Generic Name: acetaminophen, dichloralphenazone, and isometheptene (a SEET a MIN oh fen, dye KLOR al FEN a zone, EYE soe me THEP teen)
Brand Names: Duradrin, Epidrin, Isocom, Midrin, Migquin, Migrapap, Migratine, Migrazone

What is Migquin (acetaminophen, dichloralphenazone, and isometheptene)?

Acetaminophen is a pain reliever and a fever reducer.

Dichloralphenazone is a sedative that slows the central nervous system.

Isometheptene causes narrowing of blood vessels (vasoconstriction).

The combination of acetaminophen, dichloralphenazone, and isometheptene is used to treat migraine headaches or severe tension headaches.

Acetaminophen, dichloralphenazone, and isometheptene may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Migquin (acetaminophen, dichloralphenazone, and isometheptene)?

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. You should not take this medication if you are allergic to acetaminophen (Tylenol), dichloralphenazone, isometheptene, or chloral hydrate (Somnote), or if you have glaucoma or if you are also taking sodium oxybate (Xyrem).

Before taking acetaminophen, dichloralphenazone, and isometheptene, tell your doctor if you have liver or kidney disease, coronary artery disease, circulation problems, high blood pressure, stomach ulcer, problems with your esophagus, depression, a history of drug or alcohol addiction, or if you have recently had a stroke or heart attack.

Do not take more than 5 capsules in 12 hours to treat a migraine, or 8 capsules in 24 hours to treat a tension headache. Avoid drinking alcohol. Alcohol can cause headaches, and may also increase your risk of liver damage while taking acetaminophen. If you drink more than 3 alcoholic beverages per day, talk with your doctor before taking any medication that contains acetaminophen. Alcohol may increase your risk of liver damage while taking acetaminophen. Do not use any cold, allergy, pain, migraine, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen, or APAP.

What should I discuss with my healthcare provider before taking Migquin (acetaminophen, dichloralphenazone, and isometheptene)?

Do not take this medication if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Dangerous side effects could result. You should not take this medication if you are allergic to acetaminophen (Tylenol), dichloralphenazone, isometheptene, or chloral hydrate (Somnote), or if you have:

• glaucoma; or

• if you are also taking sodium oxybate (Xyrem).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• liver disease;
• kidney disease;

• coronary artery disease, circulation problems;

• high blood pressure;

• stomach ulcer or problems with your esophagus;

• depression;

• a history of drug or alcohol addiction; or

• if you have recently had a stroke or heart attack.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before you take acetaminophen, dichloralphenazone, and isometheptene, tell your doctor if you are pregnant. This medication can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Migquin (acetaminophen, dichloralphenazone, and isometheptene)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use more of this medication than is recommended. An overdose of acetaminophen can cause serious harm. The maximum amount for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Using more acetaminophen could cause damage to your liver. If you drink more than three alcoholic beverages per day, talk to your doctor before taking acetaminophen and never use more than 2 grams (2000 mg) per day.

You may take this medication with or without food.

Take the medicine with a full glass of water.

To treat migraine headache pain:

• Take the first dose of this medication as soon as you notice headache symptoms, or after an attack has already begun.

• If your headache does not completely go away, take 1 capsule every hour until you feel relief.

• Do not take more than a total of 5 capsules in any 12-hour period to treat a migraine.

• If you still have migraine symptoms after taking a total of 5 capsules, call your doctor.

To treat tension headache pain:

• Take the first dose of this medication as soon as you notice tension headache symptoms.

• If your headache does not completely go away, take 1 capsule every 4 hours until you feel relief.

• Do not take more than a total of 8 capsules in any 24-hour period to treat a tension headache.

• If you still have tension headache pain after taking a total of 8 capsules, call your doctor.

Call your doctor if this medication seems to stop working as well in relieving your pain. Also call your doctor if your headaches get worse or you have more than 2 headaches per week.

Do not stop using this medication suddenly if you have been using it for longer than 2 weeks in a row, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when you stop using acetaminophen, dichloralphenazone, and isometheptene. If you need to have any type of surgery, tell the surgeon ahead of time that you are using this medication.

This medication can cause you to have unusual results with certain lab tests, including tests to check for glucose (sugar) in the urine. Tell any doctor who treats you that you are using acetaminophen, dichloralphenazone, and isometheptene.

Store this medication at room temperature away from heat, moisture, and light.

What happens if I miss a dose?

Since acetaminophen, dichloralphenazone, and isometheptene is taken only when needed, you will not be on a daily dosing schedule.

Do not take more than 5 capsules in 12 hours to treat a migraine, or 8 capsules in 24 hours to treat a tension headache.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.

Other overdose symptoms may include severe dizziness or drowsiness, feeling restless or cold, changes in your breathing or heart rate, and fainting.

What should I avoid while taking Migquin (acetaminophen, dichloralphenazone, and isometheptene)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. Alcohol can cause headaches, and may also increase your risk of liver damage while taking acetaminophen. Do not use any cold, allergy, pain, migraine, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen, or APAP.

Migquin (acetaminophen, dichloralphenazone, and isometheptene) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using acetaminophen, dichloralphenazone, and isometheptene and call your doctor at once if you have a serious side effect such as:

• low fever with nausea, stomach pain, and loss of appetite;

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fast or uneven heart rate;

• easy bruising or bleeding, unusual weakness; or

• fever, chills, sore throat, body aches, flu symptoms.

Less serious side effects may include:

• dizziness, drowsiness;

• mild nausea; or

• mood changes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Migquin (acetaminophen, dichloralphenazone, and isometheptene)?

