Sample Article Directory Trinidad and Tobago: May 2012

Tuesday, 29 May 2012

Atypical Mycobacterial Infection Medications

There are currently no drugs listed for "Atypical Mycobacterial Infection".

Learn more about Atypical Mycobacterial Infection

Medical Encyclopedia:

Atypical mycobacterial infection

Drug List:

Friday, 25 May 2012

Icar Suspension

Pronunciation: EYE-urn
Generic Name: Iron
Brand Name: Icar

Icar Suspension is used for:

Supplementing iron in the diet and treating or preventing anemia (low red blood cell levels) due to low iron levels. It may also be used for other conditions as determined by your doctor.

Icar Suspension is a mineral. It works by helping the body to make hemoglobin, which is found in red blood cells. Hemoglobin allows red blood cells to carry oxygen throughout the body, which helps to reduce the effects of anemia.

Do NOT use Icar Suspension if:

you are allergic to any ingredient in Icar Suspension

you have high levels of iron in the blood

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

Before using Icar Suspension:

Some medical conditions may interact with Icar Suspension. 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 colon problems, Crohn disease, or a peptic ulcer

if you have anemia not caused by iron deficiency, porphyria cutanea tarda, liver or kidney problems, thalassemia, or a history of alcohol abuse, or you have had multiple blood transfusions

Some MEDICINES MAY INTERACT with Icar Suspension. However, no specific interactions with Icar Suspension are known at this time.

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

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

Icar Suspension is absorbed better on an empty stomach, but may be taken with food if it upsets your stomach.

Shake well before using.

Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.

Do not take antacids within 1 hour before or 2 hours after taking Icar Suspension.

Take Icar Suspension with a full glass (8 oz/240 mL) of water.

Do not lie down for 30 minutes after taking Icar Suspension.

If you miss a dose of Icar Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

Do not take large doses of vitamins (megadoses or megavitamin therapy) unless otherwise instructed by your doctor.

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. In case of accidental overdose, call a doctor or poison control center immediately.

Some of these products contain sulfites, which can cause allergic reactions in certain individuals (eg, asthma patients). If you have previously had allergic reactions to sulfites, contact your pharmacist to determine if the product you are taking contains sulfites.

Some of these products may contain tartrazine dye (FD&C Yellow No. 5), which can cause allergic reactions in certain patients. If you have previously had an allergic reaction to tartrazine, contact your pharmacist to determine if the medicine you are taking contains tartrazine.

Icar Suspension may cause incorrect test results with kits used to check for blood in the stool or blood cholesterol. Check with your doctor if you are using either kind of test kit.

LAB TESTS, including blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Icar Suspension during pregnancy. If you are or will be breast-feeding while you are using Icar Suspension, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Icar Suspension:

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; diarrhea; nausea; stomach discomfort.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood or streaks of blood in the stool; fever; sharp stomach pain; vomiting.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Icar 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. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children younger than 6 years of age. In case of accidental overdose, call a doctor or poison control center immediately. Symptoms may include loss of consciousness; nausea; seizures; stomach pain; tarry stools; tiredness; vomiting; weak, fast heartbeat.

Proper storage of Icar Suspension:

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

General information:

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

Icar Suspension 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 Icar Suspension. 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

More Icar resources

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

Compare Icar with other medications

Iron Deficiency Anemia

Thursday, 24 May 2012

Pneumococcal 13-Valent Conjugate Vaccine

Pronunciation: NEU-mo-KOK-al
Generic Name: Pneumococcal 13-Valent Conjugate Vaccine
Brand Name: Prevnar 13

Pneumococcal 13-Valent Conjugate Vaccine is used for:

Preventing certain infections caused by the bacteria Streptococcus pneumoniae.

Pneumococcal 13-Valent Conjugate Vaccine is a vaccine. It works by stimulating the body to make antibodies to S. pneumoniae bacteria.

Do NOT use Pneumococcal 13-Valent Conjugate Vaccine if:

you are allergic to any ingredient in Pneumococcal 13-Valent Conjugate Vaccine, in the pneumococcal 7-valent vaccine, or to any vaccine that contains diphtheria toxoid

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

Before using Pneumococcal 13-Valent Conjugate Vaccine:

Some medical conditions may interact with Pneumococcal 13-Valent Conjugate Vaccine. 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 (including rubber)

if you have a fever or a history of seizures, spleen problems, sickle cell disease, or certain kidney problems (nephrotic syndrome)

if you have bleeding or blood clotting problems, or you have low blood platelet levels

if you have a weakened immune system (eg, cancer, HIV infection) or are taking medicines or treatments (eg, radiation therapy) that may weaken the immune response

if the patient is a child who was born prematurely

Some MEDICINES MAY INTERACT with Pneumococcal 13-Valent Conjugate Vaccine. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin) because the risk of side effects, such as bleeding at the injection site, may be increased

Medicines that decrease the immune response, such as corticosteroids (eg, prednisone) or cancer medicines, because they may decrease Pneumococcal 13-Valent Conjugate Vaccine's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if Pneumococcal 13-Valent Conjugate Vaccine 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 Pneumococcal 13-Valent Conjugate Vaccine:

Use Pneumococcal 13-Valent Conjugate Vaccine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Pneumococcal 13-Valent Conjugate Vaccine is given as an injection at your doctor's office, hospital, or clinic.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Pneumococcal 13-Valent Conjugate Vaccine, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Pneumococcal 13-Valent Conjugate Vaccine.

Important safety information:

Before you are given Pneumococcal 13-Valent Conjugate Vaccine, a health care provider should inform you of the benefits and risks. Vaccine information statements should be provided to you before each vaccination.

Make sure your health care provider has a complete record of your vaccinations and is aware of your current health status. Be sure that your medical record shows that you have received Pneumococcal 13-Valent Conjugate Vaccine.

It is important that you complete the vaccination series. Pneumococcal 13-Valent Conjugate Vaccine is not a substitute for routine diphtheria immunization.

Pneumococcal 13-Valent Conjugate Vaccine may not protect everyone who receives it. It will not protect against pneumonia or other infections (including ear infections) caused by organisms not covered by this vaccine.

Pneumococcal 13-Valent Conjugate Vaccine is not recommended for use in the ELDERLY or other adults and should not be used as a substitute for the pneumococcal polysaccharide vaccine for elderly patients.

Pneumococcal 13-Valent Conjugate Vaccine is for use in infants and toddlers. Safety and effectiveness of Pneumococcal 13-Valent Conjugate Vaccine in premature INFANTS, INFANTS younger than 6 weeks old, or CHILDREN 6 years old or older has not been determined.

PREGNANCY and BREAST-FEEDING: Pneumococcal 13-Valent Conjugate Vaccine is not approved for use in adults. It is not known if Pneumococcal 13-Valent Conjugate Vaccine can cause harm to the fetus. If you become pregnant while taking Pneumococcal 13-Valent Conjugate Vaccine, contact your doctor. You will need to discuss the benefits and risks of using Pneumococcal 13-Valent Conjugate Vaccine while you are pregnant. It is not known if Pneumococcal 13-Valent Conjugate Vaccine is found in breast milk.

Possible side effects of Pneumococcal 13-Valent Conjugate Vaccine:

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:

Decreased appetite; fever; irritability; redness, swelling, or tenderness at the injection site; sleep changes.

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; unusual hoarseness); persistent cough; severe or persistent fever; severe or persistent diarrhea or vomiting; seizures; shortness of breath; stomach pain or cramps; wheezing.

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: Pneumococcal3-Valent Conjugate 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.

Proper storage of Pneumococcal 13-Valent Conjugate Vaccine:

Pneumococcal 13-Valent Conjugate Vaccine is usually handled and stored by a health care provider. If you are using Pneumococcal 13-Valent Conjugate Vaccine at home, store Pneumococcal 13-Valent Conjugate Vaccine as directed by your pharmacist or health care provider. Keep Pneumococcal 13-Valent Conjugate Vaccine out of the reach of children and away from pets.

General information:

If you have any questions about Pneumococcal 13-Valent Conjugate Vaccine, please talk with your doctor, pharmacist, or other health care provider.

