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Excedrin

30/06/10

Generic Name: Acetaminophen/Caffeine (ah-seet-ah-MIN-oh-fen /ka-FEEN)
Brand Name: Excedrin

Excedrin is used for:

Relieving fever and minor aches and pains caused by headache, toothache, colds, sinus swelling, muscle aches, menstrual cramps, and arthritis. It may also be used for other conditions as determined by your doctor.

Excedrin is an analgesic and antipyretic combination. It works by raising the pain threshold and acting on the heat control center in the brain.

Do NOT use Excedrin if:

you are allergic to any ingredient in Excedrin

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

Before using Excedrin:

Some medical conditions may interact with Excedrin. Tell your health care provider 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 anxiety or sleeplessness, liver disease, viral hepatitis, severe heart disease, or kidney problems

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

Isoniazid or quinolones (eg, ciprofloxacin) because side effects of Excedrin may be increased
Oral blood thinners (eg, warfarin) because side effects, including risk of bleeding, may be increased by Excedrin
Theophyllines (eg, aminophylline) because the risk of side effects may be increased by Excedrin

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

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

Excedrin may be taken with or without food.
If you miss a dose of Excedrin and you are using it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

Excedrin contains acetaminophen. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your doctor or pharmacist if you have any questions about which medicines contain acetaminophen.
Acetaminophen may cause liver damage. If you drink 3 or more alcoholic drinks every day, do not take Excedrin without first discussing it with your doctor. Alcohol use combined with acetaminophen may increase your risk for liver damage.
Adults should not take more than a total of 4 grams (4,000 mg) of acetaminophen per day (3 grams [3,000 mg] if you have liver disease). Maximum dosage in children varies according to weight.
Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate.
Stop using Excedrin and ask your doctor if pain gets worse or lasts more than 10 days, if fever gets worse or lasts more than 3 days, or if new symptoms occur or redness or swelling is present.
Excedrin may cause false results with some in-home test kits for blood cholesterol. Check with your doctor or pharmacist if you are taking Excedrin and need to check your blood cholesterol at home.
PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Excedrin during pregnancy. Excedrin is excreted in breast milk. If you are or will be breast-feeding while you are using Excedrin, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Excedrin:

All medicines may cause side effects, but many people have no, or minor, side effects. Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine or pale stools; unusual tiredness; 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; irregular heartbeat; low blood pressure; stomach pain; vomiting; yellowing of the skin or eyes.

Proper storage of Excedrin:

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

General information:

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

Issue Date: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

Comments (0)

Excedrin Capsules

30/06/10

Generic Name: Acetaminophen/Aspirin/Caffeine (a-SEET-a-MIN-oh-fen/AS-pir-in/KAF-een)
Brand Name: Examples include Excedrin and Vanquish

Excedrin Capsules is used for:

Relieving headaches, migraine headaches, toothaches, muscle aches, premenstrual or menstrual aches, or other minor aches and pains (eg, due to sinusitis or colds). It may also be used for other conditions as determined by your doctor.

Excedrin Capsules is an analgesic and antipyretic combination. It works by blocking substances in the body that cause pain and inflammation.

Do NOT use Excedrin Capsules if:

you are allergic to any ingredient in Excedrin Capsules
you are a child or teenager with influenza (flu) or chickenpox
you have bleeding problems, such as hemophilia, von Willebrand disease, or low blood platelets
you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to aspirin, tartrazine, or a nonsteroidal anti-inflammatory drug (NSAID) (eg, celecoxib, ibuprofen, naproxen)
you are taking another medicine that contains acetaminophen

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

Before using Excedrin Capsules:

Some medical conditions may interact with Excedrin Capsules. Tell your health care provider 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 if you consume 3 or more alcohol-containing drinks every day
if you are 60 years of age or older
if you are taking a diuretic, a corticosteroid (eg, prednisone), an anticoagulant (eg, warfarin), or ketorolac
if you have asthma, bleeding or clotting problems, growths in the nose (nasal polyps), kidney or liver problems, hepatitis, severe heart problems, stomach or peptic ulcers (bleeding ulcers), heartburn, upset stomach, stomach pain, influenza (flu) or chickenpox, vitamin K deficiency, anxiety, or trouble sleeping
if the patient is a child with a stroke, a weakened blood vessel (cerebral aneurysm) or bleeding in the brain, or Kawasaki syndrome (a rare inflammation causing heart problems in children)