Before using this medication, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by acetaminophen, dichloralphenazone, and isometheptene.

Tell your doctor about all other medications you use, especially:

• a blood thinner such as warfarin (Coumadin);

• isoniazid (for treating tuberculosis); or

• an antidepressant such as amitriptyline (Elavil, Vanatrip), doxepin (Sinequan), desipramine (Norpramin), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, dichloralphenazone, and isometheptene. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, dichloralphenazone, and isometheptene.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 4.01. Revision Date: 02/10/2010 4:20:21 PM.

Generic Name: Caffeine/Ergotamine (ka-FEEN/er-GOT-a-meen)
Brand Name: Examples include Cafergot and Migergot

Migergot Suppositories are 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.

Migergot Suppositories are 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 Migergot Suppositories if:

• you are allergic to any ingredient in Migergot 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 Migergot Suppositories:

Some medical conditions may interact with Migergot 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 Migergot 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 Migergot 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 Migergot Suppositories

This may not be a complete list of all interactions that may occur. Ask your health care provider if Migergot 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 Migergot Suppositories:

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

• Migergot Suppositories may be taken with or without food.
• Eating grapefruit or drinking grapefruit juice may affect the amount of Migergot Suppositories in your blood. Talk with your doctor before including grapefruit or grapefruit juice in your diet.
• Migergot Suppositories are only to be used as needed for a migraine attack.
• Use Migergot 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 Migergot 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 Migergot 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 Migergot Suppositories and you still have a headache, use it as soon as you remember. Do not use a dose of Migergot 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 Migergot Suppositories.

Important safety information:

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

Possible side effects of Migergot 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.

Seek medical attention right away if any of these SEVERE side effects occur:

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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), 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.

Proper storage of Migergot Suppositories:

Store Migergot 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 Migergot Suppositories out of the reach of children and away from pets.

General information:

• If you have any questions about Migergot Suppositories, please talk with your doctor, pharmacist, or other health care provider.
• Migergot Suppositories are 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 Migergot 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.

Generic Name: miglitol (MIG lih tall)
Brand Names: Glyset

What is miglitol?

Miglitol delays the digestion of carbohydrates (forms of sugar) in your body. This decreases the amount of sugar that passes into your blood after a meal and prevents periods of hyperglycemia (high blood sugar).

Miglitol is used to treat non-insulin-dependent (Type II) diabetes mellitus.

Miglitol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about miglitol?

Take each dose of miglitol with the first bite of a main meal.

Know the signs and symptoms of low blood sugar, which include headache, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, and, nausea. Carry glucose tablets, paste, or another glucose or dextrose substance to treat episodes of low blood sugar.

Who should not take miglitol?

Before taking this medication, tell your doctor if you have

• an inflammatory bowel disease, such as ulcerative colitis or Chron’s disease; or any other disease of the stomach or intestines;

• ulcers of the colon;

• a blockage or obstruction in your intestines; or

• kidney disease.

You may not be able to take miglitol, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Call your doctor if you develop a fever or an infection, or if you experience a serious injury. You may require insulin for a period of time to control your blood sugar levels.

Miglitol is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. Do not take miglitol without first talking to your doctor if you are pregnant. Miglitol passes into breast milk and may affect a nursing infant. Do not take miglitol without first talking to your doctor if you are breast-feeding a baby.

How should I take miglitol?

Take miglitol exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water. Take each dose with the first bite of a main meal. Store miglitol at room temperature away from moisture and heat.

See also: Miglitol dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of this medication.

What happens if I overdose?

Seek emergency medical attention.

An overdose of this medication is unlikely to occur. Symptoms of an overdose are unknown, but stomach pain, gas, bloating, and diarrhea might be expected.

What should I avoid while taking miglitol?

Follow your doctor’s diet and exercise recommendations to help control your blood sugar levels.

Use alcohol cautiously. Alcohol may affect your blood sugar levels.

Miglitol side effects

Stop taking miglitol and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects, are more likely to occur. Continue to take miglitol and talk to your doctor if you experience

• abdominal pain,

• diarrhea,

• flatulence, or

• a rash.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Miglitol Dosing Information

Usual Adult Dose for Diabetes Mellitus Type II:

Initial dose: 25 mg orally 3 times a day at the beginning (with the first bite) of each meal.

What other drugs will affect miglitol?

Digestive-enzyme supplements such as pancreatin (amylase, protease, lipase) in products such as Arco-Lase, Cotazym, Donnazyme, Pancrease, Creon, Ku-Zyme, and others may decrease the effects of miglitol. These medications should not be taken at the same time as miglitol.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

• propranolol (Inderal);

• ranitidine (Zantac, Zantac 75);

• digoxin (Lanoxin, Lanoxicaps),

• another diabetes medicine such as glyburide (Micronase, Diabeta, Glynase), glipizide (Glucotrol), tolbutamide (Orinase), metformin (Glucophage), and others;

• a thiazide diuretic (water pill) such as hydrochlorothiazide (HCTZ, Hydrodiuril, others), chlorothiazide (Diuril), chlorthalidone (Thalitone), indapamide (Lozol), and others;

• a steroid medication such as prednisone (Deltasone), methylprednisolone (Medrol), and others;

• an estrogen (Premarin, Ogen, and others) or an estrogen-containing birth control pill;

• a thyroid medication (Synthroid, Levoxyl, and others);

• phenytoin (Dilantin); or

• a calcium channel blocker such as verapamil (Calan, Verelan, Isoptin), diltiazem (Cardizem, Dilacor XR), nifedipine (Procardia, Adalat), and others.

