IMPORTANT NOTE: The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

ERGOTAMINE/CAFFEINE/BELLADONNA/PENTOBARB - ORAL

(er-GOT-uh-meen/kaff-EEN/bell-uh-DON-uh/PENT-oh-barb)

COMMON BRAND NAME(S): Cafatine PB, Micomp-PB, Urkaf-PB

USES: This medication is used to treat migraine and other types of recurring, throbbing headaches accompanied with nausea and vomiting or associated with nervous tension.

HOW TO USE: Take this medication by mouth as directed at the earliest sign a headache is starting. It will take longer to be effective if you wait until the headache becomes severe. For best results, lie down in a quiet, dark room for an hour or two after taking this to help relieve the headache. Take this medication exactly as directed. If necessary, the dose may be repeated every 30 minutes until the headache pain stops or a total of 6 tablets for adults or 3 tablets for children have been ingested, whichever comes first. Adults should not take more than 10 tablets or children more than 3 tablets in a one week period. If you require more medication than this, consult your doctor. Long-term use or excessive dosing may lead to dependence. If stomach upset occurs, this may be taken with food or milk.

SIDE EFFECTS: Stomach upset, nausea, vomiting, drowsiness, frequent urination and constipation have been reported. If any of these effects continue or become bothersome, inform your doctor. Notify your doctor if you experience: muscle pain, weakness in the legs, tingling in the fingers or toes, fast/irregular heartbeat, dry mouth, blurred vision, painful urination. If you notice other effects not listed above, contact your doctor or pharmacist.

PRECAUTIONS: Tell your doctor if you have: liver disease, kidney disease, heart disease, chest pain, high blood pressure, blood vessel disease, poor circulation, glaucoma, prostate trouble, ulcers, a severe infection, allergies (especially to caffeine). Use caution performing tasks requiring alertness if this medication makes you drowsy. Avoid the use of alcohol while taking this medication. This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. This combination drug contains ingredients that are excreted into breast milk and may have undesirable effects on a nursing infant. Breast-feeding should not be undertaken while using this medication.

DRUG INTERACTIONS: Infrequently, a very serious, life-threatening decrease in the amount of blood supply to the hands and feet (peripheral ischemia) and rarely to the brain can occur when this medication is taken with drugs that affect liver metabolism (e.g., potent CYP 3A4 enzyme inhibitors). Do not take this medication with macrolide antibiotics (e.g., erythromycin, clarithromycin, troleandomycin), protease inhibitors (e.g., ritonavir, nelfinavir, indinavir, amprenavir, saquinavir), azole antifungals (e.g., ketoconazole, itraconazole). Tell your doctor of all over-the-counter or prescription medications you may use including: propranolol, high blood pressure medication, blood thinners, sedatives, narcotic pain relievers, sleeping pills, nitrates (e.g., isosorbide, nitroglycerin), nefazodone, fluconazole, fluoxetine, fluvoxamine, zileuton, clotrimazole, other mild CYP 3A4 enzyme inhibitors. Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor instructs you otherwise. This drug may interfere with the effectiveness of birth control pills. Discuss using other methods of birth control with your doctor. Avoid drinking caffeine-containing beverages (coffee, tea, colas) and eating large amounts of chocolate. Because this medication contains caffeine, the risk of side effects may be increased. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include blurred vision, dilated pupils, hot and dry skin, dizziness, dryness of mouth, and slow or shallow breathing.

NOTES: This medication is used to treat a headache once it occurs. It is not effective in preventing a migraine headache from occurring. This medication is not to be taken to treat an ordinary headache.

MISSED DOSE: This medication is not taken routinely. As with most medications, if you miss a dose, do not "double-up" the dose to catch up.

STORAGE: Store at room temperature between 59 and 86 degrees F (15 to 30 degrees C) away from heat and light. Do not store in the bathroom. Keep out of reach of children.

Developed by First DataBank, Inc., San Bruno, CA
Copyright 2004 by First DataBank, Inc.