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

Carbonic anhydrase inhibitors (eg, acetazolamide) because they may decrease Excedrin Capsules’s effectiveness
Anticoagulants (eg, warfarin), clopidogrel, heparin, ketorolac, NSAIDs (eg, celecoxib, ibuprofen, naproxen), or serotonin reuptake inhibitors (eg, fluoxetine) because the risk of bleeding may be increased
Insulin, isoniazid, oral hypoglycemics (eg, glyburide, repaglinide), or quinolone antibiotics (eg, ciprofloxacin) because the risk of their side effects may be increased by Excedrin Capsules
Methotrexate, theophylline, or valproic acid because their actions and the risk of their side effects may be increased by Excedrin Capsules
Probenecid or sulfinpyrazone because their effectiveness may be decreased by Excedrin Capsules

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

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

Take Excedrin Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Take Excedrin Capsules with a full glass of water (8 oz/240 mL). Do not lie down for 30 minutes after taking Excedrin Capsules.
Use Excedrin Capsules exactly as directed on the package, unless instructed differently by your doctor. If you are taking Excedrin Capsules without a prescription, follow any warnings and precautions on the label.
If you miss a dose of Excedrin Capsules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Excedrin Capsules.

Important safety information:

Excedrin Capsules has acetaminophen, aspirin, and caffeine in it. Before you start any new medicine, check the label to see if it has acetaminophen, aspirin, or caffeine in it too. If it does or if you are not sure, check with your doctor or pharmacist.
Excedrin Capsules may harm your liver. Your risk may be greater if you drink alcohol while you are using Excedrin Capsules. Talk to your doctor before you take Excedrin Capsules or other fever reducers if you drink more than 3 drinks with alcohol per day.
Aspirin has been linked to a serious illness called Reye syndrome. Do not give Excedrin Capsules to a child or teenager who has the flu, chickenpox, or a viral infection. Contact your doctor with any questions or concerns.
Avoid large amounts of food or drink that have caffeine (eg, coffee, tea, cocoa, cola, chocolate). This includes any medicines that contain caffeine.
Serious stomach ulcers or bleeding can occur with the use of Excedrin Capsules. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Excedrin Capsules with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
Excedrin Capsules may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
Tell your doctor or dentist that you take Excedrin Capsules before you receive any medical or dental care, emergency care, or surgery.
Do not take Excedrin Capsules for at least 7 days after any surgery unless directed by your health care provider.
If your pain does not get better or becomes worse, or if you have a fever that becomes worse or lasts for more than 3 days, contact your doctor.
Excedrin Capsules may cause false results with some in-home test kits for blood cholesterol. Check with your doctor or pharmacist if you are taking Excedrin Capsules and need to check your blood cholesterol at home.
Different brands of Excedrin Capsules may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Excedrin Capsules while you are pregnant. Excedrin Capsules is not recommended during the last 3 months (third trimester) of pregnancy because it may cause harm to the fetus. Excedrin Capsules is found in breast milk. If you are or will be breast-feeding while you use Excedrin Capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Excedrin Capsules:

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:

Heartburn; nausea; upset stomach.

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); black or bloody stools; confusion; dark urine or pale stools; fainting; hearing loss; ringing in the ears; severe stomach pain; unusual tiredness; vomiting blood; yellowing of the skin or eyes.

If OVERDOSE is suspected:

Proper storage of Excedrin Capsules:

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

General information:

If you have any questions about Excedrin Capsules, please talk with your doctor, pharmacist, or other health care provider.
Excedrin Capsules 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 Excedrin Capsules. 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

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Evoclin Foam

30/06/10

Generic Name: Clindamycin (KLIN-da-MYE-sin)
Brand Name: Evoclin

Evoclin Foam is used for:

Treating acne. It may also be used for other conditions as determined by your doctor.

Evoclin Foam is a topical lincomycin antibiotic. It works by killing sensitive bacteria that cause acne and reducing the amount of free fatty acids that irritate the skin surface.

Do NOT use Evoclin Foam if:

you are allergic to any ingredient in Evoclin Foam or to lincomycin
you have Crohn disease or a history of severe bowel problems (eg, regional enteritis), colitis associated with antibiotic use, or ulcerative colitis

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

Before using Evoclin Foam:

Some medical conditions may interact with Evoclin Foam. 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 gastrointestinal (bowel) disease or diarrhea

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

Nondepolarizing muscle relaxants (eg, vecuronium) or succinylcholine because their actions and the risk of their side effects may be increased by Evoclin Foam
Erythromycin because it may decrease Evoclin Foam’s effectiveness

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

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

Evoclin Foam is for topical use on the skin only.
Wash the affected areas to be treated with mild soap and water and allow the skin to dry thoroughly.
To use Evoclin Foam, hold the can upright and dispense the amount of medicine to be used directly into the cap or onto a cool surface. Pick up small amounts of the foam with your fingertips and gently massage it into the affected areas until the foam disappears.
If the can seems warm or the foam seems runny, hold the can under cold running water to cool it. Do not dispense the medicine directly onto your skin or hands because it will melt too soon.
Throw away any unused medicine that has been dispensed out of the can.
If you miss a dose of Evoclin Foam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Evoclin Foam.

