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Vosol HC

30/06/10

Generic Name: hydrocortisone and acetic acid (Otic route)

hye-droe-KOR-ti-sone, a-SEE-tik AS-id

Commonly used brand name(s):

In the U.S.

Acetasol HC
Vosol HC

Available Dosage Forms:

Solution

Therapeutic Class: Anti-Infective/Anti-Inflammatory Combination

Pharmacologic Class: Adrenal Glucocorticoid

Chemical Class: Acetic Acid (class)

Uses For Vosol HC

Corticosteroid and acetic acid combinations are used to treat certain problems of the ear canal. They also help relieve the redness, itching, and swelling that may accompany these conditions.

These medicines may also be used for other conditions as determined by your doctor.

Corticosteroid and acetic acid combinations are available only with your doctor’s prescription.

Before Using Vosol HC

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

There is no specific information comparing the use of otic corticosteroids in children under 3 years of age with use in other age groups.

Geriatric

Although there is no specific information comparing the use of otic corticosteroids in the elderly with use in other age groups, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy

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

Breast Feeding

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

Interactions with Medicines

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

Rotavirus Vaccine, Live

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.

Aldesleukin
Bupropion
Quetiapine

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.

Alatrofloxacin
Alcuronium
Atracurium
Balofloxacin
Cinoxacin
Ciprofloxacin
Clinafloxacin
Colestipol
Enoxacin
Fleroxacin
Flumequine
Gallamine
Gemifloxacin
Grepafloxacin
Hexafluorenium
Itraconazole
Levofloxacin
Licorice
Lomefloxacin
Metocurine
Moxifloxacin
Norfloxacin
Ofloxacin
Pefloxacin
Primidone
Prulifloxacin
Rifapentine
Rosoxacin
Rufloxacin
Saiboku-To
Sparfloxacin
Temafloxacin
Tosufloxacin
Trovafloxacin Mesylate

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 hydrocortisone and acetic acid

This section provides information on the proper use of a number of products that contain hydrocortisone and acetic acid. It may not be specific to Vosol HC. Please read with care.

To use:

Lie down or tilt the head so that the affected ear faces up. Gently pull the ear lobe up and back for adults (down and back for children) to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several (about 5) minutes to allow the medicine to run to the bottom of the ear canal. A sterile cotton plug may be gently inserted into the ear opening to prevent the medicine from leaking out. At first, your doctor may want you to put more medicine on the cotton plug during the day to keep it moist.

To keep the medicine as germ-free as possible, avoid touching the dropper or applicator tip to any surface as much as possible (including the ear). Also, always keep the container tightly closed.

For patients using hydrocortisone and acetic acid ear drops:

Do not wash the dropper or applicator tip, because water may get into the medicine and make it weaker. If necessary, you may wipe the dropper or applicator tip with a clean tissue.

Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Do not use any leftover medicine for future ear problems without first checking with your doctor. This medicine should not be used if certain kinds of infections are present. To do so may make the infection worse.

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 hydrocortisone and acetic acid
For ear drops dosage form:
- For ear infections:
  - Adults and children over 3 years of age—Use 3 to 5 drops in the affected ear every four to six hours for the first twenty-four hours, then 5 drops three to four times daily.
  - Children under 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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 stop treatment abruptly.

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.

Precautions While Using Vosol HC

If your condition does not improve within 5 to 7 days, or if it becomes worse, check with your doctor.

Vosol HC 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.

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

Anorexia, weakness, weight loss (in children)
stinging, itching, irritation, or burning of the ear

There have not been any other side effects reported with this medicine. However, if you notice any other effects, check with your doctor.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided “AS IS” and “as available” for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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VoSpire ER

30/06/10

Generic Name: albuterol (Oral route)

al-BUE-ter-ol

Commonly used brand name(s):

In the U.S.

Proventil
Proventil Repetabs
Ventolin
Volmax
VoSpire ER

In Canada

Apo-Salvent Inhaler

Available Dosage Forms:

Tablet
Syrup
Tablet, Extended Release

Therapeutic Class: Bronchodilator

Pharmacologic Class: Sympathomimetic

Uses For VoSpire ER

Albuterol is used to treat bronchospasm or wheezing in patients with reversible obstructive airway disease, such as asthma.

Albuterol belongs to the family of medicines known as adrenergic bronchodilators. Adrenergic bronchodilators are medicines that open up the bronchial tubes (air passages) in the lungs. They relieve cough, wheezing, shortness of breath, and troubled breathing by increasing the flow of air through the bronchial tubes.

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

Before Using VoSpire ER

Allergies

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of albuterol in children 2 years of age and older.

Geriatric

No information is available on the relationship of age to the effects of albuterol in geriatric patients. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving albuterol.

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

Interactions with Medicines

Acebutolol
Alprenolol
Arotinolol
Atenolol
Atomoxetine
Befunolol
Betaxolol
Bevantolol
Bisoprolol
Bopindolol
Brofaromine
Bucindolol
Bupranolol
Carteolol
Carvedilol
Celiprolol
Clorgyline
Dilevalol
Esmolol
Furazolidone
Iproniazid
Isocarboxazid
Labetalol
Landiolol
Lazabemide
Levobetaxolol
Levobunolol
Linezolid
Mepindolol
Metipranolol
Metoprolol
Moclobemide
Nadolol
Nebivolol
Nialamide
Nipradilol
Oxprenolol
Pargyline
Penbutolol
Phenelzine
Pindolol
Procarbazine
Propranolol
Rasagiline
Selegiline
Sotalol
Talinolol
Tertatolol
Timolol
Toloxatone
Tranylcypromine

Interactions with Food/Tobacco/Alcohol

Proper Use of albuterol

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

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine or any asthma medicine without telling your doctor. To do so may increase the chance for breathing problems.