The drugs listed above may interact with miglitol or affect blood sugar levels. You may require a dosage adjustment or special monitoring during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with miglitol or affect your condition. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

Where can I get more information?

• Your pharmacist has more information about miglitol written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.04. Revision Date: 4/12/2009 4:42:39 PM.

MIG-li-tol

Commonly used brand name(s):

In the U.S.

• Glyset

Available Dosage Forms:

• Tablet

Therapeutic Class: Antidiabetic

Pharmacologic Class: Alpha-Glucosidase Inhibitor

Uses For miglitol

Miglitol is used to treat high blood sugar levels that are caused by type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. In type 2 diabetes, your body does not work properly to store the excess sugar and the sugar remains in your bloodstream. Having high blood sugar can lead to serious health problems in the future. Proper diet is the first step in managing type 2 diabetes but often medicines are needed to help your body. Miglitol is a medicine that slows the digestion of sugars so your body has time to store extra sugar. Sometimes another medicine called sulfonylurea can be used in combination with miglitol to help your body store more sugar.

miglitol is available only with your doctor’s prescription.

Before Using miglitol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For miglitol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to miglitol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on miglitol have been done only in adult patients, and there is no specific information comparing use of miglitol in children with use in other age groups.

Geriatric

miglitol has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using miglitol with any of the following medicines is usually not recommended, but may be required 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.

• Alatrofloxacin
• Balofloxacin
• Ciprofloxacin
• Clinafloxacin
• Enoxacin
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Levofloxacin
• Lomefloxacin
• Moxifloxacin
• Norfloxacin
• Ofloxacin
• Pefloxacin
• Prulifloxacin
• Rufloxacin
• Sparfloxacin
• Temafloxacin
• Tosufloxacin
• Trovafloxacin Mesylate

Using miglitol with any of the following medicines may cause an increased 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.

• Acebutolol
• Alprenolol
• Atenolol
• Betaxolol
• Bevantolol
• Bisoprolol
• Bitter Melon
• Bucindolol
• Carteolol
• Carvedilol
• Celiprolol
• Clorgyline
• Dilevalol
• Esmolol
• Glucomannan
• Guar Gum
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Mepindolol
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Oxprenolol
• Pargyline
• Penbutolol
• Phenelzine
• Pindolol
• Procarbazine
• Propranolol
• Psyllium
• Selegiline
• Sotalol
• St John’s Wort
• Talinolol
• Tertatolol
• Timolol
• Toloxatone
• Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of miglitol. Make sure you tell your doctor if you have any other medical problems, especially:

• Digestion problems or
• Inflammatory bowel disease or
• Intestinal blockage or
• Other intestinal problems—Miglitol should not be used

• Kidney disease—Higher levels of miglitol may result and a smaller dose may be needed

Proper Use of miglitol

Follow carefully the special meal plan you doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

For miglitol to work properly it should be taken with the first bite of each main meal.

Dosing

The dose of miglitol 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 miglitol. 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 type 2 diabetes:
    • Adults—At first the dose is 25 milligrams (mg) three times a day, at the start (with the first bite) of each main meal. After four to eight weeks, your doctor may increase your dose to 50 mg three times a day. Then, after an additional twelve weeks, if necessary, your doctor may increase your dose to 100 mg three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of miglitol, 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.

Precautions While Using miglitol

Your doctor will want to check your progress at regular visits, especially during the first few weeks that you take miglitol.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• Other medicines—Do not take other medicines during the time you are taking miglitol unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
• Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
• Travel—Keep a recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.

In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all your medicines.

Symptoms of hypoglycemia (low blood sugar) include anxiety; behavior change similar to being drunk; blurred vision; cold sweats; confusion; cool, pale skin; difficulty in thinking; drowsiness; excessive hunger; fast heartbeat; headache (continuing); nausea; nervousness; nightmares; restless sleep; shakiness; slurred speech; or unusual tiredness or weakness.

Miglitol does not cause low blood sugar. However, it can occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, or take miglitol with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly.

If symptoms of low blood sugar occur, eat glucose tablets or gel or honey, or drink fruit juice to relieve the symptoms. Table sugar (sucrose) or regular (nondiet) soft drinks will not work. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Symptoms of hyperglycemia (high blood sugar) include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination; ketones in urine; loss of appetite; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your health care professional for instructions.

miglitol Side Effects

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:

More common

• Bloated full feeling
• excess air or gas in stomach or intestines
• increase in bowel movements
• loose stools
• passing gas
• soft stools
• stomach or abdomen pain

Less common

• Skin rash

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

mif-e-PRIS-tone

Commonly used brand name(s):

In the U.S.

• Mifeprex

Available Dosage Forms:

• Tablet

Therapeutic Class: Antiprogesterone

Uses For mifepristone

Mifepristone is used to end a pregnancy that is less than 49 days in duration. It works by stopping the supply of hormones that maintains the interior of the uterus. Without these hormones, the uterus cannot support the pregnancy and the contents of the uterus are expelled.

mifepristone is available only with your doctor’s prescription.

Before Using mifepristone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mifepristone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mifepristone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of mifepristone. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal failure—Mifepristone may not work appropriately

• Bleeding problems—May cause excessive vaginal bleeding

• Diabetes or
• Heart disease or
• High blood pressure or
• Kidney disease or
• Liver disease or
• Lung disease
• Women older than 35 years of age who smoke cigarettes (10 or more a day)—You should use caution if you have any of these chronic conditions and let your doctor know before beginning treatment with mifepristone.

