Web Content Directory Sint Eustatius: September 2016

Friday, September 30, 2016

Zopiklon

Zopiklon may be available in the countries listed below.

Ingredient matches for Zopiklon

Eszopiclone

Zopiclone is reported as an ingredient of Zopiklon in the following countries:

Norway

International Drug Name Search

Biselect

Biselect may be available in the countries listed below.

Ingredient matches for Biselect

Bifonazole

Bifonazole is reported as an ingredient of Biselect in the following countries:

Germany

Bisoprolol

Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Biselect in the following countries:

Vietnam

International Drug Name Search

Viread

Generic Name: tenofovir (Oral route)

ten-OF-oh-vir dye-soe-PROX-il FUE-ma-rate

Oral route(Tablet)

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs. Severe acute exacerbations of hepatitis have been reported in HBV-infected patients who have discontinued anti-hepatitis B therapy, including tenofovir disoproxil fumarate. Upon therapy discontinuation, monitor hepatic function closely and resume anti-hepatitis B therapy if warranted .

Commonly used brand name(s)

In the U.S.

Viread

Available Dosage Forms:

Tablet

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Nucleotide Reverse Transcriptase Inhibitor

Uses For Viread

Tenofovir is used in combination with other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).

Tenofovir will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Tenofovir will not keep you from spreading HIV to other people. People who receive this medicine may continue to have some of the problems usually related to AIDS or HIV disease.

Tenofovir is also used to treat chronic (long-term) hepatitis B virus (HBV) infection.

This medicine is available only with your doctor's prescription.

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

Human immunodeficiency virus (HIV) infection in combination with hepatitis B virus (HBV) infection

Before Using Viread

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

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tenofovir in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric

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

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 this medicine, 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 this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Adefovir Dipivoxil

Atazanavir

Didanosine

Telaprevir

Using this medicine 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.

Lopinavir

Ritonavir

Tipranavir

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 Viread

Take this medicine exactly as directed by your doctor. Do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking this medicine without checking first with your doctor.

Keep taking tenofovir for the full time of treatment, even if you or your child begin to feel better.

You may take this medicine with or without food.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses.

When your tenofovir supply runs low, get more from your pharmacy or from your doctor. The amount of virus in your blood may increase if the medicine is stopped, even for a short time. The virus may develop resistance to tenofovir and be harder to treat. Do not allow yourself to run out of this medicine.

It is important to take tenofovir as part of a combination regimen. Take all of the medicines your doctor prescribed at the right time of day. This will make your medicines work better.

This medicine comes with a patient information leaflet. Read and follow the information carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For HIV and chronic hepatitis B infections:
  - Adults—300 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
  - Adolescents or children 12 years of age and older who weigh over 35 kilograms (kg)—300 mg once a day.
  - Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

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

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Viread

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not use this medicine if you or your child are also taking adefovir (Hepsera®), Atripla™, or Truvada®. Tell your doctor right away if you or your child are using any of these medicines. Do not start using tenofovir until your doctor tells you to.

Two rare but serious reactions to this medicine are lactic acidosis (build-up of acid in the blood) and liver toxicity, including an enlarged liver. These are more common if you are female, very overweight (obese), or have been taking anti-HIV medicines for a long time. Call your doctor right away if you or your child have stomach discomfort or cramping; nausea, vomiting, or diarrhea; a decreased appetite; a general feeling of discomfort; muscle cramping or pain; unusual tiredness or weakness; trouble with breathing; or yellow skin or eyes.

This medicine may increase your risk of having bone fractures. Ask your doctor about this if you or your child have any concerns.

When you or your child start taking HIV medicines, your immune system may get stronger. If you or your child have infections that are hidden in your body (e.g., pneumonia or tuberculosis), you may notice new symptoms when your body tries to fight them. If this occurs, tell your doctor right away.

This medicine may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area. You might also lose fat from the legs, arms, and face.

Tenofovir does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not re-use or share needles with anyone. If you have any questions about this, check with your doctor.

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

Viread Side Effects

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

Check with your doctor immediately if any of the following side effects occur:

Less common

Chest pain

cough

fever or chills

shortness of breath

sneezing

sore throat

tightness in the chest

troubled breathing

wheezing

Rare

Abdominal or stomach discomfort

decreased appetite

diarrhea

fast, shallow breathing

general feeling of discomfort

muscle pain or cramping

nausea

sleepiness

unusual tiredness or weakness

Incidence not known

Agitation

bloating

bloody or cloudy urine

bone pain

coma

confusion

constipation

convulsions or seizures

darkened urine

decreased frequency or amount of urine

depression

difficult or painful urination

dizziness

fast heartbeat

fever

headache

hostility

increased blood pressure

increased thirst

indigestion

irritability

lethargy

loss of appetite

muscle twitching

pains in the stomach, side, or abdomen, possibly radiating to the back

stupor

swelling of the face, fingers, or lower legs

vomiting

weight gain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Anxiety

back pain

hives or welts

itching skin

lack or loss of strength

pain

redness of the skin

skin rash

Less common

Acid or sour stomach

belching

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

difficulty with moving

heartburn

joint pain

muscle pains or stiffness

passing of gas

redistribution or accumulation of body fat

sleeplessness

stomach discomfort, upset, or pain

swollen joints

trouble sleeping

unable to sleep

weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Viread 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.