Swallow the extended-release tablet whole with water or liquids. Do not break, crush, or chew the tablet.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Dosing

For treatment of bronchospasm:
- For oral dosage form (syrup, tablets):
  - Adults and children older than 12 years of age—2 or 4 milligrams (mg) taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given 4 times per day.
  - Children 6 to 12 years of age—2 mg taken 3 or 4 times per day. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given 4 times per day.
  - Children 2 to 6 years of age—Dose is based on body weight and must be determined by your doctor. The usual dose is 0.1 milligram (mg) per kilogram (kg) of body weight per dose, given 3 times per day, and each dose will not be more than 2 mg. Your doctor may increase your dose as needed up to a maximum dose of 12 mg per day, divided and given 3 times a day.
  - Children younger than 2 years of age—Use and dose must be determined by your child’s doctor.
- For oral dosage form (extended-release tablets):
  - Adults and children older than 12 years of age—8 milligrams (mg) every 12 hours. Your doctor may increase your dose as needed up to a maximum of 32 mg per day, divided and given every 12 hours.
  - Children 6 to 12 years of age—4 mg every 12 hours. Your doctor may increase your dose as needed up to a maximum dose of 24 mg per day, divided and given every 12 hours.
  - Children younger than 6 years of age—Use and dose must be determined by your child’s 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 VoSpire ER

It is very important that your doctor check your progress or your child’s progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for any unwanted effects.

This medicine may cause paradoxical bronchospasm, which means your breathing or wheezing will get worse. Paradoxical bronchospasm may be life-threatening. Check with your doctor right away if you or your child have coughing, difficulty breathing, shortness of breath, or wheezing after using this medicine.

You or your child may also be taking an antiinflammatory medicine, such as a steroid, together with this medicine. Do not stop taking the antiinflammatory medicine, even if your asthma seems better, unless you are told to do so by your doctor.

Albuterol may cause allergic reactions. Stop using the medicine and check with your doctor right away if you or your child develop a skin rash, hives, itching, swelling, or any type of allergic reaction after taking this medicine.

Hypokalemia (low potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you or your child have more than one of the following symptoms: convulsions; decreased urine; dry mouth; increased thirst; irregular heartbeat; loss of appetite; mood changes; muscle pain or cramps; nausea or vomiting; numbness or tingling in the hands, feet, or lips; shortness of breath; or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

VoSpire ER Side Effects

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

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

More common

Shakiness in the legs, arms, hands, or feet
trembling or shaking of the hands or feet

Less common

Fast, irregular, pounding, or racing heartbeat or pulse

Rare

Cough
difficulty breathing
difficulty with swallowing
hives or welts
hoarseness
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
noisy breathing
redness of the skin
shortness of breath
skin rash
slow or irregular breathing
swelling of the mouth or throat
tightness in the chest
wheezing

Incidence not known

Agitation
anxiety
arm, back, or jaw pain
blurred vision
chest pain or discomfort
confusion
convulsions
extra heartbeats
fainting
hallucinations
headache
irritability
lightheadedness
mood or mental changes
muscle pain or cramps
muscle spasm or jerking of all extremities
nervousness
nightmares
pounding in the ears
restlessness
sudden loss of consciousness
sweating
total body jerking
unusual feeling of excitement
vomiting

Less common

Dizziness
feeling of warmth
irritability
nausea
redness of the face, neck, arms, and occasionally, upper chest
sleeplessness
trouble with holding or releasing urine
trouble sleeping
unable to sleep

Rare

Sleepiness
unusual drowsiness

Incidence not known

Bad, unusual, or unpleasant (after) taste
change in taste
feeling of constant movement of self or surroundings
gagging
rough, scratchy sound to voice
sensation of spinning
tightness in the throat

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.

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Vospire ER Extended-Release Tablets

30/06/10

Generic Name: Albuterol (al-BUE-ter-ol)
Brand Name: Vospire ER

Vospire ER Extended-Release Tablets are used for:

Treating breathing problems in patients who have asthma or certain other airway diseases. It may also be used for other conditions as determined by your doctor.

Vospire ER Extended-Release Tablets are a sympathomimetic (beta agonist) bronchodilator. It works by relaxing the smooth muscle in the airway, which allows air to flow in and out of the lungs more easily.

Do NOT use Vospire ER Extended-Release Tablets if:

you are allergic to any ingredient in Vospire ER Extended-Release Tablets
you are taking another sympathomimetic (eg, pseudoephedrine), except for a bronchodilator inhaler as directed by your doctor

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

Before using Vospire ER Extended-Release Tablets:

Some medical conditions may interact with Vospire ER Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of heart problems, (eg, fast or irregular heartbeat, heart failure), blood vessel problems, high blood pressure, or low blood potassium levels
if you have a history of seizures, diabetes, an overactive thyroid, kidney problems, or an adrenal gland tumor (pheochromocytoma)
if you have ever had an unusual reaction to another sympathomimetic medicine (eg, pseudoephedrine)
if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken either of these medicines within the last 14 days

Some MEDICINES MAY INTERACT with Vospire ER Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood potassium levels may be increased
Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), epinephrine, MAOIs (eg, phenelzine), short-acting sympathomimetic bronchodilators (eg, metaproterenol), stimulants (eg, amphetamine), sympathomimetics (eg, pseudoephedrine), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Vospire ER Extended-Release Tablets’s side effects
Beta-blockers (eg, propranolol) because they may decrease Vospire ER Extended-Release Tablets’s effectiveness
Digoxin because its effectiveness may be decreased by Vospire ER Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vospire ER Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Vospire ER Extended-Release Tablets:

Use Vospire ER Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Vospire ER Extended-Release Tablets by mouth with or without food.
Take Vospire ER Extended-Release Tablets with liquid.
Swallow Vospire ER Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
Do not stop using Vospire ER Extended-Release Tablets without checking with your doctor.
If you miss a dose of Vospire ER Extended-Release Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Vospire ER Extended-Release Tablets.

Important safety information:

Vospire ER Extended-Release Tablets may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Vospire ER Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
If your usual dose does not provide relief, your symptoms become worse, or you need to use it more often than usual, contact your doctor at once. This may be a sign of seriously worsening asthma. Your doctor may need to change your dose or medicine.
Vospire ER Extended-Release Tablets should work for up to 12 hours or longer. Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor. The risk of severe heart problems and sometimes death may be increased with overuse of Vospire ER Extended-Release Tablets.
Tell your doctor or dentist that you take Vospire ER Extended-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
Check with your doctor before using any other asthma medicines, including inhaled medicines, while you are using Vospire ER Extended-Release Tablets.
Diabetes patients – Vospire ER Extended-Release Tablets may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
When your medicine supply begins to run low, call your doctor or pharmacy as soon as possible for a refill.
Use Vospire ER Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
Caution is advised when using Vospire ER Extended-Release Tablets in CHILDREN; they may be more sensitive to its effects, especially excitability, nervousness, and fast heartbeat.
Vospire ER Extended-Release Tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Vospire ER Extended-Release Tablets while you are pregnant. It is not known if Vospire ER Extended-Release Tablets are found in breast milk. If you are or will be breast-feeding while you use Vospire ER Extended-Release Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Vospire ER Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; excitability; headache; nausea; nervousness; sinus inflammation; sore or dry throat; tremor; trouble sleeping; vomiting.

