Generic Name: boric acid (ophthalmic) (BOR ik AS id off THAL mik)
Brand Names: Collyrium Fresh

What is boric acid ophthalmic?

Boric acid has mild antibiotic properties against fungal or bacterial infection.

Boric acid ophthalmic (for the eyes) is used as an eye wash to cleanse or irrigate the eyes. Boric acid provides soothing relief from eye irritation, and helps remove pollutants from the eye such as smog, chlorine, or other chemicals.

Boric acid ophthalmic may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about boric acid ophthalmic?

You should not use this medication if you are allergic to boric acid.

Avoid using this medication if you have any open wound or other skin injury around your eyes.

Boric acid ophthalmic is for use only in the eyes. Do not allow the medicine to get in your mouth, nose, or ears. Avoid getting this medication on any skin wound or abrasion. Do not use boric acid ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using boric acid ophthalmic before putting your contact lenses in. Call your doctor at once if you have a serious side effect such as severe burning or stinging of your eyes, severe eye pain, vision changes that last for several hours after use, or if your eye condition does not improve or if it gets worse after using boric acid.

Boric acid is a weak antibiotic and should not be used to treat any type of infection without the advice of a doctor. There are many other, more effective antibiotics available.

What should I discuss with my health care provider before taking boric acid ophthalmic?

You should not use this medication if you are allergic to boric acid.

Avoid using this medication if you have any open wound or other skin injury around your eyes.

Boric acid is a weak antibiotic and should not be used to treat any type of infection without the advice of a doctor. There are many other, more effective antibiotics available. Before using this medication, tell your doctor if you are pregnant or breast-feeding.

How should I take boric acid ophthalmic?

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

Boric acid is usually given using an eye cup.

Use only a clean or sterile eye cup. Avoid touching the rim of the eye cup with your fingers while you are using it.

It may be best to use this medicine while standing over a sink or eye wash fountain.

Fill the eye cup about half way with boric acid ophthalmic solution. Bend your head forward and bring the cup to your eye. Press it tightly to your face around the eye. Then tilt your head back and open your eye wide.

Move the eye around in all directions to allow the boric acid to cleanse the eyeball thoroughly.

While still pressing the cup to your eye, bend forward over a sink. Remove the eye cup from your face and empty it into the sink. Allow any remaining boric acid solution to drain from your eye into the sink.

Repeat this procedure with your other eye if needed.

After using this medication, pat the skin dry around your eye using a clean tissue or towel. Do not rub your eyelids with the tissue or towel, or apply it directly to your eye.

Store boric acid ophthalmic at room temperature away from moisture and heat.

Keep boric acid ophthalmic solution in its sealed container until you are ready to use it.

What happens if I miss a dose?

Since boric acid ophthalmic is used only when needed, you are not likely to be on a dosing schedule. If your condition does not improve after using boric acid ophthalmic, ask your doctor before using a second dose of this medication.

What happens if I overdose?

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

An overdose of boric acid ophthalmic is not likely to cause life-threatening symptoms.

What should I avoid while taking boric acid ophthalmic?

Do not use boric acid ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using boric acid ophthalmic before putting your contact lenses in. Boric acid ophthalmic is for use only in the eyes. Do not allow the medicine to get in your mouth, nose, or ears. Avoid getting this medication on any skin wound or abrasion.

Boric acid ophthalmic 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 doctor at once if you have a serious side effect such as:

• severe burning or stinging of your eyes;

• severe eye pain;

• vision changes that last for several hours after use; or

• if your eye condition does not improve or if it gets worse after using boric acid.

Less serious side effects may include:

• mild stinging or eye irritation;

• blurred vision;

• watery eyes; or

• eye redness.

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 boric acid ophthalmic?

Avoid using boric acid together with a contact lens wetting solution, or any other ophthalmic solution that contains polyvinyl alcohol.

It is not likely that other drugs you take orally or inject will have an effect on boric acid applied to the eyes. But many drugs can interact with each other. 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 boric acid ophthalmic.

• 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: 1.02. Revision Date: 4/12/2009 4:42:15 PM.

Generic Name: Acetic Acid/Aluminum Acetate (a-SEE-tik ASS-is/ah-LOO-min-uhm ah-SEH-tate)
Brand Name: Borofair

Borofair Solution is used for:

Treating mild ear infections.

Borofair Solution is an antibacterial. It works by killing sensitive bacteria.

