Clozaril

Pronunciation: KLOE-za-peen
Generic Name: Clozapine
Brand Name: Clozaril

Clozaril may cause serious blood disorders, heart problems, low blood pressure (with or without fainting), breathing problems, and seizures. Blood tests will be required before and during treatment with Clozaril. You will not be able to have your medicine filled without these blood tests. Discuss these blood tests with your doctor.

The risk of seizures may be greater with higher doses or if you have a history of seizures. Do not perform activities in which a sudden loss of consciousness could cause harm to yourself or others (eg, driving, swimming).

The risk of heart or breathing problems may be greater if you are taking benzodiazepines (eg, lorazepam) or other medicines for mental or mood problems. Tell your doctor about any other medicines that you take.

Clozaril may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Clozaril is not approved to treat mental problems caused by dementia.

Clozaril is used for:

Managing schizophrenia in patients who do not respond to other medicines. It is used to decrease the risk of suicidal behavior in certain patients. It may also be used for other conditions as determined by your doctor.

Clozaril is an atypical antipsychotic. It may work by affecting certain chemicals in the brain, which has an effect on thinking and behavior.

Do NOT use Clozaril if:

• you are allergic to any ingredient in Clozaril


• you have bone marrow problems (eg, myeloproliferative disorders) or certain blood problems


• you have a history of blood or heart problems caused by Clozaril


• you have uncontrolled seizures (eg, epilepsy) or bowel blockage (paralytic ileus)


• you have severe drowsiness


• you are taking metoclopramide


• you are taking other medicines that may decrease bone marrow function or cause certain blood problems. Ask your doctor if you are unsure if any of your medicines may cause these problems

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

Before using Clozaril:

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

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of blood clots, blood problems, blood vessel problems, heart problems or a heart attack, high blood pressure, a stroke, lung or breathing problems, or high blood cholesterol levels


• if you or a member of your family have had a certain type of irregular heartbeat (QT prolongation, long QT syndrome)


• if you have low blood potassium or magnesium levels, or if you are at risk for low blood potassium or magnesium levels


• if you have a history of blood problems caused by another medicine


• if you have a history of an enlarged prostate; prolonged, painful erections; liver or kidney problems; seizures (eg, epilepsy); neuroleptic malignant syndrome (NMS); glaucoma; stomach or bowel problems; or dementia


• if you have diarrhea, poor health, severe loss of weight or muscle caused by another disease (eg, cancer), diabetes, or a family member with diabetes, or if you are very overweight


• if you have decreased metabolism of certain medicines


• if you smoke, are exposed to tobacco smoke, or you regularly consume food and drinks high in caffeine (eg, coffee, tea, soda)


• if you are scheduled for surgery or to receive anesthesia

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

• Benzodiazepines (eg, lorazepam) or other medicines for mental or mood problems because the risk of heart or breathing problems may be increased


• Antiarrhythmics (eg, amiodarone, propafenone, flecainide, quinidine), diuretics (eg, furosemide, hydrochlorothiazide), dolasetron, droperidol, iloperidone, macrolide antibiotics (eg, erythromycin), mefloquine, methadone, ondansetron, pentamidine, phenothiazines (eg, chlorpromazine, thioridazine), pimozide, quinolone antibiotics (eg, ciprofloxacin), tacrolimus, ziprasidone or any other medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat


• Cimetidine, lithium, metoclopramide, risperidone, selective serotonin reuptake inhibitors (SSRIs) (eg, citalopram, fluoxetine, fluvoxamine), or tramadol because they may increase the risk of Clozaril's side effects


• Barbiturates (eg, phenobarbital), hydantoins (eg, phenytoin), or rifamycins (eg, rifampin) because they may decrease Clozaril's effectiveness


• Anticholinergics (eg, benztropine), carbamazepine, debrisoquin, dextromethorphan, medicines for depression or high blood pressure, or tricyclic antidepressants (eg, amitriptyline) because the risk of their side effects may be increased by Clozaril

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

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

• Clozaril may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.


• Continue to take Clozaril even if you feel well. Do not miss any doses.


• Taking Clozaril at the same time each day will help you to remember to take it.


• Do not suddenly stop taking Clozaril. You may have an increased risk of side effects. If you need to stop Clozaril or add a new medicine, your doctor will gradually lower your dose.


• If you miss a dose of Clozaril, 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. If you miss taking a dose of Clozaril for more than 2 days, do not start taking it again. Contact your doctor right away for instructions.

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

Important safety information:

• Clozaril may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Clozaril with caution. Do not drive or perform other possibly unsafe tasks while you take Clozaril.


• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Clozaril; it may increase their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Clozaril may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do not take more than the recommended dose without checking with your doctor.


• Clozaril may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor right away if you notice any signs of infection like fever, sore throat, rash, chills, mouth or nose sores, or unusual tiredness or weakness.


• Women and patients of Jewish background may be at greater risk of developing blood problems with Clozaril.


• Seizures may occur in patients who take Clozaril, which may cause you to suddenly lose consciousness. Avoid activities in which loss of consciousness could be dangerous to you or others (eg, driving, swimming, climbing, operating machinery).


• Serious, and possibly fatal, heart problems have rarely occurred in patients who take Clozaril. Symptoms may include chest pain; fast or irregular heartbeat; fever; rapid or difficult breathing; swelling of the hands, feet, or ankles; or unusual tiredness. Seek immediate medical attention if you experience any of these symptoms.


• Clozaril may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.


• Avoid food and drink high in caffeine, like coffee, tea, cocoa, cola, and chocolate.


• Tell your doctor or dentist that you take Clozaril before you receive any medical or dental care, emergency care, or surgery.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Clozaril. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.


• Some patients who take Clozaril may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Clozaril in high doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your tongue, face, mouth, jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements), arms, or legs while taking Clozaril.


