Monday, 25 June 2012

Zenchent Fe


Generic Name: ethinyl estradiol and norethindrone (ETH in il ess tra DYE ole and nor ETH in drone)

Brand Names: Aranelle, Balziva, Brevicon, Briellyn, Cyclafem 1/35, Cyclafem 7/7/7, Estrostep Fe, Femcon FE, Generess Fe, Gildess FE 1.5/0.03, Gildess FE 1/0.2, Junel 1.5/30, Junel 1/20, Junel Fe 1.5/30, Junel Fe 1/20, Leena, Lo Loestrin Fe, Loestrin 21 1.5/30, Loestrin 21 1/20, Loestrin 24 Fe, Loestrin Fe 1.5/30, Loestrin Fe 1/20, Microgestin 1.5/30, Microgestin 1/20, Microgestin FE 1.5/30, Microgestin FE 1/20, Modicon, Necon 0.5/35, Necon 1/35, Necon 10/11, Necon 7/7/7, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Ortho-Novum 1/35, Ortho-Novum 7/7/7, Ovcon 35, Ovcon 35 Fe, Ovcon 50, Tilia Fe, Tri-Legest Fe, Tri-Norinyl, Zenchent Fe, Zeosa


What is Zenchent Fe (ethinyl estradiol and norethindrone)?

Ethinyl estradiol and norethindrone contains a combination of female hormones that prevent ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus.


Ethinyl estradiol and norethindrone are used as contraception to prevent pregnancy. It is also used to treat severe acne.


Ethinyl estradiol and norethindrone may also be used for purposes not listed in this medication guide.


What is the most important information I should know about Zenchent Fe (ethinyl estradiol and norethindrone)?


Do not use birth control pills if you are pregnant or if you have recently had a baby. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, a hormone-related cancer such as breast or uterine cancer, abnormal vaginal bleeding, liver disease or liver cancer, or a history of jaundice caused by birth control pills.

You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35.

Some drugs can make birth control pills less effective, which may result in pregnancy. 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.


What should I discuss with my healthcare provider before taking Zenchent Fe (ethinyl estradiol and norethindrone)?


This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant, or if you miss two menstrual periods in a row. If you have recently had a baby, wait at least 4 weeks before taking birth control pills (6 weeks if you are breast-feeding). You should not take birth control pills if you have:

  • coronary artery disease, a severe or uncontrolled heart valve disorder, untreated or uncontrolled high blood pressure;




  • a history of a stroke, blood clot, or circulation problems;




  • a hormone-related cancer such as breast or uterine cancer;




  • unusual vaginal bleeding that has not been checked by a doctor;




  • liver disease or liver cancer;




  • severe migraine headaches; or




  • a history of jaundice caused by pregnancy or birth control pills.



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



  • high blood pressure or a history of heart disease;




  • high cholesterol, gallbladder disease, or diabetes;




  • migraine headaches or a history of depression; or




  • a history of breast cancer or an abnormal mammogram.




The hormones in birth control pills can pass into breast milk and may harm a nursing baby. This medication may also slow breast milk production. Do not use if you are breast-feeding a baby.

How should I take Zenchent Fe (ethinyl estradiol and norethindrone)?


Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Take your first pill on the first day of your period or on the first Sunday after your period begins (follow your doctor's instructions).


You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions.


The 28-day birth control pack contains seven "reminder" pills to keep you on your regular cycle. Your period will usually begin while you are using these reminder pills.


You may have breakthrough bleeding, especially during the first 3 months. Tell your doctor if this bleeding continues or is very heavy.

Take one pill every day, no more than 24 hours apart. When the pills run out, start a new pack the following day. You may get pregnant if you do not use this medication regularly. Get your prescription refilled before you run out of pills completely.


The chewable tablet may be chewed or swallowed whole. If chewed, drink a full glass of water just after you swallow the pill.


If you need surgery or medical tests or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using birth control pills.


Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Missing a pill increases your risk of becoming pregnant. If you miss one "active" pill, take two pills on the day that you remember. Then take one pill per day for the rest of the pack.


If you miss two "active" pills in a row in week one or two, take two pills per day for two days in a row. Then take one pill per day for the rest of the pack. Use back-up birth control for at least 7 days following the missed pills.


If you miss two "active" pills in a row in week three, or if you miss three pills in a row during any of the first 3 weeks, throw out the rest of the pack and start a new one the same day if you are a Day 1 starter. If you are a Sunday starter, keep taking a pill every day until Sunday. On Sunday, throw out the rest of the pack and start a new one that day.


If you miss two or more pills, you may not have a period during the month. If you miss a period for two months in a row, call your doctor because you might be pregnant.

If you miss any reminder pills, throw them away and keep taking one pill per day until the pack is empty. You do not need back-up birth control if you miss a reminder pill.


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, and vaginal bleeding.

What should I avoid while taking Zenchent Fe (ethinyl estradiol and norethindrone)?


Do not smoke while using birth control pills, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by birth control pills.

Birth control pills will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases.


Zenchent Fe (ethinyl estradiol and norethindrone) side effects


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

  • sudden numbness or weakness, especially on one side of the body;




  • sudden severe headache, confusion, problems with vision, speech, or balance;




  • sudden cough, wheezing, rapid breathing, coughing up blood;




  • pain, swelling, warmth, or redness in one or both legs;




  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;




  • a change in the pattern or severity of migraine headaches;




  • pain in your upper stomach, jaundice (yellowing of the skin or eyes);




  • a lump in your breast;




  • swelling in your hands, ankles, or feet; or




  • symptoms of depression (sleep problems, weakness, mood changes).



Less serious side effects may include:



  • mild nausea or vomiting, appetite or weight changes;




  • breast swelling or tenderness;




  • headache, nervousness, dizziness;




  • problems with contact lenses;




  • freckles or darkening of facial skin, loss of scalp hair; or




  • vaginal itching or discharge.



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 Zenchent Fe (ethinyl estradiol and norethindrone)?


Some drugs can make ethinyl estradiol and norethindrone less effective, which may result in pregnancy. Before using ethinyl estradiol and norethindrone, tell your doctor if you are using any of the following drugs:



  • acetaminophen (Tylenol) or ascorbic acid (vitamin C);




  • bosentan (Tracleer);




  • prednisolone (Orapred);




  • St. John's wort;




  • theophylline (Elixophyllin, Theo-24, Uniphyl);




  • an antibiotic;




  • HIV or AIDS medications;




  • phenobarbital (Solfoton) and other barbiturates; or




  • seizure medication.



This list is not complete and other drugs may interact with birth control pills. 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 Zenchent Fe resources


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


  • Aranelle Prescribing Information (FDA)

  • Balziva Prescribing Information (FDA)

  • Brevicon Prescribing Information (FDA)

  • Briellyn Prescribing Information (FDA)

  • Cyclafem 1/35 Prescribing Information (FDA)

  • Cyclafem 7/7/7 Prescribing Information (FDA)

  • Estrostep Fe Prescribing Information (FDA)

  • Femcon FE Prescribing Information (FDA)

  • Femcon Fe Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Femhrt Consumer Overview

  • Femhrt Prescribing Information (FDA)

  • Femhrt MedFacts Consumer Leaflet (Wolters Kluwer)

  • Jevantique Prescribing Information (FDA)

  • Jinteli Prescribing Information (FDA)

  • Leena Prescribing Information (FDA)

  • Lo Loestrin Fe MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lo Loestrin Fe Consumer Overview

  • Lo Loestrin Fe Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lo Loestrin Fe Prescribing Information (FDA)

  • Loestrin 24 FE Prescribing Information (FDA)

  • Loestrin 24 Fe Consumer Overview

  • Loestrin Fe 1/20 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Ovcon 35 MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tilia FE Prescribing Information (FDA)