Do NOT use Borofair Solution if:

• you are allergic to any ingredient in Borofair Solution
• you have a perforated or ruptured eardrum

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

Before using Borofair Solution:

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

• if you are pregnant, if you 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

Some MEDICINES MAY INTERACT with Borofair Solution. Because little, if any, of Borofair Solution is absorbed into the blood, the risk of it interacting with another medicine is low.

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

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

• Borofair Solution is for use in the ear only. Avoid contact with the eyes, nose, or mouth. If you get Borofair Solution in your eyes, rinse immediately with cool tap water.
• To use ear drops, lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for 5 minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from entering the medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.
• If you miss a dose of Borofair Solution, 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 Borofair Solution.

Important safety information:

• Before you have any medical or dental treatments, emergency care, or surgery, tell your doctor or dentist that you are using Borofair Solution.
• PREGNANCY and BREAST-FEEDING: It is unknown if Borofair Solution can cause harm to the fetus. If you become pregnant while taking Borofair Solution, discuss with your doctor the benefits and risks of using Borofair Solution during pregnancy. If you are or will be breast-feeding while you are using Borofair Solution, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Borofair Solution:

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; itching; stinging.

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); irritation; sensitivity.

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.

Proper storage of Borofair Solution:

Store Borofair Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Protect from freezing. Store away from heat and light. Do not store in the bathroom. Keep Borofair Solution out of the reach of children and away from pets.

General information:

• If you have any questions about Borofair Solution, please talk with your doctor, pharmacist, or other health care provider.
• Borofair Solution 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 summary only. It does not contain all information about Borofair Solution. 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: bortezomib (bor TEZ oh mib)
Brand Names: Velcade

What is bortezomib?

Bortezomib interferes with the growth of some cancer cells and keeps them from spreading in your body.

Bortezomib is used to treat multiple myeloma and mantle cell lymphoma.

Bortezomib is sometimes given after other cancer medications have been tried without successful treatment.

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

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

This medication can cause harm to an unborn baby. Do not receive bortezomib without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Bortezomib 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. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid becoming dehydrated if you have any vomiting or diarrhea. Symptoms of dehydration include dizziness, dry mouth, fainting, or hot and dry skin. Talk with your doctor about how best to keep yourself hydrated.

Bortezomib 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.

What should I discuss with my healthcare provider before receiving bortezomib?

You should not use this medication if you are allergic to bortezomib, mannitol, or boron.

If you have certain conditions, you may need a dose adjustment or special tests to safely receive this medication. Before you receive bortezomib, tell your doctor if you have:

• diabetes;

• liver disease;
• if you are on dialysis;

• a bleeding or blood clotting disorder;

• a low level of platelets or white or red blood cells;

• heart disease, congestive heart failure;

• herpes or a history of shingles;

• high or low blood pressure; or

• nerve problems such as burning, numbness, burning, pain, or tingly feeling.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not receive bortezomib without telling your doctor if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. It is not known whether bortezomib passes into breast milk. Do not receive bortezomib without telling your doctor if you are breast-feeding a baby.

How is bortezomib given?

Bortezomib is given as an injection through a needle placed into a vein.

You will receive this injection in a clinic or hospital setting. A doctor, nurse, or other healthcare provider will give you this injection.

Bortezomib is usually injected 2 times a week for 2 weeks, followed by 10 days without an injection. Bortezomib may also be given once a week for 4 weeks followed by 13 days without an injection. Follow your doctor’s instructions about your individual dosing schedule.

Bortezomib 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. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

What happens if I miss a dose?

Call your doctor for instructions if you will miss an appointment for your bortezomib injection.

What happens if I overdose?

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

Overdose may cause weakness, bruising or bleeding, pinpoint red spots on your skin, and fainting.

What should I avoid while receiving bortezomib?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Avoid becoming dehydrated if you have any vomiting or diarrhea. Symptoms of dehydration include dizziness, dry mouth, fainting, or hot and dry skin. Talk with your doctor about how best to keep yourself hydrated.

Bortezomib 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.

Dizziness may be more likely to occur when rising from a sitting or lying position. Get up slowly to keep from falling.