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); chest pain; ear pain; fast or irregular heartbeat; new or worsened trouble breathing; pounding in the chest; red, swollen, blistered, or peeling skin; severe headache or dizziness; unusual hoarseness; 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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include chest pain; fast or irregular heartbeat; seizures; severe headache or dizziness; severe or persistent nervousness or trouble sleeping; tremor.

Proper storage of Vospire ER Extended-Release Tablets:

Store Vospire ER Extended-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vospire ER Extended-Release Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Vospire ER Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Vospire ER Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Vospire ER Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: May 5, 2010

Database Edition 10.2.1.002

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vorinostat (Oral route)

30/06/10

vor-IN-oh-stat

Commonly used brand name(s):

In the U.S.

Zolinza

Available Dosage Forms:

Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Histone Deacetylase Inhibitor

Uses For vorinostat

Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL), a type of cancer that affects certain white blood cells and causes lesions to develop on the skin. It works by interfering with the growth of the cancerous cells, which are eventually destroyed .

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

vorinostat is available only with your doctor’s prescription .

Before Using vorinostat

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 vorinostat, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to vorinostat 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 vorinostat in children up to 18 years of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of vorinostat in the elderly. However, elderly patients may be more sensitive to the effects of vorinostat than younger adults .

Pregnancy

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

Breast Feeding

Interactions with Medicines

Using vorinostat 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.

Valproic Acid

Using vorinostat 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.

Acenocoumarol
Dicumarol
Phenprocoumon
Warfarin

Interactions with Food/Tobacco/Alcohol

Proper Use of vorinostat

Medicines used to treat cancer are very strong and can have many side effects. Before receiving vorinostat, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

vorinostat sometimes causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if you begin to feel ill. Ask your doctor for ways to lessen these effects.

Drink at least 2 liters of fluids per day while you are using vorinostat. This will help prevent dehydration and keep your kidneys working well .

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

Dosing

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

For cutaneous T-cell lymphoma:
- For oral dosage form (capsules):
  - Adults—400 milligrams (mg) once a day with food. Your doctor will adjust your dose as needed.
  - Children—Use and dose must be determined by your doctor .

Missed Dose

If you miss a dose of vorinostat, 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.

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

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using vorinostat

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

Check with your doctor right away if you start having pain in your chest, groin, or legs, especially the calves; trouble breathing; severe, sudden headache; slurred speech; sudden, unexplained shortness of breath; sudden loss of coordination; sudden, severe weakness or numbness in arm or leg; or vision changes. These may be symptoms of blood clotting problems .

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

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

vorinostat may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, check with your doctor. Carefully follow your doctor’s instructions about any special diet .

Check with your doctor right away if you have severe diarrhea, nausea, or vomiting. You may also receive medicines to help prevent these symptoms .

vorinostat can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats .

vorinostat Side Effects

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

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

More common

Anxiety
black, tarry stools
bleeding gums
bloating or swelling of face, arms, hands, lower legs, or feet
blood in urine or stools
body aches or pain
chest pain
chills
confusion
convulsions
cough
decreased urine
diarrhea
dizziness or lightheadedness
dry mouth
ear congestion
fainting
fast heartbeat
fever
headache
increased thirst
irregular heartbeat
large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
loss of appetite
loss of voice
lower back or side pain
mood changes
muscle pain or cramps
nasal congestion
nausea or vomiting
no blood pressure
no breathing
no pulse
numbness or tingling in face, arms or legs
numbness or tingling in hands, feet, or lips
pain, redness, or swelling in arm or leg
painful or difficult urination
pale skin
pinpoint red spots on skin
rapid weight gain
runny nose
shortness of breath
sore throat
sores, ulcers, or white spots on lips or in mouth
sudden shortness of breath or troubled breathing
swollen glands
trouble speaking, thinking or walking
troubled breathing with exertion
unusual bleeding or bruising
unusual drowsiness, dullness, or feeling of sluggishness
unusual tiredness or weakness

Less common

Persistent non-healing sore
pink growth
reddish patch or irritated area
shiny bump
white, yellow or waxy scar-like area

Rare

Chest discomfort
general feeling of illness
hoarseness
indigestion
pain or discomfort in arms, jaw, back, or neck
rapid, shallow breathing
severe nausea or vomiting
sneezing
stomach pain
sweating
tightness in chest
vomiting of blood or material that looks like coffee grounds
wheezing
yellow skin and eyes

More common

Change in taste
cracks in the skin
difficulty having a bowel movement (stool)
hair loss, thinning of hair
itching skin
lack or loss of strength
loss of heat from the body
loss of taste
muscle spasm
red, swollen skin
scaly skin

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

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

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vorinostat

30/06/10

Generic Name: vorinostat (vor IN o stat)
Brand Names: Zolinza

What is vorinostat?

Vorinostat is used to treat skin problems caused by cutaneous T-cell lymphoma.

Vorinostat is usually given after other treatments have been tried without successful treatment of symptoms.

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

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

Do not use this medication without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Drink at least 2 liters of water each day to keep from getting dehydrated while you are taking vorinostat. Tell your doctor if you have severe vomiting or diarrhea during treatment.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not crush or open a vorinostat capsule. Swallow the pill whole. The medicine inside the capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If contact occurs, wash the skin area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken capsule, ask your doctor or pharmacist how to safely dispose of it.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be tested. Do not miss any scheduled visits to your doctor.

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

Do not use this medication if you are allergic to vorinostat.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have:

diabetes;
liver disease;
kidney disease;
an electrolyte imbalance (such as high or low potassium levels);
a personal or family history of “Long QT syndrome”;
a history of stroke or blood clot; or
if you have recently been vomiting or had diarrhea.