• Lab tests, including complete blood cell counts and heart function, may be performed while you use Clozaril and for at least 4 weeks after you stop taking it. These tests may be used to monitor your progress or check for side effects. Be sure to keep all doctor and lab appointments.


• Use Clozaril with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems, dizziness (especially when standing), fast heartbeat, urinary problems, and constipation.


• Clozaril should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been determined.


• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Clozaril while you are pregnant. Using Clozaril during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. It is not known if Clozaril is found in breast milk. Do not breast-feed while taking Clozaril.

Possible side effects of Clozaril:

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:

Constipation; dizziness; drowsiness; dry mouth; headache; heartburn; increased sweating or saliva production; lightheadedness when standing up; nausea; strange dreams; trouble sleeping; weight gain.

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); agitation; burning, numbness, or tingling; calf or leg pain or tenderness; chest pain; confusion; dark urine; decreased coordination; delirium; fainting; fast or difficult breathing; fast or irregular heartbeat; fever, chills, or sore throat; increased hunger, thirst, or urination; involuntary movements of the tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements); loss of appetite; new or worsening mental or mood changes; numbness of an arm or leg; obsessive-compulsive symptoms (eg, washing hands or checking doors continuously); persistent cough; restlessness; seizures; severe headache, dizziness, or vomiting; severe or persistent nausea or constipation; severe stomach pain; shortness of breath; sluggishness; stiff muscles; sudden, unusual weight gain; swelling of the hands, ankles, or feet; symptoms of a stroke (eg, one-sided weakness, slurred speech); tremor; trouble swallowing; trouble urinating; uncontrolled muscle movements; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomiting; 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 .

See also: Clozaril side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; delirium; excessive salivation; fainting; fast or irregular heartbeat; seizures; severe or persistent dizziness or drowsiness; slow or shallow breathing.

Proper storage of Clozaril:

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

General information:

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


• Clozaril 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.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Clozaril. 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: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Clozaril resources

• Clozaril Side Effects (in more detail)
• Clozaril Dosage
• Clozaril Use in Pregnancy & Breastfeeding
• Drug Images
• Clozaril Drug Interactions
• Clozaril Support Group
• 5 Reviews for Clozaril - Add your own review/rating

• Clozaril Consumer Overview


• Clozaril Advanced Consumer (Micromedex) - Includes Dosage Information


• Clozaril Prescribing Information (FDA)


• Clozapine Prescribing Information (FDA)


• Clozapine Monograph (AHFS DI)


• Clozapine Professional Patient Advice (Wolters Kluwer)


• FazaClo Prescribing Information (FDA)


• Fazaclo Consumer Overview

Compare Clozaril with other medications

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• Schizophrenia

ethotoin

ETH-oh-toin

Commonly used brand name(s)

In the U.S.

• Peganone

Available Dosage Forms:

• Tablet

Therapeutic Class: Anticonvulsant

Chemical Class: Hydantoin (class)

Uses For ethotoin

Ethotoin is used to control tonic-clonic (grand mal) and complex partial seizures. ethotoin is an anticonvulsant that works in the brain tissue to stop seizures.

ethotoin is available only with your doctor's prescription.

Before Using ethotoin

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 ethotoin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to ethotoin 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 ethotoin in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ethotoin in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ethotoin.

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

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. When you are taking ethotoin, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using ethotoin 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.

• Ketorolac


• Naproxen

Using ethotoin 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.

• Ginkgo

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

• Blood disorders or


• Liver problems—Should not be used in patients with these conditions.

• Depression, history of or


• Megaloblastic anemia—Use with caution. May make these conditions worse.

Proper Use of ethotoin

Take ethotoin only 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.

ethotoin should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

It is best to take ethotoin after meals.

It is best to plan your doses so they are evenly spaced during the day. Talk with your doctor if you have questions about when to take ethotoin.

Dosing

The dose of ethotoin 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 ethotoin. 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 seizures:
    
    • Adults—At first, 1000 milligrams (mg) per day, divided and given in 4 to 6 doses per day. Your doctor may increase your dose as needed. The usual dose is 2000 to 3000 mg per day.
    
    
    • Children 1 year of age and older—Dose is based on age and body weight and must be determined by your doctor. The usual dose is 500 to 1000 milligrams (mg) per day, divided and given in 4 to 6 doses per day.
    
    
    • Infants younger than 1 year of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of ethotoin, 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 ethotoin

It is very important that your doctor check the progress of you or your child at regular visits while you or your child are using ethotoin to see if it is working properly and to allow for a change in the dose. Blood and urine tests may be needed to check for any unwanted effects.

Using ethotoin while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking seizure medicines.

Do not stop taking ethotoin without first checking with your doctor. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.

Ethotoin may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Call your doctor right away if you or your child have a fever; nosebleeds; skin rash; small red or purple spots on the skin; a sore throat; unusual bruising or bleeding; unusual tiredness or weakness; or generally feel ill. These may be signs that you have an infection or a bleeding problem.

Lymph node problems may occur while using ethotoin. Check with your doctor right away if you or your child have swollen, painful, or tender lymph glands in your neck, armpit, or groin.

ethotoin 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:

Rare

• Enlarged gums


• shakiness and unsteady walk


• unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

• Blistering, peeling, or loosening of the skin


• chest pain


• cough


• diarrhea


• fever and chills


• general feeling of discomfort or illness


• hair loss


• headaches


• hives or itching


• joint or muscle pain


• numbness


• red, irritated eyes


• red skin lesions, often with a purple center


• shortness of breath or troubled breathing


• skin rash


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• swollen glands


• swollen, painful, or tender lymph glands in the neck, armpit, or groin


• unusual tiredness or weakness

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

Symptoms of overdose

• Blurred or loss of vision


• change in consciousness


• disturbed color perception


• double vision


• drowsiness


• halos around lights


• loss of consciousness


• nausea


• night blindness


• overbright appearance of lights


• tunnel vision

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:

Incidence not known

• Dizziness


• sleeplessness


• trouble sleeping


• unable to sleep


• uncontrolled eye movements


• vomiting

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.