• Ectopic pregnancy (e.g., a pregnancy that develops in fallopian tubes instead of the uterus) or
• Lower abdominal mass—Mifepristone will not terminate an ectopic pregnancy

• An intrauterine device (IUD) that is still in the uterus—Must be removed before mifepristone therapy is started

• Porphyria, inherited

• Anemia, severe or
• Poor blood circulation or
• Inability of blood to clot properly—Mifepristone causes heavy bleeding in a small portion of users, this may be intensified in patients with bleeding disorders

Proper Use of mifepristone

Dosing

The dose of mifepristone 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 mifepristone. 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.

• To terminate a pregnancy of 49 days or less duration:
  • For oral dosage form (tablets):
    • Adults—600 milligrams (mg) (three 200 mg tablets) as a single oral dose followed two days later by 400 micrograms (mcg) (two 200 mcg tablets) of misoprostol as a single oral dose as needed.

Precautions While Using mifepristone

You must have 3 visits to your physicians office during the treatment procedure. It is extremely important that you attend all three visits.

Check with your physician if the vaginal bleeding becomes severe or seems to last longer than expected (i.e., soaking through two thick full-size sanitary pads per hour for two consecutive hours).

You may need to have a surgical procedure to stop excessive vaginal bleeding or to terminate a pregnancy that was not terminated with the medical treatment procedure.

You should check with your physician immediately if signs or symptoms of serious infection (i.e., continuing fever ≥ 100.4 °F, severe stomach pain, pelvic tenderness, weakness, nausea, vomiting, diarrhea or abnormally fast heartbeat) occur.

mifepristone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

• Excessively heavy vaginal bleeding
• unusual tiredness or weakness

Incidence not known

• Chest pain or discomfort
• confusion
• cough or hoarseness
• fast, weak pulse
• fever or chills
• lower back or side pain
• pain or discomfort in arms, jaw, back or neck
• painful or difficult urination
• pale, cold, clammy skin
• shortness of breath
• sudden increase in abdominal or shoulder pain
• sweating
• unusual or large amount of vaginal bleeding

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:

More common

• Abdominal pain or uterine cramping
• back pain
• diarrhea
• dizziness
• headache
• nausea or vomiting

Less common

• Acid or sour stomach
• anxiety
• belching
• cough
• fainting or light-headedness when getting up from a lying or sitting position
• fever
• flu-like symptoms
• headache
• heartburn
• increased clear or white vaginal discharge
• indigestion
• itching of the vagina or genital area
• lack or loss of strength
• pain during sexual intercourse
• pain or tenderness around eyes and cheekbones
• pale skin
• shaking chills
• shortness of breath or troubled breathing
• sleeplessness or trouble sleeping
• stomach discomfort, upset, or pain
• tightness of chest or wheezing
• troubled breathing, exertional
• unusual bleeding or bruising
• stuffy or runny nose

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.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

Generic Name: caffeine and ergotamine (oral/rectal) (KAF een and er GOT a meen)
Brand Names: Cafergot, Migergot

What is caffeine and ergotamine?

Caffeine is a stimulant that causes narrowing of blood vessels (vasoconstriction).

Ergotamine is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain. Ergotamine also affects blood flow patterns that are associated with certain types of headaches.

The combination of caffeine and ergotamine is used to treat or prevent a migraine type headache.

This medication will only treat a headache that has already begun. It will not prevent migraine headaches or reduce the number of attacks.

Caffeine and ergotamine should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches.

Caffeine and ergotamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about caffeine and ergotamine?

This medication can harm an unborn baby or a nursing baby. Do not use caffeine and ergotamine if you are pregnant or breast-feeding. Do not use this medication if you are allergic to caffeine and ergotamine or other ergot medicines, or if you have a history of heart disease, angina (chest pain), blood circulation problems, history of a heart attack or stroke, coronary artery disease, uncontrolled high blood pressure, severe liver or kidney disease, or a serious infection. Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Tell your doctor about all other medications you are using, especially antibiotics, antidepressants, heart or blood pressure medications, or medicines to treat HIV or AIDS.

Also tell your doctor about all of your medical conditions, especially breathing problems, high blood pressure, liver or kidney disease, or risk factors for coronary artery disease (diabetes, high blood pressure or cholesterol, menopause or hysterectomy, smoking, taking birth control pills, being overweight, having a family history of coronary artery disease, or being a man older than 40).

This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Never use more than your prescribed dose of caffeine and ergotamine. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. An overdose of caffeine and ergotamine can be fatal.

What should I discuss with my healthcare provider before using caffeine and ergotamine ?

Do not use this medication if you are allergic to caffeine or ergotamine, or other ergot medicine such as dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).

Do not use caffeine and ergotamine if you are pregnant or breast-feeding, or if you have:

• a history of heart disease, angina (chest pain), blood circulation problems, or history of a heart attack or stroke;

• coronary artery disease or “hardening of the arteries”;

• uncontrolled high blood pressure;

• severe liver disease;
• severe kidney disease; or

• a serious infection called sepsis.

Using certain medications together with caffeine and ergotamine can cause even greater decreases in blood flow than caffeine and ergotamine used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use caffeine and ergotamine if you are also using any of the following medications:

• conivaptan (Vaprisol);

• diclofenac (Arthrotec, Cataflam, Voltaren, Flector Patch, Solareze);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);

• an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);

• an antidepressant such as nefazodone;

• heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or

• HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).

Caffeine and ergotamine can cause rare but serious side effects on the heart, including heart attack or stroke. If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using caffeine and ergotamine, tell your doctor if you have:

• breathing problems;

• high blood pressure;

• liver disease;

• kidney disease; or

• coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).

