Compound W One-Step Wart Remover Topical

Generic Name: salicylic acid (Topical route)

sal-i-SIL-ik AS-id

Commonly used brand name(s)

In the U.S.

• Akurza


• Aliclen


• Avosil


• Betasal


• Compound W


• Corn Removing


• Dermarest Psoriasis


• DHS Sal


• Drytex


• Duofilm


• Duoplant


• Durasal


• Freezone


• Fung-O


• Gets-It Corn/Callus Remover


• Gordofilm


• Hydrisalic


• Ionil


• Ionil Plus


• Keralyt


• Keralyt Scalp


• Lupicare


• Mediplast


• Mg217 Sal-Acid


• Mosco Corn & Callus Remover


• Neutrogena


• Occlusal-HP


• Off-Ezy


• Oxy Balance


• P & S


• Palmer's Skin Success Acne Cleanser


• Propa pH


• Salac


• Sal-Acid Plaster


• Salactic Film


• Salex


• Salitop


• Salkera


• Sal-Plant Gel


• Salvax


• Seba-Clear


• Stri-Dex


• Thera-Sal


• Therasoft Anti-Acne


• Tinamed


• Ti-Seb


• Virasal


• Wart-Off Maximum Strength


• Zapzyt

In Canada

• Acnex


• Acnomel Acne Mask


• Clear Away Wart Removal System


• Compound W One-Step Wart Remover


• Compound W Plus


• Dr. Scholl's Clear Away One Step Plantar Wart Remover


• Dr. Scholl's Cushlin Ultra Slim Callus Removers


• Dr. Scholl's Cushlin Ultra Slim Corn Removers


• Duoforte 27


• Freezone - One Step Callus Remover Pad


• Freezone - One Step Corn Remover Pad

Available Dosage Forms:

• Soap


• Lotion


• Liquid


• Foam


• Ointment


• Gel/Jelly


• Solution


• Cream


• Pad


• Paste


• Shampoo


• Dressing


• Stick

Therapeutic Class: Antiacne

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Non-Aspirin

Uses For Compound W One-Step Wart Remover

Salicylic acid is used to treat many skin disorders, such as acne, dandruff, psoriasis, seborrheic dermatitis of the skin and scalp, calluses, corns, common warts, and plantar warts, depending on the dosage form and strength of the preparation.

Some of these preparations are available only with your doctor's prescription.

Before Using Compound W One-Step Wart Remover

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

Young children may be at increased risk of unwanted effects because of increased absorption of salicylic acid through the skin. Also, young children may be more likely to get skin irritation from salicylic acid. Salicylic acid should not be applied to large areas of the body, used for long periods of time, or used under occlusive dressing (air-tight covering, such as kitchen plastic wrap) in infants and children. Salicylic acid should not be used in children younger than 2 years of age.

Geriatric

Elderly people are more likely to have age-related blood vessel disease. This may increase the chance of problems during treatment with this medicine.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

• Abciximab


• Argatroban


• Bivalirudin


• Cilostazol


• Citalopram


• Clovoxamine


• Dabigatran Etexilate


• Dipyridamole


• Escitalopram


• Femoxetine


• Flesinoxan


• Fluoxetine


• Fluvoxamine


• Fondaparinux


• Heparin


• Lepirudin


• Nefazodone


• Paroxetine


• Protein C


• Rivaroxaban


• Sertraline


• Sibutramine


• Ticlopidine


• Tirofiban


• Vilazodone


• Zimeldine

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.

• Acenocoumarol


• Anisindione


• Ardeparin


• Azilsartan Medoxomil


• Azosemide


• Bemetizide


• Bendroflumethiazide


• Benzthiazide


• Bumetanide


• Buthiazide


• Candesartan Cilexetil


• Certoparin


• Chlorothiazide


• Chlorthalidone


• Clopamide


• Cyclopenthiazide


• Dalteparin


• Danaparoid


• Dicumarol


• Enoxaparin


• Eprosartan


• Ethacrynic Acid


• Furosemide


• Hydrochlorothiazide


• Hydroflumethiazide


• Indapamide


• Irbesartan


• Losartan


• Methyclothiazide


• Metolazone


• Nadroparin


• Olmesartan Medoxomil


• Parnaparin


• Phenindione


• Phenprocoumon


• Piretanide


• Polythiazide


• Probenecid


• Reviparin


• Tamarind


• Tasosartan


• Telmisartan


• Tinzaparin


• Torsemide


• Trichlormethiazide


• Valsartan


• Warfarin


• Xipamide

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood vessel disease

• Diabetes mellitus (sugar diabetes)—Use of this medicine may cause severe redness or ulceration, especially on the hands or feet

• Inflammation, irritation, or infection of the skin—Use of this medicine may cause severe irritation if applied to inflamed, irritated, or infected area of the skin

• Influenza (flu) or


• Varicella (chicken pox)—This medicine should not be used in children and teenagers with the flu or chicken pox. There is a risk of Reye's syndrome.

• Kidney disease or


• Liver disease—Using this medicine for a long time over large areas could result in unwanted effects

Proper Use of salicylic acid

This section provides information on the proper use of a number of products that contain salicylic acid. It may not be specific to Compound W One-Step Wart Remover. Please read with care.

It is very important that you use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for a longer time than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of absorption through the skin and the chance of salicylic acid poisoning.

If your doctor has ordered an occlusive dressing (airtight covering, such as kitchen plastic wrap) to be applied over this medicine, make sure you know how to apply it. Since an occlusive dressing will increase the amount of medicine absorbed through your skin and the possibility of salicylic acid poisoning, use it only as directed. If you have any questions about this, check with your doctor.

Keep this medicine away from the eyes and other mucous membranes, such as the mouth and inside of the nose. If you should accidentally get some in your eyes or on other mucous membranes, immediately flush them with water for 15 minutes.

To use the cream, lotion, or ointment form of salicylic acid:

• Apply enough medicine to cover the affected area, and rub in gently.

To use the gel form of salicylic acid:

• Before using salicylic acid gel, apply wet packs to the affected areas for at least 5 minutes. If you have any questions about this, check with your health care professional.


• Apply enough gel to cover the affected areas, and rub in gently.

To use the pad form of salicylic acid:

• Wipe the pad over the affected areas.


• Do not rinse off medicine after treatment.

To use the plaster form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Cut the plaster to fit the wart, corn, or callus and apply.


• For corns and calluses:
  
  • Repeat every 48 hours as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.
  
  
  • Corns or calluses may be soaked in warm water for 5 minutes to help in their removal.
  
  


• For warts:
  
  • Depending on the product, either:
    
    • Apply plaster and repeat every 48 hours as needed, or
      
      • Apply plaster at bedtime, leave in place for at least 8 hours, remove plaster in the morning, and repeat every 24 hours as needed.
      
      
    
    
  
  
  • Repeat for up to 12 weeks as needed, or as directed by your doctor, until wart is removed.
  
  


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

To use the shampoo form of salicylic acid:

• Before applying this medicine, wet the hair and scalp with lukewarm water. Apply enough medicine to work up a lather and rub well into the scalp for 2 or 3 minutes, then rinse. Apply the medicine again and rinse thoroughly.

To use the soap form of salicylic acid:

• Work up a lather with the soap, using hot water, and scrub the entire affected area with a washcloth or facial sponge or mitt.


• If you are to use this soap in a foot bath, work up rich suds in hot water and soak the feet for 10 to 15 minutes. Then pat dry without rinsing.

To use the topical solution form of salicylic acid for acne:

• Wet a cotton ball or pad with the topical solution and wipe the affected areas.