Important safety information:

Evoclin Foam is for external use only. Do not get Evoclin Foam in your eyes or on the inside of your nose or mouth. If you accidentally get the medicine in your eye, immediately flush with a large amount of cool tap water.
Be sure to use Evoclin Foam for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Several weeks may pass before you see improvement in your acne. Continue using Evoclin Foam for the full time recommended by your doctor.
Talk with your doctor before you use any other medicines or cleansers on your skin.
If severe diarrhea, stomach pain or cramping, or bloody stools develop during treatment or within several months after treatment with Evoclin Foam, check with your doctor or pharmacist right away. Do not treat it without first checking with your doctor.
Evoclin Foam should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: It is not known if Evoclin Foam can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Evoclin Foam while you are pregnant. It is not known if Evoclin Foam is found in breast milk. Do not breast-feed while taking Evoclin Foam.

Possible side effects of Evoclin Foam:

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:

Burning sensation on treated areas; dry or itchy skin; headache.

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); blood or mucus in stools; severe or persistent diarrhea; stomach cramps or pain; swelling, redness, burning, or peeling of your skin.

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. Evoclin Foam may be harmful if swallowed.

Proper storage of Evoclin Foam:

Store Evoclin Foam 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. Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Evoclin Foam out of the reach of children and away from pets.

General information:

If you have any questions about Evoclin Foam, please talk with your doctor, pharmacist, or other health care provider.
Evoclin Foam 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 Evoclin Foam. 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

Comments (0)

Evoxac

30/06/10

Generic Name: cevimeline (se vi ME leen)
Brand Names: Evoxac

What is Evoxac (cevimeline)?

Cevimeline increases the secretions of the saliva and sweat glands in the body.

Cevimeline is used to treat dry mouth in people with Sjogren’s Syndrome.

Cevimeline may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Evoxac (cevimeline)?

Do not take this medication if you are allergic to cevimeline, or if you have untreated or uncontrolled asthma, glaucoma, or an eye condition called iritis or uveitis.

Before taking cevimeline, tell your doctor if you have heart disease, heart rhythm disorder, angina (chest pain), or a history of heart attack, high blood pressure (hypertension), asthma or other breathing disorder, or a history of kidney or gall stones.

Cevimeline can cause side effects that may impair your vision, especially at night. Be careful if you drive or do anything that requires you to be able to see clearly.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Cevimeline may cause excessive sweating and you may get dehydrated more easily while taking this medication. Follow your doctor’s instructions about the type and amount of liquids you should drink.

What should I tell my healthcare provider before taking Evoxac (cevimeline)?

Do not take this medication if you are allergic to cevimeline, or if you have:

untreated or uncontrolled asthma;
glaucoma; or
an eye condition called iritis or uveitis.

Before taking cevimeline, tell your doctor if you are allergic to any drugs, or if you have:

heart disease, heart rhythm disorder, angina (chest pain), or a history of heart attack;
high blood pressure (hypertension);
asthma, chronic bronchitis, or chronic obstructive pulmonary disease (COPD); or
a history of kidney stones or gallstones.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take cevimeline.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether cevimeline 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.

How should I take Evoxac (cevimeline)?

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

Take this medication with a full glass of water.

Cevimeline is usually taken three times a day. Follow your doctor’s instructions.

Store cevimeline at room temperature away from moisture and heat.

See also: Evoxac dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, blurred vision, watery eyes, confusion, sweating, tremors or shaking, nausea, vomiting, diarrhea, stomach pain, trouble breathing, and fast, slow, or uneven heart rate.

What should I avoid while taking Evoxac (cevimeline)?

Cevimeline can cause side effects that may impair your vision, especially at night. Be careful if you drive or do anything that requires you to be able to see clearly.

Evoxac (cevimeline) 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 taking cevimeline and call your doctor at once if you have any of these serious side effects:

shortness of breath, wheezing, or tightness in your chest;
chest pain, uneven heart rate;
attacks of severe stomach pain on the right side, extending up to your shoulder (sometimes worse after meals);
nausea and vomiting, bloating, fever, chills, and jaundice (yellowing of the skin or eyes);
swelling in your hands or feet;
eye pain or drainage;
fever, ear ache, flu symptoms; or
white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

blurred vision, dry eyes;
excessive sweating or salivating, drooling;
runny or stuffy nose;
nausea, diarrhea, constipation, loss of appetite;
dry mouth;
muscle pain;
vaginal itching or discharge;

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Evoxac (cevimeline)?