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More Viread resources

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

Viread Prescribing Information (FDA)

Viread Monograph (AHFS DI)

Viread MedFacts Consumer Leaflet (Wolters Kluwer)

Viread Consumer Overview

Compare Viread with other medications

Hepatitis B
HIV Infection
Nonoccupational Exposure

Thursday, September 29, 2016

Votrient

Generic Name: pazopanib (paz OH pa nib)

Brand Names: Votrient

What is pazopanib?

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

Pazopanib is used to treat advanced renal cell carcinoma (kidney cancer).

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

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

Do not use pazopanib if you are pregnant. It could harm the unborn baby.

Before you take pazopanib, tell your doctor if you have liver disease, heart disease, high blood pressure, underactive thyroid, an ulcer or other stomach disorder, or a history of Long QT syndrome, blood clot, or bleeding (stomach, intestinal, or brain).

There are many other drugs that can interact with pazopanib. Tell your doctor about all medications you use.

To be sure this medication is not causing harmful effects, your blood may need to be tested often. Visit your doctor regularly.

If you need surgery, tell the surgeon ahead of time that you are using pazopanib. You may need to stop using the medicine for a short time. Stop using pazopanib and call your doctor at once if you have a serious side effect such as bloody or tarry stools, coughing up blood, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes), sudden numbness or weakness, problems with speech or balance, chest pain, or vision and hearing problems.

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

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

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

liver disease;

heart disease;

high blood pressure;

a personal or family history of Long QT syndrome;

a history of blood clot;

underactive thyroid;

an ulcer or other stomach disorder;

a head injury or bleeding in your brain within the past 6 months; or

stomach or intestinal bleeding within the past 6 months.

FDA pregnancy category D. Do not use pazopanib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment. It is not known whether pazopanib passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take pazopanib?

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

Take pazopanib on an empty stomach, at least 1 hour before or 2 hours after a meal.

Pazopanib is usually taken once per day. Your doctor may occasionally change your dose to make sure you get the best results.

Do not crush a pazopanib tablet. Swallow the pill whole. Crushing the pill may cause your body to absorb too much of the drug at one time. The medicine from a crushed or broken pill can be dangerous if it gets on your skin. If this occurs, wash your skin with soap and water and rinse thoroughly. To be sure this medication is not causing harmful effects, your blood and urine may need to be tested often. Your heart rate may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Visit your doctor regularly. If you need surgery, tell the surgeon ahead of time that you are using pazopanib. You may need to stop using the medicine for a short time. Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include extreme tiredness or high blood pressure (severe headache, hearing or vision problems, anxiety, chest pain, shortness of breath, uneven heartbeats).

What should I avoid while taking pazopanib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Pazopanib side effects

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

slow healing of a wound or surgical incision;

dizziness, fainting, fast or pounding heartbeat;

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

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

sudden numbness or weakness (especially on one side of the body), sudden severe headache, confusion, problems with vision, speech, or balance;

chest pain or heavy feeling, pain spreading to the arm or shoulder; or

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

Less serious side effects may include:

mild nausea or vomiting, diarrhea;

changes in hair color;

tired feeling; or

headache.

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

What other drugs will affect pazopanib?

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

ADHD medications;

an antibiotic or antifungal medication;

an antidepressant or medicine to treat a psychiatric disorder;

anti-malaria medications;

asthma or allergy medication;

cholesterol-lowering drugs;

diabetes medication you take by mouth;

drugs to treat erectile dysfunction;

heart or blood pressure medications, heart rhythm medication;

HIV or AIDS medications;

medicines used to prevent organ transplant rejection;

medicine to treat or prevent nausea and vomiting;

migraine headache medicines, including ergot medicines or "triptans";

other cancer medications;

sedatives or narcotic pain medication;

seizure medication; or

a steroid.

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

More Votrient resources

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

Votrient Prescribing Information (FDA)

Votrient Monograph (AHFS DI)

Votrient Advanced Consumer (Micromedex) - Includes Dosage Information

Votrient Consumer Overview

Votrient MedFacts Consumer Leaflet (Wolters Kluwer)

Pazopanib Professional Patient Advice (Wolters Kluwer)

Compare Votrient with other medications

Renal Cell Carcinoma

Where can I get more information?

Your pharmacist can provide more information about pazopanib.

See also: Votrient side effects (in more detail)

Amytal Sodium

In the US, Amytal Sodium is a member of the drug class barbiturates and is used to treat Insomnia and Sedation.

Ingredient matches for Amytal Sodium

Amobarbital

Amobarbital sodium salt (a derivative of Amobarbital) is reported as an ingredient of Amytal Sodium in the following countries:

United States

International Drug Name Search

Triconidazol

Triconidazol may be available in the countries listed below.

Ingredient matches for Triconidazol

Tinidazole

Tinidazole is reported as an ingredient of Triconidazol in the following countries:

Peru

International Drug Name Search

Amlocard

Amlocard may be available in the countries listed below.

Ingredient matches for Amlocard

Amlodipine

Amlodipine is reported as an ingredient of Amlocard in the following countries:

Bangladesh

Estonia

Germany

Lithuania

Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Amlocard in the following countries:

Latvia

International Drug Name Search

Wednesday, September 28, 2016

Sinacort

Sinacort may be available in the countries listed below.

Ingredient matches for Sinacort

Betamethasone

Betamethasone 17α,21-dipropionate (a derivative of Betamethasone) is reported as an ingredient of Sinacort in the following countries:

Bangladesh

International Drug Name Search

Bayer Plus

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

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

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

There are many brands and forms of aspirin available and not all brands are listed on this leaflet.