  • Tri-Norinyl Prescribing Information (FDA)

  • Zenchent FE Prescribing Information (FDA)

  • Zeosa Prescribing Information (FDA)



Compare Zenchent Fe with other medications


  • Abnormal Uterine Bleeding
  • Acne
  • Birth Control
  • Endometriosis
  • Gonadotropin Inhibition
  • Menstrual Disorders
  • Polycystic Ovary Syndrome
  • Postmenopausal Symptoms
  • Prevention of Osteoporosis


Where can I get more information?


  • Your pharmacist can provide more information about ethinyl estradiol and norethindrone.

See also: Zenchent Fe side effects (in more detail)


Tuesday, 19 June 2012

lanreotide


Generic Name: lanreotide (lan REE oh tide)

Brand Names: Somatuline Depot


What is lanreotide?

Lanreotide is a man-made protein that is similar to a hormone in the body called somatostatin. Lanreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.


Lanreotide is used to as a long-term treatment in people with acromegaly who cannot be treated with surgery or radiation.


Lanreotide is sometimes given when surgery or radiation treatments have been tried without successful treatment of symptoms.


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


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


Before using lanreotide, tell your doctor if you have diabetes, gallbladder disease, heart disease or a heart rhythm disorder, thyroid problems, kidney disease, or liver disease. Tell your doctor if you are allergic to latex or natural rubber.


Lanreotide is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.


Each prefilled syringe of lanreotide is for one use only. After giving your injection, throw away used the used needle and syringe in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.


Serious side effects of lanreotide include slow or uneven heartbeats, pain in your upper right stomach with nausea and vomiting, pale skin, weakness, easy bruising or bleeding, low blood sugar (confusion, weakness, sweating, tremor, nausea), or high blood sugar (increased thirst or urination, loss of appetite, fruity breath odor, dry skin).


What should I discuss with my healthcare provider before using lanreotide?


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



  • diabetes;




  • gallbladder disease;




  • heart disease or a heart rhythm disorder;




  • thyroid problems;



  • kidney disease;

  • liver disease; or


  • if you are allergic to latex or natural rubber.



If you have any of the conditions listed above, you may not be able to use lanreotide, or you may need a dose adjustment or special tests during treatment.


FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether lanreotide passes into breast milk. Do not use lanreotide without telling your doctor if you are breast-feeding a baby.

How should I use lanreotide?


Lanreotide should be used exactly as your doctor has prescribed it for you. Do not use more of the medication than recommended. Do not use lanreotide for longer than your doctor has prescribed.


Lanreotide is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles and syringes used in giving the medicine.


Each prefilled syringe of lanreotide is for one use only. After giving your injection, throw away used the used needle and syringe in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.


To be sure this medication is helping your condition, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.


Store this medication in its sealed pouch in the refrigerator, protected from light. Do not allow the medication to freeze.

To reduce discomfort from your injection, take the pouch out of the refrigerator about 30 minutes before using the medication. Allow the medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave. Keep the pouch sealed until you are ready for your injection.


What happens if I miss a dose?


Lanreotide is usually given every 4 weeks for 3 months at a time. Contact your doctor for instructions if you miss an appointment for your lanreotide injection.


What happens if I overdose?


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

An overdose of lanreotide is not expected to produce life-threatening side effects.


What should I avoid while using lanreotide?


Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using lanreotide.


Lanreotide side effects


Stop using lanreotide and 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:

  • slow or uneven heartbeats;




  • gallbladder problems (pain in your upper right stomach area with nausea and vomiting);




  • thyroid problems (may be detected by blood tests);




  • pale skin, weakness, easy bruising or bleeding;




  • low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or




  • high blood sugar (increased thirst, loss of appetite, fruity breath odor, increased urination, drowsiness, dry skin).