• Do not rinse off medicine after treatment.

To use the topical solution form of salicylic acid for warts, corns, or calluses:

• This medicine comes with patient instructions. Read them carefully before using.


• This medicine is flammable. Do not use it near heat or open flame or while smoking.


• Do not use this medicine on irritated skin or on any area that is infected or reddened. Also, do not use this medicine if you are a diabetic or if you have poor blood circulation.


• Do not use this medicine on warts with hair growing from them or on warts on the face, in or on the genital (sex) organs, or inside the nose or mouth. Also do not use on moles or birthmarks. To do so may cause severe irritation.


• Avoid breathing in the vapors from the medicine.


• Wash the area to be treated and dry thoroughly. Warts may be soaked in warm water for 5 minutes before drying.


• Apply the medicine one drop at a time to completely cover each wart, corn, or callus. Let dry.


• For warts—Repeat one or two times a day as needed for up to 12 weeks, or as directed by your doctor, until wart is removed.


• For corns and calluses—Repeat one or two times a day as needed for up to 14 days, or as directed by your doctor, until the corn or callus is removed.


• Corns and calluses may be soaked in warm water for 5 minutes to help in their removal.


• If discomfort gets worse during treatment or continues after treatment, or if the wart spreads, check with your doctor.

Unless your hands are being treated, wash them immediately after applying this medicine to remove any medicine that may be on them.

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 cream dosage form:
  
  • For corns and calluses:
    
    • Adults and children—Use the 2 to 10% cream as needed. Use the 25 to 60% cream one time every three to five days.
    
    
  
  


• For gel dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 5% gel one time a day.
    
    
  
  
  • For psoriasis:
    
    • Adults and children—Use the 5% gel one time a day.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 5 to 26% gel one time a day.
    
    
  
  


• For lotion dosage form:
  
  • For acne:
    
    • Adults and children—Use the 1 to 2% lotion one to three times a day.
    
    
  
  
  • For dandruff and antiseborrhic dermatitis of the scalp:
    
    • Adults and children—Use the 1.8 to 2% lotion on the scalp one or two times a day.
    
    
  
  


• For ointment dosage form:
  
  • For acne:
    
    • Adults and children—Use the 3 to 6% ointment as needed.
    
    
  
  
  • For psoriasis and seborrheic dermatitis:
    
    • Adults and children—Use the 3 to 10% ointment as needed.
    
    
  
  
  • For common warts:
    
    • Adults and children—Use the 3 to 10% ointment as needed. Use the 25 to 60% ointment one time every three to five days.
    
    
  
  


• For pads dosage form:
  
  • For acne:
    
    • Adults and children—Use one to three times a day.
    
    
  
  


• For plaster dosage form:
  
  • For corns, calluses, common warts, or plantar warts:
    
    • Adults and children—Use one time a day or one time every other day.
    
    
  
  


• For shampoo dosage form:
  
  • For dandruff or seborrheic dermatitis of the scalp:
    
    • Adults and children—Use on the scalp one or two times a week.
    
    
  
  


• For soap dosage form:
  
  • For acne:
    
    • Adults and children—Use as needed.
    
    
  
  


• For topical solution dosage form:
  
  • For acne:
    
    • Adults and children—Use the 0.5 to 2% topical solution one to three times a day.
    
    
  
  
  • For common warts and plantar warts:
    
    • Adults and children—Use the 5 to 27% topical solution one or two times a day.
    
    
  
  
  • For corns and calluses:
    
    • Adults and children—Use the 12 to 27% topical solution one or two times a day.
    
    
  
  

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.

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 Compound W One-Step Wart Remover

When using salicylic acid, do not use any of the following preparations on the same affected area as this medicine, unless otherwise directed by your doctor:

• Abrasive soaps or cleansers


• Alcohol-containing preparations


• Any other topical acne preparation or preparation containing a peeling agent (for example, benzoyl peroxide, resorcinol, sulfur, or tretinoin [vitamin A acid])


• Cosmetics or soaps that dry the skin


• Medicated cosmetics


• Other topical medicine for the skin

To use any of the above preparations on the same affected area as salicylic acid may cause severe irritation of the skin.

Check with your doctor right away if you have nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy hyperpnea, diarrhea, and psychic disturbances. These could be symptoms of a serious condition called salicylate toxicity, especially in children under 12 years of age and patients with kidney or liver problems.

Compound W One-Step Wart Remover Side Effects

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

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

Less common or rare

• Skin irritation not present before use of this medicine (moderate or severe)

Frequency not known

• Dryness and peeling of skin


• flushing


• redness of skin


• unusually warm skin

Symptoms of salicylic acid poisoning

• Confusion


• diarrhea


• dizziness


• fast or deep breathing


• headache (severe or continuing)


• hearing loss


• lightheadedness


• nausea


• rapid breathing


• ringing or buzzing in ears (continuing)


• severe drowsiness


• stomach pain


• vomiting

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

More common

• Skin irritation not present before use of this medicine (mild)


• stinging

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

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

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

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

More Compound W One-Step Wart Remover Topical resources

• Compound W One-Step Wart Remover Topical Use in Pregnancy & Breastfeeding
• Compound W One-Step Wart Remover Topical Drug Interactions
• Compound W One-Step Wart Remover Topical Support Group
• 0 Reviews for Compound W One-Step Wart Remover Topical - Add your own review/rating

Compare Compound W One-Step Wart Remover Topical with other medications

• Acne
• Warts

Compro rectal

Generic Name: prochlorperazine (rectal) (pro klor PER a zeen)

Brand Names: Compro

What is rectal prochlorperazine?

Prochlorperazine is in a group of drugs called phenothiazines (FEEN-oh-THYE-a-zeens). It works by changing the actions of chemicals in your brain.

Prochlorperazine is used to treat psychotic disorders such as schizophrenia. It is also used to treat anxiety, and to control severe nausea and vomiting.

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

What is the most important information I should know about rectal prochlorperazine?

Stop using this medication and call your doctor at once if you have twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs. These could be early signs of dangerous side effects. Do not use prochlorperazine if you have brain damage, bone marrow depression, or are using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to prochlorperazine or other phenothiazines.

Before using prochlorperazine, tell your doctor about all your medical conditions, and all other medications you use.

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Treatments for depression are getting better everyday and there are things you can start doing right away.

What should I discuss with my healthcare provider before using rectal prochlorperazine?

Prochlorperazine is not for use in psychotic conditions related to dementia. Prochlorperazine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use prochlorperazine if you have brain damage, bone marrow depression, or are also using large amounts of alcohol or medicines that make you sleepy. Do not use if you are allergic to prochlorperazine or other phenothiazines such as chlorpromazine (Thorazine), promethazine (Adgan, Pentazine, Phenergan), and others.

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

• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• liver or kidney disease;


• 
  

  severe asthma, emphysema, or other breathing problem;

  
  


• 
  

  a history of seizures;

  
  


• 
  

  adrenal gland tumor (pheochromocytoma);

  
  


• 
  

  Parkinson's disease;

  
  


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  a bone marrow disease;

  
  


• 
  

  an infectious disease such as chickenpox, measles, stomach flu, or an infection of the central nervous system;

  
  


• 
  

  past or present breast cancer; or

  
  


• 
  

  low levels of calcium in your blood (hypocalcemia).

  
  

Tell your doctor if you will be exposed to extreme heat or to insecticide poisons while you are using prochlorperazine.