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

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

a recent history of stomach or intestinal bleeding;

a bleeding disorder such as hemophilia; or

an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

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

asthma or seasonal allergies;

stomach ulcers;

liver disease;

kidney disease;

a bleeding or blood clotting disorder;

heart disease, high blood pressure, or congestive heart failure;

gout; or

nasal polyps.

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take aspirin?

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

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose symptoms may include ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

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

black, bloody, or tarry stools;

coughing up blood or vomit that looks like coffee grounds;

severe nausea, vomiting, or stomach pain;

fever lasting longer than 3 days;

swelling, or pain lasting longer than 10 days; or

hearing problems, ringing in your ears.

Less serious side effects may include:

upset stomach, heartburn;

drowsiness; or

headache.

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

What other drugs will affect aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

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

a blood thinner such as warfarin (Coumadin); or

another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

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

More Bayer Plus resources

Bayer Plus Side Effects (in more detail)
Bayer Plus Use in Pregnancy & Breastfeeding
Bayer Plus Drug Interactions
Bayer Plus Support Group
1 Review for Bayer Plus - Add your own review/rating

Aspirin Monograph (AHFS DI)

Aspirin Prescribing Information (FDA)

Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)

Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information

ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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Angina
Angina Pectoris Prophylaxis
Ankylosing Spondylitis
Antiphospholipid Syndrome
Aseptic Necrosis
Back Pain
Fever
Heart Attack
Ischemic Stroke
Ischemic Stroke, Prophylaxis
Juvenile Rheumatoid Arthritis
Kawasaki Disease
Myocardial Infarction, Prophylaxis
Niacin Flush
Osteoarthritis
Pain
Prosthetic Heart Valves
Prosthetic Heart Valves, Mechanical Valves
Revascularization Procedures, Prophylaxis
Rheumatic Fever
Rheumatoid Arthritis
Sciatica
Systemic Lupus Erythematosus
Thromboembolic Stroke Prophylaxis
Transient Ischemic Attack

Where can I get more information?

Your pharmacist can provide more information about aspirin.

See also: Bayer Plus side effects (in more detail)

Donodol

Donodol may be available in the countries listed below.

Ingredient matches for Donodol

Clonixin

Clonixin lysine salt (a derivative of Clonixin) is reported as an ingredient of Donodol in the following countries:

Mexico

International Drug Name Search

Vinate IC

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Vinate IC (prenatal multivitamins)?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

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

What is the most important information I should know about prenatal vitamins?

There are many brands and forms of prenatal vitamin available and not all brands are listed on this leaflet.

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

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

Never take more than the recommended dose of prenatal vitamins.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Prenatal vitamins side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

upset stomach;

headache; or

unusual or unpleasant taste in your mouth.

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

What other drugs will affect prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

diuretics (water pills);

heart or blood pressure medications;

tretinoin (Vesanoid);

isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

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

More Vinate IC resources

Vinate IC Use in Pregnancy & Breastfeeding
Vinate IC Drug Interactions
Vinate IC Support Group
0 Reviews for Vinate IC - Add your own review/rating

Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)

CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)

CitraNatal Assure Prescribing Information (FDA)

CitraNatal Harmony Prescribing Information (FDA)

Concept DHA Prescribing Information (FDA)

Docosavit Prescribing Information (FDA)

Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)

Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)

Folcal DHA Prescribing Information (FDA)

Folcaps Care One Prescribing Information (FDA)

Gesticare DHA Prescribing Information (FDA)

Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)

Inatal Advance Prescribing Information (FDA)

Inatal Ultra Prescribing Information (FDA)

Multi-Nate DHA Prescribing Information (FDA)

Multi-Nate DHA Extra Prescribing Information (FDA)

MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)

Natelle One Prescribing Information (FDA)

Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)

Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)

OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)

Paire OB Plus DHA Prescribing Information (FDA)

PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)

PreNexa Prescribing Information (FDA)

PreferaOB Prescribing Information (FDA)

Prenatal Plus Prescribing Information (FDA)

Prenatal Plus Iron Prescribing Information (FDA)

Prenate Elite Prescribing Information (FDA)

Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)

Prenate Elite tablets

Prenate Essential Prescribing Information (FDA)

PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)

PrimaCare ONE capsules

PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)

Renate DHA Prescribing Information (FDA)

Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Se-Natal 19 Prescribing Information (FDA)

Tandem DHA Prescribing Information (FDA)

Tandem OB Prescribing Information (FDA)

TriAdvance Prescribing Information (FDA)

Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)

Triveen-PRx RNF Prescribing Information (FDA)

UltimateCare ONE NF Prescribing Information (FDA)

Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)

Vinate AZ Prescribing Information (FDA)

Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)

Zatean-CH Prescribing Information (FDA)

Compare Vinate IC with other medications

Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

Your pharmacist can provide more information about prenatal vitamins.

Tuesday, September 27, 2016

Vivaglobin

Generic Name: immune globulin (Intramuscular route, Intravenous route, Subcutaneous route)

i-MUNE GLOB-ue-lin

Intravenous route(Powder for Solution;Solution)

Immune globulin intravenous (IGIV) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. Use caution in patients predisposed to acute renal failure and administer at the minimum concentration available and the minimum rate of infusion practicable in such patients. Higher rates of renal failure were associated with IGIV products containing sucrose . Flebogamma(R) 5%, Flebogamma(R) 5% DIF, Flebogamma(R) 10% DIF, Gammagard (R), Gamunex(R)-C, and Previgen(R) do not contain sucrose . Glycine is used as a stabilizer in Gamunex(R)-C .