FDA pregnancy category X. This medication can cause birth defects. Do not use caffeine and ergotamine if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using caffeine and ergotamine. Caffeine and ergotamine passes into breast milk and may be harmful to a nursing infant. Do not use caffeine and ergotamine without telling your doctor if you are breast-feeding a baby.

How should I use caffeine and ergotamine?

Use this medication exactly as prescribed by your doctor. Never use more than your prescribed dose of caffeine and ergotamine. Follow the directions on your prescription label. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks. Caffeine and ergotamine is not for daily use.

To use caffeine and ergotamine tablets: Take 2 tablets of caffeine and ergotamine as soon as you notice headache symptoms, or after an attack has already begun.

If your headache does not completely go away, you may take 1 more tablet after at least 30 minutes have passed. If additional medication is needed, you may take 1 tablet every 30 minutes up to a total of 6 tablets for one migraine attack.

If you still have migraine symptoms after taking a total of 6 tablets, call your doctor. Do not take more than a total of 6 tablets in any 24-hour period. Do not take more than a total of 10 tablets over a period of 7 days.

To use caffeine and ergotamine rectal suppositories: Insert 1 suppository at the first sign of migraine headache symptoms, or after an attack has already begun. If your headache does not completely go away, use 1 more suppository after at least 1 hour has passed.

Do not take a rectal suppository by mouth. It is for use only in your rectum.

Try to empty your bladder just before using the suppository. Remove the outer wrapper from the suppository and insert it gently into the rectum, pointed tip first. Avoid handling the suppository too long or it will melt in your hands.

For best results, lie down after inserting the suppository and hold it in for a few minutes. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in. Avoid using the bathroom just after you have inserted the suppository.

If you still have migraine symptoms after using a total of 2 rectal suppositories, call your doctor. Do not use more than a total of 2 suppositories per headache. Do not use more than a total of 5 suppositories over a period of 7 days. Do not give this medication to anyone else, even if they have the same headache symptoms you have. Caffeine and ergotamine can be dangerous if it is used to treat headache in a person who has not been diagnosed by a doctor as having true migraine headaches. Store caffeine and ergotamine at room temperature away from moisture, heat, and light. Do not use any stored caffeine and ergotamine if the expiration date on the label has passed.

What happens if I miss a dose?

Since caffeine and ergotamine is used only when needed, you are not likely to miss a dose.

Do not take more than 6 caffeine and ergotamine tablets per day or more than 10 tablets per week. Do not use more than 2 suppositories per headache or 5 suppositories per week.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of caffeine and ergotamine can be fatal.

Overdose can cause vomiting, confusion, drowsiness, weak pulses in your arms and legs, numbness and tingling or pain in your hands or feet, blue-colored fingers or toes, fainting, and seizure (convulsions).

What should I avoid while using caffeine and ergotamine?

Do not use caffeine and ergotamine within 24 hours before or after using another migraine headache medicine, including:

• dihydroergotamine (D.H.E. 45, Migranal), caffeine and ergotamine (Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), methysergide (Sansert); or

• almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), sumatriptan (Imitrex), rizatriptan (Maxalt, Maxalt-MLT), or zolmitriptan (Zomig).

Grapefruit and grapefruit juice may interact with caffeine and ergotamine and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Caffeine and ergotamine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using caffeine and ergotamine and call your doctor at once if you have a serious side effect such as:

• sudden numbness or weakness, especially on one side of the body;

• sudden headache, confusion, problems with vision, speech, or balance;

• fast or slow heart rate;

• muscle pain in your arms or legs;

• leg weakness;

• numbness or tingling and a pale or blue-colored appearance in your fingers or toes;

• severe pain in your stomach or lower back;

• urinating less than usual or not at all;

• painful sores on your rectum after using the rectal suppositories;

• swelling or itching in any part of your body;

• cough with stabbing chest pain and trouble breathing; or

• dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, confusion, chest pain, shortness of breath, uneven heartbeats, seizure).

Less serious side effects may include:

• dizziness, spinning sensation;

• weakness;

• nausea, vomiting; or

• mild itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect caffeine and ergotamine?

Many drugs can interact with caffeine and ergotamine. Below is just a partial list. Talk with your doctor before using caffeine and ergotamine if you are also taking:

• birth control pills;

• zileuton (Zyflo);

• cold or allergy medications;

• nicotine (Nicoderm, Nicorette);

• diet pills, stimulants, or medication to treat ADHD (such as Ritalin or Adderall);

• an antidepressant such fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), nefazodone (Serzone), paroxetine (Paxil), sertraline (Zoloft), and others;

• nitroglycerin or other nitrate medicines such as isosorbide (Isordil, Dilatrate, Imdur, Monoket); or

• heart or blood pressure medication such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others.

This list is not complete and there may be other drugs that can interact with caffeine and ergotamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about caffeine and ergotamine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 09/15/2009 11:39:18 AM.

Generic Name: mifepristone (mih feh PRIH stone)
Brand Names: Mifeprex

What is Mifeprex (mifepristone)?

Mifepristone blocks the actions of the naturally occurring hormone progesterone, which is necessary for pregnancy to continue.

When used together with another medicine called misoprostol, mifepristone is used to end an early pregnancy.

Mifepristone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Mifeprex (mifepristone)?

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

What should I discuss with my healthcare provider before taking Mifeprex (mifepristone)?