See also: ethotoin side effects (in more detail)

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.

More ethotoin resources

• Ethotoin Side Effects (in more detail)
• Ethotoin Use in Pregnancy & Breastfeeding
• Ethotoin Drug Interactions
• Ethotoin Support Group
• 0 Reviews for Ethotoin - Add your own review/rating

• ethotoin Concise Consumer Information (Cerner Multum)


• Ethotoin MedFacts Consumer Leaflet (Wolters Kluwer)


• Ethotoin Professional Patient Advice (Wolters Kluwer)


• Peganone Prescribing Information (FDA)

Compare ethotoin with other medications

• Epilepsy
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• Seizures

Betnovate Cream

10000000050051

Betnovate Cream

betamethasone valerate

Read all of this leaflet carefully before you start using this medicine.

• Keep this leaflet. You may need to read it again.


• If you have any further questions, ask your doctor or pharmacist.


• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.


• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

• 
  1 What Betnovate is and what it is used for


• 
  2 Before you use Betnovate


• 
  3 How to use Betnovate


• 
  4 Possible side effects


• 
  5 How to store Betnovate


• 
  6 Further information

What Betnovate is and what it is used for

Betnovate contains a medicine called betamethasone valerate. It belongs to a group of medicines called steroids. It helps to reduce swelling and irritation.

Betnovate is used to help reduce the redness and itchiness of certain skin problems, such as eczema, psoriasis and dermatitis.

Before you use Betnovate

Do not use Betnovate:

• if you are allergic (hypersensitive) to betamethasone valerate or any of the other ingredients of Betnovate (listed in Section 6)


• on a child under 1 year


• to treat any of the following skin problems, it could make them worse:
  
  
  • acne
  • severe flushing of skin on and around your nose (rosacea)
  • spotty red rash around your mouth (perioral dermatitis)
  • itching around your back passage or private parts - unless your doctor has told you to do so
  • viral infections, such as cold sores, herpes or chicken pox
  • fungal infections, such as ringworm, athletes foot or thrush
  • skin blisters or sores that are caused by bacterial infections, such as impetigo.

Do not use if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before using Betnovate.

Take special care with Betnovate

Check with your doctor or pharmacist before using your medicine if:

• you are applying the cream under an airtight dressing, including a child’s nappy. These dressings make it easier for the active ingredient to pass through the skin. It is possible to accidentally end up using too much.


• you have psoriasis, your doctor will want to see you more often.

Pregnancy and breast-feeding

Talk to your doctor or pharmacist before using this medicine if you are pregnant, might become pregnant or are breast-feeding.

How to use Betnovate

Always use Betnovate exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Using this medicine

• You usually apply Betnovate 2 or 3 times a day. This may be reduced as your skin begins to get better.


• This cream is for use on your skin only.


• Do not use more than the amount prescribed for you.


• Do not use on large areas of the body for a long time (such as every day for many weeks or months) - unless your doctor tells you to.


• The germs that cause infections like warm, moist conditions under bandages or dressings so always clean the skin before a fresh dressing is put on.


• If you are applying the cream on someone else make sure you wash your hands after use or wear disposable plastic gloves.


• If your skin problem does not improve in 2 to 4 weeks, talk to your doctor.

Guidance on how to apply the cream

• 
  1 Wash your hands.


• 
  2 Gently rub the correct amount of cream into the skin until it has all disappeared. You can measure how much Betnovate to use with your fingertip. This picture shows one fingertip unit.

• 
  3 Unless you are meant to apply the cream to your hands as a part of the treatment, wash them again after using the cream.

For an adult

You should find that:

• two fingertips of cream will cover both hands or one foot


• three fingertips of cream will cover one arm


• six fingertips of cream will cover one leg


• fourteen fingertips of cream will cover the front and back of the body.

Do not worry if you find you need a little more or a little less than this. It is only a rough guide.

For a child

• Do not use it on children under 1 year of age.


• The smaller the child the less you will need to use.


• A child of 4 years needs about a third of the adult amount.


• A course of treatment for a child should not normally last more than 5 days - unless your doctor has told you to use it for longer.

If you have psoriasis

If you have thick patches of psoriasis on your elbows or knees, your doctor may suggest applying the cream under an airtight dressing. It will only be at night to help the cream to start working. After a short period of time you will then apply the cream as normal.

If you apply the Betnovate to your face

You should only apply the cream to your face if your doctor tells you to. It should not be used for more than 5 days, as the skin on your face thins easily. Do not let the cream get into your eyes.

If you use more Betnovate than you should

If, by mistake on a few occasions you use more than you should, do not worry. If you apply a lot or a lot is accidentally swallowed, it could make you ill. Talk to your doctor or go to the hospital as soon as possible.

If you forget to use Betnovate

If you forget to apply your cream, apply it as soon as you remember. If it is close to the time you are next meant to apply it, wait until this time.

If you stop using Betnovate

If you use Betnovate regularly make sure you talk to your doctor before you stop using it.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Betnovate Cream Side Effects

Like all medicines, Betnovate can cause side effects, although not everybody gets them.

Stop using Betnovate and tell your doctor as soon as possible if:

• you find that your skin condition gets worse or becomes swollen during treatment. You may be allergic to the Betnovate, have an infection or need other treatment.


• you have psoriasis you may get raised bumps with pus under the skin. This can happen very rarely during or after treatment and is known as pustular psoriasis.

Other side effects you may notice when using Betnovate include:

Common (affects less than 1 in 10 people)

• a feeling of burning, irritation or itching where the cream is applied.