Subcutaneous route(Solution)

Commonly used brand name(s)

In the U.S.

Baygam

Carimune

Gamimune N

Gammagard

Gammar-P

Hizentra

Iveegam EN

Octagam

Panglobulin NF

Polygam S/D

Sandoglobulin

Vivaglobin

Available Dosage Forms:

Solution

Powder for Solution

Therapeutic Class: Immune Serum

Uses For Vivaglobin

Immune globulin injection belongs to a group of medicines known as immunizing agents. It is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic inflammatory demyelinating polyneuropathy (CIDP).

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

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

Chronic parvovirus B19 infection (treatment).

Dermatomyositis (treatment).

Guillain-Barré syndrome (treatment).

Hyperimmunoglobulinemia E syndrome (treatment).

Infections in low-birth-weight preterm high-risk neonates (prophylaxis and treatment adjunct).

Lambert-Eaton myasthenic syndrome (treatment).

Multifocal motor neuropathy (treatment).

Relapsing-remitting multiple sclerosis (treatment).

Before Using Vivaglobin

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. However, safety and efficacy have not been established in children with CIDP, safety and efficacy have not been established for Flebogamma® and subcutaneous injection of Gamunex®-C in children with PI, and safety and efficacy have not been established for Gammagard Liquid and Vivaglobin® in children younger than 2 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

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

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

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

Interactions with Food/Tobacco/Alcohol

Proper Use of immune globulin

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

A doctor or other trained health professional will give you or your child this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you or your child are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gamunex®-C, Hizentra®, and Vivaglobin® products may sometimes be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. If you or your child are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. Be sure you understand how to use the medicine.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you or your child must change the brand or type of medicine, talk to your doctor before giving yourself an injection.

If you or your child are using Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin® at home, you will be shown the body areas where the medicine can be given. Use a different body area each time you give yourself an infusion. Keep track of where you give each infusion to make sure you rotate body areas. This will help prevent skin problems.

Allow the Gammagard Liquid, Gamunex®-C, or Vivaglobin® brand to reach room temperature before using it.

To use Gammagard Liquid, Gamunex®-C, Hizentra®, or Vivaglobin®:

First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.

Wash your hands with soap and water before and after using this medicine.

If you have been told to wear gloves when preparing your infusion, put the gloves on.

Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.

If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.

Follow your doctor's instructions on how to prepare the correct amount of medicine.

Choose an injection site on your body (e.g., abdomen or stomach area, thigh, upper arm, upper leg, or hip). Clean the injection site with a fresh alcohol wipe, and let it dry.

With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.

Put sterile gauze and tape over the injection site to keep the needle from coming out.

Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.

Follow your doctor's instructions on how to use the infusion pump.

Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.

It usually takes about 60 minutes for each infusion.

When all of the medicine has been infused, turn off the pump.

Take the gauze off and remove the needle and tube from your skin.

Clean and store the infusion pump.

Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture. Keep from freezing.

Protect the Hizentra® product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C and Vivaglobin® products in the refrigerator, but do not freeze the medicine. Store it in the original container.

You may store the Gammagard Liquid product in the refrigerator for 36 months, or at room temperature for up to 12 months (if within the first 24 months of the date of manufacture). Check the box for the date of manufacture. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Precautions While Using Vivaglobin

It is very important that your doctor check the progress of you or your child at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

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

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you or your child start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you or your child have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you or your child start having chest pain; difficult, fast, or noisy breathing, sometimes with wheezing; blue lips and fingernails; fever; pale skin; increased sweating; coughing that sometimes produces a pink frothy sputum; shortness of breath; or swelling of the legs and ankles, after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you or your child suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking. .

Check with your doctor right away if you or your child start having red or dark brown urine; lower back or side pain; a sudden weight gain; a swollen face, arms, or legs; decreased urine output; or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Vivaglobin Side Effects

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

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Chills

cough

difficulty with breathing

fast, pounding, or irregular heartbeat or pulse

fever

noisy breathing

shortness of breath

tightness in the chest

troubled breathing

unusual tiredness or weakness

Less common

Bluish coloring of the lips or nailbeds

burning sensation in the head

faintness or lightheadedness

Rare

Difficulty with swallowing

hives or welts

itching, especially of the feet or hands

reddening of the skin, especially around the ears

swelling of the eyes, face, or inside of the nose

Incidence not known

Back, leg, or stomach pains

bleeding gums

blistering, peeling, or loosening of the skin

bloody, black, or tarry stools

blurred vision

change in consciousness

chest pain or discomfort

cold, clammy, or pale skin

confusion

convulsions

coughing that sometimes produces a pink frothy sputum

dark urine

decrease in urine amount

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fever with or without chills

headache that is severe and occurs suddenly

increased sweating

light-colored stools

loss of appetite

loss of bladder control

loss of consciousness

low blood pressure or pulse

muscle spasm or jerking of all extremities

nausea or vomiting

nosebleeds

painful or difficult urination

pains in the chest, groin, or legs, especially calves of the legs

red skin lesions, often with a purple center

red, irritated eyes

shakiness in the legs, arms, hands, or feet

shivering

skin blisters

slurred speech that occurs suddenly

slow breathing

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

sudden loss of consciousness

sudden loss of coordination

sudden vision changes

sudden, severe weakness or numbness in the arm or leg

sweating

swelling in the legs and ankles

tightness in the chest

trembling or shaking of the hands or feet

unusual bleeding or bruising

yellow eyes or skin

More common

Diarrhea

dizziness

headache

joint pain

muscle pain

redness, swelling, itching, or pain at the injection site

skin rash

Less common

Hip pain

leg cramps

Incidence not known

Feeling of warmth

redness of the face, neck, arms, and occasionally, upper chest

stomach pain

swollen glands

tiredness

weakness

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.