Bortezomib 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 doctor at once if you have a serious side effect such as:

• new or worsening nerve problems such as numbness, burning, pain, weakness, or tingly feeling;

• feeling like you might pass out;

• dry cough and trouble breathing;

• severe headache, vision problems, confusion, and/or seizure (convulsions);

• black, bloody, or tarry stools, vomit that looks like blood or coffee grounds;

• severe constipation;

• easy bruising or bleeding, unusual weakness;

• fever, chills, body aches, flu symptoms;

• feeling short of breath, even with mild exertion;

• fast or slow heart rate, weak pulse, lower back pain, blood in your urine;

• urinating less than usual or not at all;

• muscle weakness, tightness, or contraction, overactive reflexes; 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:

• mild nausea, vomiting, upset stomach;

• diarrhea, constipation;

• headache, blurred vision, dizziness;

• muscle pain, bone or joint pain;

• sleep problems (insomnia);

• mild rash or itching; or

• skin irritation where the medicine was injected.

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.

Bortezomib Dosing Information

Usual Adult Dose for Lymphoma:

For use in the treatment of mantle cell lymphoma:

1.3 mg/m2 as a bolus intravenous injection twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21)

The three week period is considered a treatment cycle.

A minimum of 72 hours should elapse between consecutive doses of bortezomib.

Usual Adult Dose for Multiple Myeloma:

For use in the treatment of previously untreated multiple myeloma:

Usual dose: 1.3 mg/m2 administered as a 3 to 5 second bolus IV injection in combination with oral melphalan and oral prednisone for nine 6-week treatment cycles.

In cycles 1 through 4, bortezomib is administered twice weekly (days 1, 4, 8, 11, 22, 25, 29 and 32). In cycles 5 through 9, bortezomib is administered once weekly (days 1, 8, 22 and 29). At least 72 hours should elapse between consecutive doses of bortezomib.

For use in the treatment of relapsed multiple myeloma:

1.3 mg/m2 as a bolus intravenous injection twice weekly for two weeks (days 1, 4, 8, and 11) followed by a ten day rest period (days 12 through 21)

The three week period is considered a treatment cycle.

A minimum of 72 hours should elapse between consecutive doses of bortezomib.

What other drugs will affect bortezomib?

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

• dexamethasone (Decadron, Hexadrol);

• rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

• St. John’s wort;

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);

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

• an antidepressant such as nefazodone, paroxetine (Paxil), or sertraline (Zoloft);

• a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Solfoton);

• diabetes medications you take by mouth (your dose may need to be adjusted when your bortezomib treatment starts);

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), etravirine (Intelence), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), saquinavir (Invirase), or ritonavir (Norvir);

• medicines to treat narcolepsy, such as armodafanil (Nuvigil) or modafanil (Progivil); or

• seizure medication such as carbamazepine (Carbatrol, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), or phenytoin (Dilantin), or primidone (Mysoline).

This list is not complete and there may be other drugs that can interact with bortezomib. 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 bortezomib.

• 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: 4.02. Revision Date: 08/12/2009 10:43:57 AM.

bor-TEZ-oh-mib

Commonly used brand name(s):

In the U.S.

• Velcade

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Proteasome Inhibitor

Uses For bortezomib

Bortezomib belongs to the general group of medicines known as antineoplastics or cancer medicines. It is used to treat multiple myeloma in patients with or without a prior history of treatment, and mantle cell lymphoma in patients who have received at least one treatment that has not helped.

Bortezomib interferes with the growth of cancer cells, which are then eventually destroyed by the body. Since the growth of normal body cells may also be affected by bortezomib, 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. Some effects may not occur until months or years after the medicine is used.

Bortezomib is to be administered only by or under the supervision of your doctor.

Before Using bortezomib

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 bortezomib, the following should be considered:

Allergies

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

• Ketoconazole

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 bortezomib. Make sure you tell your doctor if you have any other medical problems, especially:

• Dehydration or
• Heart disease or
• Lung disease or
• Peripheral neuropathy or
• Syncope, history of—May make these conditions worse.

• Herpes zoster (shingles)—May reactivate this condition.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Sensitivity to boron or
• Sensitivity to mannitol—bortezomib should not be used in patients with these conditions.

• Tumor lysis syndrome, risk of—May increase your chance of getting this condition.

Proper Use of bortezomib

You will receive bortezomib while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you bortezomib. bortezomib is given through a needle placed in one of your veins.

Precautions While Using bortezomib

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

bortezomib may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to bortezomib before you drive, use machines, or do anything else that could be dangerous if you are not alert. You may rise up slowly from sitting or lying position to help prevent lightheadedness or dizziness.

bortezomib may cause vomiting and diarrhea, so it is important to drink plenty of fluids. If you experience dizziness or lightheadedness, contact your doctor. These could be symptoms of dehydration (not enough water in your body).