Side effects if you use Betnovate for a long time, you use a lot each time you apply it, or you apply it under an airtight dressing:

Very rare (affects less than 1 in 10,000 people)

• stretch marks may develop


• veins under the surface of your skin may become more noticeable


• increased hair growth and changes in skin colour


• thinning of your skin and it may also damage more easily


• weight gain, rounding of the face and high blood pressure. These are more likely to happen in infants and children.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

How to store Betnovate

• Keep out of the reach and sight of children.


• Do not use Betnovate after the expiry date on the tube end or carton (Exp). The expiry date refers to the last day of that month.


• Do not store above 25°C.


• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

Further information

What Betnovate cream contains

• The active ingredient is betamethasone valerate. Each 1 g contains 1 mg of betamethasone (0.1% w/w) as valerate.


• The other ingredients are chlorocresol, cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, liquid paraffin, sodium acid phosphate, phosphoric acid, sodium hydroxide and purified water

What Betnovate looks like and contents of the pack

Within each carton is a tube with a plastic screw cap, which contains either 30 or 100 g of cream.

Marketing Authorisation Holder and Manufacturer

Product Licence held by

GlaxoSmithKline UK

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

Manufactured by

Glaxo Wellcome Operations

Barnard Castle

Durham

DL12 8DT

If you have any questions or are not sure about anything, ask your doctor or pharmacist who will advise you. Other sources of information are:

National Eczema Society

Hill House

Highgate Hill

London

N19 5NA

The Psoriasis Association

2 Queensbridge

Northampton

NN4 7BF

You may also be able to find out more from books in public libraries.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

Product name

Betnovate Cream

Reference number

10949/0014

This is a service provided by the Royal National Institute of Blind People.

Leaflet date: October 2007

Betnovate is a registered trademark of the GlaxoSmithKline group of companies

© 2007 GlaxoSmithKline group of companies

Gantrisin Pediatric

Generic Name: sulfisoxazole (sul fi SOX a zole)

Brand Names:

What is Gantrisin Pediatric (sulfisoxazole)?

Sulfisoxazole is a sulfonamide ("sulfa") antibiotic that helps keep bacteria from growing in your body.

Sulfisoxazole is used to treat or prevent many different types of infections caused by bacteria, such as bladder infections, ear infections, or meningitis.

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

What is the most important information I should know about Gantrisin Pediatric (sulfisoxazole)?

Take this medication for the full prescribed length of time. Your symptoms may get better before the infection is completely cleared. Sulfisoxazole will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking sulfisoxazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

What should I discuss with my health care provider before taking Gantrisin Pediatric (sulfisoxazole)?

You should not use this medication if you are allergic to sulfisoxazole or to any other sulfa drugs such as Azulfidine, Bactrim, Cotrim, Septra, or Sulfazine. Women who are in late pregnancy or are breast-feeding should not take sulfisoxazole.

To make sure you can safely take sulfisoxazole, tell your doctor if you have any of these other conditions:

• 
  

  asthma;

  
  


• 
  

  diabetes;

  
  


• 
  

  liver disease;

  
  


• 
  

  kidney disease;

  
  


• 
  

  anemia (a lack of red blood cells);

  
  


• 
  

  an enzyme deficiency called G6PD (glucose-6-phosphate dehydrogenase) deficiency;

  
  


• 
  

  a history of any type of allergy; or

  
  


• 
  

  if you are unable to urinate.

  
  

FDA pregnancy category C. It is not known whether sulfisoxazole will harm an unborn baby. Sulfisoxazole can cause jaundice (yellowing of the skin or eyes) and other problems in a newborn if the mother has taken this medication late in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Sulfisoxazole can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking sulfisoxazole, especially if your baby is younger than 2 months old. Do not give this medicine to a child younger than 2 months old without the advice of a doctor.

How should I take Gantrisin Pediatric (sulfisoxazole)?

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.

You may take sulfisoxazole with or without food.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. While you are taking sulfisoxazole, drink 6 to 8 glasses of water each day. This will help prevent kidney stones or crystals in the urine.

To be sure this medication is helping your condition, your blood may need to be tested often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using sulfisoxazole. You may need to stop using the medicine for a short time. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Sulfisoxazole will not treat a viral infection such as the common cold or flu. Do not share this medication with another person, even if they have the same symptoms you have. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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.

Overdose symptoms may include headache, drowsiness, nausea, vomiting, stomach pain, loss of appetite, fever, blood in your urine, pale skin, easy bruising or bleeding, flu symptoms, feeling light-headed, or fainting.

What should I avoid while taking Gantrisin Pediatric (sulfisoxazole)?

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking sulfisoxazole and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Sulfisoxazole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid exposure to sunlight or tanning beds. Sulfisoxazole can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Gantrisin Pediatric (sulfisoxazole) 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:

• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  fever, chills, body aches, flu symptoms;

  
  


• 
  

  cough, feeling short of breath, pale skin, joint pain, unusual bruising;

  
  


• 
  

  fast or pounding heartbeat;

  
  


• 
  

  blue lips or fingernails, feeling light-headed, fainting;

  
  


• 
  

  swelling around your neck or throat;

  
  


• 
  

  urinating more or less than usual;

  
  


• 
  

  severe pain in your side or lower back, blood in your urine;

  
  


• 
  

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

  
  


• 
  

  fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  
  


• 
  

  agitation, confusion, unusual thoughts or behavior; or

  
  


• 
  

  seizure (black-out or convulsions).

  
  

Less serious side effects may include:

• 
  

  mild stomach pain, bloating, gas;

  
  


• 
  

  headache, dizziness;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  swollen, black, or "hairy" tongue.

  
  

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

What other drugs will affect Gantrisin Pediatric (sulfisoxazole)?