Less serious side effects may include:



  • nausea, vomiting;




  • diarrhea, constipation;




  • mild stomach pain or gas;




  • headache;




  • weight loss;




  • joint pain; or




  • pain, itching, or skin lump where injection was given.



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.


Lanreotide Dosing Information


Usual Adult Dose for Acromegaly:

Initial dose: lanreotide depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months

Usual Geriatric Dose for Acromegaly:

Initial dose: lanreotide depot 90 mg given via the deep subcutaneous route, at 4 week intervals for 3 months

It is not necessary to alter the starting dose in elderly patients as expected lanreotide serum concentrations in the elderly are well within the range of serum concentrations safely tolerated in healthy young subjects. Similarly, it is not necessary to alter the titration or maintenance doses as dose selection is based on therapeutic response.


What other drugs will affect lanreotide?


Before using lanreotide, tell your doctor if you are taking any of the following medicines:



  • cyclosporine (Neoral, Sandimmune, Gengraf);




  • bromocriptine (Parlodel);




  • diabetes medication such as insulin, glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolbutamide (Orinase), metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others; or




  • a beta-blocker such as acebutolol (Sectral), atenolol (Tenormin), betaxolol (Kerlone), bisoprolol (Zebeta), carteolol (Cartrol), carvedilol (Coreg), esmolol (Brevibloc), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), penbutolol (Levatol), pindolol (Visken), propranolol (Inderal, InnoPran), sotalol (Betapace), or timolol (Blocadren).



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



More lanreotide resources


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


  • lanreotide Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lanreotide MedFacts Consumer Leaflet (Wolters Kluwer)

  • Lanreotide Acetate Monograph (AHFS DI)

  • Somatuline Depot Prescribing Information (FDA)

  • Somatuline Depot Consumer Overview



Compare lanreotide with other medications


  • Acromegaly


Where can I get more information?


  • Your pharmacist can provide more information about lanreotide.

See also: lanreotide side effects (in more detail)


Friday, 15 June 2012

Sotradecol


Generic Name: sodium tetradecyl sulfate (Intravenous route)


SOE-dee-um tet-ra-DEK-ul SUL-fate


Commonly used brand name(s)

In the U.S.


  • Sotradecol

Available Dosage Forms:


  • Solution

Therapeutic Class: Sclerosing Agent


Uses For Sotradecol


Sodium tetradecyl sulfate is a type of medicine called a sclerosing agent. It is used for the treatment of small varicose veins of the lower extremities.


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


Before Using Sotradecol


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


Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of sodium tetradecyl sulfate in children with use in other age groups.


Geriatric


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


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal 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


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


Interactions with Food/Tobacco/Alcohol


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:


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


  • Allergic conditions or

  • Bedridden or

  • Cellulitis or

  • Deep vein incompetence or

  • Huge superficial veins with connections to deeper veins or

  • Infections or

  • Phlebitis migrans or

  • Respiratory diseases or

  • Skin diseases or

  • Thrombophlebitis or

  • Valvular vein incompetence or

  • Varicosities caused by abdominal and pelvic tumors (unless the tumor has been removed)—Sodium tetradecyl sulfate should not be administered.

  • Asthma or

  • Blood dyscrasias or

  • Diabetes or

  • Hyperthyroidism or

  • Neoplasm or

  • Sepsis or

  • Tuberculosis—Sodium tetradecyl sulfate should not be administered.

  • Peripheral arteriosclerosis or

  • Thromboangiitis obliterans (Buerger's disease)—Extreme caution should be used; sodium tetradecyl sulfate may make these conditions worse.

Proper Use of Sotradecol


It is important to have a preinjection evaluation.


It is important to give slow injections with a small amount (not over 2 milliliters) of sodium tetradecyl sulfate solution.


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 injection dosage form:
    • For varicose veins:
      • Adults—0.5 to 2 milliliters injected into the vein, depending on the size and degree of varicosity.

      • Children—Use and dose must be determined by your doctor.