It is not known whether prochlorperazine will harm an unborn baby. Prochlorperazine may cause side effects in a newborn if the mother uses the medication during pregnancy. Before using this medication, tell your doctor if you are pregnant. Prochlorperazine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Talk with your doctor before giving this medication to a child who has been ill with a fever or flu symptoms. Prochlorperazine is not for use in children younger than 2 years old or weighing less than 20 pounds.

How should I use rectal prochlorperazine?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Do not take rectal prochlorperazine by mouth.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. You may wet the suppository with a small amount of water to make it easier to insert. Gently insert the suppository into the rectum, pointed tip first. The suppository will begin to melt once inserted.

If you need to have an x-ray or CT scan of your spinal column using a dye that is injected into a vein, you may need to temporarily stop using prochlorperazine. Be sure the doctor knows ahead of time that you are using this medication.

Do not stop using prochlorperazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms.

Store prochlorperazine at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose can cause dry mouth, constipation, bloating or stomach cramps, extreme drowsiness or feeling restless and agitated, changes in heart rate, fever, and fainting.

What should I avoid while using rectal prochlorperazine?

Prochlorperazine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid drinking alcohol. It can increase some of the side effects of prochlorperazine. Avoid exposure to sunlight or tanning beds. Prochlorperazine can make your skin more sensitive to sunlight. Wear sunscreen (SPF 15 or higher) and protective clothing when you are outdoors.

Rectal prochlorperazine 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 prochlorperazine and call your doctor at once if you have a serious side effect such as:

• 
  

  twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  
  


• 
  

  tremor (uncontrolled shaking), drooling, trouble swallowing, problems with balance or walking;

  
  


• 
  

  high fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, rapid breathing;

  
  


• 
  

  fainting, seizure (black-out or convulsions);

  
  


• 
  

  decreased night vision, tunnel vision, watery eyes, increased sensitivity to light;

  
  


• 
  

  nausea and stomach pain, skin rash, and jaundice (yellowing of the skin or eyes);

  
  


• 
  

  pale skin, easy bruising or bleeding, fever, sore throat, flu symptoms;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  joint pain or swelling with fever, swollen glands, muscle aches, chest pain, vomiting, unusual thoughts or behavior, and patchy skin color; or

  
  


• 
  

  slow heart rate, weak pulse, fainting, slow breathing (breathing may stop).

  
  

Less serious side effects may include:

• 
  

  dizziness, drowsiness, anxiety, headache;

  
  


• 
  

  sleep problems (insomnia), strange dreams;

  
  


• 
  

  blurred vision, dry mouth, stuffy nose;

  
  


• 
  

  constipation;

  
  


• 
  

  breast swelling or discharge, a missed menstrual period;

  
  


• 
  

  ;

  
  


• 
  

  weight gain, swelling in your hands or feet;

  
  


• 
  

  impotence, trouble having an orgasm; or

  
  


• 
  

  mild itching or skin rash.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect rectal prochlorperazine?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can interact with prochlorperazine and cause medical problems or increase side effects. Tell your doctor if you regularly use any of these medicines, or any other anti-psychotic medications.

Also tell your doctor if you are taking any of the following medicines:

• 
  

  atropine (Atreza, Sal-Tropine);

  
  


• 
  

  lithium (Eskalith, Lithobid);

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  an antibiotic;

  
  


• 
  

  birth control pills or hormone replacement estrogens;

  
  


• 
  

  blood pressure medication;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  certain asthma medications or bronchodilators;

  
  


• 
  

  drugs to treat a prostate disorder;

  
  


• 
  

  incontinence medications;

  
  


• 
  

  insulin or diabetes medications you take by mouth;

  
  


• 
  

  medication for nausea, vomiting, or motion sickness;

  
  


• 
  

  medications to treat or prevent malaria;

  
  


• 
  

  medicines used to prevent organ transplant rejection;

  
  


• 
  

  numbing medicine such as lidocaine or Novocain, medications used for general anesthesia;

  
  


• 
  

  a stimulant or ADHD medication;

  
  


• 
  

  ulcer or irritable bowel medications; or

  
  


• 
  

  medicines to treat Parkinson's disease, restless leg syndrome, or pituitary gland tumor (prolactinoma).

  
  

This list is not complete and there are many other medicines that can interact with prochlorperazine. 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. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More Compro resources

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

Compare Compro with other medications

• Anxiety
• Hiccups
• Nausea/Vomiting
• Psychosis

Where can I get more information?

• Your pharmacist can provide more information about rectal prochlorperazine.

See also: Compro side effects (in more detail)

Carbon Dioxide

Dosage Form: gas
Carbon Dioxide, LIQUID USP Carbon Dioxide, REFRIGERATED LIQUID U.S.P.

UN2187

DO NOT REMOVE THIS PRODUCT LABEL

ROBERTS OXYGEN COMPANY, INC. ROCKVILLE, MD. 20855 301-948-8100

Rx Only. WARNING: Administration of Carbon Dioxide may be hazardous or contraindicated.  For use only by or under the supervision of a licensed practitioner who is experienced in the use and administration of Carbon Dioxide and is familiar with the indications, effects, dosages, methods and frequency and duration of administration, and with the hazards, contraindications and side effects and the precautions to be taken.  WARNING: COLD LIQUID AND GAS UNDER PRESSURE. CAN CAUSE RAPID SUFFOCATION.  CAN INCREASE RESPIRATION AND HEART RATE.  MAY CAUSE FROSTBITE.  ALWAYS KEEP CONTAINER IN UPRIGHT POSITION.  AVOID BREATHING GAS.  STORE AND USE WITH ADEQUATE VENTILATION.  DO NOT GET LIQUID IN EYES, ON SKIN OR CLOTHING.  FOR LIQUID WITHDRAWAL, WEAR FACE SHIELD AND GLOVES.  DO NOT DROP.  USE HAND TRUCK FOR CYLINDER MOVEMENT.  CLOSE VALVE AFTER EACH USE AND WHEN EMPTY.  CONTAINER TEMPERATURE SHOULD NOT EXCEED 52C (125F).  USE BACKFLOW PREVENTATIVE DEVICE IN THE PIPING.  DO NOT CHANGE OR FORCE FIT CONNECTIONS.  USE IN ACCORDANCE WITH MSDS AND CGA PAMPHLETS P-1 AND P-2.

FIRST AID:  IF INHALED, remove to fresh air.  If not breathing, give artificial respiration.  If breathing is difficult, give oxygen.  Call a physician.  IN CASE OF FROSTBITE, obtain medical treatment immediately.

Carbon Dioxide  Carbon Dioxide  gas

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 46123-042 Route of Administration RESPIRATORY (INHALATION) DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Carbon Dioxide (Carbon Dioxide) Carbon Dioxide 990 mL  in 1 L

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46123-042-01 95042 L In 1 DEWAR None 2 46123-042-02 113365 L In 1 DEWAR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved medical gas		11/01/2011

Labeler - Roberts Oxygen Company, Inc. (042646877)

Revised: 12/2011Roberts Oxygen Company, Inc.

cisapride

Generic Name: cisapride (SISS a pride)

Brand names: Propulsid

What is cisapride?

Cisapride increases the rate at which your esophagus, stomach, and intestines move during digestion. It also increases the rate at which your stomach empties into your intestines and increases the strength of your lower esophageal sphincter (the muscle between your stomach and your esophagus).

Cisapride is used to treat gastric reflux (the regurgitation of stomach acid into the esophagus), which is usually experienced as heartburn.