If you are diabetic and you take an oral antidiabetic medicine, you should check your blood sugar level often and report any unusual changes to your doctor.

Make sure your doctor knows if you are pregnant or breastfeeding. Using bortezomib while you are pregnant can harm your unborn baby. Use an effective form of birth control while you are using bortezomib to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Tell your doctor right away if you start having numbness, tingling, pain, a burning feeling in the feet or hands, or weakness in the arms or legs. These may be symptoms of a condition called peripheral neuropathy.

Some people who have used bortezomib developed serious heart problems. Tell your doctor right away if you have chest pain or discomfort, shortness of breath, irregular heartbeat, or swelling of the feet, ankles, or legs while you are using bortezomib.

bortezomib may increase your chance of having a brain condition called reversible posterior leukoencephalopathy syndrome (RPLS). Stop using bortezomib and check with your doctor right away if you start having headaches, seizures, extreme drowsiness, confusion, or problems with vision while you are using bortezomib.

Bortezomib 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.

bortezomib 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

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
• chest pain
• chills
• confusion
• cough
• cough producing mucus
• decreased urination
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• dry mouth
• ear congestion
• fainting
• fever
• headache
• increase in heart rate
• loss of voice
• lower back or side pain
• nasal congestion
• nerve pain
• painful blisters on trunk of body
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• rapid breathing
• runny nose
• shortness of breath
• sneezing
• sore throat
• stuffy nose
• sunken eyes
• sweating
• swollen glands
• thirst
• tightness in the chest
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet
• wheezing
• wrinkled skin

Less common

• Decreased urine output
• dilated neck veins
• general feeling of discomfort or illness
• increased sensitivity to pain
• increased sensitivity to touch
• irregular breathing
• irregular heartbeat
• swelling of the face, fingers, feet, or lower legs
• thickening of bronchial secretions
• tingling in the hands and feet
• troubled breathing
• unsteadiness or awkwardness
• weight gain

Incidence not known

• Abdominal pain and tenderness
• agitation
• back pain
• blistering, peeling, or loosening of the skin
• bloating
• bruising
• change in consciousness
• coma
• coughing or vomiting blood
• dark urine
• deafness
• deep or fast breathing with dizziness, numbness to feet, hands, and around the mouth
• diarrhea
• drowsiness
• fast heartbeat
• fear or nervousness
• general tiredness and weakness
• hallucinations
• irritability
• itching
• light-colored stools
• loss of consciousness
• mood or mental changes
• pains in the stomach, side, or abdomen, possibly radiating to the back
• persistent bleeding or oozing from puncture sites, mouth, or nose
• pounding, slow heartbeat
• rectal bleeding
• red skin lesions, often with a purple center
• red, irritated eyes
• restlessness
• seeing, hearing, or feeling things that are not there
• seizures
• shaking
• stiff neck
• trouble sleeping
• upper right abdominal pain
• yellow eyes or skin

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

• Acid or sour stomach
• belching
• bone pain
• constipation
• difficulty having a bowel movement
• difficulty in moving
• fatigue
• feeling unusually cold; shivering
• heartburn
• indigestion
• itching skin
• loss of appetite
• loss of taste
• malaise
• mental depression
• muscle cramps
• muscle pain or stiffness
• nausea
• pain in the joints
• pain in the limb
• rash
• sleeplessness
• stomach discomfort, upset, or pain
• swelling
• swollen joints
• unable to sleep
• vomiting
• weight loss

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: bosentan (boe SEN tan)
Brand Names: Tracleer

What is Bosentan?

Bosentan prevents thickening of the blood vessels, especially those in the lungs and heart. Bosentan also lowers blood pressure in your lungs, helping your heart pump blood more efficiently.

Bosentan is used to treat pulmonary arterial hypertension (PAH). It improves your ability to exercise and prevents your condition from getting worse.

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

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

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

Do not use this medication if you are allergic to bosentan, or if you are also taking cyclosporine (Sandimmune, Neoral, Gengraf), glyburide (Micronase, DiaBeta, Glynase Pres Tab), or HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir). Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely.

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

Do not use this medication if you are allergic to bosentan, or if you:

• are also taking HIV/AIDS medication that contains lopinavir or ritonavir (Kaletra, Norvir);

• are also taking using glyburide (Micronase, DiaBeta, Glynase Pres Tab);

• are pregnant or might become pregnant during treatment; or

• are also using cyclosporine (Sandimmune, Neoral, Gengraf).