Precautions While Using Sotradecol


Embolisms (i.e., blood clots) may occur up to 4 weeks following injection of sodium tetradecyl sulfate.


It is possible that deep vein thrombosis (i.e., blood clot in a deep vein) can develop.


Sotradecol Side Effects


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


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


Frequency not known
  • Anxiety

  • burning

  • chest pain

  • cough

  • difficulty breathing

  • difficulty swallowing

  • dizziness or light-headedness

  • fainting

  • fast heartbeat

  • hayfever

  • hives

  • itching

  • nausea

  • noisy breathing

  • pain, redness, or swelling in arm or leg

  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue

  • raised red swellings on the skin, lips, tongue, or in the throat

  • redness of skin

  • skin rash

  • sudden shortness of breath or troubled breathing

  • tightness in chest

  • unusual tiredness or weakness

  • vomiting

  • wheezing

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:


Frequency not known
  • Headache

  • pain, local

  • pain or redness at site of injection

  • pale skin at site of injection

  • peeling or sloughing of skin

  • ulceration at site of injection

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


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

See also: Sotradecol side effects (in more detail)



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


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


More Sotradecol resources


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


  • Sotradecol Prescribing Information (FDA)

  • Sotradecol Concise Consumer Information (Cerner Multum)

  • Sotradecol MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sodium Tetradecyl Sulfate Professional Patient Advice (Wolters Kluwer)



Compare Sotradecol with other medications


  • Varicose Veins

Tuesday, 12 June 2012

Calcitrene



calcipotriene

Dosage Form: ointment
Calcitrene™ (Calcipotriene) Ointment 0.005%

FOR TOPICAL DERMATOLOGIC USE ONLY.

Not for Ophthalmic, Oral or Intravaginal Use.


Rx Only



Calcitrene Description


Calcitrene™ (calcipotriene) ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin D3 derivative for topical dermatological use.


Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol-, with the empirical formula C27H40O3, a molecular weight of 412.6, and the following structural formula:



Calcipotriene is a white or off-white crystalline substance. Calcitrene™ (calcipotriene) ointment, 0.005% contains calcipotriene 50 µg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, petrolatum, propylene glycol, α-tocopherol, steareth-2 and purified water.



Calcitrene - Clinical Pharmacology


In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D3.


Clinical studies with radiolabelled ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application.


Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihyroxy vitamin D3 (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone. The primary metabolites are much less potent than the parent compound.


There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin.



Clinical Studies


Adequate and well-controlled trials of patients treated with Calcitrene™ (calcipotriene) ointment, 0.005% have demonstrated improvement usually beginning after two weeks of therapy. This improvement continued in patients using calcipotriene once daily and twice daily. After 8 weeks of once daily calcipotriene, 56.7% of patients showed at least marked improvements (6.4% showed complete clearing). After 8 weeks of twice daily calcipotriene, 70.0% of patients showed at least marked improvement (11.3% showed complete clearing).


Subtracting percentages of patients using placebo (vehicle only) from percentages of patients using calcipotriene who had at least marked improvements after 8 weeks yields 39.9% for once daily and 49.6% for twice daily. This adjustment for placebo effect indicated that what might appear to be differences between once and twice daily use may reflect differences in the studies independent from the frequency of dosing. Although there was a numerical difference in comparison across studies, twice daily dosing has not been shown to be superior in efficacy to once daily dosing.


Over 400 patients have been treated in open label clinical studies of calcipotriene for periods of up to one year. In half of these studies, patients who previously had not responded well to calcipotriene were excluded. The adverse events in these extended studies included skin irritation in approximately 25% of patients and worsening of psoriasis in approximately 10% of patients. In one of these open label studies, half of the patients no longer required calcipotriene by 16 weeks of treatment, because of satisfactory therapeutic results.



Indications and Usage for Calcitrene


Calcitrene™ (calcipotriene) ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.