Do not take mifepristone if

• it has been more than 49 days (7 weeks) since your last menstrual period began;

• you have an IUD;

• your healthcare provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy);

• you have problems with your adrenal glands (chronic adrenal failure);

• you take a medicine such as warfarin (Coumadin) to thin your blood;

• you have a bleeding problem;

• you take certain steroid medicines:

• you cannot return for the next 2 visits;

• you cannot easily get emergency medical help in the 2 weeks after you take mifepristone; or

• you are allergic to medicines that contain misoprostol, such as Cytotec or Arthrotec.

Before taking mifepristone, tell your healthcare provider about any other medical conditions that you have and if you smoke 10 or more cigarettes a day. You may not be able to take mifepristone, or you may require special monitoring during treatment.

Mifepristone is in the FDA pregnancy category X. This means that mifepristone is known to cause birth defects in an unborn baby. Mifepristone treatment that does not end in termination of pregnancy may cause birth defects in the unborn baby. It is not known whether mifepristone passes into breast milk. Do not take mifepristone without first talking to your doctor if you are breast-feeding a baby.

How should I take Mifeprex (mifepristone)?

Take mifepristone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

On Day 1 at your healthcare provider’s office, you will read the Medication Guide for mifepristone and discuss the benefits and risks of using mifepristone. If you decide that mifepristone is right for you, you will sign the Patient Agreement then, after getting a physical exam, swallow 3 tablets of mifepristone.

When you return to your healthcare provider’s office on Day 3, your healthcare provider will check to see if you are still pregnant. If you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may send you home with medicines for these symptoms.

About Day 14 (2 weeks after you took mifepristone), you will return to your healthcare provider’s office to be sure you are well and that you are not pregnant. Your healthcare provider will check to see whether the pregnancy has completely ended. If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

What happens if I miss a dose?

Your doctor will administer mifepristone, so you will not miss a dose.

What happens if I overdose?

An overdose of mifepristone is unlikely to threaten life and is unlikely to occur since the tablets are administered at your doctor’s office.

Symptoms of a mifepristone overdose are not known.

What should I avoid while taking Mifeprex (mifepristone)?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

Mifeprex (mifepristone) side effects

Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives). Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

Other less serious side effects may include:

• diarrhea, nausea, vomiting;

• headache or dizziness;

• back pain; or

• tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Mifeprex (mifepristone)?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

Where can I get more information?

• Your pharmacist has additional information about mifepristone written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 4/12/2009 4:44:28 PM.

Generic Name: mifepristone (mih feh PRIH stone)
Brand Names: Mifeprex

What is mifepristone?

Mifepristone blocks the actions of the naturally occurring hormone progesterone, which is necessary for pregnancy to continue.

When used together with another medicine called misoprostol, mifepristone is used to end an early pregnancy.

Mifepristone may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about mifepristone?

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

What should I discuss with my healthcare provider before taking mifepristone?

Do not take mifepristone if

• it has been more than 49 days (7 weeks) since your last menstrual period began;

• you have an IUD;

• your healthcare provider has told you that you have a pregnancy outside the uterus (ectopic pregnancy);

• you have problems with your adrenal glands (chronic adrenal failure);

• you take a medicine such as warfarin (Coumadin) to thin your blood;

• you have a bleeding problem;

• you take certain steroid medicines:

• you cannot return for the next 2 visits;

• you cannot easily get emergency medical help in the 2 weeks after you take mifepristone; or

• you are allergic to medicines that contain misoprostol, such as Cytotec or Arthrotec.

Before taking mifepristone, tell your healthcare provider about any other medical conditions that you have and if you smoke 10 or more cigarettes a day. You may not be able to take mifepristone, or you may require special monitoring during treatment.

Mifepristone is in the FDA pregnancy category X. This means that mifepristone is known to cause birth defects in an unborn baby. Mifepristone treatment that does not end in termination of pregnancy may cause birth defects in the unborn baby. It is not known whether mifepristone passes into breast milk. Do not take mifepristone without first talking to your doctor if you are breast-feeding a baby.

How should I take mifepristone?

Take mifepristone exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Mifepristone is used to end an early pregnancy. Early pregnancy means it is 49 days (7 weeks) or less since your last menstrual period. Mifepristone must not be used to attempt to end pregnancy beyond this time.

Before taking mifepristone, you will need to read and understand the information in the Medication Guide that will be given to you. Then you will need to sign a statement (Patient Agreement) that you have decided to end the pregnancy.

On Day 1 at your healthcare provider’s office, you will read the Medication Guide for mifepristone and discuss the benefits and risks of using mifepristone. If you decide that mifepristone is right for you, you will sign the Patient Agreement then, after getting a physical exam, swallow 3 tablets of mifepristone.

When you return to your healthcare provider’s office on Day 3, your healthcare provider will check to see if you are still pregnant. If you are still pregnant, you will take 2 misoprostol tablets. Misoprostol may cause cramps, nausea, diarrhea, and other symptoms. Your healthcare provider may send you home with medicines for these symptoms.

About Day 14 (2 weeks after you took mifepristone), you will return to your healthcare provider’s office to be sure you are well and that you are not pregnant. Your healthcare provider will check to see whether the pregnancy has completely ended. If you are still pregnant after mifepristone therapy, you may need a surgical procedure to end the pregnancy. There is a chance that there may be birth defects from mifepristone if the pregnancy is not ended. Your healthcare provider will talk with you about the other choices you have, including a surgical procedure to end the pregnancy.

This treatment causes cramping and bleeding. Usually, these symptoms mean the treatment is working. But sometimes you can get cramping and bleeding and still be pregnant. This is why you must return to your provider on Day 3 and about day 14.

Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

See also: Mifepristone dosage in more detail

What happens if I miss a dose?