Bosentan can cause severe liver problems. Symptoms include nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Call your doctor at once if you have any of these symptoms. Your liver function will need to be tested before you start taking bosentan, and again each month during your treatment. FDA pregnancy category X. This medication can cause birth defects. Do not use bosentan if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

Your doctor may have you take a pregnancy test before you start using this medicine, to make sure you are not pregnant. You may also be re-tested each month during your treatment.

It is not known whether bosentan passes into breast milk or if it could harm a nursing baby. Do not take this medication without telling your doctor if you are breast-feeding a baby.

How should I take bosentan?

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

Take each dose with a full glass (8 ounces) of water.

Bosentan can be taken with or without food.

Bosentan is usually taken twice a day, morning and evening.

Do not stop taking bosentan without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store bosentan at room temperature away from moisture and heat.

See also: Bosentan 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 the 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 can cause headache, nausea, vomiting, increased heart rate and fainting or dizziness (low blood pressure).

What should I avoid while using bosentan?

Follow your doctor’s instructions about any restrictions on food, beverages, or activity while you are using bosentan.

Bosentan 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 doctor at once if you have any of these serious side effects:

• nausea, stomach pain, loss of appetite;

• dark urine, clay-colored stools; or

• jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

• headache;

• flushing;

• swelling of the feet, ankles, or legs;

• dizziness;

• upset stomach;

• fatigue; or

• 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.

Bosentan Dosing Information

Usual Adult Dose for Pulmonary Hypertension:

greater than or equal to 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: increase to a maintenance dose of 125 mg twice daily

less than 40 kg:
Initial dose: 62.5 mg twice daily for 4 weeks
Maintenance dose: continue dosing of 62.5 mg twice daily

What other drugs will affect bosentan?

Do not take bosentan without first talking to your doctor if you are taking any of the following medicines:

• amiodarone (Cordarone, Pacerone);

• diltiazem (Tiazac, Cartia, Cardizem);

• erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin);

• rifampin (Rifadin, Rifater, Rifamate, Rimactane);

• tacrolimus (Prograf);

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

• a blood thinner such as warfarin (Coumadin); or

• a cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), or atorvastatin (Lipitor).

This list is not complete and there may be other drugs not listed that can affect bosentan. 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 doctor or pharmacist can provide more information about bosentan.

• 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: 5.01. Revision Date: 08/11/2009 3:23:13 PM.

boe-SEN-tan

Commonly used brand name(s):

In the U.S.

• Tracleer

Available Dosage Forms:

• Tablet

Therapeutic Class: Antihypertensive

Pharmacologic Class: Endothelin Receptor Antagonist

Uses For bosentan

Bosentan is used to treat the symptoms of pulmonary arterial hypertension. This is the high blood pressure that occurs in the main artery that carries blood from the right side of the heart (the ventricle) to the lungs. When the smaller blood vessels in the lungs become more resistant to blood flow, the right ventricle must work harder to pump enough blood through the lungs. Bosentan works by blocking a hormone (a naturally occurring substance), that is found in the blood and lungs in large quantities of the people with pulmonary arterial hypertension. Bosentan helps by increasing the supply of blood to the lungs and reducing the workload of the heart.

bosentan is available only under a special restricted distribution program called the Tracleer Access Program (T.A.P.).

Before Using bosentan

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 bosentan, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bosentan 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 bosentan 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 bosentan in the elderly. However, elderly patients are more likely to have age-related heart, liver, or kidney problems, which may require caution in patients receiving bosentan.

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

Using bosentan with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Cyclosporine
• Glyburide

Using bosentan 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.

• Ritonavir

Using bosentan 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.

• Atorvastatin
• Desogestrel
• Drospirenone
• Estradiol Cypionate
• Ethinyl Estradiol
• Etonogestrel
• Gestodene
• Ketoconazole
• Levonorgestrel
• Lovastatin
• Medroxyprogesterone
• Mestranol
• Norelgestromin
• Norethindrone
• Norgestimate
• Norgestrel
• Rifampin
• Sildenafil
• Simvastatin
• Warfarin

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 bosentan. Make sure you tell your doctor if you have any other medical problems, especially:

• Edema (fluid retention or body swelling) or
• Heart failure or
• Liver disease, mild or
• Lung problems—Use with caution. Bosentan may make these conditions worse.