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

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

You should not take cisapride if you are allergic to it, or if you have bleeding or an obstruction in your stomach, heart disease or hardening of the arteries, congestive heart failure, slow heart rate or a heart rhythm disorder, a personal or family history of "Long QT syndrome," a structural heart defect, heart block or other conduction disorders, severe dehydration, malnutrition, an eating disorder, kidney failure, or severe lung problems or advanced cancer. There are many other drugs that can cause serious or life-threatening medical problems if you take them together with cisapride. The following drugs should not be used while you are taking cisapride: Drinking alcohol can increase certain side effects of cisapride. Do not consume grapefruit or grapefruit juice while taking cisapride. Grapefruit products may increase amount of cisapride available in your body, which could lead to dangerous side effects.

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

You should not use cisapride if you are allergic to it, or if you have:

• 
  

  bleeding or obstruction in your stomach;

  
  


• 
  

  heart disease or hardening of the arteries;

  
  


• 
  

  congestive heart failure;

  
  


• 
  

  slow heart rate or a heart rhythm disorder;

  
  


• 
  

  a personal or family history of "Long QT syndrome";

  
  


• 
  

  a structural heart defect;

  
  


• 
  

  heart block or other conduction disorders;

  
  


• 
  

  severe dehydration, malnutrition, an eating disorder;

  
  


• kidney failure; or


• 
  

  severe lung problems or advanced cancer.

  
  

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

• 
  

  antibiotics such as clarithromycin (Biaxin), erythromycin (Ery-Tab, E.E.S., E-Mycin, others);

  
  


• 
  

  antidepressants such as amitriptyline (Elavil, Vanatrip) or nefazodone (Serzone);

  
  


• 
  

  antifungal medications such as fluconazole (Diflucan), itraconazole (Sporanox), and ketoconazole (Extina, Ketozole, Nizoral, Xolegal);

  
  


• 
  

  phenothiazines such as prochlorperazine (Compazine, others) and promethazine (Phenergan, others);

  
  


• 
  

  heart medications such as procainamide (Procan SR, Procanbid, Pronestyl) and quinidine (Quin-G); or

  
  


• 
  

  HIV medications such as indinavir (Crixivan) and ritonavir (Norvir, Kaletra).

  
  

To make sure you can safely take cisapride, tell your doctor if you have kidney or liver disease.

FDA pregnancy category C. It is not known whether cisapride will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Cisapride can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take cisapride?

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.

Shake the oral suspension (liquid) well just before you measure a dose. Measure the liquid with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Cisapride is usually taken four times a day, at least 15 minutes before meals and at bedtime. Follow your doctor's instructions.

Store at room temperature away from moisture and heat.

See also: Cisapride dosage (in more detail)

What happens if I miss a dose?

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

What happens if I overdose?

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

Overdose symptoms may include nausea, vomiting, rumbling noises in the stomach, flatulence, diarrhea, urinary frequency, tremors, seizures, and weakness.

What should I avoid while taking cisapride?

Do not consume grapefruit or grapefruit juice while taking cisapride. Grapefruit products may increase amount of cisapride available in your body, which could lead to dangerous side effects. Drinking alcohol can increase certain side effects of cisapride.

Cisapride side effects

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

• 
  

  fast or irregular heartbeats; or

  
  


• 
  

  feeling like you might pass out.

  
  

Less serious side effects may include:

• 
  

  stomach pain, nausea, diarrhea; or

  
  


• 
  

  increased urination.

  
  

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.

Cisapride Dosing Information

Usual Adult Dose for Gastroesophageal Reflux Disease:

10 mg orally 4 times a day 15 minutes before meals and at bedtime.
May be increased to 20 mg per dose if necessary.

Usual Adult Dose for Gastroparesis:

10 mg orally 4 times a day 15 minutes before meals and at bedtime.
May be increased to 20 mg per dose if necessary.

Usual Adult Dose for Dyspepsia:

5 mg orally 3 times a day 15 minutes before meals.
May be increased to 10 mg per dose if necessary.

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

>1 year: 0.2 to 0.3 mg/kg/dose orally 3 to 4 times a day.
Maximum: 10 mg per dose.

What other drugs will affect cisapride?

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

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

• 
  

  belladonna (Donnatal);

  
  


• 
  

  cimetidine (Tagamet, Tagamet HB)

  
  


• 
  

  dicyclomine (Bentyl);

  
  


• 
  

  clidinium (Quarzan);

  
  


• 
  

  hyoscyamine (Levsin, Cystospaz, Anaspaz);

  
  


• 
  

  propantheline (Pro-Banthine); or

  
  


• 
  

  a blood thinner such as warfarin (Coumadin).

  
  

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

More cisapride resources

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

• cisapride Advanced Consumer (Micromedex) - Includes Dosage Information


• Propulsid Prescribing Information (FDA)

Compare cisapride with other medications

• Gastroparesis
• GERD
• Indigestion

Where can I get more information?

• Your pharmacist can provide more information about cisapride.

See also: cisapride side effects (in more detail)

CIS-MDP

Dosage Form: injection

DIAGNOSTIC FOR INTRAVENOUS USE

Rx Only

Description

CIS-MDP™  Kit for the Preparation of Technetium Tc 99m Medronate is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Medronate Injection for diagnostic use by Intravenous injection.

Each 10mL multidose vial contains:

Medronic acid: 20 mg

Ascorbic acid: 1 mg

Stannous fluoride, SnF2: 0.13 mg (minimum)

Total tin (maximum, as stannous fluoride, SnF2): 0.38 mg

The pH is adjusted to 6.5 (6.3 to 6.7) with sodium hydroxide and/or hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present in the vial. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The structural formula is:

When a solution of sterile, non-pyrogenic, oxidant-free Sodium Pertechnetate Tc 99m Injection is added to the vial, the diagnostic agent, Technetium Tc 99m Medronate is formed for administration by intravenous injection. The pH of the reconstituted product is 5.4 to 6.8. The precise structure of Technetium Tc 99m Medronate Injection is not known at this time.

PHYSICAL CHARACTERISTICS:

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours1. The principal photon that is useful for detection and imaging studies is listed in Table 1.

TABLE 1 Principal Radiation Emission Data

Radiation	Mean % per Disintegration	Mean Energy (keV)
Gamma-2	89.07	140.5

1

Kocher, DC: Radioactive Decay Data Tables, DOE/TIC-11026, 108, 1981.

EXTERNAL RADIATION:

The specific gamma ray constant for Tc 99m is 0.78 R/millicurie-hr at 1 cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of the various thicknesses of Pb is shown in Table 2. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

TABLE 2 Radiation Attenuation by Lead Shielding

Shield Thickness (Pb) cm	Coefficient of Attenuation
0.017	0.5
0.08	10-1
0.16	10-2
0.25	10-3
0.33	10-4

 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

TABLE 3 Physical Decay Chart: Tc 99m, Half-Life 6.02 Hours

* Calibration Time
Hours	Fraction Remaining	Hours	Fraction Remaining
0*	1.000	7	0.447
1	0.891	8	0.398
2	0.794	9	0.355
3	0.708	10	0.316
4	0.631	11	0.282
5	0.562	12	0.251
6	0.501

Clinical Pharmacology

During the initial 24 hours following intravenous injection of Technetium Tc 99m Medronate, about 50% of each dose is retained in the skeleton, and about 50% is excreted in the urine. Upon intravenous injection, Technetium Tc 99m Medronate exhibits a specific affinity for areas of altered osteogenesis. In humans, blood levels fall to 4 to 10% of the injected dose by two hours post-injection and to 3 to 5% by three hours.

Uptake of Technetium Tc 99m Medronate Injection in bone appears to be related to osteogenic activity and to skeletal blood perfusion. The deposition in the skeleton is bilaterally symmetrical, with increased accumulation in the axial structure as compared to the appendicular skeleton. There is increased activity in the distal aspect on long bones as compared to the diaphyses.

