Wigraine® Tablets:  Each tablet contains the following:

Ergotamine Tartrate, USP      1 mg

Caffeine, USP      100 mg

Each tablet also contains: Lactose, Magnesium Stearate, Microcrystalline Cellulose, Corn Starch, Glycerin, Acacia Powder, Colloidal Silicon Dioxide, and Purified Water as inactive ingredients.

Wigraine® tablets are uncoated and prepared to insure rapid disintegration (by an exclusive manufacturing process) and facilitate quick absorption. Rapid onset of effect is important for the satisfactory treatment of acute attacks of vascular headaches.

Last updated on RxList: 12/8/2004

Wigraine® (ergotamine tartrate and caffeine tablets, USP) is indicated as therapy to abort or prevent vascular headaches such as migraine, migraine variants, or so-called histamine cephalalgia.

Best results are obtained if the tablets are administered at the first sign of an attack.

The average adult dose is 2 tablets at the start of a vascular headache (migraine) attack; followed by 1 additional tablet every ¹ / ₂ hour if needed, up to 6 tablets per attack. Total weekly dosage should not exceed 10 tablets.

Wigraine® tablets are white tablets embossed with "ORGANON 542" on one side. They are individually foil stripped and packaged in boxes of 20's NDC #0052-0542-20 and 100's NDC #0052-0542-91.

STORAGE

Wigraine® tablets should be stored at a maximum of 30°C (86°F).

CAUTION

Rx only

Organon Inc.
West Orange, NJ 07052

Last updated on RxList: 12/8/2004

In order of decreasing severity; precordial distress and pain, muscle pains in the extremities, numbness and tingling in fingers and toes, transient tachycardia or bradycardia, vomiting, nausea, weakness in the legs, diarrhea, localized edema and itching.

No Information Provided.

Last updated on RxList: 12/8/2004

No Information Provided.

Although signs and symptoms of ergotism rarely develop even after long term intermittent use of the orally administered drug, care should be exercised to remain within the limits of recommended dosage.

Pregnancy Category X.   See Contraindications section.

Nursing Mothers.   It is not known whether the ergotamine tartrate in Wigraine® is excreted in human milk. Because some ergot alkaloids have been found in the milk of nursing mothers resulting in symptoms of ergotism in their children, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Usage.   Safety and effectiveness in children have not been established.

Last updated on RxList: 12/8/2004

The toxic effects of an acute overdosage of Wigraine® are due primarily to the ergotamine component. The amount of caffeine is such that its toxic effects will be overshadowed by those of ergotamine. Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses, hypertension or hypotension, drowsiness, stupor, coma, convulsions and shock. Treatment consists of removal of the offending drug by induction of emesis, gastric lavage and catharsis. Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be used with benefit but caution must be exercised to avoid aggravating an already existing hypotension. The LD50 limits of the various components as outlined in NIOSH 1978 Registry of Toxic Effects of Chemical Substances, published by U.S. Department of Health, Education and Welfare are as follows: Ergotamine Tartrate IV LD50 in rats = 80mg/Kg, Caffeine IV LD50 in rats = 105mg/Kg.

Wigraine® can cause fetal harm when administered to a pregnant women. It can produce prolonged uterine contractions which can result in abortion. Wigraine® is contraindicated in women who are or may become pregnant. If this is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential hazard to the fetus.

Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function, sepsis and hypersensitivity to any of the components.

Last updated on RxList: 12/8/2004

Ergotamine is an alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater. Caffeine, also a cranial vasoconstrictor is added to further enhance the vasoconstrictive effect without the necessity of increasing ergotamine dosage.

Last updated on RxList: 12/8/2004

No Information Provided.

Last updated on RxList: 12/8/2004

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

ERGOTAMINE/CAFFEINE - ORAL

(er-GOT-uh-meen/KAF-een)

COMMON BRAND NAME(S): Ercaf, Wigraine

WARNING: This medication has infrequently caused a lack of blood flow to the hands and feet (peripheral ischemia). It has also rarely caused a lack of blood flow to the brain (cerebral ischemia). The chances of these effects are increased when this medication is taken with certain drugs. Do not take this medication with macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin, telithromycin), protease inhibitors (e.g., amprenavir, indinavir, nelfinavir, ritonavir, saquinavir), or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Consult your doctor or pharmacist for more details.

USES: 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 increasing the absorption of ergotamine and also by narrowing the widened blood vessels in the head.

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor.

Dosage is based on your medical condition and response to therapy. This medication works best if it is taken 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 taken only as needed. It is not meant for long-term daily use. The maximum dose is 6 tablets for a single headache attack and 10 tablets in any 7-day period.

This medication may cause dependence, especially if it has been used regularly for an extended time (more than a few weeks) or if it has been used in high doses. In such cases, if you suddenly stop this drug, "rebound headaches" may occur. 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.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit can increase the amount of certain medications in your bloodstream. 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: 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.

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, vision changes, confusion, slurred speech.

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking 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 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, recent 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, diabetes, high blood pressure (controlled), stomach problems (e.g., ulcers).

This drug may make you dizzy; use caution while engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Remember that alcohol may be a cause of headaches.

This medication may harm an unborn baby. Therefore, it must not be used during pregnancy. It is recommended that men and women use two effective forms of birth control (e.g., condoms, birth control pill) while taking this medication. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control.

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.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: delavirdine, efavirenz, sibutramine.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this medication.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: adenosine, certain beta blockers (e.g., propranolol), cimetidine, dopamine, drugs affecting liver enzymes that remove ergotamine from your body (such as fluoxetine, fluvoxamine, metronidazole, nefazodone, zileuton), lithium, nicotine (e.g., nicotine gum, nicotine patches), nitrates (e.g., isosorbide, nitroglycerin), other ergot alkaloids (e.g., methysergide), theophylline.

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 document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: severe dizziness/drowsiness, loss of feeling in the fingers/toes, rapid/weak heartbeat, bluish hands/feet, seizures.

NOTES: 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.

MISSED DOSE: If you miss a dose, take 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.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. 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 July 2008 Copyright(c) 2008 First DataBank, Inc.