• Liver disease, moderate or severe—Should not be used in patients with this condition.

Proper Use of bosentan

Take bosentan 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. Also, do not change the dose or stop using bosentan without checking first with your doctor.

It is very important that you understand the requirements of the Tracleer® access program, and become familiar with the Tracleer® educational materials and Patient Medication Guide. Direct any questions to your doctor or pharmacist before starting bosentan therapy.

You may take bosentan with or without food.

Dosing

The dose of bosentan 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 bosentan. 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 pulmonary arterial hypertension:
    • Adults—At first, 62.5 milligrams (mg) two times a day (morning and evening) for 4 weeks. Your doctor may increase your dose up to 125 mg two times a day. If you are also taking bosentan with ritonavir for at least 10 days, starting dose is 62.5 mg once a day or every other day as directed by your doctor.
    • Children above 12 years of age and weighing less than 40 kilograms (kg) (88 pounds)—62.5 mg two times a day.
    • Children below 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of bosentan, 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.

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 bosentan

It is very important that your doctor check your progress at regular visits to make sure bosentan is working properly and to check for unwanted effects.

It is also important that your doctor does a blood test to check your liver function before you start bosentan and each month after that.

Using bosentan while you are pregnant can cause very serious birth defects. Use two forms of effective birth control to keep from getting pregnant while you are using bosentan (even if the medicine is temporarily stopped), and for at least one month after you stop taking the medicine. The most effective forms of birth control are hormone birth control pills, patches, shots, vaginal rings, or implants, an IUD, or a vasectomy (for men). One of these forms of birth control should be combined with a condom, a diaphragm, or a cervical cap. If a woman has had a tubal ligation, she does not need to use a second form of birth control. If you think you have become pregnant while using bosentan, tell your doctor right away.

You must have a negative pregnancy test before you will be allowed to take bosentan. You will also be required to have a pregnancy test every month during your treatment. If you miss a period while you are using bosentan, tell your doctor right away.

Liver problems may occur while you are using bosentan. Stop using bosentan and check with your doctor right away if you are having more than one of these symptoms: dark urine, fever with or without chills, light colored stools, loss of appetite, nausea and vomiting, skin rash, stomach pain, unusual tiredness, or yellow eyes or skin.

Bosentan may decrease the amount of sperm men make and affect their ability to have children. If you plan to have children, talk with your doctor before using bosentan.

bosentan may cause fluid retention (edema) in some patients. Check with your doctor right away if you are gaining weight rapidly; have swelling in your hands, ankles, feet, or all over the body; or if you have trouble with breathing while you are using bosentan.

Pulmonary edema may occur while using bosentan. Stop using bosentan and check with your doctor right away if you have chest pain; difficult, fast, noisy breathing, sometimes with wheezing; blue lips and fingernails; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; or shortness of breath.

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 or vitamin supplements.

bosentan 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

• Blurred vision
• confusion
• dizziness
• dark urine
• faintness or lightheadedness when getting up from a lying or sitting position
• fever with or without chills
• light-colored stools
• loss of appetite
• nausea and vomiting
• stomach pain
• sudden sweating
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Swelling

Incidence not known

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blue lips and fingernails
• chest pain
• chills
• clay-colored stools
• coughing that sometimes produces a pink frothy sputum
• coughing up blood
• dark urine
• decrease in the amount of urine
• difficult, fast, or noisy breathing, sometimes with wheezing
• fainting
• fast heartbeat
• fatigue on exertion
• fever
• headache
• hives
• hoarseness
• increased sweating
• irritation
• itching
• joint pain, stiffness, or swelling
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• noisy, rattling breathing
• pale skin
• pinpoint red spots on the skin
• rash
• redness of the skin
• shortness of breath
• swelling of the eyelids, face, lips, hands, fingers, legs, ankles, or feet
• tightness in the chest
• troubled breathing at rest
• troubled breathing or swallowing
• troubled breathing with exertion
• unpleasant breath odor
• unusual bleeding or bruising
• vomiting of blood
• weight gain
• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Increased heart rate

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

• Fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• muscle aches
• redness of the face, neck, arms, and occasionally upper chest
• sore throat
• stuffy or runny nose

Less common

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort, upset, or pain

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: onabotulinumtoxina (Intramuscular route)

on-a-BOT-yoo-li-num-TOX-in-A

Commonly used brand name(s):

In the U.S.