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

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use vorinostat without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether vorinostat 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 vorinostat?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Vorinostat is usually taken once daily with food. Drink at least 2 liters of water each day to keep from getting dehydrated while you are taking vorinostat. Tell your doctor if you have severe vomiting or diarrhea during treatment. Do not crush or open a vorinostat capsule. Swallow the pill whole. The medicine inside the capsule can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If contact occurs, wash the skin area with soap and water or rinse the eyes thoroughly with plain water. If you must handle a broken capsule, ask your doctor or pharmacist how to safely dispose of it.

Store vorinostat at room temperature away from moisture and heat.

See also: Vorinostat dosage in more detail

What happens if I miss a dose?

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

What happens if I overdose?

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

Symptoms of a vorinostat overdose are not known.

What should I avoid while taking vorinostat?

Avoid becoming overheated or dehydrated during exercise and in hot weather. Drink at least 2 liters of water each day while you are taking vorinostat.

Vorinostat 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 vorinostat and call your doctor at once if you have any of these serious side effects:

sudden shortness of breath, chest pain that gets worse with breathing, coughing up blood, fainting;
pain or swelling in one or both legs;
pale skin, easy bruising or bleeding, unusual weakness;
black, bloody, or tarry stools;
severe or prolonged vomiting or diarrhea;
increased thirst or urination;
dry mouth, confusion, nausea, vomiting, feeling light-headed, fainting, decreased sweating, and hot, dry skin;

Continue taking vorinostat and talk with your doctor if you have any of these less serious side effects:

nausea, vomiting, diarrhea, constipation;
headache, tired feeling;
loss of appetite;
dry mouth, changes in the way things taste;
weight loss;
chills;
hair loss; or
muscle spasms.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Vorinostat Dosing Information

Usual Adult Dose for Cutaneous T-cell Lymphoma:

400 mg orally once daily with food

Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Voriconazole capsules should not be opened or crushed.

What other drugs will affect vorinostat?

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

valproic acid; or
a blood thinner such as warfarin (Coumadin).

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

There may be other drugs not listed that can affect vorinostat. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist has information about vorinostat written for health professionals that you may read.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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voriconazole (Oral route, Intravenous route)

30/06/10

vor-i-KON-a-zole

Commonly used brand name(s):

In the U.S.

Vfend
Vfend I.V.

Available Dosage Forms:

Powder for Suspension
Tablet
Powder for Solution

Therapeutic Class: Antifungal

Chemical Class: Triazole

Uses For voriconazole

Voriconazole is used to treat different kinds of serious fungal infections. It may also be used to treat patients with serious fungal infections who cannot tolerate other types of treatment or do not respond to other types of treatment.

voriconazole is available only with your doctor’s prescription.

Before Using voriconazole

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 voriconazole, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to voriconazole 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 voriconazole in children up to 12 years of age. Safety and efficacy have not been established .

Geriatric

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

Pregnancy

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

Breast Feeding

Interactions with Medicines

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

Astemizole
Carbamazepine
Cisapride
Dihydroergotamine
Dronedarone
Ergoloid Mesylates
Ergonovine
Ergotamine
Mephobarbital
Methylergonovine
Methysergide
Phenobarbital
Pimozide
Quinidine
Rifabutin
Rifampin
Ritonavir
Sirolimus
St John’s Wort
Terfenadine

Using voriconazole 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.

Acenocoumarol
Alprazolam
Amiodarone
Bretylium
Chloramphenicol
Clarithromycin
Clopidogrel
Cyclosporine
Darunavir
Dasatinib
Delavirdine
Dicumarol
Dofetilide
Efavirenz
Erythromycin
Everolimus
Fosphenytoin
Ibutilide
Ixabepilone
Lapatinib
Lopinavir
Nevirapine
Nilotinib
Pazopanib
Phenprocoumon
Phenytoin
Ranolazine
Romidepsin
Sotalol
Sunitinib
Tacrolimus
Telavancin
Temsirolimus
Triazolam
Vinblastine
Vincristine
Vincristine Liposome
Vinorelbine
Warfarin

Using voriconazole 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.

Alfentanil
Amprenavir
Atorvastatin
Cerivastatin
Ethinyl Estradiol
Etravirine
Fosamprenavir
Glipizide
Glyburide
Lovastatin
Meloxicam
Methadone
Midazolam
Nelfinavir
Norethindrone
Omeprazole
Oxycodone
Saquinavir
Simvastatin
Tolbutamide
Tretinoin

Interactions with Food/Tobacco/Alcohol

Proper Use of voriconazole

Dosing

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

A nurse or other trained health professional will give you the IV form of voriconazole. voriconazole is given through a needle placed in one of your veins. It will be given slowly, so the needle will remain in place for up to 2 hours .

For the oral suspension, shake well before measuring the dose. Use the oral dispenser supplied with your medicine to measure the dose.

For oral dosage forms (oral suspension or tablets):
- For serious fungal infections:
  - Adults and children 12 years of age and above—Your dose will be determined based on your weight and other medicines you are taking. Check with your doctor for more dosage information. Oral suspension or tablets should be taken 1 hour before or after a meal.
  - Children below 12 years of age—Use and dose will be determined by your doctor .

Missed Dose

If you miss a dose of voriconazole, 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.

Throw away any unused oral suspension after the date listed on the label.

Precautions While Using voriconazole

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

If your symptoms do not improve within a few days or if they become worse, 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. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions .

You should NOT use any of the following medicines while you are using voriconazole :

Astemizole (e.g., Hismanal®)
Carbamazepine (e.g., Tegretol®)
Cisapride (e.g., Propulsid®)
Ergot medicines (e.g., ergotamine, dihydroergotamine, methysergide, bromocriptine, Sansert®, or Parlodel®)
Phenobarbital (e.g., Luminal®)
Pimozide (e.g., Orap®)
Quinidine (e.g., Quinora®)
Rifabutin (e.g., Mycobutin®)
Rifampin (e.g., Rifadin®)
Sirolimus (e.g., Rapamune®)
St. John’s wort
Terfenadine (e.g., Seldane®)

Check with your doctor first before using efavirenz (Sustiva®) or ritonavir (Norvir®) during voriconazole treatment. Your doses of these medicines will need to be adjusted .

voriconazole may cause some people to have changes in vision, such as blurred vision and seeing bright spots or wavy lines. Make sure you know how you react to voriconazole before you drive, use machines, or do anything else that could be dangerous if you have vision changes.