Pneumococcal 13-Valent Conjugate Vaccine 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 Pneumococcal 13-Valent Conjugate Vaccine. 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

More Pneumococcal 13-Valent Conjugate Vaccine resources

Pneumococcal 13-Valent Conjugate Vaccine Side Effects (in more detail)
Pneumococcal 13-Valent Conjugate Vaccine Use in Pregnancy & Breastfeeding
Pneumococcal 13-Valent Conjugate Vaccine Drug Interactions
Pneumococcal 13-Valent Conjugate Vaccine Support Group
0 Reviews for Pneumococcal3-Valent Conjugate - Add your own review/rating

Prevnar 13 Prescribing Information (FDA)

Prevnar 13 Advanced Consumer (Micromedex) - Includes Dosage Information

Prevnar 13 Consumer Overview

Compare Pneumococcal 13-Valent Conjugate Vaccine with other medications

Pneumococcal Disease Prophylaxis

MigraMax

MigraMax 900 mg / 10 mg, Powder for oral solution

Acetylsalicylic acid (as DL-lysine acetylsalicylate)

Metoclopramide hydrochloride

Is this leaflet hard to see or read?

Phone 01483 505515 for help

Read all of this leaflet carefully before you start taking 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 MigraMax is and what it is used for

2. Before you take MigraMax

3. How to take MigraMax

4. Possible side effects

5. How to store MigraMax

6. Further information

What MigraMax is and what it is used for

The name of your medicine is MigraMax 900 mg / 10 mg, Powder for oral solution (called MigraMax in this leaflet).

What MigraMax contains

MigraMax contains two different medicines. These are called:

Metoclopramide hydrochloride: this belongs to a group of medicines called anti-emetics
It works on muscles in the upper part of the digestive system causing your stomach to empty. It also works on a part of your brain that prevents you from feeling sick (nausea) or being sick (vomiting)

DL-lysine acetylsalicylate: This belongs to a group of medicines called painkillers (analgesics).

DL-lysine acetylsalicylate is broken down in your body to aspirin (acetylsalicylic acid)

This works by blocking a substance that naturally occurs in your body called cyclo-oxygenase.

Cyclo-oxygenase makes some of the chemicals that cause pain. If it is blocked, pain is relieved

What MigraMax is used for

MigraMax is used to treat the signs of migraine, such as headache, feeling sick (nausea) or being sick (vomiting).

Before you take MigraMax

Do not take this medicine and tell your doctor if:

You are allergic (hypersensitive) to:
- Metoclopramide hydrochloride
- DL-lysine acetylsalicylate (aspirin)
- Other salicylates or non-steroidal anti-inflammatory medicines (NSAIDs)
- Any of the other ingredients of MigraMax (listed in Section 6 below)
Signs of an allergic reaction include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue

You are under the age of 20

You have haemophilia or any other blood clotting or bleeding problems

You have a blockage or bleeding in your stomach or intestine

You have an ulcer in your stomach or gut. Signs include burning or aching pain in your stomach, with an empty feeling and hunger

You have had an operation on your stomach or intestine (gut). Do not take during the first 3 to 4 days after your operation

You have a tumour on the adrenal gland (called phaeochromocytoma)

You are pregnant. This is especially important during the third trimester (week 26 to delivery). See Pregnancy and breast-feeding section below

You are breast-feeding (see Pregnancy and breast-feeding section below)

Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking MigraMax.

Take special care with MigraMax

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

You have ever had an ulcer in your stomach or gut.

Signs include burning or aching pain in your stomach, with an empty feeling and hunger

You have asthma

You have a runny nose, itching, sneezing and stuffy nose (called rhinitis)

You have growths inside your nose causing an obstruction (called nasal polyps)

You have liver problems

You have gout

You have ever had any bleeding in the stomach or intestine

You have menstrual periods which are heavier or last longer than usual

You use an intrauterine contraceptive device (IUD)

You have epilepsy. This is because MigraMax may increase the chances of you having a fit

You drink a lot of alcohol

You have kidney problems

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking MigraMax

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines. This includes medicines you buy without a prescription, including herbal medicines. This is because MigraMax can affect the way some other medicines work. Also some medicines can affect the way MigraMax works.

In particular tell your doctor if you are taking any of the following:

MigraMax may increase the effects of the following medicines:

Medicines for mental illness known as ‘antipsychotics’

Medicines to calm or reduce anxiety (hypnotics, anxiolytics)

Medicines to help you sleep (sedatives, barbiturates)

Medicines used for epilepsy such as phenytoin or sodium valproate

Some medicines used for depression such as mirtazapine or venlafaxine

Medicines to prevent blood clotting (anti-coagulants) such as warfarin

Ciclosporin - used to help prevent rejection of transplants. Your doctor may change your dose of ciclosporin

Clonidine - used for high blood pressure, migraine or hot fl ushes in the menopause

Medicines used to treat muscle spasms (anticholinergics) for irritable bowel syndrome (IBS) such as meberverine or hyoscine

Medicines used to treat incontinence such as oxybutynin, propiverine or tolterodine

Some medicines for moderate to severe pain (morphine products) such as codeine, dihydrocodeine or dextropropxyphene

Oral medicines used for diabetes (sulphonylureas) such as gliclazide

Medicines that can make you sleepy that are used for hay fever, rashes or other allergies called sedative antihistamines such as chlorphenamine or promethazine

Methotrexate - used to treat rheumatoid arthritis, cancer and some other conditions

Zafirlukast - used for asthma

MigraMax can make the following medicines work less well:

Medicines used to lower the amount of uric acid in your body (uricosurics) such as probenecid or sulfinpyrazone

Digoxin - used for heart problems. Your doctor may change your dose of digoxin

Interferon alpha - used to treat certain types of infections and certain forms of cancer

Mifepristone - usually given in hospital for termination of a pregnancy

Water tablets (diuretics) such as spironolactone, triamterene or amiloride

The following medicines can increase the chance of you getting side effects, when taken with MigraMax:

Other related painkillers that lower inflammation (non-steroidal anti-inflammatory medicines, NSAIDs) such as ibuprofen

Medicines used to prevent blood clots such as clopidogrel, ticlopidine or dipyridamole

Medicines for indigestion and heartburn (antacids)

Steroid medicines - used for lots of different illnesses such as inflammation, allergy or immune system problems

Levodopa - used for Parkinson’s disease

Taking MigraMax with food and drink

Drinking alcohol while taking MigraMax may make you feel sleepy.

Pregnancy and breast-feeding

Do not take this medicine if:

You are pregnant, might become pregnant or think you may be pregnant. This is especially important during the third trimester, week 26 to delivery

You are breast-feeding or planning to breast feed. This is because small amounts may pass into mothers’ milk

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.

Driving and using machines

You may feel sleepy after taking this medicine.

This is more likely if you have drunk alcohol or taken other medicines that cause drowsiness. If this happens, do not drive or use any tools or machines.

Important information about some of the ingredients of MigraMax

This medicine contains aspartame. This is a source of phenylalanine. It may be harmful for people with phenylketonuria.

How to take MigraMax

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

Taking this medicine

Take this medicine by mouth

Pour the contents of one sachet into some water, mix well and drink straight away

If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but ask your doctor

How much to take

Adults (20 years and older) and the elderly:

Take one sachet when you have the first warning of a migraine attack

If you do not feel better, you may take a second sachet 2 hours later

Do not take more than three sachets in a 24 hour period

Children and adults under 20

Do not take if you are under 20 years old.

If you take more MigraMax than you should

If you take more MigraMax than you should, tell a doctor or go to a hospital casualty department straight away. Take the medicine pack with you. This is so the doctor knows what you have taken.