• Botox
• Botox Cosmetic

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Musculoskeletal Agent

Pharmacologic Class: Neuromuscular Blocker, Non-Depolarizing

Uses For Botox

OnabotulinumtoxinA is used to treat certain eye conditions, such as blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) or strabismus (a condition where the eyes do not line up properly). This medicine is also used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck) and some types of axillary hyperhidrosis (severe sweating of the armpits). It is used for increased muscle stiffness in the elbow, wrist, and finger muscles in adults with upper limb spasticity. OnabotulinumtoxinA is used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines).

OnabotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.

OnabotulinumtoxinA is injected into the muscles that are affected. Depending on your condition, more than one treatment may be required.

This medicine is available only with your doctor’s prescription and will be administered by your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, onabotulinumtoxinA is used in certain patients with the following medical conditions:

• Frey’s syndrome or gustatory sweating (red areas and sweating on the cheeks and ears after eating).
• Palmar and plantar hyperhidrosis (severe sweating of the palms and feet).
• Spasms of the arms in stroke patients.
• Spasms of the face.
• Spasms of the feet and hands, including writer’s cramp.
• Spasms of the arms and legs in patients with multiple sclerosis.

Before Using Botox

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onabotulinumtoxinA in children. However, safety and effectiveness have not been established in children younger than 12 years of age for blepharospasm or strabismus, or in children younger than 16 years of age for cervical dystonia, or in children younger than 18 years of age for hyperhidrosis and upper limb spasticity. Use of onabotulinumtoxinA to treat glabellar lines is not recommended in children.

Geriatric

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

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Amyotrophic lateral sclerosis (Lou Gehrig’s disease) or
• Dermatochalasis (a skin problem) or
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle or nerve problem) or
• Myasthenia gravis (severe muscle weakness) or
• Sebaceous skin, thick (oily or fatty skin) or
• Surgery on the face, history of—May increase risk for more serious side effects.

• Breathing problems (e.g., asthma or emphysema) or
• Dysarthria (trouble with speaking) or
• Dysphagia (trouble with swallowing) or
• Dysphonia (voice problem) or
• Heart attack, recent or history of or
• Heart disease or
• Heart rhythm problems or
• Lung problems (e.g., bronchitis) or
• Ptosis (droopy eyelid) or
• Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.

• Infection at the injection site—Should not be used in patients with this condition.

Proper Use of onabotulinumtoxina

This section provides information on the proper use of a number of products that contain onabotulinumtoxina. It may not be specific to Botox. Please read with care.

Your doctor will give you this medicine in a hospital or clinic. This medicine is given as a shot under your skin or into one of your muscles.

This medicine should come with a medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will only use onabotulinumtoxinA (Botox® or Botox® Cosmetic) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

Precautions While Using Botox

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require treatment in a hospital or clinic.

This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

After you have received this medicine and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.

One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and required testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Botox 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 or nurse immediately if any of the following side effects occur:

More common

• Difficulty with swallowing

Rare

• Difficulty with breathing or speaking
• muscle weakness

More common—for blepharospasm

• Dryness of the eyes
• inability to close the eyelids completely

Less common or rare—for blepharospasm

• Decreased blinking
• irritation of the cornea (colored portion) of the eyes
• turning outward or inward of the edge of the eyelids

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—for blepharospasm

• Blue or purplish bruise on the eyelids
• drooping of the upper eyelids
• irritation or watering of the eyes
• sensitivity of the eyes to light

More common—for cervical dystonia

• Body aches or pain
• chills
• cough, fever, sneezing, or sore throat
• ear congestion
• headache
• loss of voice
• nasal congestion
• neck pain
• runny nose
• unusual tiredness or weakness

More common—for hyperhidrosis

• Back, neck, or side pain
• body aches or pain
• chills
• congestion
• cough
• diarrhea
• dryness or soreness of the throat
• fear
• fever
• general feeling of discomfort or illness
• headache
• heavy bleeding from the place where shot was given
• hoarseness
• itching skin
• joint pain
• loss of appetite
• muscle aches and pains
• nausea
• nervousness
• painful or difficult urination
• runny nose
• shivering
• sweating
• tender, swollen glands in the neck
• trouble sleeping
• trouble swallowing
• voice changes
• vomiting

More common—for strabismus

• Drooping of the upper eyelid
• eye pointing upward or downward instead of straight ahead

Less common or rare—for blepharospasm

• Skin rash
• swelling of the eyelid skin

Less common or rare—for strabismus

• Difficulty finding the location of objects
• double vision

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: timolol (TIH mo lol)
Brand Names: Blocadren

What is Blocadren (timolol)?