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

• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  methotrexate (Rheumatrex, Trexall); or

  
  


• 
  

  diabetes medications such as acetohexamide (Dymelor), chlorpropamide (Diabinese), glimepiride (Amaryl, Avandaryl, Duetact), glipizide (Glucotrol), glyburide (DiaBeta, Glynase PresTab, Micronase), tolazamide (Tolinase), or tolbutamide (Orinase).

  
  

This list is not complete and other drugs may interact with sulfisoxazole. 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.

More Gantrisin Pediatric resources

• Gantrisin Pediatric Side Effects (in more detail)
• Gantrisin Pediatric Use in Pregnancy & Breastfeeding
• Gantrisin Pediatric Drug Interactions
• Gantrisin Pediatric Support Group
• 0 Reviews for Gantrisin Pediatric - Add your own review/rating

• Gantrisin Pediatric Advanced Consumer (Micromedex) - Includes Dosage Information


• Gantrisin Prescribing Information (FDA)


• Gantrisin Suspension MedFacts Consumer Leaflet (Wolters Kluwer)


• Sulfisoxazole MedFacts Consumer Leaflet (Wolters Kluwer)


• Sulfisoxazole Professional Patient Advice (Wolters Kluwer)

Compare Gantrisin Pediatric with other medications

• Bacterial Infection
• Bladder Infection
• Chancroid
• Chlamydia Infection
• Inclusion Conjunctivitis
• Kidney Infections
• Malaria
• Meningitis, Haemophilus influenzae
• Meningitis, Meningococcal
• Nocardiosis
• Otitis Media
• Pelvic Inflammatory Disease
• Toxoplasmosis
• Trachoma

Where can I get more information?

• Your pharmacist can provide more information about sulfisoxazole.

See also: Gantrisin Pediatric side effects (in more detail)

Aspirin Caplets 300mg (Boots Company plc)

Boots Aspirin Caplets 300 mg

Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription to treat minor conditions. However, you still need to take it carefully to get the best results from it.

• Keep this leaflet, you may need to read it again


• Ask your pharmacist if you need more information or advice

What this medicine is for

This medicine contains Aspirin which belongs to a group of medicines called analgesics and antipyretics which act to relieve pain and reduce fever.

It can be used to relieve headache, migraine, rheumatic pains, neuralgia, period pain, toothache and the symptoms of colds and flu.

Before you take this medicine

This medicine can be taken by adults and children aged 16 years and over. However, some people should not take this medicine or should seek the advice of their pharmacist or doctor first.

Do not take:

• 
  If you are allergic to any of the ingredients


• 
  If you have ever had a bad reaction to aspirin or any other non-steroidal anti-inflammatory drugs (you have had asthma, swelling of the lips or face, itchy skin or runny nose after taking them)


• 
  If you have a stomach ulcer, or have had one


• 
  If you have severe liver or kidney problems


• 
  If you have a blood clotting disorder or gout


• 
  If you are pregnant or breastfeeding
  

Talk to your pharmacist or doctor:

• If you have mild kidney problems

Other important information

There is a possible association between aspirin and Reye's syndrome when given to children. Reye's syndrome is a very rare disease, which can be fatal. For this reason aspirin should not be given to children aged under 16 years, unless on the advice of a doctor.

Do not drink alcohol (wine, beer, spirits) whilst taking this medicine

If you take other medicines

Before you take these caplets, make sure that you tell your pharmacist about ANY other medicines you might be using at the same time, particularly the following:

• Methotrexate (for cancer, skin and rheumatic problems)


• Warfarin or other blood thinners


• Tablets for diabetes


• Medicines for gout


• Corticosteroids

If you are unsure about interactions with any other medicines, talk to your pharmacist. This includes medicines prescribed by your doctor and medicine you have bought for yourself, including herbal and homeopathic remedies.

How to take this medicine

Check the foil is not broken before use. If it is, do not take that caplet.

Follow the instructions in the table on the back of the leaflet.

Adults and children of 16 years and over

Take one to three caplets

Every 4 hours, if you need to, up to 4 times in 24 hours.

Don't take more than 12 caplets in 24 hours.

Swallow the caplets with a glass of water.

Do not give to children under 16 years.

Do not take more than the amount recommended above.

If symptoms do not go away talk to your doctor.

If you take too many caplets: Talk to a doctor straight away.

Possible side effects

Most people will not have problems, but some may get some.

If you get any of these serious side effects, stop taking the caplets. See a doctor at once:

• You are sick and it contains blood or dark particles that look like coffee grounds


• Pass blood in your stools or pass black tarry stools


• Severe stomach pain


• Rash, swelling of the face, runny nose, tight chest, wheezing (severe allergic reactions)

These other effects are less serious. If they bother you talk to a pharmacist:

• Indigestion, feeling sick, being sick


• Water retention


• Worsening of existing kidney problems


• Rarely, liver problems

If any side effect becomes severe, or you notice any side effect not listed here, please tell your pharmacist or doctor.

How to store this medicine

Do not store above 25°C.

Keep this medicine in a safe place out of the sight and reach of children, preferably in a locked cupboard.

Use by the date on the end flap of the carton.

What is in this medicine

Each tablet contains Aspirin 300 mg, which is the active ingredient.

As well as the active ingredient, the tablets also contain maize starch.

This pack contains 16 or 32 capsule-shaped tablets.

Who makes this medicine

Manufactured for the Marketing Authorisation holder

The Boots Company PLC

Nottingham

NG2 3AA

by

Hamol Limited

Nottingham

NG90 2DB

Leaflet prepared August 2008

If you would like any further information about this medicine, please contact

The Boots Company PLC

Nottingham

NG2 3AA

Other formats

To request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK only)

Please be ready to give the following information:

Product name: Boots Aspirin Caplets 300 mg

Reference number: 00014/0584

This is a service provided by the Royal National Institute of the Blind.