More Vivaglobin resources

Vivaglobin Use in Pregnancy & Breastfeeding
Vivaglobin Drug Interactions
Vivaglobin Support Group
5 Reviews for Vivaglobin - Add your own review/rating

Vivaglobin Prescribing Information (FDA)

Vivaglobin MedFacts Consumer Leaflet (Wolters Kluwer)

Vivaglobin Consumer Overview

Immune Globulin Subcutaneous Professional Patient Advice (Wolters Kluwer)

Hizentra Consumer Overview

Hizentra Prescribing Information (FDA)

Hizentra MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Vivaglobin with other medications

Autoimmune Neutropenia
Bone Marrow Transplantation
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
Chronic Lymphocytic Leukemia
Evan's Syndrome
HIV Infection
Idiopathic Thrombocytopenic Purpura
Kawasaki Disease
Myasthenia Gravis
Polymyositis/Dermatomyositis
Primary Immunodeficiency Syndrome

Vidaza

Generic Name: Azacitidine
Class: Antineoplastic Agents
Chemical Name: 4-Amino-1-β-d-ribofuranosyl-s-triazin-2(1H)-one
Molecular Formula: C₈H₁₂N₄O₅
CAS Number: 320672

Introduction

Antineoplastic agent;¹ ² ³ ⁴ ⁶ ⁷ a synthetic pyrimidine nucleoside analog of cytidine.¹ ⁷

Uses for Vidaza

Myelodysplastic Syndrome (MDS)

Treatment of MDS;¹ ² ³ ⁴ ⁶ designated an orphan drug by FDA for this use.⁵

Used in patients with the following French-American-British (FAB) subtypes of MDS:¹ ² ³ ⁴ ⁶ refractory anemia (RA) or RA with ringed sideroblasts (RARS) if requiring blood transfusions or accompanied by neutropenia or thrombocytopenia, RA with excess blasts (RAEB), RAEB in transformation (RAEB-T) (now reclassified; see Acute Myelogenous Leukemia [AML] under Uses), and chronic myelomonocytic leukemia (CMMoL).¹ ⁹ ¹²

Use in combination with supportive care is superior to supportive care alone in improving hematologic deficits (e.g., transfusion dependence).¹ ⁶ ¹² Improved response rates (complete responses, partial responses, and hematologic improvements), as well as improved survival, when compared with conventional care (best supportive care, low-dose cytarabine, or an anthracycline/cytarabine induction regimen) in high-risk MDS patients.¹ ¹⁰⁰⁰⁴ ¹⁰⁰⁰⁵ ¹⁰⁰⁰⁶ ¹⁰⁰¹²

Acute Myelogenous Leukemia (AML)

May be considered a reasonable choice (accepted, with possible conditions) for the treatment of AML with multilineage dysplasia† (previously classified as RAEB-T, a high-risk subtype of MDS¹⁰⁰¹³ ), including in patients with poor-risk cytogenetics.¹⁰⁰⁰¹ ¹⁰⁰⁰² ¹⁰⁰⁰³ ¹⁰⁰⁰⁴ ¹⁰⁰⁰⁵ ¹⁰⁰¹¹

May be considered a reasonable choice (accepted, with possible conditions) for initial treatment of AML in geriatric patients (>60 years of age) who are not candidates for standard induction therapy (i.e., because of compromised performance status or the presence of a clinically important comorbidity).¹⁰⁰⁰² ¹⁰⁰⁰⁷ ¹⁰⁰⁰⁸ ¹⁰⁰⁰⁹ ¹⁰⁰¹¹

Use can be recommended (accepted) in geriatric patients with AML with normal to favorable karyotypes†; use in geriatric patients with AML with poor-risk or complex cytogenetics† is not fully established because of equivocal evidence.¹⁰⁰⁰⁷ ¹⁰⁰⁰⁹ ¹⁰⁰¹¹

Use in geriatric patients with relapsed or refractory AML† is not fully established because of equivocal evidence.¹⁰⁰⁰⁷ ¹⁰⁰⁰⁸ ¹⁰⁰¹¹

Vidaza Dosage and Administration

General

Consult specialized references for proper handling and disposal of antineoplastics.¹

Pretreatment for nausea and vomiting is recommended by the manufacturer.¹ ⁹

Administration

Administer by sub-Q injection or short IV infusion.¹

Has been administered by continuous IV infusion† in at least one clinical trial.¹ ⁶ ¹⁰ ¹¹

Sub-Q Administration

Administer suspension by sub-Q injection into the thigh, abdomen, or upper arm; rotate injection sites.¹

Give new injections ≥2.54 cm (1 inch) from an old site; do not give injections into areas where the skin is tender, bruised, red, or hard.¹

If the dose exceeds 4 mL, divide the dose equally into 2 syringes and inject into 2 separate sites.¹

Immediately prior to administration, resuspend syringe contents by vigorously rolling the syringe between the palms until a uniform suspension is achieved.¹