Using voriconazole while you are pregnant can harm your unborn baby. It is important that contraception (birth control) be used during treatment with voriconazole. If you think you have become pregnant while using voriconazole, tell your doctor right away .

The IV form of voriconazole may cause a serious side effect called an infusion reaction. This can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have fever, chills, trouble with breathing, lightheadedness, fainting, or chest tightness within a few hours after you receive it .

voriconazole may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds .

voriconazole Side Effects

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

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

More common

Rash

Less common

Abdominal or stomach pain
bloating or swelling of face, arms, hands, lower legs, or feet
blurred vision
chills
clay-colored stools
confusion
convulsions
dark urine
decreased urine
dizziness
dry mouth
faintness or light-headedness when getting up from a lying or sitting position
fever
headache
increased thirst
irregular or pounding heartbeat
itching
loss of appetite
mood or mental changes
muscle pain or cramps
muscle spasms or twitching
nausea
nervousness
numbness or tingling in hands, feet, or lips
pounding in the ears
rapid weight gain
rash with flat lesions or small raised lesions on the skin
shortness of breath
slow or fast heartbeat
suddenly sweating
trembling
unpleasant breath odor
unusual tiredness or weakness
vasodilation (flushing)
vomiting of blood
yellow eyes or skin

Rare

Abnormal kidney function
black, bloody, or tarry stools
bleeding gums
blood in eye
blood in urine or stools
chest pain
eye pain
painful or difficult urination
pale skin
pinpoint red spots on skin
redness in whites of eyes
sore throat
sores, ulcers, or white spots on lips or in mouth
sudden kidney failure
swollen glands
trouble breathing with activity
unusual bleeding or bruising

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

Change in color vision
difficulty seeing at night
increased sensitivity of eyes to sunlight

More Common

Seeing things that are not there

Less common

Diarrhea
disturbance in vision
dry mouth
feeling unusually cold
shivering
vomiting

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

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

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Voriconazole Suspension

30/06/10

Generic Name: Voriconazole (VOR-i-KON-a-zole)
Brand Name: Vfend

Voriconazole Suspension is used for:

Treating fungal infections.

Voriconazole Suspension is an azole antifungal. It works by blocking fungal cell wall growth, resulting in the death of the fungus.

Do NOT use Voriconazole Suspension if:

you are allergic to any ingredient in Voriconazole Suspension
you are taking a barbiturate (eg, phenobarbital), carbamazepine, cisapride, an ergot alkaloid (eg, ergotamine), an H₁ antagonist (eg, astemizole, terfenadine), pimozide, quinidine, rifabutin, rifampin, sirolimus, or St. John’s wort
you have galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
you are taking ritonavir
you have untreated low blood calcium, magnesium, or potassium levels

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

Before using Voriconazole Suspension:

Some medical conditions may interact with Voriconazole 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 are allergic to other azole antifungals (eg, fluconazole, itraconazole)
if you have a history of heart problems (eg, cardiomyopathy) or abnormal blood calcium, magnesium, or potassium levels
if you have liver problems (eg, cirrhosis), kidney problems, pancreas problems, or a blood disease
if you have ever been on chemotherapy or have had a stem cell transplant

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

Barbiturates (eg, phenobarbital), carbamazepine, rifampin, ritonavir, or St. John’s wort because they may decrease Voriconazole Suspension’s effectiveness
Anticoagulants (eg, warfarin), aripiprazole, benzodiazepines (eg, alprazolam), calcium channel blockers (eg, felodipine), cyclosporine, ergot alkaloids (eg, ergotamine), erlotinib, HMG-CoA reductase inhibitors (eg, atorvastatin), macrolide immunosuppressants (eg, sirolimus, tacrolimus), methadone, non-nucleoside reverse transcriptase inhibitors (NNRTIs) (eg, nevirapine), sulfonylureas (eg, glipizide), or vinca alkaloids (eg, vincristine) because the risk of their side effects may be increased by Voriconazole Suspension
Cisapride, H₁ antagonists (eg, astemizole, terfenadine), methadone, pimozide, or quinidine because the risk of their side effects, such as irregular heartbeat, may be increased by Voriconazole Suspension
Efavirenz, hydantoins (eg, phenytoin), or rifabutin because the risk of their side effects may be increased by Voriconazole Suspension or they may decrease Voriconazole Suspension’s effectiveness
HIV protease inhibitors (eg, ritonavir), oral contraceptives (birth control pills), or proton pump inhibitors (eg, omeprazole) because the risk of side effects of both medicines may be increased

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

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

An extra patient leaflet is available with Voriconazole Suspension. Talk to your pharmacist if you have questions about this information.
Take Voriconazole Suspension by mouth on an empty stomach at least 1 hour before or after eating.
Shake well before each use.
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 mix Voriconazole Suspension with any other medicine or flavoring.
To clear up your infection completely, take Voriconazole Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.
If you miss a dose of Voriconazole 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 Voriconazole Suspension.

Important safety information:

Voriconazole Suspension may cause blurred vision or sensitivity to light. These effects may be worse if you take it with alcohol or certain medicines. Use Voriconazole Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Avoid driving at night while you are using Voriconazole Suspension.
Voriconazole Suspension may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Voriconazole Suspension. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
Voriconazole Suspension may make your eyes more sensitive to sunlight. It may help to wear sunglasses. Avoid strong, direct sunlight.
Tell your doctor or dentist that you take Voriconazole Suspension before you receive any medical or dental care, emergency care, or surgery.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.
Women of childbearing age should use an effective form of contraception (eg, birth control pills) while taking Voriconazole Suspension.
Lab tests, including eye exams, liver and kidney function, and pancreas function, may be performed while you use Voriconazole Suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Voriconazole Suspension should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Voriconazole Suspension may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Voriconazole Suspension while you are pregnant. It is not known if Voriconazole Suspension is found in breast milk. If you are or will be breast-feeding while you use Voriconazole Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Voriconazole 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:

Blurred vision; change in color perception; diarrhea; dizziness; headache; mental or mood changes; nausea; sensitivity to light; sensitivity to the sun; stomach pain; vomiting.