BTC33944 vD 12/01/09

Ellence

Generic Name: Epirubicin Hydrochloride
Class: Antineoplastic Agents
VA Class: AN200
Chemical Name: (8S - cis) - 10 - [(3 - Amino - 2,3,6 - trideoxy - α - l - arabino - hexopyranosyl)oxy] - 7,8,9,10 - tetrahydro - 6,8,11 - trihydroxy - 8 - (hydroxyacetyl) - 1 - methoxy-5,12-naphthacenedione hydrochloride
Molecular Formula: C₂₇H₂₉NO₁₁•HCl
CAS Number: 56390-09-1

• 
  

  Severe local tissue necrosis if extravasation occurs.¹ Do not administer IM or sub-Q.¹

  
  


• 
  

  Possible cardiotoxicity and potentially fatal CHF during or after therapy.¹ Increased risk of CHF with cumulative doses >900 mg/m²; exceed this cumulative dose with extreme caution.¹ Toxicity may occur at lower cumulative doses, regardless of whether cardiac risk factors are present.¹ Cardiac effects of epirubicin and other anthracyclines or anthracenediones may be additive.¹

  
  


• 
  

  Possible secondary acute myelogenous leukemia (AML); risk of refractory AML increases when epirubicin is combined with other DNA-damaging antineoplastics, after extensive exposure to cytotoxic drugs, or when anthracycline doses have been escalated.¹

  
  


• 
  

  Reduce dosage in patients with hepatic impairment.¹ (See Hepatic Impairment under Dosage and Administration.)

  
  


• 
  

  Severe myelosuppression may occur.¹

  
  


• 
  

  Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

  
  

Introduction

Anthracycline glycoside antineoplastic antibiotic; the 4′-epimer of doxorubicin; a semisynthetic derivative of daunorubicin.^{1 2 3 4 5}

Uses for Ellence

Breast Cancer

A component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast carcinoma; efficacy was established in combination with cyclophosphamide and fluorouracil.^{1 2 3 4 5}

Ellence Dosage and Administration

General

• 
  

  Optimize results and minimize adverse effects by basing dose on clinical, cardiac, hepatic, renal, and hematologic response; patient tolerance; and other chemotherapy or irradiation being used.¹

  
  


• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.

  
  

Administration

Extremely irritating to tissues.¹ Administer IV only; do not administer IM or sub-Q.¹

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer slowly into tubing of a freely running IV infusion of 0.9% sodium chloride or 5% dextrose injection.¹ Do not use veins over joints or in extremities with compromised venous or lymphatic drainage.¹

Avoid extravasation.¹ If signs or symptoms of extravasation occur, immediately stop the injection or infusion and restart at another site.¹

Handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., latex gloves) and wash hands after removal of the latex gloves.¹

Immediately treat accidental contact with the skin, mucous membranes, or eyes by copious lavage with water, soap and water, or sodium bicarbonate solution, but avoid abrasion of skin by use of a scrub brush; seek prompt medical attention.¹

Rate of Administration

Usually administered over 3–20 minutes, depending on the volume of the infusion solution and the dosage.¹

Rapid administration may cause local erythematous streaking along the vein and/or facial flushing;¹ local phlebitis or thrombophlebitis may follow.¹

Dosage

Available as epirubicin hydrochloride; dosage expressed in terms of the salt.¹

Adults

Breast Cancer

IV

100–120 mg/m² in repeated 3- to 4-week cycles; give total dose for each cycle as a single dose on day 1 or as 2 equally divided doses on days 1 and 8.^{1 4}

In clinical trials, the 100-mg/m² epirubicin hydrochloride regimen included fluorouracil 500 mg/m² and cyclophosphamide 500 mg/m², with all drugs administered IV on day 1 of a 21-day cycle and repeated for 6 cycles.^{1 4}

In clinical trials, the 120-mg/m² epirubicin hydrochloride regimen was given IV as 60 mg/m² of the anthracycline and fluorouracil 500 mg/m² on days 1 and 8 of each cycle combined with oral cyclophosphamide 75 mg/m² on days 1–14 of each cycle, with the cycles being repeated at 28-day intervals, for 6 cycles.¹

Adjust dosage after first treatment cycle based on hematologic and nonhematologic toxicities.¹

In patients with nadir platelet counts <50,000/mm³, absolute neutrophil counts (ANCs) <250/mm³, neutropenic fevers, or grade 3 or 4 nonhematologic toxicity, reduce day-1 dose of each antineoplastic agent in subsequent cycles to 75% of the day-1 dose given in current cycle.¹

Delay day-1 chemotherapy in subsequent cycles until platelet counts are ≥100,000/mm³, ANCs are ≥1500/mm³, and nonhematologic toxicities have recovered to grade 1 or better.¹

If epirubicin hydrochloride dose is divided between days 1 and 8, reduce the day-8 dose of each drug to 75% of the day-1 dose if platelet counts and ANCs are 75,000–100,000 and 1000–1499/mm³, respectively.¹

If day-8 platelet counts or ANCs are <75,000 or 1000/mm³, respectively, or grade 3 or 4 nonhematologic toxicity has occurred, omit day-8 dose of each drug.¹

Special Populations

Hepatic Impairment

In clinical studies, patients with serum bilirubin concentration of 1.2–3 mg/dL or AST concentration 2–4 times the upper limit of normal (ULN) received 50% of recommended initial dosage of epirubicin hydrochloride.¹

In clinical studies, patients with serum bilirubin concentration of >3 mg/dL or AST >4 times the ULN received 25% of initial recommended dosage of epirubicin hydrochloride.¹

Epirubicin is not recommended in patients with severe hepatic impairment.¹

Renal Impairment

Consider dosage reduction if S_cr is >5 mg/dL; not studied in those undergoing dialysis.¹

