This medication has rarely caused a very serious lack of blood flow to the hands and feet (peripheral ischemia) or to the brain, which could cause a stroke. The risk is increased when this medication is taken with other drugs that can affect the removal of ergotamine from your body. Examples include azole antifungals (such as ketoconazole, itraconazole), boceprevir, cobicistat, mifepristone, telaprevir, certain antidepressants (such as nefazodone), macrolide antibiotics (such as clarithromycin, erythromycin, troleandomycin), HIV NNRTIs (such as delavirdine), HIV protease inhibitors (such as ritonavir, nelfinavir, indinavir), SSRIs (such as fluoxetine, paroxetine, fluvoxamine), among others.Who should not take Cafetrate rectal?
This combination medication is used to treat or prevent a certain type of headache (vascular headaches such as migraine headaches and cluster headaches). Ergotamine helps narrow widened blood vessels in the head, which reduces the throbbing effects of vascular headaches. Caffeine increases the effects of ergotamine by also narrowing the widened blood vessels in the head.
Unwrap and insert one suppository rectally as directed by your doctor. Remain lying down for a few minutes, and avoid having a bowel movement for an hour or longer so the drug will be absorbed. The suppository is for rectal use only.
If the suppository is exposed to heat and softens, chill in ice-cold water before unwrapping and using the suppository.
Dosage is based on your medical condition and response to therapy. This medication works best if it is used as the first signs of the headache occur. If you wait until the headache has worsened, the medication may not work as well.
This medication usually should be used only as needed. It is not meant for long-term daily use. The maximum dose is 2 suppositories for a single headache attack and 5 suppositories in any 7-day period.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time (more than a few weeks) or in high doses. In such cases, rebound headaches may occur if you suddenly stop using this medication. This headache may be different from your original headache and may last a few days. Report any such headaches to your doctor immediately. Consult your doctor or pharmacist for more details.
Inform your doctor if you notice increased use of this medication, the medication not working as well, a worsening of headaches, an increase in the number of headaches, or use of this medication for more than 2 headache episodes a week. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: rectal pain/bleeding, slow/fast/irregular heartbeat, tingling/pain/coldness in the fingers/toes, whitish fingers/toes/nails, loss of feeling in the fingers/toes, bluish hands/feet, muscle pain/weakness, severe stomach/abdominal pain, lower back pain, little or no urine.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before using this medication, tell your doctor or pharmacist if you are allergic to ergotamine or caffeine; or to other ergot alkaloids (e.g., dihydroergotamine) or to other xanthine drugs (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: blood circulation disease (e.g., peripheral vascular disease such as arteriosclerosis, thrombophlebitis, Raynaud's disease), uncontrolled high blood pressure, nutrient deficiency (malnutrition), heart/blood vessel disease (e.g., coronary artery disease, stroke, heart attack), liver disease, kidney disease, severe infection, severe itching.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: abnormal heart rhythm, smoking/tobacco use, diarrhea, diabetes, high blood pressure (controlled), stomach problems (e.g., ulcers).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Remember that alcohol may be a cause of headaches.
Using tobacco/nicotine products while using this medication can increase the risk of serious side effects such as heart problems (including chest pain, fast/slow/irregular heartbeat) and decreased blood flow to the brain/hands/feet. Do not use tobacco while taking this medication. If you smoke, talk to your doctor about how to stop smoking.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control (such as condoms, birth control pills) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.
This drug may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
If you also take "triptan" migraine drugs (e.g., sumatriptan, rizatriptan), you will need to separate your "triptan" dose from your dose of this medication to reduce the risk of serious side effects. Ask your doctor how long you should wait between your doses of these drugs.
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, other migraine medications) because they may contain caffeine or other ingredients that could increase your heart rate or blood pressure. Also keep in mind that certain beverages (e.g., coffee, colas, tea) contain caffeine. Ask your pharmacist about the safe use of those products.
This medication may interfere with certain medical/laboratory tests (including dipyridamole-thallium imaging tests, urine catecholamine levels, urine 5-HIAA levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe dizziness/drowsiness, loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish hands/feet, seizures.
Do not share this medication with others.
Certain foods/beverages or food additives (e.g., red wine, cheese, chocolate, monosodium glutamate, alcohol) as well as some lifestyle patterns (e.g., irregular eating/sleeping habits, stress) may bring about a migraine headache. Avoiding these "triggers" may help decrease the frequency of migraine headaches. Consult your doctor for more details.
If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store US product in the refrigerator between 36-46 degrees F (2-8 degrees C) away from heat and moisture. Do not freeze. Do not store in the bathroom.
Store the Canadian product below 77 degrees F (25 degrees C) away from heat and moisture. Do not freeze. Do not store in the bathroom.
Keep all medicines away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised December 2014. Copyright(c) 2014 First Databank, Inc.
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