Your doctor will administer mifepristone, so you will not miss a dose.

What happens if I overdose?

An overdose of mifepristone is unlikely to threaten life and is unlikely to occur since the tablets are administered at your doctor’s office.

Symptoms of a mifepristone overdose are not known.

What should I avoid while taking mifepristone?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

Mifepristone side effects

Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives). Bleeding and spotting is expected for an average of 9 to 16 days and may last for up to 30 days after taking mifepristone. Bleeding may be similar to, or greater than, a normal heavy period. You may pass blood clots and tissue that come from the uterus. In about 1 out of 100 women, bleeding can be so heavy that it requires a surgical procedure (curettage) to stop it. Talk with your provider about what to do if you need emergency care to stop heavy and possibly dangerous bleeding. Contact your healthcare provider right away if you bleed enough to soak through two thick full-size sanitary pads per hour for two consecutive hours or if you are concerned about heavy bleeding.

Other less serious side effects may include:

• diarrhea, nausea, vomiting;

• headache or dizziness;

• back pain; or

• tiredness.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Mifepristone Dosing Information

Usual Adult Dose for Abortion:

Day 1: three 200 mcg tablets (600 mcg total) orally administered as a single, one time dose.

Day 3: the patient returns to the health care provider 2 days after mifepristone ingestion. Unless abortion has been confirmed via clinical examination or ultrasonographic scan upon follow-up visit, the patient is given two 200 mcg tablets (400 mcg total) of MISOPROSTOL orally, administered as a single dose one time. The patient then returns 14 days after administration of mifepristone to confirm complete termination of early pregnancy.

What other drugs will affect mifepristone?

You should not take certain other medicines because they may interfere with mifepristone treatment. Ask your healthcare provider about what medicines you can take for pain. Do not take any other prescription or non-prescription medicines (including herbal medicines and supplements) at any time during the treatment period without first asking your healthcare provider.

Where can I get more information?

• Your pharmacist has additional information about mifepristone written for health professionals that you may read.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 3.04. Revision Date: 4/12/2009 4:44:28 PM.

Generic Name: Acetaminophen/Pamabrom/Pyrilamine (a-SEET-a-MIN-oh-fen/PAM-a-brom/pir-IL-a-meen)
Brand Name: Examples include Menstrual PMS and Midol PMS

Midol PMS is used for:

Treating symptoms associated with menstrual periods, such as muscle aches, cramps, bloating, headache, fatigue, breast tenderness, and water weight gain.

Midol PMS is an analgesic, antihistamine, and mild diuretic combination. The analgesic and antihistamine work in the brain to help reduce aches, pain, and discomfort associated with the menstrual period. The diuretic helps you to get rid of excess water to help relieve bloating and water weight gain.

Do NOT use Midol PMS if:

• you are allergic to any ingredient in Midol PMS
• you are taking sodium oxybate (GHB)

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

Before using Midol PMS:

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

• if you are pregnant, 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 alcohol abuse or you drink more than 3 alcohol-containing drinks every day
• if you have hepatitis, liver or kidney problems, lung or breathing problems (eg, asthma, emphysema or chronic bronchitis), increased pressure in the eye, glaucoma, a blockage of your bladder, prostate problems, or trouble urinating
• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or medicines that may damage the liver; ask your doctor or pharmacist if you are unsure if you take these types of medicines

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

• Sodium oxybate (GHB) because severe drowsiness and prolonged sleep duration may occur
• Anticoagulants (eg, warfarin) because the risk of their side effects, including bleeding, may be increased by Midol PMS
• Isoniazid because the risk of liver problems may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Midol PMS 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 Midol PMS:

Use Midol PMS as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Midol PMS by mouth with or without food.
• If you miss a dose of Midol PMS and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Midol PMS.

Important safety information:

• Midol PMS may cause drowsiness. This effect may be worse if you take it with alcohol or certain medicines. Use Midol PMS with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Midol PMS; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Check with your doctor if your pain symptoms do not get better within 10 days, if they get worse, or if new symptoms occur.
• Midol PMS has acetaminophen in it. Before you start any new medicine, check the label to see if it has acetaminophen in it too. If it does or if you are not sure, check with your doctor or pharmacist.
• Midol PMS may harm your liver. Your risk may be greater if you drink alcohol while you are using Midol PMS. Talk to your doctor before you take Midol PMS or other fever reducers if you drink more than 3 drinks with alcohol per day.
• Caution is advised when using Midol PMS in CHILDREN; they may be more sensitive to its effects, especially excitability.
• Check with your child’s doctor before giving Midol PMS to a CHILD younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Midol PMS while you are pregnant. It is not known if Midol PMS is found in breast milk. If you are or will be breast-feeding while you use Midol PMS, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Midol PMS:

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:

Drowsiness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; severe or persistent stomach pain; unusual fatigue; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately. Symptoms may include dark urine; excessive sweating; extreme fatigue; nausea and vomiting; stomach pain.

Proper storage of Midol PMS:

Store Midol PMS at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Midol PMS out of the reach of children and away from pets.

General information:

• If you have any questions about Midol PMS, please talk with your doctor, pharmacist, or other health care provider.
• Midol PMS 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 Midol PMS. 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.

Generic Name: acetaminophen, pamabrom, and pyrilamine (ah SEET a MIN o fen, PAM a brom, pir IL a meen)
Brand Names: Midol PMS Maximum Strength, Pamprin ES Multi-Symptom Relief Formula, Pamprin Maximum Pain, Premesyn PMS

What is Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine)?

Acetaminophen is a pain reliever and fever reducer.