Handle cautiously; if the reconstituted suspension contacts skin or mucosa, wash the skin immediately and thoroughly with soap and water or flush the mucosa with copious amounts of water.¹

Reconstitution

Reconstitute vial containing 100 mg of azacitidine with 4 mL of sterile water for injection to provide a suspension containing 25 mg/mL.¹ Suspension will be cloudy.¹

Vigorously shake or roll the vial until complete dissolution has occurred.¹

Do not administer such concentrated suspensions IV.¹ ¹⁴

Vials are intended for single use only; discard any unused portions of the suspension.¹

IV Administration

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

Infuse IV solution over 10–40 minutes.¹ IV administration must be completed within 1 hour of reconstitution.¹

The concentrated suspension intended for sub-Q injection must not be administered IV.¹ ¹⁴

Handle cautiously; if the reconstituted solution contacts skin or mucosa, wash the skin immediately and thoroughly with soap and water or flush the mucosa with copious amounts of water.¹

Reconstitution

Reconstitute vial containing 100 mg of azacitidine with 10 mL of sterile water for injection to provide a solution containing 10 mg/mL.¹ Solution should be clear.¹

Shake vial vigorously or roll until complete dissolution has occurred.¹

Reconstituted solution should be further diluted prior to IV administration.¹

Dilution

Withdraw the desired dose of reconstituted azacitidine solution from the vial and inject into a 50- to 100-mL infusion bag containing 0.9% sodium chloride injection or lactated Ringer’s injection.¹

Vials are intended for single use only; discard any unused portions.¹

Rate of Administration

Infuse solution over 10–40 minutes.¹

Dosage

Adults

Myelodysplastic Syndrome (MDS)

Sub-Q or IV

Initially, 75 mg/m² daily for 7 days every 4 weeks.¹ ² ⁶ ⁹

Daily dosage may be increased to 100 mg/m² if no beneficial effect is observed after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred.¹ ⁹

The manufacturer recommends that patients receive at least 4–6 treatment cycles, although additional treatment cycles may be needed to achieve complete or partial response.¹

Continue azacitidine as long as the patient is deriving benefit from therapy.¹ ⁹

Monitor for hematologic and renal toxicities (see Hematologic Effects and also Renal Toxicity, under Cautions); delay treatment or reduce dosage accordingly.¹ ⁹

Acute Myelogenous Leukemia (AML)†

Sub-Q or IV

Dosage of 75 mg/m² daily for 7 days every 28 days has been used.¹⁰⁰⁰¹ ¹⁰⁰⁰² ¹⁰⁰⁰⁵ ¹⁰⁰⁰⁷ ¹⁰⁰⁰⁹ In several clinical trials, patients who achieved complete response received 3 additional cycles of the drug; those exhibiting partial response or improvement received the drug until complete response or relapse occurred.¹⁰⁰⁰¹

Dosage Modification for Hematologic Toxicity in Patients with Baseline (start of treatment) WBC of ≥3000/mm³, ANC of ≥1500/mm³, and Platelet Count of ≥75,000/mm³

Sub-Q or IV

Adjust the azacitidine dosage in the next treatment cycle based on nadir ANC and platelet counts observed in the current cycle.¹ (See Table 1.)

Table 1. Dosage Modification for Hematologic Toxicity if Baseline WBC is ≥3000/mm3, ANC is ≥1500/mm3, and Platelet Count is ≥75,000/mm31
Nadir ANC (per mm³)	Nadir Platelets (per mm³)	Dosage in Next Cycle (expressed as % of dose in current cycle)
<500	<25,000	50%
500–1500	25,000–50,000	67%
>1500	>50,000	100%

Dosage Modification for Hematologic Toxicity in Patients with Baseline (start of treatment) WBC of <3000/mm³, ANC of <1500/mm³, or Platelet Count of <75,000/mm³

Sub-Q or IV

Base dosage adjustments on nadir blood cell counts and bone marrow biopsy cellularity at the time of the nadir count (see Table 2), unless clear improvement in differentiation (increased percentage of mature granulocytes and higher ANC) is observed at the time of initiation of the subsequent cycle relative to the time of initiation of the previous cycle.¹ If such improvement in differentiation is observed, continue the current dosage.¹

The next 7-day course of azacitidine should be given 28 days after initiation of the previous course, provided that both the WBC and platelet counts at day 28 exceed the nadir counts by ≥25% and are increasing.¹ If an increase in WBC and platelet counts of ≥25% has not occurred by day 28, reassess these blood cell counts every 7 days;¹ if increases of ≥25% do not occur by day 42, patients should receive 50% of the scheduled dosage.¹

Table 2. Dosage Modification for Hematologic Toxicity if Baseline WBC is <3000/mm3, ANC is <1500/mm3, or Platelet Count is <75,000/mm31
Nadir WBC or Platelet Count (expressed as % decrease from baseline count)	Bone Marrow Biopsy Cellularity (%) at Time of Nadir Count	Dosage in Next Cycle (expressed as % of dose in previous cycle)
50–75	30–60	100
	15–30	50
	<15	33
>75	30–60	75
	15–30	50
	<15	33

Dosage Modification for Renal Impairment

Sub-Q or IV

If unexplained elevations of BUN or S_cr occur, delay the next cycle until such values return to normal or baseline levels and reduce the dosage of azacitidine in the next treatment cycle by 50%.¹

Dosage Modification for Serum Electrolyte Disturbances

Sub-Q or IV

If unexplained decreases in serum bicarbonate concentrations (to <20 mEq/L) occur, reduce the dosage of azacitidine in the next treatment cycle by 50%.¹

Special Populations

No special population dosage recommendations at this time.¹ ⁹

Cautions for Vidaza

Contraindications

Known hypersensitivity to azacitidine or mannitol.¹

Advanced malignant hepatic tumors.¹

Warnings/Precautions

Hematologic Effects.