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; chest pain; dark urine; decreased urination; depression; fast or irregular heartbeat; fever or chills; flushing; hallucinations; one-sided weakness; pain or numbness of an arm or leg; red, swollen, or blistered skin; seizures; severe stomach pain; shortness of breath; speech changes; sudden, severe headache, nausea, dizziness, or fainting; suicidal thoughts; swelling of the arms or legs; unusual bruising or bleeding; unusual fatigue; unusual vaginal bleeding; yellowing of the eyes or skin.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include cloudy cornea; depression; dilated pupils; droopy eyelids; loss of balance; seizures; shortness of breath; swollen abdomen; unusual saliva production.

Proper storage of Voriconazole Suspension:

Store Voriconazole Suspension at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Do not refrigerate or freeze. Store away from heat, light, and moisture. Do not store in the bathroom. Discard any unused medicine after 14 days. Keep Voriconazole Suspension out of the reach of children and away from pets.

General information:

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

This information is a summary only. It does not contain all information about Voriconazole 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: May 5, 2010

Database Edition 10.2.1.002

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Vopac

30/06/10

Generic Name: acetaminophen and codeine (a SEET a MIN o fen and KOE deen)
Brand Names: Capital with Codeine Suspension, Cocet, EZ III, Tylenol with Codeine #3, Tylenol with Codeine #4, Vopac

What is Vopac (acetaminophen and codeine)?

Codeine is in a group of drugs called narcotic pain relievers. Acetaminophen is a less potent pain reliever that increases the effects of codeine.

The combination of acetaminophen and codeine is used to relieve moderate to severe pain.

Acetaminophen and codeine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Vopac (acetaminophen and codeine)?

Tell your doctor if you drink more than three alcoholic beverages per day or if you have ever had alcoholic liver disease (cirrhosis). You may not be able to take medication that contains acetaminophen.

An overdose of acetaminophen can damage your liver. Adults should not take more than 1 gram (1000 mg) of acetaminophen per dose or 4 grams (4000 mg) per day. If you drink more than three alcoholic beverages per day, you should never use more than 2 grams (2000 mg) of acetaminophen per day. Ask a doctor or pharmacist before using any cold, allergy, pain, or sleep medicine. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. Taking certain products together can cause you to get too much acetaminophen. Check the label to see if a medicine contains acetaminophen or APAP. Codeine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

What should I discuss with my healthcare provider before taking Vopac (acetaminophen and codeine)?

Do not use this medication if you are allergic to acetaminophen (Tylenol) or codeine. Codeine may be habit-forming and should be used only by the person it was prescribed for. Never share acetaminophen and codine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

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

asthma, COPD, sleep apnea, or other breathing disorders;
liver or kidney disease;
a history of head injury or brain tumor;
epilepsy or other seizure disorder;
low blood pressure;
a stomach or intestinal disorder;
underactive thyroid;
Addison’s disease or other adrenal gland disorder;
enlarged prostate, urination problems;
curvature of the spine;
mental illness; or
a history of drug or alcohol addiction.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby, but it could cause breathing problems or addiction/withdrawal symptoms in a newborn. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.. Acetaminophen and codeine can pass into breast milk and may harm a nursing baby. The use of codeine by some nursing mothers may lead to life-threatening side effects in the baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Vopac (acetaminophen and codeine)?

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. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

One acetaminophen and codeine tablet may contain up to 650 mg of acetaminophen. Know the amount of acetaminophen in the specific product you are taking.

Take this medicine with food or milk to ease stomach upset.

Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Drink 6 to 8 full glasses of water daily to help prevent constipation while you are taking acetaminophen and codeine. Do not use a stool softener (laxative) without first asking your doctor. Do not stop using acetaminophen and codeine suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using acetaminophen and codeine.

This medication can cause unusual results with certain urine tests. Tell any doctor who treats you that you are using acetaminophen and codeine.

If you need surgery, tell the surgeon ahead of time that you are using acetaminophen and codeine. You may need to stop using the medicine for a short time.

Store at room temperature away from moisture and heat. Keep track of the amount of medicine used from each new bottle. Codeine is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Since this medication is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of acetaminophen and codeine can be fatal.

Overdose symptoms may include extreme drowsiness, sweating, pinpoint pupils, nausea, vomiting, dark urine, jaundice (yellowing of the skin or eyes), confusion, cold and clammy skin, fainting, weak pulse, seizure (convulsions), coma, blue lips, shallow breathing, or no breathing.

What should I avoid while taking Vopac (acetaminophen and codeine)?

Acetaminophen and codeine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not use any other cold, allergy, pain, or sleep medication without first asking your doctor or pharmacist. Acetaminophen (sometimes abbreviated as “APAP”) is contained in many combination medicines. If you use certain products together you may accidentally use too much acetaminophen. Read the label of any other medicine you are using to see if it contains acetaminophen or APAP. Avoid drinking alcohol. It may increase your risk of liver damage.

Vopac (acetaminophen and codeine) side effects

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

shallow breathing, slow heartbeat;
feeling light-headed, fainting;
confusion, unusual thoughts or behavior;
seizure (convulsions);
easy bruising or bleeding; or
nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects include:

feeling dizzy or drowsy;
mild nausea, vomiting, upset stomach, constipation;
headache;
blurred vision; or
dry 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 Vopac (acetaminophen and codeine)?

Before taking acetaminophen and codeine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, other pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by codeine.

Also tell your doctor if you are using any of the following drugs:

glycopyrrolate (Robinul);
mepenzolate (Cantil);
atropine (Donnatal, and others), benztropine (Cogentin), dimenhydrinate (Dramamine), methscopolamine (Pamine), or scopolamine (Transderm-Scop);
bladder or urinary medications such as darifenacin (Enablex), flavoxate (Urispas), oxybutynin (Ditropan, Oxytrol), tolterodine (Detrol), or solifenacin (Vesicare);
a bronchodilator such as ipratroprium (Atrovent) or tiotropium (Spiriva); or
irritable bowel medications such as dicyclomine (Bentyl), hyoscyamine (Anaspaz, Cystospaz, Levsin, and others), or propantheline (Pro-Banthine).