Contraindications


Calcitrene™ (calcipotriene) ointment, 0.005%, is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene should not be used on the face.



Precautions



General


Use of calcipotriene may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, calcipotriene should be discontinued.


For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.


Transient, rapidly reversible elevation of serum calcium has occurred with use of calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.



Information for Patients


Patients using calcipotriene should receive the following information and instructions:


  1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash hands after application.

  2. This medication should not be used for any disorder other than that for which it was prescribed.

  3. Patients should report to their physician any signs of local adverse reactions.

  4. Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.)


Carcinogenesis, Mutagenesis, Impairment of Fertility


When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 µg/kg/day (corresponding to 9, 30 and 90 µg/m2/day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to indicate the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply calcipotriene to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients that use calcipotriene.


Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.


Studies in rats at doses up to 54 µg/kg/day (324 µg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.



Pregnancy


Teratogenic Effects

Pregnancy Category C


Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. In rabbits, increased maternal and fetal toxicity were noted at a dosage of 12 µg/kg/day (132 µg/m2/day); a dosage of 36 µg/kg/day (396 µg/m2/day) resulted in a significant increase in the incidence of incomplete ossification of the pubic bones and forelimb phalanges of fetuses. In a rat study, a dosage of 54 µg/kg/day (318 µg/m2/day) resulted in a significantly increased incidence of skeletal abnormalities (enlarged fontanelles and extra ribs). The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The estimated maternal and fetal no-effect exposure levels in the rat (43.2 µg/m2/day) and rabbit (17.6 µg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 µg/m2/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Calcitrene™ (calcipotriene) ointment, 0.005% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.



Nursing Mothers


It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Calcitrene™ (calcipotriene) ointment, 0.005% is administered to a nursing woman.



Pediatric Use


Safety and effectiveness of calcipotriene in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.



Geriatric Use


Of the total number of patients in clinical studies of Calcitrene™ (calcipotriene) ointment, 0.005%, approximately 12% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).



Adverse Reactions


In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.



Overdosage


Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of Calcitrene™ (calcipotriene) ointment, 0.005%.



Calcitrene Dosage and Administration


Apply a thin layer of Calcitrene™ (calcipotriene) ointment, 0.005% once or twice daily and rub in gently and completely.



How is Calcitrene Supplied


Calcitrene™ (calcipotriene) ointment, 0.005% is available in:

60 gram aluminum tube NDC (51672-5278-3)



STORAGE


Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze.



Manufactured by:

Glenmark Generics Ltd.

Colvale-Bardez, Goa 403 513, India


Distributed by:

TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc.

Hawthorne, NY 10532


TaroPharma® and Calcitrene™ are trademarks of Taro Pharmaceuticals U.S.A., Inc and/or its affiliates.


July, 2010



PRINCIPAL DISPLAY PANEL - 5 g Tube Carton


0.005%


OINTMENT


NDC 51672-5278-5

5 g


Rx only


Calcitrene™

Calcipotriene Ointment 0.005%


FOR TOPICAL DERMATOLOGIC USE ONLY.

NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.


Keep this and all medications out of the reach of children.

Professional Sample Only

Contains 10 tubes


TaroPharma®










Calcitrene 
calcipotriene  ointment










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)51672-5278
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcipotriene (Calcipotriene)Calcipotriene0.05 mg  in 1 g




















Inactive Ingredients
Ingredient NameStrength
sodium phosphate, dibasic, dihydrate 
edetate disodium 
mineral oil 
petrolatum 
propylene glycol 
alpha-tocopherol 
steareth-2 
water 


















Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains      






















Packaging
#NDCPackage DescriptionMultilevel Packaging
151672-5278-31 TUBE In 1 CARTONcontains a TUBE
160 g In 1 TUBEThis package is contained within the CARTON (51672-5278-3)
251672-5278-51 TUBE In 1 CARTONcontains a TUBE
25 g In 1 TUBEThis package is contained within the CARTON (51672-5278-5)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09063303/24/2010


Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)









Establishment
NameAddressID/FEIOperations
Glenmark Generics Ltd.677318665MANUFACTURE
Revised: 09/2010Taro Pharmaceuticals U.S.A., Inc.