The following effects may happen:

Being sick (vomiting); feeling thirsty (dehydration); ringing in the ears (tinnitus); balance problems, dizziness (vertigo); loss of hearing (deafness); sweating; feeling of warmth in the hands, feet or lips with a strong and forceful pulse; increased or heavy breathing

In some cases vomiting blood; very high body temperature; a sense of nervousness, shaky or sweaty (hypoglycaemia); tiredness or weakness and muscle cramps (hypokalaemia); you may also feel that your limbs are swollen (fluid retention) this is assign of changes in the way your kidneys are working

Extreme shortness of breath or difficulty breathing and a feeling of suffocating or drowning. These are signs of something called non-cardiac pulmonary oedema

You may also bleed easily or have unusual bruising or bleeding - these are signs of blood problems such as thrombocytopenia. Other effects such as lack of awareness (disorientation), confusion, loss of consciousness (coma) and rapid uncontrollable shaking (convulsion) may also occur

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

MigraMax Side Effects

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

Stop taking MigraMax and see a doctor or go to a hospital straight away if:

You have an allergic reaction. Severe allergic reactions can occur very rarely and usually happen soon after taking Paramax. These can involve difficulty breathing, tightness in the throat, rapidly spreading rashes, dizziness, very fast heart beat or even loss of consciousness

You have difficulty breathing, wheezing or tightness in the chest (called bronchospam)

You develop an itchy, lumpy rash sometimes called hives (urticaria)

You are short of breath, have bluish skin colouration, headache, tiredness, dizziness and loss of consciousness. These could be signs of a very rare but serious side effect called methaemoglobinaemia

You are paler than normal, are sweating, have a high temperature, fast heartbeat, stiff muscles, fast breathing and feel confused, drowsy or agitated. These could be signs of a serious side effect called neuroleptic malignant syndrome

You have a fit

You notice that you have black tarry stools (faeces) or blood in the stools

You notice any blood or dark particles (coffee ground colour) when you are being sick

You have a burning, aching pain in your stomach, with an empty feeling and hunger. You may have an ulcer in your stomach or gut

Tell a doctor straight away if you notice any of the following serious side effects:

Problems controlling certain muscles of the body or you have muscle spasms or ‘jerks’. The affected muscles may include your tongue, mouth, jaw, arms and legs. The spasms may cause unusual movements of the face, tongue, eyes, neck and affect speech, expression and/or lead to unnatural positioning of the head and shoulders

Decrease level of consciousness, confusion, hallucination

Rigid or stiff muscles, trembling or shaking or difficulty moving

You bruise more easily than usual. This could be because of a blood disorder (thrombocytopenia)

You get infections more often and easier than normal. This could be because you have a low number of white blood cells (agranulocytosis)

Shortness of breath, fast heart beat and chest pain

Depression

Tell your doctor as soon as possible if you have any of the following side effects:

Diarrhoea

You bleed more easily than usual. You may have something called ‘hypothrombinaemia’

Feeling tired, faint, dizzy or having pale skin. These could be signs of anaemia

You have pain when passing urine with lower back pain, sometimes radiating to the sides and/or groin. These could be signs of kidney stones

Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:

Abnormal production of breast milk in men and women

Breast enlargement in men

Loss of menstrual periods

Feeling nervous (anxious), restless or confused

Difficulty sleeping, feeling drowsy or tired

Feeling dizzy or having ringing in your ears (tinnitus)

Lack or loss of strength (weakness)

Wind (flatulence)

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few days, or if you notice side effects not listed in this leaflet.

How to store MigraMax

Keep this medicine in a safe place where children cannot see or reach it.

Do not use MigraMax after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store below 25ºC.

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 to protect the environment.

Further information

What MigraMax contains

Each sachet contains 1620 mg DL-lysine acetylsalicylate equivalent to 900 mg acetylsalicylic acid (the same amount that is in three 300 mg aspirin tablets) and 10 mg metoclopramide hydrochloride (as anhydrous) as the active ingredients

MigraMax sachets also contain aspartame, glycine and lemon flavour

What MigraMax looks like and contents of the pack

MigraMax is a white powder with a lemon odour and is soluble in water.

MigraMax is available in cartons containing 2, 6 or 20 sachets. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi-aventis

One Onslow Street

Guildford

Surrey

GU1 4YS

Tel:01483 505515

Fax:01483 535432

email:uk-medicalinformation@sanofi-aventis.com

Manufacturer

Sanofi Winthrop Industrie

196 avenue du Maréchal Juin

45200 Amilly

France

Supplier

Cephalon Limited

1 Albany Place

Hyde Way

Welwyn Garden City

Hertfordshire

AL7 3BT

This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.

This leaflet was last revised in November 2008.

228143

Tuesday, 22 May 2012

Indoramina

Indoramina may be available in the countries listed below.

Ingredient matches for Indoramina

Indoramin

Indoramina (DCIT) is also known as Indoramin (Rec.INN)

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Monday, 21 May 2012

mesna Intravenous

MES-na

Commonly used brand name(s)

In the U.S.

Mesnex

Available Dosage Forms:

Solution

Therapeutic Class: Hemorrhagic Cystitis Inhibitor

Uses For mesna

Mesna is used to reduce the harmful effects of some cancer medicines on the bladder.

Mesna is to be given only by or under the immediate supervision of your doctor.

Before Using mesna

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 mesna, the following should be considered:

Allergies

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

Although there is no specific information comparing use of mesna in children with use in other age groups, mesna is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of mesna in the elderly with use in other age groups.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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 mesna, 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 mesna 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.

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.

Proper Use of mesna

Dosing

The dose of mesna 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 mesna. 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.

mesna Side Effects

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

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

Rare

Skin rash or itching

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:

Less common

Diarrhea

nausea or vomiting

unpleasant taste

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: mesna Intravenous 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 mesna Intravenous resources

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

Compare mesna Intravenous with other medications

Hemorrhagic Cystitis Prophylaxis

Sunday, 13 May 2012

Ztuss ZT

Pronunciation: gwye-FEN-e-sin/hye-droe-KOE-done
Generic Name: Guaifenesin/Hydrocodone
Brand Name: Examples include EndaCof-Tab and Ztuss ZT

Ztuss ZT is used for:

Relieving cough and throat and airway irritation due to colds, flu, or hay fever. It may also be used for other conditions as determined by your doctor.

Ztuss ZT is a cough suppressant and expectorant combination. It works by loosening mucus and lung secretions in the chest, and making coughs more productive. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use Ztuss ZT if:

you are allergic to any ingredient in Ztuss ZT or any other codeine or morphine-related medicine (eg, oxycodone)

you are taking sodium oxybate (GHB)

you have increased pressure in the brain, trouble breathing, or diarrhea due to antibiotic use

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

Before using Ztuss ZT:

Some medical conditions may interact with Ztuss ZT. 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 glaucoma, an enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, stroke, adrenal gland problems, or an underactive thyroid

if you have a history of stomach problems, bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent abdominal surgery

if you have breathing or lung problems (eg, asthma, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if cough occurs with large amounts of mucus

if you have recently had any head injury, brain injury or tumor, infection of the brain or nervous system, epilepsy, or seizures

if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior

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

Cimetidine because it may increase the risk of Ztuss ZT's side effects

Barbiturates (eg, phenobarbital) or sodium oxybate (GHB) because the risk of severe drowsiness or breathing problems may be increased

Naltrexone because it may decrease Ztuss ZT's effectiveness

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

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

Take Ztuss ZT by mouth with or without food.

Drink plenty of water while taking Ztuss ZT.

If you miss a dose of Ztuss ZT, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

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

Important safety information:

Ztuss ZT may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Ztuss ZT with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

Ztuss ZT may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Ztuss ZT.

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

Use Ztuss ZT with caution in the ELDERLY; they may be more sensitive to its effects.

Ztuss ZT should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ztuss ZT while you are pregnant. It is not known if Ztuss ZT is found in breast milk. Do not breast-feed while taking Ztuss ZT.

Possible side effects of Ztuss ZT:

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; excitability; headache; nausea; nervousness or anxiety; trouble sleeping; weakness.

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); anxiety; change in amount of urine; difficulty urinating; hearing change or loss; mental or mood changes; severe drowsiness.

See also: Ztuss ZT 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 blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of Ztuss ZT:

Store Ztuss ZT 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 Ztuss ZT out of the reach of children and away from pets.