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

Where can I get more information?

Your pharmacist can provide more information about acetaminophen and codeine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,V

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voriconazole

30/06/10

Generic Name: voriconazole (vor i KON a zole)
Brand Names: VFEND

What is voriconazole?

Voriconazole is an antifungal medication.

Voriconazole is used to treat infections caused by yeast or other types of fungus.

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

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

Do not use voriconazole without your doctor’s consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

There are many other medicines that can cause serious or life-threatening drug interactions with voriconazole. Tell your doctor about all the prescription and over-the-counter medications you use.

Before taking voriconazole, tell your doctor if you have heart rhythm problems, an electrolyte imbalance, liver or kidney disease, or a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

Use voriconazole for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

Voriconazole can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

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

Do not take this medication if you are allergic to voriconazole, or if you are taking any of the following drugs:

quinidine (Cardioquin, Quinora, Quinidex, Quinaglute, Quin-Release, Quin-G);
sirolimus (Rapamune);
carbamazepine (Tegretol);
pimozide (Orap);
phenobarbital;
ritonavir (Norvir);
efavirenz (Sustiva);
rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);
an ergot medicine such as ergotamine (Ergomar, Cafergot, Ercaf, Wigraine, others) or dihydroergotamine (D.H.E., Migranal); or
(these drugs are no longer available in the U.S.) terfenadine (Seldane) or astemizole (Hismanal).

The drugs listed above can cause dangerous serious or life-threatening drug interactions with voriconazole. Tell your doctor about all other medicines you are using.

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

heart rhythm problems;
a metabolic disorder such as high or low levels of calcium, potassium, or magnesium;
liver disease;
kidney disease; or
a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

Voriconazole tablets contain lactose. Before taking a voriconazole tablet, tell your doctor if you have a hereditary form of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use voriconazole without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using voriconazole. It is not known if voriconazole 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 voriconazole?

Take voriconazole at least one hour before or after eating a meal. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Do not mix the oral suspension with any other medicine or liquid. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

To be sure voriconazole is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

Voriconazole can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

Store voriconazole tablets at room temperature away from moisture and heat. Store the oral liquid at room temperature for up to 14 days. Throw away any unused liquid after 14 days.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. 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 vision problems, excessive mouth watering, enlarged pupils, weakness, loss of balance, shortness of breath, or seizure (convulsions).

What should I avoid while taking voriconazole?

Voriconazole may cause changes in vision including blurred vision and sensitivity to light. Wear sunglasses during the day to protect your eyes from bright light. Be careful if you drive or do anything that requires you to have clear vision. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Voriconazole can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

Voriconazole side effects

sudden behavior changes, problems with thinking or speech;
stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
urinating less than usual or not at all;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
uneven heart rate, chest pain, general ill feeling.

Less serious side effects may include:

vision problems such as blurred vision, eyes being more sensitive to light;
fever;
mild nausea, vomiting, or diarrhea;
headache; or
swelling in your hands, ankles, or feet.

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.

Voriconazole Dosing Information

Usual Adult Dose for Aspergillosis — Invasive:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Once the patient can tolerate medication given by mouth, the oral tablet form of voriconazole may be utilized. Patients who weigh more than 40 kg should receive an oral maintenance dose of 200 mg every 12 hours. Patients who weigh less than 40 kg should receive an oral maintenance dose of 100 mg every 12 hours.

Case (n=1) – Fusariosis
Greater than 16 years: 6 mg/kg orally twice daily for eight weeks. Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Fungal Pneumonia:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Pseudoallescheriosis:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Ocular Fungal Infection:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Systemic Fungal Infection:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Cutaneous Fungal Infection:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Fungal Infection — Disseminated:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Fungal Meningitis:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Adult Dose for Fusariosis:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Case (n=1) – Fusariosis
Greater than 16 years: 6 mg/kg orally twice daily for eight weeks. Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with
a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

Usual Adult Dose for Blastomycosis:

Cerebral blastomycosis – Case report (n =1)
200 mg orally twice daily, then dose was increased to 300 mg orally twice daily after 4 weeks in an attempt to achieve a higher CNS concentration. Therapy was continued for a 12-month course.

Usual Adult Dose for Coccidioidomycosis — Meningitis:

Case report (n=1) – Coccidioides posadasii: 400 mg orally twice daily for 2.5 years. Thereafter, 200 mg orally twice daily, and lifelong therapy is planned.

Usual Adult Dose for Eumycetoma:

Case report (n=1)
200 mg orally twice daily for 3 months, followed by 300 mg orally twice daily for 13 months.

Usual Adult Dose for Esophageal Candidiasis:

Less than 40 kg: 100 mg orally twice daily for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Greater than or equal to 40 kg: 200 mg orally twice daily for a minimum of 14 days and for at least 7 days following resolution of symptoms.

Usual Pediatric Dose for Aspergillosis — Invasive:

Greater than or equal to 12 to 18 years:

Loading: 6 mg/kg IV every 12 hours for 2 doses.
Maintenance: 4 mg/kg IV every 12 hours. If dose not tolerated, may decrease to 3 mg/kg IV every 12 hours.

Usual Pediatric Dose for Ocular Fungal Infection:

Case (n=1) – Fusariosis
Greater than 16 years: 6 mg/kg orally twice daily for eight weeks.
Following keratoplasty and the surgical removal of the fungal material, the anterior chamber was irrigated with a 3 mcg/mL solution of voriconazole. Also, voriconazole 10 mcg/0.1 mL was injected intracamerally. Topical voriconazole 1% was applied every half-hour.

What other drugs will affect voriconazole?

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

phenytoin (Dilantin);
clopidogrel (Plavix);
cyclosporine (Sandimmune, Neoral);
tacrolimus (Prograf);
warfarin (Coumadin);
stomach acid reducers such as esomeprazole (Nexium), omeprazole (Prilosec), lansoprazole (Prevacid), or pantoprazole (Protonix);
tranquilizers or sedatives such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), triazolam (Halcion), and others;
cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor);
vinblastine (Velban), vincristine (Oncovin), or vinorelbine (Navelbine);
a calcium channel blocker such as verapamil (Isoptin, Verelan, Calan, Covera), amlodipine (Norvasc), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), or nisoldipine (Sular); or
an oral diabetes medicine such as glipizide (Glucotrol), glyburide (DiaBeta, Micronase), tolbutamide (Orinase), tolazamide (Tolinase), or chlorpropamide (Diabinese).