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  • Psoriasis

Wednesday, 6 June 2012

Teniposide


Class: Antineoplastic Agents
VA Class: AN900
Molecular Formula: C32H32O13S
CAS Number: 29767-20-2
Brands: Vumon



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




  • Possible severe myelosuppression with resulting infection and bleeding.1 6 (See Myelosuppression under Cautions.)




  • Possible serious and potentially fatal hypersensitivity reactions.1 14 15 16 Epinephrine, with or without corticosteroids and antihistamines, has been used to alleviate signs and symptoms.1 14 15 16 (See Sensitivity Reactions under Cautions.)




Introduction

Antineoplastic agent; a semisynthetic podophyllotoxin-derivative that is structurally and pharmacologically related to etoposide.1 2 3 4 5 6


Uses for Teniposide


Acute Lymphocytic Leukemia


Induction therapy (as a component of multiple-drug antineoplastic regimens) in childhood acute lymphocytic (lymphoblastic) leukemia (ALL) that is refractory to induction with other therapy or has relapsed despite such therapy1 6 26 (designated an orphan drug by FDA for this use).25


May prolong remission;1 23 however, experience is limited, and only a minority of patients achieve long-term survival.1 2 5 21


Teniposide Dosage and Administration


General



  • Consult specialized references for procedures for proper handling and disposal of antineoplastics.1 (See IV Administration under Dosage and Administration.)



Administration


IV Administration


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


Administer diluted solution by slow IV infusion.1 Do not administer by rapid IV injection.1 (See Cardiovascular Effects under Cautions.)


To prevent leaching of diethylhexyl phthalate (DEHP) plasticizer, use IV administration sets that do not contain DEHP (e.g., lipid sets, low DEHP-containing nitroglycerin sets).1


Ensure that IV catheter or needle is in proper position and functional prior to infusion to avoid extravasation.1 (See Local Effects under Cautions.)


Flush IV access site thoroughly with 5% dextrose or 0.9% sodium chloride injection prior to and following administration.1 Heparin should not be used due to potential for drug precipitation.1


Observe carefully for possible occlusion of the IV access site, including central venous catheters, particularly during prolonged (e.g., 24-hour) infusions.1 (See Compatibility under Stability.)


Observe closely for possible hypotensive or hypersensitivity reactions during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.1 (See Cardiovascular Effects and also see Sensitivity Reactions under Cautions.)


Handle cautiously.1 Skin reactions may occur following accidental exposure; use protective equipment (e.g., gloves).1 If accidental contact occurs, wash skin thoroughly with soap and water or flush mucosa thoroughly with water.1


Dilution

Must be diluted before IV infusion.1


Plastic equipment or devices may soften or crack and possibly leak when used with undiluted teniposide injection.1


To prevent leaching of DEHP plasticizer, prepare diluted solutions in containers that do not contain DEHP (e.g., glass or polyolefin plastic bags or containers).1 Use of PVC containers not recommended.1


For IV infusion, dilute concentrate in 5% dextrose or 0.9% sodium chloride injection to a final concentration of 0.1, 0.2, 0.4, or 1 mg/mL.1


Rate of Administration

Administer over at least 30–60 minutes to minimize risk of hypotension.1 6 (See Cardiovascular Effects under Cautions.) If hypotensive reaction occurs, use slower rate of infusion and monitor carefully if restarting after discontinuance and appropriate treatment.1


Dosage


Pediatric Patients


Acute Lymphocytic Leukemia

Patients Who Failed Induction Therapy with a Cytarabine-containing Regimen

IV

165 mg/m2 (in combination with cytarabine 300 mg/m2) twice weekly for 8 or 9 doses.1