General information:

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

Ztuss ZT 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 Ztuss ZT. 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

More Ztuss ZT resources

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

Compare Ztuss ZT with other medications

Cough

Capsaicin Liquid

Pronunciation: kap-SAY-sin
Generic Name: Capsaicin
Brand Name: Capzasin

Capsaicin Liquid is used for:

Treating minor pain from arthritis, backache, and muscle sprains or strains. It may also be used for other conditions as determined by your doctor.

Capsaicin Liquid is a topical analgesic. Exactly how it works is not known. It is thought to decrease the amount of a certain substance (substance P) that transmits pain in the body.

Do NOT use Capsaicin Liquid if:

you are allergic to any ingredient in Capsaicin Liquid

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

Before using Capsaicin Liquid:

Some medical conditions may interact with Capsaicin Liquid. 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 an open wound or damaged, broken, or irritated skin

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

Ask your health care provider if Capsaicin Liquid 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 Capsaicin Liquid:

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

Wash your hands before applying Capsaicin Liquid. Wear latex gloves to apply Capsaicin Liquid, or wash your hands with soap and water immediately after applying it. If soap and water do not remove the medicine from your hands, use dishwashing liquid or cooking oil at room temperature.

Apply a thin layer of medicine to cover the affected area. Gently massage the medicine into the skin until it disappears.

If you are using Capsaicin Liquid on your hands, allow 30 minutes for the medicine to absorb before washing. Avoid touching irritated skin, contact lenses, or your eyes, nose, mouth, or genital area. Wash your hands with soap and water after 30 minutes.

Do not use Capsaicin Liquid more often than 3 or 4 times daily.

Do not apply to wounds or damaged, broken, or irritated skin.

Do not bandage or wrap the affected area.

Do not use Capsaicin Liquid with a heating pad.

If you miss a dose of Capsaicin Liquid, use it as soon as you remember. Continue to use it as directed by your doctor or on the package label.

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

Important safety information:

Capsaicin Liquid is for external use only. Avoid contact with the eyes, nose, lips, mouth, or genital area. If Capsaicin Liquid gets into any of these areas, rinse immediately with cool water. If you wear contact lenses, avoid touching them after you apply Capsaicin Liquid.

Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.

Do not use Capsaicin Liquid over large areas of the body without checking with your doctor.

If your symptoms do not get better within 7 days or if they get worse, or if they recur after a few days, check with your doctor.

Capsaicin Liquid is flammable. Do not store near fire or an open flame. Avoid fire, open flame, or smoking during and immediately after use.

Do not expose the medicine on your skin to direct sources of heat or sunlight. Avoid sunbathing, hot baths, or other sources of heat to the body. Heat or sunlight may increase the likelihood of burning or itching.

Do not inhale any residue from Capsaicin Liquid after it has dried. Coughing, sneezing, or throat or breathing irritation may occur.

You may have mild burning or itching at the application site up to 48 hours after you use Capsaicin Liquid. This should lessen as you use Capsaicin Liquid. Tell your doctor if you experience severe burning or itching, redness, or irritation.

If severe burning or itching occurs, wash the area with soap and water. If this does not work, use dishwashing liquid or cooking oil at room temperature.

Capsaicin Liquid may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

Check with your doctor before using Capsaicin Liquid in CHILDREN younger than 18 years of age; safety and effectiveness in this age group have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Capsaicin Liquid while you are pregnant. It is not known if Capsaicin Liquid is found in breast milk after topical use. If you are or will be breast-feeding while you use Capsaicin Liquid, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Capsaicin Liquid:

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:

Temporary, mild burning or stinging at the application site.

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); irritation, redness, blistering, or severe or persistent burning at the application site.

See also: Capsaicin 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. Capsaicin Liquid may be harmful if swallowed.

Proper storage of Capsaicin Liquid:

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

General information:

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

Capsaicin Liquid 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 Capsaicin Liquid. 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

More Capsaicin resources

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

Compare Capsaicin with other medications

Burning Mouth Syndrome
Diabetic Nerve Damage
Osteoarthritis
Pain
Peripheral Neuropathy
Persisting Pain, Shingles

Thursday, 10 May 2012

Iodoquinol

Class: Amebicides
VA Class: AP109
Brands: Yodoxin

Introduction

Amebicide, antiprotozoal.¹¹⁰

Uses for Iodoquinol

Amebiasis

Treatment of amebiasis caused by Entamoeba histolytica.¹⁰⁰ ¹⁰² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ ¹¹⁰

Used alone for treatment of asymptomatic intestinal amebiasis.¹⁰⁰ ¹⁰² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ Drugs of choice for asymptomatic cyst passers (intraluminal infections) are iodoquinol, paromomycin, or oral diloxanide furoate (not commercially available in the US).¹⁰⁰ ¹⁰² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ Paromomycin may be preferred in children or pregnant women.¹⁰⁵ ¹⁰⁶

Should not be used alone for treatment of symptomatic intestinal amebiasis or extraintestinal amebiasis (including amebic liver abscess) caused by E. histolytica.¹⁰⁰ ¹⁰² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ Regimen of choice for symptomatic intestinal amebiasis or extraintestinal disease (including liver abscess) is treatment with a tissue amebicide (oral metronidazole or oral tinidazole) followed by treatment with a luminal amebicide (oral iodoquinol or oral paromomycin).¹⁰⁰ ¹⁰² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ Paromomycin may be preferred for such follow-up treatment in children or pregnant women.¹⁰⁵ ¹⁰⁶

Some strains of Entamoeba are nonpathogenic (e.g., E. dispar, E. hartmanni) and asymptomatic intraluminal infections with these organisms generally do not require treatment.¹⁰⁰ ¹⁰⁵ ¹⁰⁶ ¹⁰⁷

Balantidiasis

Treatment of balantidiasis† caused by Balantidium coli.¹⁰⁰ ¹⁰² ¹⁰⁶ Tetracycline is considered the drug of choice; alternatives are iodoquinol or metronidazole.¹⁰⁰ ¹⁰² ¹⁰⁶

Blastocystis hominis Infections

Has been used in the treatment of infections caused by Blastocystis hominis†.¹⁰⁰ ¹⁰² ¹⁰⁶ ¹⁰⁸ ¹⁰⁹

Clinical importance of B. hominis as a cause of GI pathology is controversial;¹⁰⁰ ¹⁰² ¹⁰⁶ ¹⁰⁸ ¹⁰⁹ unclear when treatment is indicated.¹⁰⁰ ¹⁰⁶ ¹⁰⁸ Some clinicians suggest treatment be reserved for certain individuals (e.g., immunocompromised patients) when symptoms persist and no other pathogen or process is found to explain their GI symptoms.¹⁰⁰ ¹⁰⁶

Treatment alternatives are metronidazole, co-trimoxazole, iodoquinol, or nitazoxanide.¹⁰⁰ ¹⁰² Metronidazole resistance may be common in some areas.¹⁰²

Dientamoeba fragilis Infections

Treatment of infections caused by Dientamoeba fragilis†.¹⁰² ¹⁰⁶

Drugs of choice are iodoquinol, paromomycin, tetracycline, or metronidazole.¹⁰² ¹⁰⁶

Iodoquinol Dosage and Administration

Administration

Oral Administration

Administer orally after a meal.¹⁰² ¹¹⁰ Tablets may be crushed and mixed with applesauce or chocolate syrup.^a

Dosage

Pediatric Patients

Amebiasis Caused by Entamoeba histolytica

Asymptomatic Amebiasis

Oral

30–40 mg/kg daily (maximum: 2 g daily) administered in 3 divided doses for 20 days.¹⁰² ¹⁰⁷

Manufacturer recommends 10–13.3 mg/kg 3 times daily (up to 1.95 g daily) for 20 days.¹¹⁰

Symptomatic Intestinal Amebiasis or Extraintestinal Amebiasis (Including Amebic Liver Abscess)

Oral

30–40 mg/kg daily (maximum: 2 g daily) administered in 3 divided doses for 20 days.¹⁰² ¹⁰⁷

Manufacturer recommends 10–13.3 mg/kg 3 times daily (up to 1.95 g daily) for 20 days.¹¹⁰

Used as follow-up after a tissue amebicide (oral metronidazole or oral tinidazole).¹⁰⁰ ¹⁰² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ (See Amebiasis under Uses.)