Bone Marrow Impairment

Consider decreasing dosage for the initial cycle to 75–90 mg/m² in patients with bone marrow impairment (e.g., extensive pretreatment, preexisting myelosuppression, neoplastic bone marrow infiltration).¹

Cautions for Ellence

Contraindications

• 
  

  Known hypersensitivity to epirubicin, other anthracyclines, anthracenediones, or any ingredient in the formulation.¹

  
  


• 
  

  Baseline neutrophil count <1500/mm³.¹

  
  


• 
  

  Severe myocardial or hepatic impairment or recent myocardial infarction.¹

  
  


• 
  

  Previous anthracycline therapy up to the maximum cumulative dose.¹

  
  

Warnings/Precautions

Warnings

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic therapy.¹

Patients must have recovered from acute toxicities (e.g., stomatitis, neutropenia, thrombocytopenia, generalized infections) of prior cytotoxic therapy before starting treatment with epirubicin.¹

Prior to and during therapy, assess hematopoietic, hepatic, renal, and cardiac function; monitor for clinical complications associated with myelosuppression (e.g., granulocytopenia, infections) and potential cardiotoxicity (e.g., CHF), especially with increasing cumulative exposure to anthracyclines.¹

Provide supportive care for the treatment of toxicity (e.g., severe neutropenia, severe infectious complications, cardiotoxicity).¹

Carcinogenicity

Possible secondary AML; risk of refractory AML increases with concomitant DNA-damaging antineoplastics, extensive exposure to cytotoxic drugs, or escalation of anthracycline doses.¹

The cumulative risk for adjuvant epirubicin therapy-related leukemia is estimated as 0.2 and 0.8% at 3 and 5 years, respectively.¹

Fertility

Possible chromosomal damage in human spermatozoa; males should utilize effective contraceptive methods.¹

Possible irreversible amenorrhea in premenopausal women.¹

Local Effects

Local pain, severe tissue lesions, and severe local necrosis if extravasation occurs.¹ Must not be given IM or sub-Q (see IV Administration under Dosage and Administration).¹

Possible venous sclerosis if injected into a small vessel or injected repeatedly into the same vein.¹

Tumor Lysis Syndrome

Tumor lysis syndrome may result from extensive purine catabolism accompanying rapid cellular destruction; monitor serum uric acid concentration.¹

Minimize or prevent by adequate hydration, alkalinization of the urine, and/or administration of allopurinol.¹

Major Toxicities

Hematologic Effects

Possible dose-dependent, reversible leukopenia and/or granulocytopenia (most common acute dose-limiting toxicity).¹

Leukocyte nadir at day 10–14, with return to baseline by day 21.¹

Possible severe myelosuppression.¹

Cardiac Effects

Early (acute) cardiotoxicity (e.g, sinus tachycardia, ECG abnormalities such as nonspecific ST-T wave changes, AV block, ventricular tachycardia) does not predict subsequent development of delayed cardiotoxicity, is rarely of clinical importance, and generally is not an indication for suspension of therapy.¹

Delayed cardiotoxicity (cardiomyopathy), manifested by reduced left ventricular ejection fraction (LVEF) and CHF, may be life-threatening.¹ Active or occult cardiovascular disease, prior or concomitant irradiation to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase risk.¹

Monitor LVEF during therapy and discontinue epirubicin at the first sign of impaired cardiac function.¹

Strictly monitor cardiac function in patients with risk factors for cardiotoxicity; evaluate risk versus benefit of continued therapy in those with impaired cardiac function.¹

Cardiotoxicity is a cumulative dose-limiting toxicity of the drug.¹ Probability of developing CHF estimated as 0.9, 1.6, and 3.3% at cumulative epirubicin hydrochloride dosages of 550, 700, and 900 mg/m², respectively.¹ Risk of CHF increases rapidly with total cumulative dose >900 mg/m²; exceed this dose with extreme caution.¹ Possible toxicity at lower cumulative doses, regardless of whether cardiac risk factors are present.¹

Cardiac effects of epirubicin and other anthracyclines or anthracenediones may be additive.¹

Cardiovascular Effects

Thrombophlebitis and thromboembolic phenomena, including pulmonary embolism, sometimes fatal, have been reported.¹

GI Effects

Possible nausea and vomiting; consider prophylaxis with antiemetics.¹

Possible dose-dependent mucositis (e.g., oral stomatitis, esophagitis); may be severe.¹

Irradiation

Possible additive cytotoxicity with combined epirubicin and radiation therapy; in clinical studies with epirubicin, radiation therapy was delayed until after completion of the chemotherapy.¹

Possible inflammatory recall reaction at the site of prior irradiation.¹

Prophylactic Anti-infective Therapy

In clinical studies, prophylactic anti-infective therapy with co-trimoxazole or a fluoroquinolone was used with the 120-mg/m² regimen (see Dosage under Dosage and Administration).¹

Specific Populations

Pregnancy

Category D.¹

Lactation

Discontinue nursing because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established.¹

Possible increased risk of acute or delayed cardiotoxicity.¹

Geriatric Use

Careful monitoring for toxicity is recommended.¹

Hepatic Impairment

Use not recommended in severe impairment.¹ Dosage adjustment for mild to moderate impairment (see Hepatic Impairment under Dosage and Administration).¹

Common Adverse Effects

Alopecia, nausea/vomiting, myelosuppression (leukopenia, neutropenia, anemia, thrombocytopenia), amenorrhea, mucositis, lethargy, hot flushes (flashes), diarrhea, infection, local effects (e.g., venous irritation), conjunctivitis/keratitis, rash/pruritus, skin changes, fever, anorexia.¹

Interactions for Ellence

Antineoplastic Agents

Potential pharmacodynamic interaction (additive pharmacologic and toxic effects).¹