Before taking cevimeline, tell your doctor if you are using any of the following drugs:

amiodarone (Cordarone, Pacerone);
cimetidine (Tagamet);
cyclosporine (Gengraf, Neoral, Sandimmune);
metronidazole (Flagyl, Protostat);
antibiotics such as azithromycin (Zithromax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin), itraconazole (Sporanox), or ketoconazole (Nizoral);
antidepressants such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft);
asthma medicines such as albuterol (Proventil, Ventolin, others), bitolterol (Tornalate), epinephrine (Asthmahaler, Bronkaid, Primatene Mist Inhaler), isoetharine (Bronkometer, Bronkosol), metaproterenol (Alupent, Metaprel), pirbuterol (Maxair), salmeterol (Serevent), or terbutaline (Brethaire, Brethine);
heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac) or verapamil (Calan, Covera, Isoptin, Verelan), acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), timolol (Blocadren), and others; or
HIV /AIDS medicine such as amprenavir (Agenerase), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase, Fortovase).

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

Where can I get more information?

Your pharmacist can provide more information about cevimeline.

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.

Concise,E

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Ex-Lax Chewable Tablets

30/06/10

Generic Name: Sennosides (SEN-oh-sides)
Brand Name: Examples include Evac-u-gen and Ex-Lax

Ex-Lax Chewable Tablets are used for:

Treating constipation.

Ex-Lax Chewable Tablets are a stimulant laxative. It works by irritating bowel tissues, resulting in bowel movements.

Do NOT use Ex-Lax Chewable Tablets if:

you are allergic to any ingredient in Ex-Lax Chewable Tablets
you have had recent abdominal surgery or require immediate abdominal surgery
you have appendicitis; bleeding of the stomach, intestine, or rectum; or an obstruction in your intestines (fecal impaction)

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

Before using Ex-Lax Chewable Tablets:

Some medical conditions may interact with Ex-Lax Chewable Tablets. 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 congestive heart failure, you are experiencing nausea or vomiting, or you have undiagnosed stomach pain

Some MEDICINES MAY INTERACT with Ex-Lax Chewable Tablets. However, no specific interactions with Ex-Lax Chewable Tablets are known at this time.

Ask your health care provider if Ex-Lax Chewable Tablets 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 Ex-Lax Chewable Tablets:

Use Ex-Lax Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Ex-Lax Chewable Tablets by mouth with or without food.
Take Ex-Lax Chewable Tablets with a full glass of water (8 oz/240 mL). Drinking extra fluids while you are taking Ex-Lax Chewable Tablets are recommended. Check with your doctor for instructions.
Chew tablet or allow to dissolve in your mouth.
It is best to take Ex-Lax Chewable Tablets at bedtime.
If you miss a dose of Ex-Lax Chewable Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Ex-Lax Chewable Tablets.

Important safety information:

A bowel movement usually occurs in 6 to 12 hours.
Do not use for longer than 1 week without checking with your doctor.
Using Ex-Lax Chewable Tablets for a long time may result in loss of normal bowel function.
Do not take additional laxatives or stool softeners with Ex-Lax Chewable Tablets unless directed by your doctor.
If you notice a sudden change in bowel habits that lasts for 2 weeks or more, stop using Ex-Lax Chewable Tablets and check with your doctor.
Ex-Lax Chewable Tablets may discolor the urine pink to red, or yellow to brown.
Ex-Lax Chewable Tablets should be used with extreme caution in CHILDREN younger than 6 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 Ex-Lax Chewable Tablets while you are pregnant. It is not known if Ex-Lax Chewable Tablets are found in breast milk. If you are or will be breast-feeding while you use Ex-Lax Chewable Tablets, check with your doctor. Discuss any possible risks to your baby.

Overuse of laxatives can lead to a DEPENDENCE on laxatives to have a bowel movement. In severe overuse cases, some laxatives have caused damage to the intestines and bowel.

Possible side effects of Ex-Lax Chewable Tablets:

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:

Abdominal discomfort or cramping; diarrhea; 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); kidney inflammation; poor bowel function; rectal bleeding.

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.

Proper storage of Ex-Lax Chewable Tablets:

Store Ex-Lax Chewable Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Keep Ex-Lax Chewable Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Ex-Lax Chewable Tablets, please talk with your doctor, pharmacist, or other health care provider.
Ex-Lax Chewable Tablets 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 Ex-Lax Chewable Tablets. 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.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

E,Med-facts

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Ex-Lax Chocolated

30/06/10

Generic Name: senna (SEN nah)
Brand Names: Black Draught, Dr Caldwell Laxative, Ex-Lax Chocolated, Ex-Lax Maximum Relief Formula, Ex-Lax Regular Strength Pills, Fletchers Castoria, Innerclean, Pedia-Lax, Perdiem Overnight, Senexon, Senna, Senna Lax, Senna Smooth, Senna Soft, Senna-gen, Senokot, Senokot Extra, SenokotXTRA, SenoSol, SenoSol-X

What is Ex-Lax Chocolated (senna)?