Balantidiasis†

Oral

30–40 mg/kg daily (maximum: 2 g daily) given in 3 divided doses for 20 days.¹⁰²

Dientamoeba fragilis Infections†

Oral

30–40 mg/kg daily (maximum: 2 g daily) given in 3 divided doses for 20 days.¹⁰²

Adults

Amebiasis Caused by Entamoeba histolytica

Asymptomatic Amebiasis

Oral

650 mg 3 times daily for 20 days.¹⁰² ¹⁰⁵ ¹⁰⁷ ¹¹⁰

Symptomatic Intestinal Amebiasis or Extraintestinal Amebiasis (Including Amebic Liver Abscess)

Oral

650 mg 3 times daily for 20 days.¹⁰² ¹⁰⁵ ¹⁰⁷ ¹¹⁰

Balantidiasis†

Oral

650 mg 3 times daily for 20 days.¹⁰²

Blastocystis hominis Infections†

Oral

650 mg 3 times daily for 20 days.¹⁰² ¹⁰⁹

Dientamoeba fragilis Infections†

Oral

650 mg 3 times daily for 20 days.¹⁰²

Prescribing Limits

Pediatric Patients

Amebiasis Caused by Entamoeba histolytica

Oral

Maximum 1.95¹¹⁰ or 2 g daily.¹⁰²

Balantidiasis†

Oral

Maximum 2 g daily.¹⁰²

Dientamoeba fragilis Infections†

Oral

Maximum 2 g daily.¹⁰²

Special Populations

No special population dosage recommendations at this time.^a

Cautions for Iodoquinol

Contraindications

Known hypersensitivity to iodine and 8-hydroxyquinolines.¹¹⁰

Hepatic disease.¹¹⁰

Warnings/Precautions

Warnings

Optic Neuritis and Peripheral Neurotoxicity

Avoid long-term use.¹¹⁰ Prolonged, high dosage of halogenated 8-hydroxyquinolines has resulted in optic neuritis, optic atrophy, and peripheral neuropathy .¹¹⁰

Sensitivity Reactions

Hypersensitivity

Discontinue if hypersensitivity reactions occur.¹¹⁰

General Precautions

Thyroid Disease

Use with caution in individuals with thyroid disease.¹¹⁰ (See Laboratory Tests under Interactions.)

Nonspecific Diarrhea

Do not use for the treatment of nonspecific diarrhea.¹¹⁰

Specific Populations

Pregnancy

Category C.¹¹¹

Lactation

Not known whether iodoquinol is distributed into milk,¹¹¹ safe use during lactation not established.¹¹⁰

Pediatric Use

Do not exceed maximum daily dosage.¹¹⁰

Hepatic Impairment

Contraindicated in patients with hepatic disease.¹¹⁰

Common Adverse Effects

Iodism manifested by generalized furunculosis (iodine toxicoderma) and skin reactions (papular and pustular acneiform eruptions, bullae, vegetating or tuberous iododerma), urticaria and pruritus, GI effects (anorexia, nausea, vomiting, diarrhea, abdominal cramps, pruritus ani), fever, chills, headache, vertigo, thyroid enlargement, optic neuritis, optic atrophy, peripheral neuropathy.¹¹⁰ ^a

Interactions for Iodoquinol

Laboratory Tests

Contains 64% organically-bound iodine.¹¹⁰ May interfere with certain thyroid function tests by increasing protein-bound serum iodine concentrations.¹¹⁰ This effect may persist for as long as 6 months after cessation of iodoquinol therapy.¹¹⁰

Iodoquinol Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract; majority of an oral dose is excreted in feces^a

Some systemic absorption may occur since increased blood concentrations of iodine have been reported.^a

Distribution

Extent

Animal studies indicate the drug is distributed into tissues.^a Free iodine appears in urine.^a

Elimination

Elimination Route

Unabsorbed drug is eliminated in feces.^a Glucuronide and sulfate conjugates of iodoquinol are eliminated in urine. ^a

Stability

Storage

Oral

Tablets

15–30°C¹¹⁰ in well-closed containers.^a

Actions and SpectrumActions

A luminal or contact 8-hydroxyquinoline amebicide, acts primarily in the intestinal lumen.^a Precise mechanism of action unknown.^a

Amebicidal against Entamoeba histolytica.¹¹⁰ Active against both the trophozoite and encysted forms.¹¹⁰ Elimination of the cyst form probably results from destruction of the trophozoites.^a

Advice to Patients

Importance of taking after a meal.¹¹⁰

Importance of completing full course of treatment, even if feeling better after a few days.^a

Importance of notifying clinician of persistent or worsening symptoms of infection.^a

Importance of informing clinicians if hypersensitivity reactions or rash occurs.¹¹⁰ ^a

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹¹⁰

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

Preparations

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

Iodoquinol
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	210 mg	Yodoxin	Glenwood
		650 mg	Yodoxin	Glenwood

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.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.

102. Anon. Drugs for parasitic infections. From the Medical Letter website. 2008 Aug.

105. Ravdin JI. Amebiasis. Clin Infect Dis. 1995; 20:1453-66. [IDIS 349015] [PubMed 7548493]

106. Aucott JN. Amebiasis and “nonpathogenic” intestinal protozoa. Infect Dis Clin North Am. 1993; 7:67-85.

107. Reed SL. Amebiasis: an update. Clin Infect Dis. 1992; 14:385-93. [IDIS 292053] [PubMed 1554822]

108. Miller RA. Blastocystis hominis: an organism in search of a disease. Rev Infect Dis. 1988; 10:930-8. [IDIS 309903] [PubMed 3055191]

109. Grossman I, Weiss LM, Simon D et al. Blastocystis hominis in hospital employees. Am J Gastroenterol. 1992; 87:729-32. [PubMed 1590309]

110. Glenwood. Yodoxin (iodoquinol) tablets prescribing information. From manufacturer’s website. Accessed 2009 May 11.

111. Briggs GG, Freeman RK, Yaffe SJ. Drugs in pregnancy and lactation. 8th ed. Baltimore, MD: Williams & Wilkins; 2008:843-4.

a. AHFS drug information 2009. McEvoy GK, ed. Iodoquinol. Bethesda, MD: American Society of Health-System Pharmacists; 2009:856-7.

More Iodoquinol resources

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

Iodoquinol MedFacts Consumer Leaflet (Wolters Kluwer)

iodoquinol Concise Consumer Information (Cerner Multum)

iodoquinol Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Iodoquinol with other medications

Amebiasis
Balantidium coli
Blastocystis Infection
Dientamoeba fragilis

Wednesday, 9 May 2012

Hypoprothrombinemia, Not Associated with Anticoagulant Therapy Medications

Drugs associated with Hypoprothrombinemia, Not Associated with Anticoagulant Therapy

The following drugs and medications are in some way related to, or used in the treatment of Hypoprothrombinemia, Not Associated with Anticoagulant Therapy. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

Drug List:

Sunday, 6 May 2012

Epirubicin

Dosage Form: injection
FULL PRESCRIBING INFORMATION

WARNING: RISK OF TISSUE NECROSIS, CARDIAC TOXICITY, SECONDARY ACUTE MYELOGENOUS LEUKEMIA, AND MYELOSUPPRESSION

Severe local tissue necrosis will occur if there is extravasation during administration. Epirubicin hydrochloride injection must not be given by the intramuscular or subcutaneous route [see Warnings and Precautions (5.9)].

Cardiac toxicity, including fatal congestive heart failure (CHF), may occur either during therapy with Epirubicin hydrochloride injection or months to years after termination of therapy. The probability of developing clinically evident CHF is estimated as approximately 0.9% at a cumulative dose of 550 mg/m2, 1.6% at 700 mg/m2, and 3.3% at 900 mg/m2. In the adjuvant treatment of breast cancer, the maximum cumulative dose used in clinical trials was 720 mg/m2. The risk of developing CHF increases rapidly with increasing total cumulative doses of Epirubicin hydrochloride injection in excess of 900 mg/m2; this cumulative dose should only be exceeded with extreme caution. Active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, or concomitant use of other cardiotoxic drugs may increase the risk of cardiac toxicity. Cardiac toxicity with Epirubicin hydrochloride injection may occur at lower cumulative doses whether or not cardiac risk factors are present [see Warnings and Precautions (5.3)].

