/Ergotamine Suppositories for any other kind of headaches. Caffeine/Ergotamine Suppositories is not effective in treating other types of headaches.
• Use of nicotine may increase the risk of severe side effects with Caffeine/Ergotamine Suppositories. Talk to you doctor before using Caffeine/Ergotamine Suppositories if you smoke or use any other kind of nicotine.
• Use Caffeine/Ergotamine Suppositories with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Do not use Caffeine/Ergotamine Suppositories if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. Caffeine/Ergotamine Suppositories should not be used during labor and delivery. Caffeine/Ergotamine Suppositories is excreted in breast milk. If you are or will be breast-feeding while you are using Caffeine/Ergotamine Suppositories, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, some people develop a need to continue taking Caffeine/Ergotamine Suppositories. This is known as DEPENDENCE or addiction. It is important that you take Caffeine/Ergotamine Suppositories as instructed by your doctor. Caffeine/Ergotamine Suppositories is not for long-term daily use.

Possible side effects of Caffeine/Ergotamine Suppositories:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blue color of the fingers or toes; chest pain or tightness; cold or pale fingers or toes; diarrhea; dizziness; hallucinations; headache; irregular heartbeat; leg cramps or weakness; mental or mood changes; muscle pain; numbness or tingling of the hands, feet, or skin; rectal sores; ringing in the ears; seizure; severe or persistent nausea or vomiting; shortness of breath; swelling; temporary fast or slow heartbeat; vomiting; weak pulse.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; coma; diarrhea; difficulty breathing; drowsiness; numbness, coldness, pain, tingling, or blue color of the extremities; seizures; severe headache or dizziness; shock; vomiting; weak pulse.

Store Caffeine/Ergotamine Suppositories in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Caffeine/Ergotamine Suppositories out of the reach of children and away from pets.

General information:

• If you have any questions about Caffeine/Ergotamine Suppositories, please talk with your doctor, pharmacist, or other health care provider.
• Caffeine/Ergotamine Suppositories is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Caffeine/Ergotamine Suppositories. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.