Senna is also known as Cassia senna, tinnevelly senna, India senna, Alexandrian senna, and Khartoum senna.

Senna has been used in alternative medicine as an aid to treat constipation.

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna is often sold as an herbal supplement. There are no regulated manufacturing standards in place for many herbal compounds and some marketed supplements have been found to be contaminated with toxic metals or other drugs. Herbal/health supplements should be purchased from a reliable source to minimize the risk of contamination.

Senna may also be used for other purposes not listed in this product guide.

What is the most important information I should know about Ex-Lax Chocolated (senna)?

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Use senna as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.

Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider.

What should I discuss with my health care provider before taking Ex-Lax Chocolated (senna)?

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

a bowel disorder such as Crohn’s disease or ulcerative colitis;
heart disease; or
stomach pain, nausea, or vomiting.

Before using senna, talk to your doctor, pharmacist, herbalist, or other healthcare provider. You may not be able to use senna if you have any other medical conditions, allergies, or if you take other medicines or herbal/health supplements.

Do not take senna without first talking to your doctor if you are pregnant or could become pregnant. Do not take senna without first talking to your doctor if you are breast-feeding a baby. Some forms of senna are made for use by children. Do not give any herbal/health supplement to a child without the advice of a doctor.

How should I take Ex-Lax Chocolated (senna)?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

If you choose to use senna, use it as directed on the package or as directed by your doctor, pharmacist, or other healthcare provider. Do not use more of this product than is recommended on the label.

Senna is usually taken before bed to produce a bowel movement 6 to 12 hours later when you wake up.

Do not use different forms (such as tablets and liquid) of senna at the same time unless your healthcare provider tells you to. Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider. Store senna at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Ex-Lax Chocolated (senna)?

Follow your healthcare provider’s instructions about any restrictions on food, beverages, or activity.

Ex-Lax Chocolated (senna) 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. Call your healthcare provider at once if you have a serious side effect such as:

severe stomach pain, severe diarrhea, watery diarrhea;
weight loss;
worsening constipation after you stop taking senna;
enlargement of your fingers and toes;
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

stomach cramps, bloating, gas, mild diarrhea;
numbness or tingly feeling;
joint pain; or
discolored urine.

This is not a complete list of side effects and others may occur. Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ex-Lax Chocolated (senna)?

Do not take senna without the advice of a healthcare provider if you are using any of the following medications:

digoxin (Lanoxin);
a diuretic (water pill); or
a blood thinner such as warfarin (Coumadin).

This list is not complete and other drugs may interact with senna. Tell your healthcare provider about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

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.

Concise,E

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Ex-Lax Gentle Nature

30/06/10

What is Ex-Lax Gentle Nature (senna)?

Senna is also known as Cassia senna, tinnevelly senna, India senna, Alexandrian senna, and Khartoum senna.

Senna has been used in alternative medicine as an aid to treat constipation.

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna may also be used for other purposes not listed in this product guide.

What is the most important information I should know about Ex-Lax Gentle Nature (senna)?

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Use senna as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.

Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider.

What should I discuss with my health care provider before taking Ex-Lax Gentle Nature (senna)?

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

a bowel disorder such as Crohn’s disease or ulcerative colitis;
heart disease; or
stomach pain, nausea, or vomiting.

How should I take Ex-Lax Gentle Nature (senna)?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

Senna is usually taken before bed to produce a bowel movement 6 to 12 hours later when you wake up.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Ex-Lax Gentle Nature (senna)?

Follow your healthcare provider’s instructions about any restrictions on food, beverages, or activity.

Ex-Lax Gentle Nature (senna) side effects

severe stomach pain, severe diarrhea, watery diarrhea;
weight loss;
worsening constipation after you stop taking senna;
enlargement of your fingers and toes;
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

stomach cramps, bloating, gas, mild diarrhea;
numbness or tingly feeling;
joint pain; or
discolored urine.

What other drugs will affect Ex-Lax Gentle Nature (senna)?

Do not take senna without the advice of a healthcare provider if you are using any of the following medications:

digoxin (Lanoxin);
a diuretic (water pill); or
a blood thinner such as warfarin (Coumadin).

Where can I get more information?

Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

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.

Concise,E

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Ex-Lax Maximum Relief Formula

30/06/10

What is Ex-Lax Maximum Relief Formula (senna)?

Senna is also known as Cassia senna, tinnevelly senna, India senna, Alexandrian senna, and Khartoum senna.

Senna has been used in alternative medicine as an aid to treat constipation.

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Senna may also be used for other purposes not listed in this product guide.

What is the most important information I should know about Ex-Lax Maximum Relief Formula (senna)?

Not all uses for senna have been approved by the FDA. Senna should not be used in place of medication prescribed for you by your doctor.