Indications and Usage

Technetium Tc 99m Medronate Injection may be used as a bone imaging agent to delineate areas of altered osteogenesis.

Contraindications

None known.

Warnings

This class of compounds is known to complex cations such as calcium. Particular caution should be used with patients who have, or may be predisposed to hypocalcemia (i.e., alkalosis).

Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc 99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false-positive or false-negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternatively, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.

Precautions

General

Contents of the vial are intended only for use in the preparation of Technetium Tc 99m Medronate Injection and are NOT to be administered directly to the patient.

Technetium Tc 99m Medronate Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patient and clinical personnel consistent with proper patient management.

To minimize radiation dose to the bladder, the patients should be encouraged to drink fluids and to void immediately before the examination and as often thereafter as possible for the next 4 to 6 hours.

Technetium Tc 99m Medronate Injection should be formulated within six (6) hours prior to clinical use. Optimal imaging results are obtained 1 to 4 hours after administration.

The finding of an abnormal concentration of radioactivity implies the existence of underlying pathology, but further study is required to distinguish benign from malignant lesions.

The image quality may be adversely affected by obesity, old age, or impaired renal function.

The components of the kit are sterile and non-pyrogenic. It is essential to follow directions carefully and to adhere to strict aseptic procedures during preparation. Technetium Tc 99m labeling reactions involved depend on maintaining the stannous ion in the reduced state. Hence, Sodium Pertechnetate Tc 99m Injection containing oxidants should not be used.

The preparation contains no bacteriostatic preservative. Technetium Tc 99m Medronate Injection should be stored at 20-25ºC (68-77ºF) and discarded 6 hours after reconstitution. The solution should not be used if the contents are cloudy.

Vials are sealed under nitrogen: air or oxygen is harmful to the contents of the vials and the vials should not be vented.

The components of the CIS-MDP are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals for sterile, non-pyrogenic containers should be used during addition of the pertechnetate solution and the withdrawal of doses for patient administration.

Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection.

No special handling is required for the non-radioactive drug product.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Medronate Injection affects fertility in males or females. Mutagenesis studies have not been conducted.

Pregnancy

Category C

Animal reproduction and teratogenicity studies have not been conducted on Technetium Tc 99m Medronate Injection. It is also not known whether Technetium Tc 99m Medronate Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Technetium Tc 99m Medronate Injection should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, on a woman of childbearing capability, should be performed during the first few (approximately 10) days following the onset of menses.

Nursing mothers

Technetium Tc 99m Medronate Injection is excreted in human milk during lactation; therefore, formula feeding should be substituted for breast feeding.

Pediatric Use

Safety and effectiveness in pediatric subjects have not been established.

Adverse Reactions

Several adverse reactions due to Technetium Tc 99m Medronate Injection have been reported. These were usually hypersensitivity reactions characterized by itching, various skin rashes, hypotension, chills, nausea and vomiting. There have also been rare cases of dizziness and asthenia associated with the use of Technetium Tc 99m Medronate.

Dosage and Administration

Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection.

After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is:

370-740 megabecquerels: (10-20 millicuries) given intravenously.

Imaging is optimal at 1 to 4 hours post Injection.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Radiation Dosimetry

The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate Injection are shown in Table 4.

TABLE4 Estimated Absorbed Radiation Dose* Technetium Tc 99m Medronate

* Method of calculation: “S” Absorbed Dose Per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No 11 (1975)
Organ		(MGy/740 MBq)	(Rads / 20 mCi)
Total Body		1.3	0.13
Bone Total		7.0	0.70
Red Marrow		5.6	0.56
Kidneys		8.0	0.80
Liver		0.6	0.06
Bladder Wall	2 hour void	26	2.60
	4.8 hour void	62	6.20
Ovaries	2 hour void	2.4	0.24
	4.8 hour void	3.4	0.34
Testes	2 hour void	1.6	0.16
	4.8 hour void	2.2	0.22

How is CIS-MDP Supplied

 The CIS-MDP Kit for the Preparation of Technetium Tc 99m Medronate Injection is supplied in kits of five (5) or thirty (30) sterile, non-pyrogenic vials. Each 10 mL multidose vial contains 20 mg medronic acid, 1 mg ascorbic acid, 0.13 mg minimum stannous fluoride (SnF2) and 0.38 mg maximum total tin, as stannous fluoride, SnF2 in lyophilized form. The pH is adjusted with sodium hydroxide and/or hydrochloric acid prior to lyophilization. The vial does not contain a preservative. The contents of the vial are lyophilized and sealed under nitrogen at the time of manufacture. The pH of the reconstituted product is 5.4 to 6.8.

Kit Contents

Included in each five (5) vial kit is one (1) package insert and ten (10) radiation labels. Included in each thirty (30) vial kit is one (1) package insert and sixty (60) radiation labels.

Storage

Store the product as supplied at 20-25°C (68-77°F) [See USP]. After reconstitution store at 20-25°C (68-77°F) [See USP] (see DOSAGE AND ADMINISTRATION).

DIRECTIONS FOR PREPARATION OF TECHNETIUM Tc 99m MEDRONATE INJECTION:

Procedural Precautions

The lyophilized powder in the reaction vial is sterile and non-pyrogenic and does not contain a preservative. Shielded syringes and aseptic procedures normally employed in making additions and withdrawals from sterile, non-pyrogenic containers should be used during addition of pertechnetate solution to the reaction vial and the withdrawal of doses for patient administration.

If sodium pertechnetate Tc 99m must be diluted prior to injection into the reaction vial, only Sodium Chloride Injection USP 0.9% (without preservatives) should be used.

Technetium Tc 99m Medronate Injection is prepared from CIS-MDP  by the following aseptic procedure:

1. Waterproof gloves should be worn during the preparation procedure. Remove the plastic disk from the vial and swab the top of the vial closure with alcohol to sanitize the surface.


2. Complete the radiation label and affix to the vial. Place the reaction vial in a suitable radiation shield.


3. With a sterile, shielded syringe aseptically obtain 0.5-5 mL, of a suitable, oxidant-free, sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection containing no more than 18.5 gigabecquerels (500 millicuries). Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial. Be sure to maintain a nitrogen atmosphere in the vial by not introducing air during reconstitution.


4. Swirl the contents of the vial for one minute, and let stand for at least 10 minutes.


5. Record time and date of preparation.


6. The radiochemical purity of the prepared radiopharmaceutical should be checked prior to patient administration.


7. Examine vial contents for particulates and discoloration prior to injection. Do not use if solution is cloudy.


8. Withdrawals for administration must be made aseptically using a sterile shielded syringe and needle. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.


9. Use within six (6) hours of preparation. For optimum results, this time should be minimized. The vial contains no bacteriostatic preservative. After reconstitution store at 20-25°C (68-77°F)[See USP].


10. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

NDC# 045567-0040-1 (5 vial pack)

NDC# 045567-0040-2 (30 vial pack)

This reagent kit for the preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.533, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

RM 2M-027

04/05

CIS-US, Inc.

10 DeAngelo Drive

Bedford, MA 01730

718-275-7129

CIS-MDP  medronate disodium  injection, powder, lyophilized, for solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 45567-0040 Route of Administration INTRAVENOUS DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength medronate disodium (medronic acid) Active 20 MILLIGRAM  In 1 VIAL ascorbic acid Inactive 1 MILLIGRAM  In 1  stannous flouride Inactive 0.13 MILLIGRAM  In 1 VIAL

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 45567-0040-1 5 VIAL In 1 KIT contains a VIAL, GLASS 1 1 VIAL In 1 VIAL, GLASS This package is contained within the KIT (45567-0040-1) 2 45567-0040-2 30 VIAL In 1 KIT contains a VIAL, GLASS 2 1 VIAL In 1 VIAL, GLASS This package is contained within the KIT (45567-0040-2)

Revised: 10/2006CIS-US, Inc.