Cardioactive Agents

Potential pharmacodynamic interaction (potentiation of cardiotoxicity); monitor cardiac function closely with concurrent use of cardioactive drugs that may precipitate CHF (e.g., verapamil).¹

Cimetidine

Potential pharmacokinetic interaction (increased epirubicin concentrations); discontinue during epirubicin therapy.¹

Hepatoactive Drugs

Potential pharmacologic or pharmacokinetic interaction.¹

Ellence Pharmacokinetics

Distribution

Extent

Rapidly and widely distributed into body tissues following IV administration.¹ Appears to concentrate in red blood cells; concentrations in whole blood are approximately twice those in plasma.¹ Distributed into milk in rats; not known whether the drug is distributed into milk in humans.¹

Plasma Protein Binding

Approximately 77% bound to plasma proteins, principally albumin.¹

Elimination

Metabolism

Extensively and rapidly metabolized in the liver; also is metabolized in other organs and cells, including erythrocytes.¹ Four main metabolic pathways have been identified.¹ Only the metabolite epirubicinol appears to have cytotoxic activity; however, epirubicinol is unlikely to reach in vivo concentrations sufficient to produce cytotoxic effects.¹

Elimination Route

Epirubicin and its major metabolites are eliminated in feces via biliary excretion and to a lesser extent in urine.¹

Half-life

Plasma concentrations of epirubicin decline in a triphasic manner, with mean half-lives for the α, β, and γ phases of about 3 minutes, 2.5 hours, and 33 hours, respectively.¹

Special Populations

Clearance is reduced in geriatric women and in patients with hepatic impairment.¹

Stability

Storage

Parenteral

Injection, for IV Use

2–8^° C.¹ Do not freeze; protect from light.¹ Discard unused solution within 24 hours after initial entry into vial.^{1 HID}

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Incompatible with any alkaline pH solution (hydrolysis of drug).¹

Solution Compatibility^HID

Compatible
Dextrose 3.3% in sodium chloride 0.3%
Dextrose 5% in water
Ringer’s injection, lactated
Sodium chloride 0.9%

Drug Compatibility

Admixture Compatibility

Compatible
Ifosfamide
Incompatible
Fluorouracil

Y-Site CompatibilityHID

Compatible
Oxaliplatin

Manufacturer states that epirubicin hydrochloride should not be mixed with other drugs in the same syringe.¹

Compatibility in Syringe1HID

Compatible
Ifosfamide
Incompatible
Fluorouracil
Heparin sodium
Ifosfamide with mesna

ActionsActions

• 
  

  Pharmacologic actions similar to those of daunorubicin and doxorubicin.^{1 2 3 4}

  
  


• 
  

  Intercalates between base pairs causing template disordering and steric obstruction; thereby inhibits DNA synthesis, DNA-dependent RNA synthesis, and protein synthesis ^{1 2 4} and triggers DNA cleavage by topoisomerase II.^{1 2 3 4} Also inhibits DNA helicase and generates cytotoxic free radicals.^{1 2 3 4}

  
  


• 
  

  Compared with doxorubicin, is more lipophilic, may have improved therapeutic index, ^{3 4} and is less toxic;^{2 3} similar spectrum of activity against a wide variety of solid tumors and hematologic malignancies, and complete cross-resistance.^{2 3 4}

  
  

Advice to Patients

• 
  

  Importance of recognizing and reporting adverse effects of epirubicin, including GI and myelosuppressive effects (and related precautions), infectious complications, CHF symptoms, and injection site pain.¹

  
  


• 
  

  Risk of irreversible myocardial toxicity and leukemia.¹

  
  


• 
  

  Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy, advise pregnant women of risk to the fetus, and advise males to utilize effective contraception during therapy.¹ Inform women of risk of irreversible amenorrhea or premature menopause.¹

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.¹

  
  


• 
  

  Probable alopecia; reddish appearance of urine for 1–2 days (harmless).¹

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Epirubicin Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV use only	2 mg/mL (50 and 200 mg)	Ellence (preservative-free)	Pharmacia

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Pharmacia. Ellence (epirubicin hydrochloride) injection prescribing information. Kalamazoo, MI; 2002 Jan.

2. Coukell AJ, Faulds D. Epirubicin: an updated review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in the management of breast cancer. Drugs. 19997; 53:453-82.

3. Bonadonna G, Giannia L, Santoro A et al. Drugs ten years later: epirubicin. Ann Oncol. 1993; 4:359-69. [PubMed 8353070]

4. Pharmacia & Upjohn Co. Oncologic Drugs Advisory Committee (ODAC) brochure: NDA 21-010, epirubicin hydrochloride injection, amendment 019. Kalamazoo, MI; 1999 Jun 7.

5. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther. 2000; 42:83-92. [PubMed 10994034]

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists, Inc; 2007:626-8.

More Ellence resources

• Ellence Side Effects (in more detail)
• Ellence Use in Pregnancy & Breastfeeding
• Ellence Drug Interactions
• Ellence Support Group
• 0 Reviews for Ellence - Add your own review/rating

• Ellence Prescribing Information (FDA)


• Ellence Consumer Overview


• Ellence Advanced Consumer (Micromedex) - Includes Dosage Information


• Ellence MedFacts Consumer Leaflet (Wolters Kluwer)


• Epirubicin Prescribing Information (FDA)

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Viscosupplementation agents

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Viscosupplementation agents are preparations that have hyaluronic acid, which is injected into the knee joint to relieve pain associated with osteoarthritis. Joints affected by osteoarthritis have less hyaluronic acid, which is naturally present in the synovial fluid. Hyaluronic acid acts as a lubricant and allows bones to move smoothly without rubbing against each other. Viscosupplementation agents also improve joint movement.

See also

Medical conditions associated with viscosupplementation agents:

• Osteoarthritis

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Hyalgan

Supartz

Synvisc-One

Orthovisc

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