Use senna as directed on the label, or as your healthcare provider has prescribed. Do not use this product in larger amounts or for longer than recommended.

Call your healthcare provider if your symptoms do not improve, or if they get worse while using senna. Do not use this product for longer than 1 week without the advice of a healthcare provider.

What should I discuss with my health care provider before taking Ex-Lax Maximum Relief Formula (senna)?

Ask a doctor, pharmacist, herbalist, or other healthcare provider if it is safe for you to use this product if you have:

a bowel disorder such as Crohn’s disease or ulcerative colitis;
heart disease; or
stomach pain, nausea, or vomiting.

How should I take Ex-Lax Maximum Relief Formula (senna)?

When considering the use of herbal supplements, seek the advice of your doctor. You may also consider consulting a practitioner who is trained in the use of herbal/health supplements.

Senna is usually taken before bed to produce a bowel movement 6 to 12 hours later when you wake up.

What happens if I miss a dose?

Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking Ex-Lax Maximum Relief Formula (senna)?

Follow your healthcare provider’s instructions about any restrictions on food, beverages, or activity.

Ex-Lax Maximum Relief Formula (senna) side effects

severe stomach pain, severe diarrhea, watery diarrhea;
weight loss;
worsening constipation after you stop taking senna;
enlargement of your fingers and toes;
low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling); or
nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

stomach cramps, bloating, gas, mild diarrhea;
numbness or tingly feeling;
joint pain; or
discolored urine.

What other drugs will affect Ex-Lax Maximum Relief Formula (senna)?

Do not take senna without the advice of a healthcare provider if you are using any of the following medications:

digoxin (Lanoxin);
a diuretic (water pill); or
a blood thinner such as warfarin (Coumadin).

Where can I get more information?

Consult with a licensed healthcare professional before using any herbal/health supplement. Whether you are treated by a medical doctor or a practitioner trained in the use of natural medicines/supplements, make sure all your healthcare providers know about all of your medical conditions and treatments.

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.

Concise,E

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everolimus

30/06/10

Generic Name: everolimus (E ver OH li mus)
Brand Names: Afinitor, Zortress

What is everolimus?

Everolimus is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Everolimus also lowers your body’s immune system. The immune system helps your body fight infections. The immune system can also fight or “reject” a transplanted organ such as a liver or kidney. This is because the immune system treats the new organ as an invader.

The Afinitor brand of everolimus is used to treat advanced kidney cancer. Afinitor is usually given after sorafenib (Nexavar) or sunitinib (Sutent) have been tried without successful treatment of symptoms.

The Zortress brand of everolimus is used to prevent organ rejection after a kidney transplant. Zortress is used together with cyclosporine (Gengraf, Neoral, Sandimmune) and other medications.

Everolimus may also be used for other purposes not listed in this medication guide.

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

You should not use this medication if you are allergic to everolimus, sirolimus (Rapamune), tacrolimus (Prograf), or temsirolimus (Torisel), or if you have problems digesting lactose or galactose (sugar). Do not use the Zortress brand of everolimus if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using Zortress and for at least 8 weeks after your treatment ends.

Before taking everolimus, tell your doctor if you have a breathing disorder such as asthma or COPD, liver disease, diabetes, high cholesterol, or a history of skin cancer.

Do not receive a “live” vaccine while using everolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. There are many other drugs that can interact with everolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

To be sure this medicine is not causing harmful effects, your blood will need to be tested often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

What should I discuss with my health care provider before taking everolimus?

If you have any of these other conditions, you may need an everolimus dose adjustment or special tests:

a breathing disorder, such as asthma or COPD (chronic obstructive pulmonary disease);
liver disease;
diabetes;
high cholesterol or triglycerides.
a personal or family history of skin cancer (melanoma).

Taking everolimus may increase your risk of developing other types of cancer. Ask your doctor about your individual risk.

FDA pregnancy category C. It is not known whether Afinitor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. FDA pregnancy category D. Do not use Zortress if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using Zortress and for at least 8 weeks after your treatment ends.

This medication can affect fertility (your ability to have children), whether you are a man or a woman.

It is not known whether everolimus passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking everolimus.

How should I take everolimus?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Everolimus should be taken at the same time each day. You may take everolimus with or without food, but take it the same way each time. If you also take cyclosporine, take both medications at the same time.

Take this medication with a full glass (8 ounces) of water. Swallow the tablet whole. Do not crush or chew. The medicine from a crushed pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If this occurs, wash your skin with soap and water or rinse your eyes with water. Ask your doctor or pharmacist how to safely handle and dispose of a crushed tablet.

Everolimus can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Your blood will need to be tested often. Your liver and kidney function will also need to be tested. Visit your doctor regularly.