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

Where can I get more information?

Your pharmacist can provide more information about voriconazole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,V

Comments (0)

Volumen

30/06/10

Generic Name: barium sulfate (oral and rectal) (BER ee um SUL fate)
Brand Names: Anatrast, Baricon, Baro-Cat, Barosperse, CheeTah, CheeTah Butterscotch, CheeTah Chocolaty-Fudge, CheeTah Orange, CheeTah Raspberry, E-Z AC, E-Z Dose Kit with Polibar Plus, E-Z-Cat, E-Z-HD, E-Z-Paque, Eneset 2, Entero-H, Entrobar, Esopho-Cat, Liqui-Coat HD, Liquid Polibar, Medebar Plus, Medebar Super 250, Readi-Cat, Readi-Cat 2, Scan C, Smoothie Readi-Cat 2, Sol-O-Pake, Tonojug, Tonopaque, Varibar Nectar, Varibar Pudding, Varibar Thin, Varibar Thin Honey, Volumen

What is barium sulfate?

Barium sulfate is in a group of drugs called contrast agents. Barium sulfate works by coating the inside of your esophagus, stomach, or intestines which allows them to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Barium sulfate is used to help diagnose certain disorders of the esophagus, stomach, or intestines.

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

What is the most important information I should know about barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

Before you use barium sulfate, tell your doctor if you have any allergies, or if you have asthma, cystic fibrosis, heart disease or high blood pressure, rectal cancer, a colostomy, a blockage in your stomach or intestines, a condition called pseudotumor cerebri, or if you have recently had a rectal biopsy or surgery on your esophagus, stomach, or intestines.

Tell your doctor if you are pregnant or breast-feeding before your medical test.

Carefully follow your doctor’s instructions about what to eat or drink within the 24-hour period before your test.

Serious side effects of barium sulfate may include severe stomach pain, sweating, ringing in your ears, pale skin, weakness, or severe cramping, diarrhea, or constipation

What should I discuss with my health care provider before using barium sulfate?

You should not use this medication if you are allergic to barium sulfate. Tell your doctor if you have ever had an allergic reaction to a contrast agent.

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

asthma, eczema, or allergies;
a blockage in your stomach or intestines;
cystic fibrosis;
a colostomy;
rectal cancer;
heart disease or high blood pressure;
Hirschsprung’s disease (a disorder of the intestines);
a condition called pseudotumor cerebri (high pressure inside the skull that may cause headaches, vision loss, or other symptoms);
a recent history of surgery on your esophagus, stomach, or intestines;
a history of perforation (a hole or tear) in your esophagus, stomach, or intestines;
if you have recently had a rectal biopsy;
if you have ever choked on food by accidentally inhaling it into your lungs;
if you are allergic to simethicone (Gas-X, Phazyme, and others); or
if you are allergic to latex rubber.

It is not known whether barium sulfate is harmful to an unborn baby, but the radiation used in x-rays and CT scans may be harmful. Tell your doctor if you are pregnant. Barium sulfate may pass into breast milk and could harm a nursing baby. Before you use barium sulfate, tell your doctor if you are breast-feeding a baby.

How should I take barium sulfate?

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

Barium sulfate comes in tablets, paste, cream, or liquid forms.

In some cases, barium sulfate is taken by mouth. The liquid form may also be used as a rectal enema.

You may need to begin taking this medication at home a day before your medical test. Follow your doctor’s instructions about how much of the medication to use and how often.

If you are receiving barium sulfate as a rectal enema, a healthcare professional will give you the medication at the clinic or hospital where your testing will take place.

Do not crush, chew, or break a barium sulfate tablet. Swallow the pill whole.

Dissolve the barium sulfate powder in a small amount of water. Stir this mixture and drink all of it right away. To make sure you get the entire dose, add a little more water to the same glass, swirl gently and drink right away.

If you receive the medication as a liquid to take by mouth, shake the liquid well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Carefully follow your doctor’s instructions about what to eat or drink within the 24-hour period before your test.

Store this medication at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

If you are taking barium sulfate at home, call your doctor for instructions if you miss a 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 severe stomach pain, ongoing diarrhea, confusion, or weakness.

What should I avoid while taking barium sulfate?

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

Barium sulfate side effects

severe stomach pain;
severe cramping, diarrhea, or constipation;
sweating;
ringing in your ears;
confusion, fast heart rate; or
pale skin, weakness.

Less serious side effects may include:

mild stomach cramps;
nausea, vomiting;
loose stools or mild constipation.

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 barium sulfate?

There may be other drugs that can interact with barium sulfate. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about barium sulfate.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. (‘Multum’) is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum’s drug information does not endorse drugs, diagnose patients or recommend therapy. Multum’s drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Concise,V

Comments (0)

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Drugs & Medications:A-Z

Recent Posts

Blogroll

30/06/10

Uses For Vosol HC

Before Using Vosol HC

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of hydrocortisone and acetic acid

Dosing

Missed Dose

Storage

Precautions While Using Vosol HC

Vosol HC Side Effects

30/06/10

Uses For VoSpire ER

Before Using VoSpire ER

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of albuterol

Dosing

Missed Dose

Storage

Precautions While Using VoSpire ER

VoSpire ER Side Effects

30/06/10

Vospire ER Extended-Release Tablets are used for:

Do NOT use Vospire ER Extended-Release Tablets if:

Before using Vospire ER Extended-Release Tablets:

How to use Vospire ER Extended-Release Tablets:

Important safety information:

Possible side effects of Vospire ER Extended-Release Tablets:

If OVERDOSE is suspected:

General information:

30/06/10

Uses For vorinostat

Before Using vorinostat

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of vorinostat

Dosing

Missed Dose

Storage

Precautions While Using vorinostat

vorinostat Side Effects

30/06/10

What is vorinostat?

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

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

How should I take vorinostat?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking vorinostat?

Vorinostat side effects

Vorinostat Dosing Information

What other drugs will affect vorinostat?

Where can I get more information?

30/06/10

Uses For voriconazole

Before Using voriconazole

Allergies

Pediatric