Secondary acute myelogenous leukemia (AML) has been reported in patients with breast cancer treated with anthracyclines, including Epirubicin. The occurrence of refractory secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of anthracyclines have been escalated. The cumulative risk of developing treatment-related AML or myelodysplastic syndrome (MDS), in 7110 patients with breast cancer who received adjuvant treatment with Epirubicin hydrochloride injection-containing regimens, was estimated as 0.27% at 3 years, 0.46% at 5 years, and 0.55% at 8 years [see Warnings and Precautions (5.4)].

Severe myelosuppression may occur [see Warnings and Precautions (5.2)].

Indications and Usage for Epirubicin

Epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see Clinical Studies (14.1)].

Epirubicin Dosage and Administration

When possible, to reduce the risk of developing cardiotoxicity in patients receiving Epirubicin hydrochloride injection after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, Epirubicin hydrochloride injection-based therapy should be delayed until the other agents have cleared from the circulation [see Warnings and Precautions (5.3)].

Administer Epirubicin hydrochloride injection by intravenous infusion. Give Epirubicin hydrochloride injection in repeated 3 to 4 week cycles. The total dose of Epirubicin hydrochloride injection may be given on Day 1 of each cycle or divided equally and given on Days 1 and 8 of each cycle. The recommended dosages of Epirubicin hydrochloride injection are as follows:

Recommended Dose

The recommended dose of Epirubicin hydrochloride injection is 100 to 120 mg/m2. The following regimens are recommended:

CEF-120:	Cyclophosphamide	75 mg/m2 PO D 1 to 14
	Epirubicin Hydrochloride Injection	60 mg/m2 IV D 1, 8
	5-Fluorouracil	500 mg/m2 IV D 1, 8
	Repeated every 28 days for 6 cycles
FEC-100:	5-Fluorouracil	500 mg/m2
	Epirubicin Hydrochloride Injection	100 mg/m2
	Cyclophosphamide	500 mg/m2
	All drugs administered intravenously on Day 1 and repeated every 21 days for 6 cycles

Patients administered the 120 mg/m2 regimen of Epirubicin hydrochloride injection should receive prophylactic antibiotic therapy.

Dose Modifications

Epirubicin hydrochloride injection dosage adjustments for hematologic and non-hematologic toxicities within a cycle of treatment, is based on nadir platelet counts < 50,000/mm3, absolute neutrophil counts (ANC) < 250/mm3, neutropenic fever, or Grades 3/4 nonhematologic toxicity. Reduce Epirubicin hydrochloride injection Day 1 dose in subsequent cycles to 75% of the Day 1 dose given in the current cycle. Delay Day 1 chemotherapy in subsequent courses of treatment until platelet counts are ≥ 100,000/mm3, ANC ≥ 1500/mm3, and nonhematologic toxicities have recovered to ≤ Grade 1.

Bone Marrow Dysfunction

Consider administering a lower starting dose (75 to 90 mg/m2) for heavily pretreated patients, patients with pre-existing bone marrow depression, or in the presence of neoplastic bone marrow infiltration [see Warnings and Precautions (5)]. For patients receiving a divided dose of Epirubicin hydrochloride injection (Day 1 and Day 8), the Day 8 dose should be 75% of Day 1 if platelet counts are 75,000 to 100,000/mm3 and ANC is 1000 to 1499/mm3. If Day 8 platelet counts are < 75,000/mm3, ANC < 1000/mm3, or Grades 3/4 nonhematologic toxicity has occurred, omit the Day 8 dose.

Hepatic Impairment

Recommendations regarding use of Epirubicin hydrochloride injection in patients with hepatic impairment are not available because patients with hepatic abnormalities were not included in the adjuvant trials [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)]. In patients with elevated serum AST or serum total bilirubin concentrations, the following dose reductions are recommended:

Bilirubin 1.2 to 3 mg/dL or AST 2 to 4 times upper limit of normal 1/2 of recommended starting dose

Bilirubin > 3 mg/dL or AST > 4 times upper limit of normal 1/4 of recommended starting dose

Renal Impairment

While no specific dose recommendation can be made based on the limited available data in patients with renal impairment, consider lower doses in patients with severe renal impairment (serum creatinine > 5 mg/dL) [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)].

Preparation and Administration Precautions

Storage of the solution for injection at refrigerated conditions can result in the formation of a gelled product. This gelled product will return to a slightly viscous to mobile solution after 2 to a maximum of 4 hours equilibration at controlled room temperature (15 to 25°C).

Inspect parenteral drug products visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures for proper handling and disposal of anticancer drugs should be used when handling and preparing Epirubicin hydrochloride injection. Several guidelines on this subject have been published.1-4 [see References (15)].

Protective Measures

Take the following protective measures when handling Epirubicin hydrochloride injection:

Train personnel in appropriate techniques for reconstitution and handling.

Exclude pregnant staff from working with this drug.

Wear protective clothing: goggles, gowns, and disposable gloves and masks when handling Epirubicin hydrochloride injection.

Define a designated area for syringe preparation (preferably under a laminar flow system), with the work surface protected by disposable, plastic-backed, absorbent paper.

Place all items used for reconstitution, administration, or cleaning (including gloves) in high-risk, waste-disposal bags for high temperature incineration.

Treat spillage or leakage with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. Place all contaminated and cleaning materials in high-risk, waste-disposal bags for incineration. Treat accidental contact with the skin or eyes immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. Seek medical attention. Always wash hands after removing gloves.

Incompatibilities

Avoid prolonged contact with any solution of an alkaline pH as it will result in hydrolysis of the drug. Do not mix Epirubicin hydrochloride injection with heparin or fluorouracil due to chemical incompatibility that may lead to precipitation.

Epirubicin hydrochloride injection can be used in combination with other antitumor agents, but do not mix with other drugs in the same syringe.

Preparation of Infusion Solution

Administer Epirubicin hydrochloride injection into the tubing of a freely flowing intravenous infusion (0.9% sodium chloride or 5% glucose solution). Patients receiving initial therapy at the recommended starting doses of 100 to 120 mg/m2 should generally have Epirubicin hydrochloride injection infused over 15 to 20 minutes. For patients who require lower Epirubicin hydrochloride injection starting doses due to organ dysfunction or who require modification of Epirubicin hydrochloride injection doses during therapy, the Epirubicin hydrochloride injection infusion time may be proportionally decreased, but should not be less than 3 minutes. This technique is intended to minimize the risk of thrombosis or perivenous extravasation, which could lead to severe cellulitis, vesication, or tissue necrosis. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein [see Warnings and Precautions (5.9)]. Use Epirubicin hydrochloride injection within 24 hours of first penetration of the rubber stopper. Discard any unused solution.

Dosage Forms and Strengths

Epirubicin hydrochloride injection is provided in single-use vials containing 2 mg Epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following sizes: 50 mg/25 mL and 200 mg/100 mL.

Contraindications

Patients should not be treated with Epirubicin hydrochloride injection if they have any of the following conditions:

Severe myocardial insufficiency, recent myocardial infarction or severe arrhythmias [see Warnings and Precautions (5.3)]

Previous treatment with maximum cumulative dose of anthracyclines [see Warnings and Precautions (5)].

Hypersensitivity to Epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see Adverse Reactions (6.2)].

Warnings and Precautions

Administer Epirubicin hydrochloride injection only under the supervision of qualified physicians experienced in the use of cytotoxic therapy. Before beginning treatment with Epirubicin hydrochloride injection, patients should recover from acute toxicities (such as stomatitis, neutropenia, thrombocytopenia, and generalized infections) of prior cytotoxic treatment. Also, precede initial treatment with Epirubicin hydrochloride injection by a careful baseline assessment of blood counts; serum levels of total bilirubin, AST, and creatinine; and cardiac function as measured by left ventricular ejection function (LVEF). Carefully monitor patients during treatment for possible clinical complications due to myelosuppression. Supportive care may be necessary for the treatment of severe neutropenia and severe infectious complications. Monitoring for potential cardiotoxicity is also important, especially with greater cumulative exposure to Epirubicin hydrochloride injection.