Store at room temperature in the original container, away from moisture, heat, and light. Keep each tablet in its blister pack until you are ready to take it.

See also: Everolimus dosage in more detail

What happens if I miss a dose?

If you are less than 6 hours late in taking your medicine, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking everolimus?

Do not receive a “live” vaccine while using everolimus. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, typhoid, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine. Everolimus may increase your risk of developing skin cancer. Avoid exposure to sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit and grapefruit juice may interact with everolimus 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.

Everolimus side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

fever, chills, cough with yellow or green mucus;
stabbing chest pain, wheezing, feeling short of breath;
pain in your stomach, groin, lower back or side,
swelling, rapid weight gain, urinating less than usual or not at all;
blood in your urine, dark colored urine, pain or burning when you urinate;
pale skin, feeling light-headed, rapid heart rate, trouble concentrating;
easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
redness, warmth, swelling, oozing, or slow healing of a wound or surgical incision;
white patches or sores inside your mouth or on your lips; or
other signs of infection such as sore throat, flu symptoms, loss of appetite, nausea and vomiting, or unusual weakness.

Less serious side effects may include:

tired feeling;
headache, pain in your arms and legs;
diarrhea;
dry skin; or
sleep problems (insomnia);

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.

Everolimus Dosing Information

Usual Adult Dose for Renal Cell Carcinoma:

Recommended dose (Afinitor): 10 mg orally once daily to be taken at the same time every day, either with or without food. Everolimus tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.

Treatment should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.

Usual Adult Dose for Organ Transplant — Rejection Prophylaxis:

Initial dose (Zortress): 0.75 mg twice a day in combination with reduced dose cyclosporine, administered as soon as possible after transplantation. Adjust maintenance dose to achieve trough concentrations within the 3-8 ng/mL target range. Dose adjustments can be made at 4 to 5 day intervals. Administer consistently with or without food at the same time as cyclosporine.

What other drugs will affect everolimus?

Many drugs can interact with everolimus. Below is just a partial list. Tell your doctor if you are using:

aprepitant (Emend);
dexamethasone (Decadron, Hexadrol);
isoniazid (for treating tuberculosis);
rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);
St. John’s wort;
an antidepressant such as nefazodone;
other drugs that weaken your immune system;
an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), or voriconazole (Vfend);
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), rifapentine (Priftin), or telithromycin (Ketek);
a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), or phenobarbital (Solfoton);
heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), felodipine (Plendil), nifedipine (Nifedical, Procardia), quinidine (Quin-G), verapamil (Calan, Covera, Isoptin, Verelan), and others;
HIV medication such as delavirdine (Rescriptor), efavirenz efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Kaletra, Norvir), or saquinavir (Invirase); or
seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and there are many other drugs that can interact with everolimus. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about everolimus.

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.

Concise,E

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everolimus (Oral route)

30/06/10

e-ver-OH-li-mus

Oral routeTablet

Zortress(R)
- Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression.
- Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient.
- Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with everolimus. Therefore reduced doses of cyclosporine should be used in combination with everolimus in order to reduce renal dysfunction. It is important to monitor the cyclosporine and everolimus whole blood trough concentrations.
- An increased risk of kidney arterial and venous thrombosis, resulting in graft loss, was reported, mostly within the first 30 days post-transplantation .

Zortress(R): Increased susceptibility to infection and the possible development of lymphoma and other malignancies may result from immunosuppression. Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe everolimus. Reduced doses of cyclosporine should be used in combination with everolimus in order to reduce renal dysfunction and monitoring of cyclosporine and everolimus whole blood trough concentrations is recommended. The use of everolimus has resulted an increase risk of graft loss within the first 30 days post-transplantation .

Commonly used brand name(s):

In the U.S.

Afinitor
Zortress

Available Dosage Forms:

Tablet

Therapeutic Class: Immune Suppressant

Uses For everolimus

Everolimus is used to treat advanced (late-stage) kidney cancer in patients who have already been treated with other medicines that did not work well.

Everolimus belongs to the group of medicines known as antineoplastics or cancer medicines. It works by interfering with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by everolimus, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern.

Before you begin treatment with everolimus, you and your doctor should talk about the good everolimus will do as well as the risks of using it.

everolimus is available only with your doctor’s prescription.

Before Using everolimus

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 everolimus, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to everolimus 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

Appropriate studies have not been performed on the relationship of age to the effects of everolimus in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of everolimus in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 everolimus 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.

Amprenavir
Aprepitant
Atazanavir
Clarithromycin
Delavirdine
Diltiazem
Erythromycin
Fluconazole
Fosamprenavir
Indinavir
Itraconazole
Ketoconazole
Nefazodone
Nelfinavir
Posaconazole
Ritonavir
Saquinavir
Telithromycin
Verapamil
Voriconazole

Using everolimus 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.