Possible neutropenia, thrombocytopenia, or anemia.¹

Perform CBC and platelet counts prior to each treatment cycle and periodically thereafter as needed.¹

After administration of the recommended dosage for the first cycle, reduce or delay dosage for subsequent cycles based on nadir blood cell counts and hematologic response.¹ (See Dosage under Dosage and Administration.)

Hepatotoxicity

Progressive hepatic coma and death reported rarely in patients with extensive tumor burden secondary to metastatic disease, particularly in those with baseline serum albumin concentrations of <3 g/dL.¹

Contraindicated in patients with advanced malignant hepatic tumors.¹

Perform liver function tests prior to initiation of therapy.¹

Renal Toxicity

Renal abnormalities (e.g., elevated S_cr, renal tubular acidosis), renal failure, and death reported rarely in patients treated with IV azacitidine in combination with other antineoplastic agents (e.g., etoposide) for conditions other than MDS (e.g., chronic myelogenous leukemia).¹

Determine S_cr prior to initiation of therapy.¹

If unexplained reductions in serum bicarbonate concentrations to <20 mEq/L or elevations of BUN or S_cr occur, reduce the dosage or withhold therapy with the drug.¹ (See Dosage under Dosage and Administration.)

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryolethality demonstrated in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹

Advise male patients to not father a child while receiving azacitidine.¹

Specific Populations

Pregnancy

Category D.¹ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether azacitidine or its metabolites are distributed into milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children <16 years of age.¹³

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Assess renal function periodically, since azacitidine and its metabolites are substantially eliminated by the kidneys and geriatric patients are more likely to have decreased renal function.¹

Hepatic Impairment

Potentially hepatotoxic in patients with severe preexisting hepatic impairment; use with caution in patients with liver disease.¹ (See Hepatotoxicity under Cautions.)

Safety and efficacy not established in patients with MDS and hepatic impairment.¹

Renal Impairment

Close monitoring for toxicity is recommended.¹ Azacitidine and its metabolites are substantially eliminated by the kidneys.¹

Safety and efficacy not established in patients with MDS and renal impairment.¹

Common Adverse Effects

Sub-Q or IV administration: Nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, fatigue, injection site erythema, constipation, neutropenia, ecchymosis.¹ With IV administration, petechiae, rigors, weakness, and hypokalemia also occur commonly.¹

Interactions for Vidaza

Not known whether metabolism of azacitidine is affected by known inhibitors or inducers of hepatic microsomal enzymes.¹

Not known whether azacitidine inhibits CYP isoenzymes.¹ Azacitidine does not induce CYP isoenzyme 1A2, 2C19, 3A4, or 3A5 in vitro.¹

No formal drug interaction studies to date.¹

Vidaza Pharmacokinetics

Absorption

Bioavailability

Rapidly absorbed after sub-Q administration, with peak plasma concentration attained in about 0.5 hour.¹ Bioavailability is 89% relative to an IV dose.¹

Elimination

Metabolism

In vitro study suggests that azacitidine may be metabolized in the liver.¹

Elimination Route

Azacitidine and its metabolites are eliminated principally in urine.¹

Half-life

Elimination half-life is about 4 hours.¹

Stability

Storage

Parenteral

Powder for Injection

Powder: 25°C (may be exposed to 15–30°C).¹

Reconstituted suspension for sub-Q injection (in vial or syringe): 25°C for up to 1 hour or 2–8°C for up to 8 hours.¹ Refrigerated suspensions may be allowed to equilibrate to room temperature for up to 30 minutes prior to administration.¹

Reconstituted solution for IV infusion: 25°C; complete IV administration within 1 hour of reconstitution.¹

Compatibility

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

Parenteral

Solution Compatibility¹

Compatible
Ringer’s injection, lactated
Sodium chloride 0.9%
Incompatible
Dextrose in water
Hetastarch

Drug Compatibility

Incompatible with solutions containing sodium bicarbonate.¹

ActionsActions

Exerts antineoplastic effect by inhibiting DNA methyltransferase, thereby causing hypomethylation of DNA,⁶ ⁷ and by direct cytotoxic effect on abnormal hematopoietic cells in the bone marrow.¹ ⁹

Advice to Patients

Importance of women informing clinicians immediately if they are or plan to become pregnant.¹ Advise women to avoid pregnancy and advise men not to father a child during therapy.¹

Importance of women informing clinicians if they plan to breast-feed.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., underlying hepatic or renal disease).¹

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

Preparations

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

Azacitidine
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection, for IV or subcutaneous use	100 mg	Vidaza	Celgene

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

1. Celgene Corporation. Vidaza (azacitidine for injection) prescribing information. Summit, NJ; 2008 Aug.

2. Gryn J, Zeigler ZR, Shadduck RK et al. Treatment of myelodysplastic syndromes with 5-azacytidine. Leuk Res. 2002; 26:893-7. [IDIS 518520] [PubMed 12163049]

3. Suwanawiboon B, Sumida KN. 5-Azacitidine: an alternative treatment of myelodysplastic syndromes in patients with refractory response to hematopoietic growth factor; a case report and review of literature. Hawaii Med J. 2004; 63:14-6, 25. [PubMed 15011897]

4. Leone G, Voso MT, Teofili L et al. Inhibitors of DNA methylation in the treatment of hematological malignancies and MDS. Clin Immunol. 2003; 109:89-102. [PubMed 14585280]

5. Food and Drug Administration. Orphan designation pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act. (P.L. 97-414). Rockville, MD; From FDA website.