Injection-Related Reactions

Epirubicin hydrochloride injection is administered by intravenous infusion. Venous sclerosis may result from an injection into a small vessel or from repeated injections into the same vein. Extravasation of Epirubicin hydrochloride injection during the infusion may cause local pain, severe tissue lesions (vesication, severe cellulitis), and necrosis. Administer Epirubicin hydrochloride injection slowly into the tubing of a freely running intravenous infusion. Patients receiving initial therapy at the recommended starting doses of 100 to 120 mg/m2 should generally have Epirubicin hydrochloride injection infused over 15 to 20 minutes. For patients who require lower Epirubicin hydrochloride injection starting doses due to organ dysfunction or who require modification of Epirubicin hydrochloride injection doses during therapy, the Epirubicin hydrochloride injection infusion time may be proportionally decreased, but should not be less than 3 minutes [see Dosage and Administration (2.3)]. If possible, avoid veins over joints or in extremities with compromised venous or lymphatic drainage. Immediately terminate infusion and restart in another vein if a burning or stinging sensation indicates perivenous infiltration. Perivenous infiltration may occur without causing pain. Facial flushing, as well as local erythematous streaking along the vein, may be indicative of excessively rapid administration. It may precede local phlebitis or thrombophlebitis. Give prophylactic antibiotic therapy to patients administered the 120 mg/m2 regimen of Epirubicin hydrochloride injection as a component of combination chemotherapy [see Clinical Studies (14.1) and Dosage and Administration (2.1)].

Hematologic

Epirubicin hydrochloride injection can suppress bone marrow function as manifested by leukopenia, thrombocytopenia and anemia [see Adverse Reactions (6.1)], and myelosuppression is usually the dose-limiting toxicity. Patients should be monitored for myelosuppression during therapy [see Dosage and Administration (2.2, 2.3)].

Cardiac

Cardiotoxicity is a known risk of anthracycline treatment. Anthracycline-induced cardiac toxicity may be manifested by early (or acute) or late (delayed) events. Early cardiac toxicity of Epirubicin hydrochloride injection consists mainly of sinus tachycardia and/or electrocardiogram (ECG) abnormalities such as non-specific ST-T wave changes, but tachyarrhythmias, including premature ventricular contractions and ventricular tachycardia, bradycardia, as well as atrioventricular and bundle-branch block have also been reported. These effects do not usually predict subsequent development of delayed cardiotoxicity, are rarely of clinical importance, and are generally not considered an indication for the suspension of Epirubicin hydrochloride injection treatment. Delayed cardiac toxicity results from a characteristic cardiomyopathy that is manifested by reduced LVEF and/or signs and symptoms of congestive heart failure (CHF) such as tachycardia, dyspnea, pulmonary edema, dependent edema, hepatomegaly, ascites, pleural effusion, gallop rhythm. Life-threatening CHF is the most severe form of anthracycline-induced cardiomyopathy. This toxicity appears to be dependent on the cumulative dose of Epirubicin hydrochloride injection and represents the cumulative dose-limiting toxicity of the drug. If it occurs, delayed cardiotoxicity usually develops late in the course of therapy with Epirubicin hydrochloride injection or within 2 to 3 months after completion of treatment, but later events (several months to years after treatment termination) have been reported.

Given the risk of cardiomyopathy, exceed a cumulative dose of 900 mg/m2 Epirubicin hydrochloride injection only with extreme caution. Risk factors [active or dormant cardiovascular disease, prior or concomitant radiotherapy to the mediastinal/pericardial area, previous therapy with other anthracyclines or anthracenediones, concomitant use of other drugs with the ability to suppress cardiac contractility or cardiotoxic drugs, especially those with long half-lives (e.g., trastuzumab)] may increase the risk of Epirubicin hydrochloride injection cardiotoxicity [see Drug Interaction (7.4) and Dosage and Administration (2)]. Although not formally tested, it is probable that the toxicity of Epirubicin hydrochloride injection and other anthracyclines or anthracenediones is additive. Cardiac toxicity with Epirubicin hydrochloride injection may occur at lower cumulative doses whether or not cardiac risk factors are present.

Although endomyocardial biopsy is recognized as the most sensitive diagnostic tool to detect anthracycline-induced cardiomyopathy, this invasive examination is not practically performed on a routine basis. ECG changes such as dysrhythmias, a reduction of the QRS voltage, or a prolongation beyond normal limits of the systolic time interval may be indicative of anthracycline-induced cardiomyopathy, but ECG is not a sensitive or specific method for following anthracycline-related cardiotoxicity. The risk of serious cardiac impairment may be decreased through regular monitoring of LVEF during the course of treatment with prompt discontinuation of Epirubicin hydrochloride injection at the first sign of impaired function. The preferred method for repeated assessment of cardiac function is evaluation of LVEF measured by multi-gated radionuclide angiography (MUGA) or echocardiography (ECHO). A baseline cardiac evaluation with an ECG and a MUGA scan or an ECHO is recommended, especially in patients with risk factors for increased cardiac toxicity. Perform repeated MUGA or ECHO determinations of LVEF, particularly with higher, cumulative anthracycline doses. The technique used for assessment should be consistent through follow-up. In patients with risk factors, particularly prior anthracycline or anthracenedione use, the monitoring of cardiac function must be particularly strict and the risk-benefit of continuing treatment with Epirubicin hydrochloride injection in patients with impaired cardiac function must be carefully evaluated.

Do not administer Epirubicin hydrochloride injection in combination with other cardiotoxic agents unless the patient’s cardiac function is closely monitored. Patients receiving Epirubicin hydrochloride injection after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, may also be at an increased risk of developing cardiotoxicity. Avoid Epirubicin hydrochloride injection-based therapy for up to 24 weeks after stopping trastuzumab when possible. If Epirubicin hydrochloride injection is used before this time, monitor cardiac function carefully [see Dosage and Administration (2)].

Secondary Leukemia

The occurrence of secondary acute myelogenous leukemia, with or without a preleukemic phase, has been reported in patients treated with anthracyclines. Secondary leukemia is more common when such drugs are given in combination with DNA-damaging antineoplastic agents, when patients have been heavily pretreated with cytotoxic drugs, or when doses of the anthracyclines have been escalated. These leukemias can have a short 1 to 3 year latency period.

Epirubicin hydrochloride injection is mutagenic, clastogenic, and carcinogenic in animals [see Nonclinical Toxicology (13.1)].

Hepatic

The major route of elimination of Epirubicin is the hepatobiliary system [see Clinical Pharmacology (12.3)]. Evaluate serum total bilirubin and AST levels before and during treatment with Epirubicin hydrochloride injection. Patients with elevated bilirubin or AST may experience slower clearance of drug with an increase in overall toxicity. Lower doses are recommended in these patients [see Dosage and Administration (2.2)]. Patients with severe hepatic impairment have not been evaluated; therefore, do not use Epirubicin hydrochloride injection in this patient population.

Renal

Assess serum creatinine before and during therapy. Dosage adjustment is necessary in patients with serum creatinine > 5 mg/dL [see Dosage and Administration (2.2)]. Patients undergoing dialysis have not been studied.

Tumor-Lysis Syndrome

As with other cytotoxic agents, Epirubicin hydrochloride injection may induce hyperuricemia as a consequence of the extensive purine catabolism that accompanies drug-induced rapid lysis of highly chemosensitive neoplastic cells (tumor-lysis syndrome). Other metabolic abnormalities may also occur. While not generally a problem in patients with breast cancer, consider the potential for tumor-lysis syndrome in potentially susceptible patients and consider monitoring serum uric acid, potassium, calcium, phosphate, and creatinine immediately after initial chemotherapy administration. Hydration, urine alkalinization, and prophylaxis with allopurinol to prevent hyperuricemia may minimize potential complications of tumor-lysis syndrome.

Immunosuppressant Effects/Increased Susceptibility to Infections

Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including Epirubicin, may result in serious or fatal infections. Avoid vaccination with a live vaccine in patients receiving Epirubicin hydrochloride injection. Killed or inactivated vaccines may be administered; however, the response to such vaccines may be diminished.