Carbamazepine
Dexamethasone
Phenobarbital
Phenytoin
Rifabutin
Rifampin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using everolimus with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use everolimus, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Proper Use of everolimus

Take everolimus exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

everolimus usually comes with a patient information leaflet. Read the leaflet carefully and make sure you understand it before taking everolimus. If you have any questions, talk to your doctor.

Everolimus works best when there is a constant amount in the blood. You can keep the amount constant by taking the dose at the same time each day.

You may take everolimus with or without food. However, you should take it the same way each time.

Swallow the tablet whole with a glass of water. Do not break, crush, or chew it. If you accidentally break or crush the tablet, wash your hands with water right away.

Dosing

The dose of everolimus 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 everolimus. 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 advanced kidney cancer:
  - Adults—10 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of everolimus, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of everolimus, you may still take it up to 6 hours after the time you normally take it. However, if it is more than 6 hours, 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 everolimus

It is very important that your doctor check your progress at regular visits to make sure that everolimus is working properly. Blood tests may be needed to check for unwanted effects.

Using everolimus while you are pregnant can harm your unborn baby. Use an effective form of birth control while being treated with everolimus and for at least 8 weeks after stopping treatment. If you think you have become pregnant while using the medicine, tell your doctor right away.

If you plan to have children, talk with your doctor before using everolimus. everolimus may decrease fertility in men and women.

everolimus may cause a serious lung problem called noninfectious pneumonitis. Stop using everolimus and check with your doctor right away if you have chest pain, chills, a cough, fever, shortness of breath, or troubled breathing.

While you are being treated with everolimus, and after you stop treatment with it, it is important to talk to your doctor about the immunizations (vaccinations) you should receive. Do not get any immunizations without your doctor’s approval. Everolimus may lower your body’s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid other persons who have taken the oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Everolimus can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.
Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
Avoid contact sports or other situations where bruising or injury could occur.

Everolimus may cause mouth ulcers and sores in some patients. Tell your doctor right away if you have pain, discomfort, or open sores in your mouth while you are using everolimus. You may use a special mouthwash or mouth gel to treat these ulcers. Ask your doctor what type of products to use.

everolimus may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

everolimus may increase your cholesterol and fats in the blood. If this condition occurs, your doctor may give you some medicines that can lower the amount of cholesterol and fats in the blood.

Grapefruits and grapefruit juice may increase the effects of everolimus by increasing the amount of everolimus in your body. You should not eat grapefruit or drink grapefruit juice while you are taking everolimus.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John’s wort) or vitamin supplements.

everolimus 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 immediately if any of the following side effects occur:

More common

Bloating or swelling of the face, arms, hands, lower legs, or feet
bloody nose
chest pain
cough or hoarseness
cracked lips
decreased weight
diarrhea
difficult or labored breathing
difficulty with swallowing
fever or chills
general feeling of discomfort or illness
lower back or side pain
painful or difficult urination
rapid weight gain
shortness of breath
sores, ulcers, or white spots on the lips, tongue, or inside the mouth
swelling or inflammation of the mouth
thickening of bronchial secretions
tightness in the chest
tingling of the hands or feet
troubled with breathing
unusual weight gain or loss
wheezing

Less common

Bleeding after defecation
bleeding gums
bloody urine
blurred vision
burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
coughing up blood
decreased frequency or amount of urine
decreased urine output
dilated neck veins
dry mouth
extreme fatigue
fast, pounding, or irregular heartbeat or pulse
flushed, dry skin
fruit-like breath odor
headache
increased blood pressure
increased hunger
increased menstrual flow or vaginal bleeding
increased thirst
increased urination
irregular breathing
irregular heartbeat
loss of appetite
loss of consciousness
nausea
nervousness
nosebleeds
paralysis
pounding in the ears
prolonged bleeding from cuts
red or black, tarry stools
red or dark brown urine
runny nose
slow heartbeat
sore throat
stomachache
sweating
uncomfortable swelling around the anus
unexplained weight loss
unusual tiredness or weakness
vomiting
weight gain

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 or stomach pain
change in taste
dizziness
dry skin
itching skin
lack or loss of strength
loss of taste
pain in the arms or legs
rash
sleeplessness
trouble with sleeping
unable to sleep

Less common

Back pain
blistering, peeling, redness, or swelling of the palms, hands, or bottoms of the feet
bumps on the skin
burning, dry, or itching eyes
discharge or excessive tearing
discoloration of the fingernails or toenails
excess air or gas in the stomach or intestines
flushing or redness of the skin
full feeling
jaw pain
numbness, pain, tingling, or unusual sensations in the palms of the hands or bottoms of the feet
passing gas
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
sleepiness or unusual drowsiness
unusually warm skin

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.

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