Timolol is in a group of drugs called beta-blockers. Beta-blockers affect the heart and circulation (blood flow through arteries and veins).

Timolol is used to treat hypertension (high blood pressure).

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

What is the most important information I should know about Blocadren (timolol)?

Do not stop taking timolol without first talking to your doctor. Stopping suddenly may make your condition worse.

If you need to have any type of surgery, you may need to temporarily stop using timolol. Be sure the surgeon knows ahead of time that you are using timolol.

Timolol 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, which could increase drowsiness and dizziness while you are taking timolol.

Timolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

What should I discuss with my healthcare provider before taking Blocadren (timolol)?

Before taking timolol, tell your doctor if you have:

• asthma, bronchitis, emphysema;

• diabetes;

• low blood pressure;

• a heart problem such as heart block, sick sinus syndrome, slow heart rate, or congestive heart failure;

• depression;

• liver or kidney disease;

• a thyroid disorder;

• myasthenia gravis;

• pheochromocytoma; or

• problems with circulation (such as Raynaud’s syndrome).

If you have any of these conditions, you may not be able to use timolol, or you may need a dosage adjustment or special tests during treatment.

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. Timolol 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 Blocadren (timolol)?

Take timolol exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor.

Take this medication with a full glass of water.

Take timolol at the same time every day.

Do not skip doses or stop taking timolol without first talking to your doctor. Stopping suddenly may make your condition worse.

To be sure this medication is helping your condition, your blood pressure will need to be checked on a regular basis. It is important that you not miss any scheduled visits to your doctor.

If you need to have any type of surgery, tell the surgeon that you are using timolol. You may need to briefly stop using timolol before having surgery.

Timolol is only part of a complete program of treatment for hypertension that may also include diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely if you are being treated for hypertension.

Hypertension often has no symptoms, so you may not even feel that you have high blood pressure. Continue using this medicine as directed, even if you feel well. You may need to use blood pressure medication for the rest of your life.

Store timolol at room temperature away from moisture and heat.

See also: Blocadren dosage in more detail

What happens if I miss a dose?

Take the missed dose as soon as you remember. If your next dose is less than 8 hours away, skip the missed dose and take the medicine at the 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.

Symptoms of a timolol overdose may include uneven heartbeats, shortness of breath, bluish-colored fingernails, dizziness, weakness, fainting, or seizure (convulsions).

What should I avoid while taking Blocadren (timolol)?

Timolol 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, which could increase drowsiness and dizziness while you are taking timolol.

Blocadren (timolol) 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 doctor at once if you have any of these serious side effects:

• slow or uneven heartbeats;

• feeling light-headed, fainting;

• feeling short of breath, even with mild exertion;

• swelling of your ankles or feet;

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

• depression; or

• cold feeling in your hands and feet.

Other less serious side effects are more likely to occur, such as:

• decreased sex drive, impotence, or difficulty having an orgasm;

• sleep problems (insomnia);

• tired feeling; or

• anxiety, nervousness.

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 Blocadren (timolol)?

Before taking timolol, tell your doctor if you are using:

• allergy treatments (or if you are undergoing allergy skin-testing);

• clonidine (Catapres);

• guanabenz (Wytensin);

• an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), or selegiline (Eldepryl, Emsam);

• a diabetes medication such as insulin, glyburide (Diabeta, Micronase, Glynase), glipizide (Glucotrol), chlorpropamide (Diabinese), or metformin (Glucophage);

• a heart medication such as nifedipine (Procardia, Adalat), reserpine (Serpasil), verapamil (Calan, Verelan, Isoptin), diltiazem (Cartia, Cardizem);

• medicine for asthma or other breathing disorders, such as albuterol (Ventolin, Proventil), bitolterol (Tornalate), metaproterenol (Alupent), pirbuterol (Maxair), terbutaline (Brethaire, Brethine, Bricanyl), and theophylline (Theo-Dur, Theolair); or

• cold medicines, stimulant medicines, or diet pills.

If you are using any of these drugs, you may not be able to take timolol, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect timolol. 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 has additional information about timolol 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: 8.03. Revision Date: 4/12/2009 4:36:06 PM.