6. Silverman LR, Demakos EP, Bercedis L et al. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. 2002; 20:2429-40. [IDIS 486284] [PubMed 12011120]

7. Silverman LR. Targeting hypomethylation of DNA to achieve cellular differentiation in myelodysplastic syndromes (MDS). Oncologist. 2001; 6(Suppl 5):8-14. [PubMed 11700387]

8. Kantarjian HM. Treatment of myelodysplastic syndrome: questions raised by the azacitidine experience. J Clin Oncol. 2002; 20:2415-6. [IDIS 486283] [PubMed 12011118]

9. Pharmion. AHFS Product information form on Vidaza (azacitidine) for injectable suspension. Boulder, CO; undated.

10. Silverman LR, Holland JF, Davis RB et al. Azacitidine (Aza C) in myelodysplastic syndromes (MDS). Ann Hematol. 1994; 68:A12.

11. Silverman LR, Holland JF, Weinberg RS et al. Effect of treatment with 5-azacitidine on the in vivo and in vitro hematopoiesis in patients with myelodysplastic syndromes. Leukemia. 1993; 7(Suppl):21-9. [PubMed 7683352]

12. US Food and Drug Administration Center for Drug Evaluation and Research. Azacitidine medical officer’s review. 2004 May 19. From FDA website.

13. Pharmion, Boulder, CO; Personal communication.

14. Pharmion. Vidaza (azacitidine for injectable suspension) prescribing information. Boulder, CO; 2004 Aug 31.

10001. Silverman L, McKenzie D, Peterson B et al. Further analysis of trials with azacitidine in patients with myelodysplastic syndrome: studies 8421, 8921, and 9221 by the Cancer and Leukemia Group B. J Clin Oncol. 2006; 24: 3895-3903. [PubMed 16921040]

10002. Sudan N, Rossetti J, Shadduck R et al. Treatment of acute myelogenous leukemia with outpatient azacitidine. Cancer. 2006; 107:1839-43. [PubMed 16967444]

10003. Kaminskas E, Farrell A, Abraham S et al. Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes. Clin Cancer Res. 2005; 11: 3604-3608. [PubMed 15897554]

10004. Fenaux P, Mutfi G, Santini V et al. Azacitidine treatment prolongs overall survival in higher-risk MDS patients compared with conventional care regimens: Results of the AZA-001 Phase III study. Blood. 2007; 110: Abstract No. 817.

10005. List AF, Fenaux P, Mutfi GJ et al. Effect of azacitidine (AZA) on overall survival in higher-risk myelodysplastic syndromes (MDS) without complete remission. J Clin Oncol. 2008; 26: Abstract No. 7006.

10006. Mufti GJ, Fenaux P, Hellstrom-Lindberg E. et al. Treatment of high-risk MDS patients (pts) with -7/del(7q) with azacitidine (AZA) versus conventional care regimens (CCR): effects on overall survival. J Clin Oncol. 2008; 26: Abstract No. 7033.

10007. Fabre C, Gardin G, Mbida R et al. Treatment of AML with Azacytidine (AZA): Current results of the French ATU program. Blood. 2007; 110 (11): Abstract No. 1849.

10008. Al-Ali H, Schwind S, Becket C et al. 5-Azacitidine induces hematologic responses in a high proportion of patients with acute myeloid leukemia refractory to or not eligible for intensive chemotherapy. Blood. 2006; 108: Abstract No. 1953

10009. Goldberg S, Hsu J, Orr A et al. 5-Azacitidine therapy in elderly patients with acute myelogenous leukemia yields similar survival compared to 3+ 7 induction chemotherapy with less transfusional support, bacteremias and hospital days. Blood. 2006; 108: Abstract No. 4569.

10010. Jain N, Mattiuzzi G, Cortes J et al. Benefit of anti-infectious prophylaxis in patients with acute myeloid leukemia or high-risk myelodysplastic syndrome receiving frontline targeted therapy. Blood. 2007; 110: Abstract No. 2858.

10011. AHFS drug information off-label use determinations. McEvoy GK, ed. Azacitidine. Bethesda, MD: American Society of Health-System Pharmacists; 2008 Apr. From AHFS drug information website.

10012. Silverman LR, Demakos EP, Peterson BL et al. Randomized controlled trial of azacitidine in patients with the myelodysplastic syndrome: a study of the cancer and leukemia group B. J Clin Oncol. 2002; 20:2429-40. [IDIS 486284] [PubMed 12011120]

10013. Vardiman JW, Harris NL, Brunning RD. The World Health Organization (WHO) classification of the myeloid neoplasms. Blood. 2002; 100:2292-302. [PubMed 12239137]

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Dosage Modification for Hematologic Toxicity in Patients with Baseline (start of treatment) WBC of ≥3000/mm³, ANC of ≥1500/mm³, and Platelet Count of ≥75,000/mm³

Dosage Modification for Hematologic Toxicity in Patients with Baseline (start of treatment) WBC of <3000/mm³, ANC of <1500/mm³, or Platelet Count of <75,000/mm³