More CIS-MDP resources

• CIS-MDP Support Group
• 0 Reviews · Be the first to review/rate this drug

Cabazitaxel

Class: Antineoplastic Agents
VA Class: AN900
Chemical Name: (2α,5β,7β,10β,13α) - 4 - acetoxy - 13 - ({(2R,3S) - 3 - [(terbutoxycarbonyl) - amino] - 2 - hydroxy - 3 - phenylpropanoyl} - oxy) - 1 - hydroxy - 7,10 - dimethoxy - 9 - oxo - 5,20 - epoxytax - 11 - en - 2 - yl - benzoate–propan - 2 - one (1:1)
Molecular Formula: C₄₅H₅₇NO₁₄
CAS Number: 183133-96-2
Brands: Jevtana

• Fatal Neutropenia


• 
  

  Risk of neutropenia-related death.¹ Do not administer to patients with neutrophil counts ≤1500/mm³.¹ Obtain frequent blood cell counts to monitor for neutropenia.¹ (See Neutropenia under Cautions.)

  
  

• Severe Hypersensitivity Reactions


• 
  

  Severe hypersensitivity reactions (hypotension, bronchospasm, generalized rash/erythema) reported;¹ if severe hypersensitivity reaction occurs, immediately discontinue infusion and administer appropriate supportive treatment.¹ (See Sensitivity Reactions under Cautions.)

  
  


• 
  

  Contraindicated in patients with a history of severe hypersensitivity reactions to cabazitaxel or to drugs containing polysorbate 80.¹

  
  

Introduction

Semisynthetic taxoid; an antineoplastic agent.^{1 13}

Uses for Cabazitaxel

Prostate Cancer

Used in combination with prednisone for the treatment of hormone-refractory metastatic prostate cancer in patients whose disease has progressed following prior treatment with docetaxel-based therapy.^{1 2 3 4} Regimen improved overall survival compared with mitoxantrone and prednisone.^{1 2}

Cabazitaxel Dosage and Administration

General

• 
  

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

  
  

Premedication

• 
  

  Administer an IV antihistamine (diphenhydramine hydrochloride 25 mg or equivalent), IV histamine H₂-receptor antagonist (ranitidine 50 mg or equivalent [except cimetidine]), and IV corticosteroid (dexamethasone 8 mg or equivalent) at least 30 minutes prior to each cabazitaxel infusion to minimize risk and/or severity of hypersensitivity reactions.^{1 2 5}

  
  


• 
  

  Antiemetic prophylaxis (orally or IV as needed) is recommended.¹

  
  

Administration

IV Administration

For solution compatibility information, see Compatibility under Stability.

Administer by IV infusion.¹

Handle cautiously; use protective equipment (e.g., gloves) to minimize risk of dermal exposure.¹ Immediately treat accidental contact by thoroughly washing skin with soap and water and thoroughly flushing mucous membranes with water.¹

Cabazitaxel injection concentrate must be diluted prior to IV infusion.¹

Diluted cabazitaxel solutions are supersaturated and may crystallize over time.¹ Administer infusion solution through a 0.22-μm in-line filter.¹

Solution should be at room temperature for administration.¹

Do not use PVC containers or polyurethane administration sets during preparation or administration.^{1 5 7} Cabazitaxel injection concentrate contains polysorbate 80, which can cause leaching of diethylhexyl phthalate (DEHP) from PVC containers.^{1 7}

Dilution

Cabazitaxel injection concentrate requires 2 dilutions prior to administration.¹

First dilution step: Transfer entire contents of the diluent vial (approximately 5.7 mL of 13% [w/w] ethanol in water for injection) to a vial containing cabazitaxel 60 mg in 1.5 mL to produce a solution containing 10 mg/mL.¹ Direct diluent toward wall of vial and inject slowly to minimize foaming.¹

Mix injection concentrate and diluent by repeated inversions for ≥45 seconds; do not shake.¹ Let solution stand for a few minutes to allow any foam to dissipate; all foam does not have to dissipate to continue preparation.¹ Use initial diluted solution within 30 minutes of preparation.¹

Second dilution step: Withdraw the appropriate dose and inject into a 250-mL non-PVC infusion bag or bottle containing 0.9% sodium chloride or 5% dextrose injection to produce a final cabazitaxel concentration of 0.1–0.26 mg/mL.¹ If the required dose exceeds 65 mg, increase the volume of IV solution accordingly so that the concentration does not exceed 0.26 mg/mL.¹ Mix thoroughly by gently inverting the bag or bottle.¹

Use the final diluted solution within 8 hours (including 1 hour for administration) if stored at room temperature or within 24 hours (including 1 hour for administration) if stored under refrigeration.¹

Do not admix with other drugs.¹

Discard any unused portions.¹

Rate of Administration

Administer over 1 hour.¹

Dosage

Adults

Prostate Cancer

IV

25 mg/m² every 3 weeks in combination with oral prednisone (10 mg daily).^{1 2}

In clinical trial, treatment duration was limited to 10 cycles.^{2 3 5}

Dosage Modification for Toxicity

Dosage Modification for Severe Prolonged Neutropenia

Monitor CBC weekly during the first cycle of therapy and prior to each treatment cycle thereafter.¹

If severe prolonged neutropenia (grade 3 or greater neutropenia lasting >1 week) occurs despite appropriate use of a granulocyte colony-stimulating factor (G-CSF) (e.g., filgrastim, pegfilgrastim), interrupt cabazitaxel therapy until the neutrophil count is >1500/mm³; upon resumption of therapy, reduce dosage to 20 mg/m² every 3 weeks.¹

Manufacturer recommends secondary prophylaxis with G-CSF in patients who have experienced severe prolonged neutropenia.¹

Discontinue cabazitaxel if severe prolonged neutropenia recurs following dosage reduction to 20 mg/m² every 3 weeks.¹

Dosage Modification for Febrile Neutropenia

Monitor CBC weekly during the first cycle of therapy and prior to each treatment cycle thereafter.¹

If febrile neutropenia occurs, interrupt cabazitaxel therapy until improvement or resolution occurs and neutrophil count is >1500/mm³; upon resumption of therapy, reduce dosage to 20 mg/m² every 3 weeks.¹

Manufacturer recommends secondary prophylaxis with G-CSF in patients who have experienced an episode of febrile neutropenia.¹

Discontinue cabazitaxel if febrile neutropenia recurs following dosage reduction to 20 mg/m² every 3 weeks.¹

Dosage Modification for Diarrhea

If severe diarrhea (grade 3 or greater) or persistent diarrhea occurs despite appropriate medical therapy (e.g., antidiarrheals, fluid and electrolyte replacement), interrupt cabazitaxel therapy until the diarrhea improves or resolves; upon resumption of therapy, reduce dosage to 20 mg/m² every 3 weeks.¹

Discontinue cabazitaxel if severe or persistent diarrhea recurs following dosage reduction to 20 mg/m² every 3 weeks.¹

Prescribing Limits

Adults

Prostate Cancer

IV

No data available to support use beyond 10 cycles.⁵

Special Populations

Hepatic Impairment

Should not be used in patients with hepatic impairment (serum ALT and/or AST ≥1.5 times ULN or total serum bilirubin at or above ULN).¹ (See Hepatic Impairment under Cautions.)