Pamabrom is a diuretic (water pill).

Pyrilamine is an antihistamine.

The combination of acetaminophen, pamabrom, and pyrilamine is used to treat the symptoms of premenstrual syndrome, such as tension, bloating, water weight gain, headache, back pain, cramps, aches, and irritability.

Acetaminophen, pamabrom, and pyrilamine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine)?

Do not take more of this medication than is recommended. An overdose of acetaminophen can cause damage to your liver.

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drugs. Read the label of any other medicine you are using to see if it contains acetaminophen (sometimes abbreviated as “APAP”), pamabrom, or pyrilamine.

Avoid drinking alcohol. It can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen without your doctor’s advice, and never take more than 2 grams (2000 mg) per day.

What should I discuss with my health care provider before taking Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine)?

Do not take this medication if you are allergic to acetaminophen, pamabrom, or pyrilamine.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take acetaminophen, pamabrom, and pyrilamine, tell your doctor if you have:

• liver disease (especially cirrhosis);

• kidney disease;

• asthma, bronchitis, emphysema, or other breathing problem;

• glaucoma;

• a blockage in your stomach or intestines;

• enlarged prostate or urination problems; or

• if you drink more than three alcoholic beverages per day.

It is not known whether acetaminophen, pamabrom, and pyrilamine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether acetaminophen, pamabrom, and pyrilamine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 12 years old without the advice of a doctor. Children younger than 3 years old should not take acetaminophen, pamabrom, and pyrilamine.

How should I take Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine)?

Use this medication exactly as directed on the label, or as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended.

Take this medicine with a full glass of water.

An overdose of acetaminophen can cause serious harm. The maximum amount of acetaminophen for adults is 1 gram (1000 mg) per dose and 4 grams (4000 mg) per day. Taking more acetaminophen could cause damage to your liver. One acetaminophen, pamabrom, and pyrilamine tablet contains 500 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

If you drink more than three alcoholic beverages per day, do not take this medication without your doctor’s advice, and never take more than 2 grams (2000 mg) per day. Call your doctor if your symptoms do not improve after 10 days of treatment with acetaminophen, pamabrom, and pyrilamine. Store acetaminophen, pamabrom, and pyrilamine at room temperature away from moisture and heat.

What happens if I miss a dose?

Since this medication is often taken only when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

Never take more than 8 tablets in one 24-hour period.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of acetaminophen can cause serious harm.

Overdose symptoms may include dizziness, drowsiness, feeling restless or nervous, nausea, vomiting, diarrhea, stomach pain, loss of appetite, dry mouth, increased sweating, warmth or tingly feeling, jaundice (yellowing of your skin or eyes), feeling irritable, seizure (convulsions), and coma.

What should I avoid while taking Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine)?

Do not use any other cough, cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”), pamabrom, and pyrilamine are contained in many combination medicines. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains acetaminophen, APAP, pamabrom, or pyrilamine.

Avoid drinking alcohol. It can increase drowsiness caused by pyrilamine, and can increase the risk of liver damage while you are taking acetaminophen. If you drink more than three alcoholic beverages per day, do not take acetaminophen, pamabrom, and pyrilamine without your doctor’s advice, and never take more than 2 grams (2000 mg) of acetaminophen per day. This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using acetaminophen, pamabrom, and pyrilamine and call your doctor at once if you have a serious side effect such as:

• hot, dry skin with decreased sweating, headache, and increased thirst;

• fast, pounding, or uneven heartbeat;

• urinating less than usual or not at all;

• easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• dizziness, drowsiness;

• feeling restless, excited, or nervous;

• dry mouth;

• blurred vision;

• constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Midol PMS Maximum Strength (acetaminophen, pamabrom, and pyrilamine)?

Before using acetaminophen, pamabrom, and pyrilamine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by acetaminophen, pamabrom, and pyrilamine.

The following drugs may interact with acetaminophen, pamabrom, and pyrilamine. Tell your doctor if you are using any of these:

• atropine (Atreza, Sal-Tropine);

• cholestyramine (Questran);

• isoniazid;

• warfarin (Coumadin);

• zidovudine (Retrovir, AZT);

• a bronchodilator;

• diabetes medications you take by mouth;

• gout medications such as probenecid (Benemid);

• medications to treat or prevent nausea, vomiting, or motion sickness; or

• medicine to treat stomach ulcers, incontinence, or irritable bowel syndrome.

Acetaminophen can be harmful to the liver, and these effects may be increased when acetaminophen, pamabrom, and pyrilamine is used together with other medicines that can harm the liver. Before taking this medication, tell your doctor if you are also using:

• cancer medications

• tuberculosis medications;

• birth control pills or hormone replacement therapy;

• methotrexate (Rheumatrex, Trexall);

• arthritis medications such as auranofin (Ridaura);

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), and others;

• an antibiotic such as dapsone, erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or rifampin (Rifadin, Rifamate);

• an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), or ketoconazole (Nizoral);

• cholesterol medications such as niacin (Advicor), atorvastatin (Lipitor), lovastatin (Altocor, Mevacor), simvastatin (Zocor), and others;

• HIV/AIDS medications such as abacavir/lamivudine/zidovudine (Trizivir), lamivudine (Combivir, Epivir), nevirapine (Viramune), tenofovir (Viread), or zidovudine (Retrovir);

• an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or

• seizure medications such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), and others.

This list is not complete and there may be other drugs that can interact with acetaminophen, pamabrom, and pyrilamine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about acetaminophen, pamabrom, and pyrilamine.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.05. Revision Date: 08/12/2009 10:22:55 AM.