Gastrointestinal

Epirubicin hydrochloride injection is emetigenic. Antiemetics may reduce nausea and vomiting; prophylactic use of antiemetics should be considered before administration of Epirubicin hydrochloride injection, particularly when given in conjunction with other emetigenic drugs [see Adverse Reactions (6.2)].

Thrombophlebitis and Thromboembolic Phenomena

As with other cytotoxic agents, thrombophlebitis and thromboembolic phenomena, including pulmonary embolism (in some cases fatal) have been coincidentally reported with the use of Epirubicin hydrochloride injection.

Coadministration With Cimetidine

Cimetidine increased the AUC of Epirubicin by 50%. Stop Cimetidine treatment during treatment with Epirubicin hydrochloride injection [see Clinical Pharmacology (12.3)].

Pregnancy

Epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. Epirubicin was embryolethal and teratogenic in rats and rabbits. There are no adequate and well-controlled studies of Epirubicin hydrochloride injection in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations (8.1)].

Male Fertility and Reproductive Outcomes

Males with female sexual partners of childbearing potential should use contraception during and after cessation of fludarabine phosphate therapy. Fludarabine phosphate may damage testicular tissue and spermatozoa. Possible sperm DNA damage raises concerns about loss of fertility and genetic abnormalities in fetuses. The duration of this effect is uncertain [see Nonclinical Toxicology (13.1)].

Laboratory Testing

Assess blood counts, including absolute neutrophil counts, and liver function before and during each cycle of therapy with Epirubicin hydrochloride injection. Perform repeated evaluations of LVEF during therapy [see Warnings and Precautions (5.5 and 5.6)].

Inflammation following Irradiation

As with other anthracyclines, administration of Epirubicin hydrochloride injection after previous radiation therapy may induce an inflammatory recall reaction at the site of the irradiation.

Adverse Reactions

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Integrated safety data are available from two studies (Studies MA-5 and GFEA-05) [see Clinical Studies (14.1)] evaluating Epirubicin hydrochloride injection-containing combination regimens in patients with early breast cancer. Of the 1260 patients treated in these studies, 620 patients received the higher-dose Epirubicin hydrochloride injection regimen (FEC-100/CEF-120), 280 patients received the lower-dose Epirubicin hydrochloride injection regimen (FEC-50), and 360 patients received CMF. Serotonin-specific antiemetic therapy and colony-stimulating factors were not used in these trials. Clinically relevant acute adverse events are summarized in Table 2.

Table 2. Clinically Relevant Acute Adverse Events in Patients with Early Breast Cancer
Event	% of Patients
	FEC-100/CEF-120 (N=620)		FEC-50 (N=280)		CMF (N=360)
	Grades 1 to 4	Grades 3/4	Grades 1 to 4	Grades 3/4	Grades 1 to 4	Grades 3/4
Hematologic
Leukopenia	80.3	58.6	49.6	1.5	98.1	60.3
Neutropenia	80.3	67.2	53.9	10.5	95.8	78.1
Anemia	72.2	5.8	12.9	0	70.9	0.9
Thrombocytopenia	48.8	5.4	4.6	0	51.4	3.6
Endocrine
Amenorrhea	71.8	0	69.3	0	67.7	0
Hot flashes	38.9	4.0	5.4	0	69.1	6.4
Body as a Whole
Lethargy	45.8	1.9	1.1	0	72.7	0.3
Fever	5.2	0	1.4	0	4.5	0
Gastrointestinal
Nausea/vomiting	92.4	25.0	83.2	22.1	85.0	6.4
Mucositis	58.5	8.9	9.3	0	52.9	1.9
Diarrhea	24.8	0.8	7.1	0	50.7	2.8
Anorexia	2.9	0	1.8	0	5.8	0.3
Infection
Infection	21.5	1.6	15.0	0	25.9	0.6
Febrile neutropenia	NA	6.1	0	0	NA	1.1
Ocular
Conjunctivitis/keratitis	14.8	0	1.1	0	38.4	0
Skin
Alopecia	95.5	56.6	69.6	19.3	84.4	6.7
Local toxicity	19.5	0.3	2.5	0.4	8.1	0
Rash/itch	8.9	0.3	1.4	0	14.2	0
Skin changes	4.7	0	0.7	0	7.2	0

FEC & CEF = cyclophosphamide + Epirubicin hydrochloride injection + fluorouracil; CMF = cyclophosphamide + methotrexate + fluorouracil; NA = not available

Grade 1 or 2 changes in transaminase levels were observed but were more frequently seen with CMF than with CEF.

Delayed Events

Table 3 describes the incidence of delayed adverse events in patients participating in the MA-5 and GFEA-05 trials.

Table 3. Long-Term Adverse Events in Patients with Early Breast Cancer
* In study MA-5, cardiac function was not monitored after 5 years.
Event	% of Patients
Event	FEC-100/CEF-120 (N = 620)	FEC-50 (N=280)	CMF (N=360)
Cardiac events
Asymptomatic drops in LVEF	2.1*	1.4	0.8*
CHF	1.5	0.4	0.3
Leukemia
AML	0.8	0	0.3

Two cases of acute lymphoid leukemia (ALL) were also observed in patients receiving Epirubicin hydrochloride injection. However, an association between anthracyclines such as Epirubicin hydrochloride injection and ALL has not been clearly established.

Overview of Acute and Delayed Toxicities

Hematologic

Dose-dependent, reversible leukopenia and/or neutropenia is the predominant manifestation of hematologic toxicity associated with Epirubicin hydrochloride injection and represents the most common acute dose-limiting toxicity of this drug. In most cases, the white blood cell (WBC) nadir is reached 10 to 14 days from drug administration. Leukopenia/neutropenia is usually transient, with WBC and neutrophil counts generally returning to normal values by Day 21 after drug administration. As with other cytotoxic agents, Epirubicin hydrochloride injection at the recommended dose in combination with cyclophosphamide and fluorouracil can produce severe leukopenia and neutropenia. Severe thrombocytopenia and anemia may also occur. Clinical consequences of severe myelosuppression include fever, infection, septicemia, septic shock, hemorrhage, tissue hypoxia, symptomatic anemia, or death. If myelosuppressive complications occur, use appropriate supportive measures (e.g., intravenous antibiotics, colony-stimulating factors, transfusions). Myelosuppression requires careful monitoring. Assess total and differential WBC, red blood cell (RBC), and platelet counts before and during each cycle of therapy with Epirubicin hydrochloride injection [see Warnings and Precautions (5.2)].

Gastrointestinal

A dose-dependent mucositis (mainly oral stomatitis, less often esophagitis) may occur in patients treated with Epirubicin hydrochloride injection. Clinical manifestations of mucositis may include a pain or burning sensation, erythema, erosions, ulcerations, bleeding, or infections. Mucositis generally appears early after drug administration and, if severe, may progress over a few days to mucosal ulcerations; most patients recover from this adverse event by the third week of therapy. Hyperpigmentation of the oral mucosa may also occur. Nausea, vomiting, and occasionally diarrhea and abdominal pain can also occur. Severe vomiting and diarrhea may produce dehydration. Antiemetics may reduce nausea and vomiting; consider prophylactic use of antiemetics before therapy [see Warnings and Precautions (5.10)].

Cutaneous and Hypersensitivity Reactions

Alopecia occurs frequently, but is usually reversible, with hair regrowth occurring within 2 to 3 months from the termination of therapy. Flushes, skin and nail hyperpigmentation, photosensitivity, and hypersensitivity to irradiated skin (radiation-recall reaction) have been observed. Urticaria and anaphylaxis have been reported in patients treated with Epirubicin hydrochloride injection; signs and symptoms of these reactions may vary from skin rash and pruritus to fever, chills, and shock.

Cardiovascular

In a retrospective survey, including 9144 patients, mostly with solid tumors in advanced stages, the probability of developing CHF increased with increasing cumulative doses of Epirubicin hydrochloride injection (Figure 1). The estimated risk of Epirubicin hydrochlo