Renal Impairment

No specific dosage recommendations.¹ (See Renal Impairment under Cautions.)

Cautions for Cabazitaxel

Contraindications

• 
  

  Known severe hypersensitivity reaction to cabazitaxel or other formulations containing polysorbate 80.¹

  
  


• 
  

  Baseline neutrophil count ≤1500/mm³.¹

  
  

Warnings/Precautions

Warnings

Neutropenia

Risk of severe, sometimes fatal, neutropenia.¹

Monitor CBCs weekly during the first treatment cycle and prior to each treatment cycle thereafter.¹ Administer recommended dose for initial cycle; adjust dosage for each subsequent cycle as needed based on hematologic recovery.¹ (See Dosage Modification for Toxicity under Dosage and Administration.) Do not administer cabazitaxel until neutrophil count is >1500/mm³.¹

Consider primary prophylaxis with G-CSF in patients with high-risk clinical features that could potentially increase risk of complications associated with prolonged neutropenia (e.g., age >65 years, poor performance status, prior episodes of febrile neutropenia, extensive prior radiation, poor nutritional status, other serious comorbidities).^{1 3}

Consider therapeutic use of G-CSF and secondary prophylaxis in all patients at increased risk for neutropenic complications.¹ (See Dosage Modification for Toxicity under Dosage and Administration.)

If severe prolonged neutropenia occurs despite appropriate treatment (e.g., G-CSF) or if febrile neutropenia occurs, temporary interruption of cabazitaxel therapy followed by dosage reduction or discontinuance of cabazitaxel therapy may be required.¹ (See Dosage Modification for Toxicity under Dosage and Administration.)

Sensitivity Reactions

Risk of severe hypersensitivity reactions (e.g., hypotension, bronchospasm, generalized rash/erythema).¹

Premedicate all patients prior to each infusion to reduce the risk and/or severity of hypersensitivity reactions.¹ (See Premedication under Dosage and Administration.)

Closely observe patient for hypersensitivity reactions, especially during the first and second infusions.^{1 3} Have appropriate facilities and equipment for the treatment of hypotension and bronchospasm readily available, since hypersensitivity reactions may occur within minutes following initiation of an infusion.¹

If severe hypersensitivity reaction occurs, discontinue infusion immediately and institute appropriate supportive treatment.¹

Cabazitaxel injection concentrate contains polysorbate 80; do not administer to patients with a history of severe hypersensitivity reactions to cabazitaxel or to other agents containing polysorbate 80.¹

Other Warnings and Precautions

GI Effects

Risk of nausea and vomiting.^{1 4} Manufacturer recommends antiemetic prophylaxis (orally or IV as needed).¹

Risk of severe diarrhea.¹ Death related to diarrhea, dehydration, and electrolyte imbalance reported.^{1 2}

Administer rehydration therapy and antidiarrheal and antiemetic agents as needed; intensive measures may be required for management of severe diarrhea and electrolyte imbalance.¹ In patients with severe or persistent diarrhea, temporary interruption of therapy followed by dosage reduction, or discontinuance of cabazitaxel therapy, may be required.¹ (See Dosage Modification for Diarrhea under Dosage and Administration.)

Renal Effects

Renal failure reported,^{1 2} generally in association with sepsis, dehydration, or obstructive uropathy; some deaths due to renal failure did not have a clear etiology.¹ If renal failure develops, take appropriate measures to identify the cause and treat aggressively.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.¹ Embryotoxic, fetotoxic, and abortifacient in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹

Adequate Patient Evaluation and Monitoring

Administer under the supervision of a qualified clinician experienced in the use of cytotoxic agents.¹ Have appropriate diagnostic and treatment facilities readily available for management of treatment-related complications.¹

Monitor CBCs weekly during first treatment cycle and prior to each treatment cycle thereafter.¹

Patients must have recovered from acute toxicities (i.e., neutrophils recovered to >1500/mm³, improvement or resolution of febrile neutropenia or diarrhea) before each cycle.¹

Specific Populations

Pregnancy

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

Lactation

Cabazitaxel or its metabolites are distributed into milk in rats; not known whether distributed into human milk.¹ Discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in pediatric patients.¹

Geriatric Use

No overall differences in efficacy or pharmacokinetics in individuals ≥65 years of age compared with younger adults.¹ However, patients ≥65 years of age had higher incidence of neutropenia, fatigue, asthenia, pyrexia, dizziness, urinary tract infection, and dehydration; also had higher rate of death within 30 days of the last cabazitaxel dose from a cause other than disease progression.¹

Hepatic Impairment

Safety and efficacy not established.¹ However, cabazitaxel is extensively metabolized, and hepatic impairment is likely to increase serum concentrations of the drug.¹

Hepatic impairment increases the risk of severe or life-threatening complications of other taxanes (e.g., docetaxel).^{1 14} Manufacturer states that cabazitaxel should not be used in patients with hepatic impairment (serum ALT and/or AST ≥1.5 times ULN or total serum bilirubin at or above ULN).¹

Renal Impairment

Safety and efficacy not studied specifically to date.¹

Mild to moderate renal impairment (Cl_cr 30 to <80 mL/minute) does not substantially alter clearance.¹

Not studied in patients with severe renal impairment (Cl_cr <30 mL/minute) or end-stage renal disease;¹ use with caution in these patients.¹

Common Adverse Effects

Myelosuppression^{1 2} (neutropenia,^{1 2} leukopenia,^{1 2} anemia,^{1 2} thrombocytopenia^{1 2} ), diarrhea,^{1 2} fatigue,^{1 2} nausea,^{1 2} vomiting,^{1 2} constipation,^{1 2} asthenia,^{1 2} abdominal pain,^{1 2} anorexia,¹ back pain,^{1 2} hematuria,^{1 2} peripheral neuropathy,^{1 2} pyrexia,^{1 2} dyspnea,^{1 2} cough,¹ dysgeusia,¹ arthralgia,^{1 2} alopecia.¹

Interactions for Cabazitaxel

No formal drug interaction studies to date.¹

Metabolized principally by CYP3A4/5 and to a lesser extent by CYP2C8.^{1 4}

Cabazitaxel does not induce CYP isoenzymes in vitro.¹ In vitro data indicate low potential for inhibition of CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, and 3A4/5.¹

Substrate of P-glycoprotein (P-gp), but not a substrate of multidrug resistance proteins MRP1 and MRP2 or breast cancer resistance protein (BCRP).¹

Cabazitaxel 25 mg/m² is unlikely to inhibit MRP1, MRP2, P-gp, or BCRP in vivo.¹ Does not inhibit MRP1 or MRP2 in vitro; inhibition of P-gp transport and BCRP observed in vitro, but at concentrations at least 38 times those achieved clinically.¹

Drugs Affecting Hepatic Microsomal Enzymes

Potent CYP3A inhibitors: Potential pharmacokinetic interaction (increased plasma cabazitaxel concentrations).^{1 4} Avoid concomitant use.¹

Moderate CYP3A inhibitors: Use concomitantly with caution.¹

Potent CYP3A inducers: Potential pharmacokinetic interaction (decreased plasma cabazitaxel concentrations).^{1 4} Avoid concomitant use.¹

Drugs Metabolized by Hepatic Microsomal Enzymes

Unlikely to inhibit metabolism of drugs that are substrates of CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 2E1, or 3A4/5.¹

Specific Drugs

Drug	Interaction	Comments
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Probable decrease in plasma cabazitaxel concentrations1	Avoid concomitant use1
Antifungals (itraconazole, ketoconazole, voriconazole)	Probable increase in plasma cabazitaxel concentrations1	Avoid concomitant use1
Antimycobacterials (rifabutin, rifampin, rifapentine)	Probable decrease in plasma cabazitaxel concentrations1 4	Avoid concomitant use1
HIV protease inhibitors (e.g., atazanavir, indinavir, nelfinavir, ritonavir, saquinavir)	Probable increase in plasma cabazitaxel concentrations1 4	Avoid concomitant use1
Macrolides (clarithromycin, telithromycin)	Probable increase in plasma cabazitaxel concentrations1 4	Avoid concomitant use1
Nefazodone	Probable increase in plasma cabazitaxel concentrations1	Avoid concomitant use1
Prednisone, prednisolone	No effect on cabazitaxel pharmacokinetics at prednisone or prednisolone dosage of 10 mg daily1
St. John's wort (Hypericum perforatum)	Probable decrease in plasma cabazitaxel concentrations1	Avoid concomitant use1

Cabazitaxel Pharmacokinetics

Distribution

Extent

Not known whether cabazitaxel is distributed into human milk.¹ (See Lactation under Cautions.) Crosses placenta and distributes into milk in rats.¹

Plasma Protein Binding

89–92% (mainly albumin and lipoproteins).¹

Elimination

Metabolism

Extensively (>95%) metabolized in the liver, mainly by CYP3A4/5 and to a lesser extent by CYP2C8.¹

Elimination Route

Eliminated in feces (76%) as metabolites and in urine (3.7%) as unchanged drug or metabolites; about 20 metabolites have been identified in urine or feces.¹

Half-life

Terminal half-life: 95 hours.¹

Special Populations

Hepatic impairment is expected to result in increased serum cabazitaxel concentrations.¹ (See Hepatic Impairment under Cautions.)

Mild to moderate renal impairment (Cl_cr 30 to <80 mL/minute) does not substantially alter cabazitaxel pharmacokinetics.¹ Not studied in severe renal impairment (Cl_cr <30 mL/minute) or end-stage renal disease.¹

Stability

Storage

Parenteral

Injection Concentrate

25°C (may be exposed to 15–30°C); do not refrigerate.¹

Diluted cabazitaxel solutions are supersaturated and may crystallize over time.¹

Use initial diluted solution (10 mg/mL) within 30 minutes of preparation.¹

Use final diluted solution (0.1–0.26 mg/mL) within 8 hours (including 1 hour for administration) if stored at room temperature or within 24 hours (including 1 hour for administration) if stored under refrigeration.¹

Compatibility

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

Parenteral

Solution Compatibility

Compatible
Dextrose 5% in water1
Sodium chloride 0.9%1

Actions

• 
  

  A semisynthetic taxoid derived from the major natural taxoid (10-deacetyl baccatin III) extracted from the needles of various species of yew trees (Taxus species).^{1 4 9 10 13} The 7,10-dimethoxy analog of docetaxel.⁵

  
  


• 
  

  Like other taxanes (e.g., docetaxel, paclitaxel), cabazitaxel binds to β-tubulin subunits on microtubules and stabilizes and suppresses microtubule activity, thereby resulting in mitotic arrest and cell death.^{1 3 4 9 10 11 12 13}

  
  


• 
  

  Active against some cell lines and tumors that are resistant to various chemotherapeutic agents, including other taxanes (i.e., docetaxel, paclitaxel).^{1 2 3 9 10 11 13}

  
  

Advice to Patients

• 
  

  Risk of hypersensitivity reactions.¹ Importance of informing clinician immediately if manifestations of severe hypersensitivity (e.g., rash, itching, dizziness or faintness, difficulty breathing, chest or throat tightness, facial swelling) occur.¹ Importance of informing clinician of any history of hypersensitivity to cabazitaxel or other agents containing polysorbate 80.¹

  
  


• 
  

  Risk of infection, including severe or potentially fatal infection.¹ Importance of patients monitoring their temperature frequently and immediately notifying clinician if fever or other manifestations of infection (e.g., cough, burning on urination, myalgia) occur.¹

  
  


• 
  

  Risk of dehydration.¹ Importance of informing clinician if substantial vomiting or diarrhea occurs.¹

  
  


• 
  

  Risk of renal failure.¹ Importance of informing clinician if decreased urine output occurs or if edema develops.¹

  
  


• 
  

  Importance of routine monitoring of blood cell counts.¹

  
  


• 
  

  Importance of taking the oral prednisone component of the cabazitaxel/prednisone regimen for prostate cancer as directed.¹ Importance of informing clinician if not adherent to oral prednisone regimen.¹

  
  


• 
  

  Importance of informing geriatric patients that certain adverse effects may be more frequent or severe in older patients.¹ (See Geriatric Use under Cautions.)

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹ Apprise patient of potential hazard to the fetus if used during pregnancy; women of childbearing potential should avoid becoming pregnant.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and herbal supplements, as well as any concomitant illnesses.¹

  
  


• 
  

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

  
  

Preparations

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

Cabazitaxel

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection concentrate, for IV infusion only	40 mg/mL (60 mg)	Jevtana (with water for injection containing alcohol 13% w/w diluent)	Sanofi-Aventis

Disclaimer

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

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

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions September 12, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Sanofi-Aventis. Jevtana (cabazitaxel) injection prescribing information. Bridgewater, NJ; 2010 Jun.

2. de Bono JS, Oudard S, Ozguroglu M et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010; 376:1147-54. [PubMed 20888992]

3. Pal SK, Twardowski P, Sartor O. Critical appraisal of cabazitaxel in the management of advanced prostate cancer. Clin Interv Aging. 2010; 5:395-402. [PubMed 21152241]

4. . New treatments for metastatic prostate cancer. Med Lett Drugs Ther. 2010; 52:69-70. [PubMed 20814400]

5. Sanofi-Aventis. Bridgewater, NJ: Personal Communication.

6. Froehner M, Wirth MP. Cabazitaxel for castration-resistant prostate cancer. Lancet. 2011; 377:121-2; author reply 122-3. [PubMed 21215875]

7. Pearson SD, Trissel LA. Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am J Hosp Pharm. 1993; 50:1405-9. [PubMed 8362871]

8. Kullak-Ublick GA, Becker MB. Regulation of drug and bile salt transporters in liver and intestine. Drug Metab Rev. 2003; 35:305-17. [PubMed 14705863]

9. Kurata T, Shimada Y, Tamura T et al. Phase I and pharmacokinetic study of a new taxoid, RPR 109881A, given as a 1-hour intravenous infusion in patients with advanced solid tumors. J Clin Oncol. 2000; 18:3164-71. [PubMed 10963645]

10. Mita AC, Denis LJ, Rowinsky EK et al. Phase I and pharmacokinetic study of XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every 3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009; 15:723-30. [PubMed 19147780]

11. Pivot X, Koralewski P, Hidalgo JL et al. A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients. Ann Oncol. 2008; 19:1547-52. [PubMed 18436520]

12. Cisternino S, Bourasset F, Archimbaud Y et al. Nonlinear accumulation in the brain of the new taxoid TXD258 following saturation of P-glycoprotein at the blood-brain barrier in mice and rats. Br J Pharmacol. 2003; 138:1367-75. [PubMed 12711638]

13. Bouchet BP, Galmarini CM. Cabazitaxel, a new taxane with favorable properties. Drugs Today (Barc). 2010; 46:735-42. [PubMed 21076710]

14. Sanofi-Aventis. Taxotere (docetaxel) injection concentrate prescribing information. Bridgewater, NJ; 2010 May.

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