Patients Who Failed Induction Therapy with Vincristine/Prednisone-containing Regimens

IV

250 mg/m2 (in combination with vincristine 1.5 mg/m2) weekly for 4–8 weeks with oral prednisone 40 mg/m2 daily for 28 days.1


Special Populations


Hepatic Impairment


Use with caution; dosage adjustments may be necessary.1


Renal Impairment


Dosage adjustments may be necessary.1


Patients with Down’s Syndrome


Initially, give half the usual dose; subsequent doses may be increased depending on degree of myelosuppression and mucositis encountered with previous doses.1


Cautions for Teniposide


Contraindications



  • Known hypersensitivity to teniposide or polyoxyl 35 castor oil (Cremophor EL, polyoxyethylated castor oil).1 (See Sensitivity Reactions under Cautions.)



Warnings/Precautions


Warnings


Adequate Patient Evaluation and Monitoring

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


Perform CBCs and renal and hepatic function tests prior to, during, and after completion of therapy.1 (See Myelosuppression under Cautions.)


Myelosuppression

Risk of dose-limiting myelosuppression (e.g., neutropenia, leukopenia, thrombocytopenia, anemia).1 2 5 6 8 9 Severe myelosuppression with resulting infection or bleeding may occur.1 6


Monitor for myelosuppression frequently during and after treatment.1 Perform CBCs (leukocyte count with differential, platelet count, hemoglobin) prior to initiation of therapy and before each subsequent dose.1 If severe myelosuppression occurs, consider supportive therapy, antibiotics for complicating infections, and blood product transfusions; repeat bone marrow examination before continuing therapy.1


Cardiovascular Effects

Transient hypotension reported following rapid IV administration, possibly resulting from direct effect of polyoxyl 35 castor oil contained in preparation.1


Administer over at least 30–60 minutes; observe patient closely during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.1


If clinically important hypotension occurs, discontinue infusion.1 BP usually normalizes within hours in response to infusion discontinuance and administration of IV fluids and other supportive therapy as necessary.1 Use slower rate of infusion and monitor carefully if restarting after discontinuance and appropriate treatment.1


Sudden death secondary to intractable hypotension and probable arrhythmia reported in at least 1 geriatric patient receiving teniposide in combination therapy for a nonleukemic malignancy.1 Hypertensive reactions, sometimes severe and accompanied by cardiac failure, reported rarely.12 13


Nervous System Effects

Acute CNS depression (manifested as somnolence and lethargy) and hypotension, accompanied by metabolic acidosis,11 reported in patients pretreated with antiemetics and receiving high-dose regimens of teniposide.1 11 CNS depression possibly resulting from depressant effects of antiemetic agents and high alcohol content of teniposide formulation.1


Fetal/Neonatal Morbidity and Mortality

May cause fetal harm.1 19 Teratogenicity and embryotoxicity demonstrated in animals.1 Avoid pregnancy during therapy.1 If used during pregnancy or if pregnancy occurs during therapy, apprise of potential fetal hazard.1


Sensitivity Reactions


Hypersensitivity Reactions

Risk of hypersensitivity reactions,1 14 15 16 including anaphylaxis-like manifestations (e.g., chills, fever, urticaria, tachycardia, flushing, bronchospasm, dyspnea, hypotension or hypertension).1 Reaction may occur with initial dose or with repeated exposure and may be life-threatening if not treated promptly with antihistamines, corticosteroids, epinephrine, IV fluids, and other supportive measures as necessary.1 Etiology unknown, but reactions may result from polyoxyl 35 castor oil component or from teniposide itself.1 14 15 16 Frequency possibly increased in patients with neuroblastomas or brain tumors.1 14 15 Observe patients closely during administration (i.e., for ≥60 minutes after initiation of infusion) and frequently thereafter.1 If manifestations of anaphylaxis occur, discontinue infusion immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, antihistamines, pressor agents, IV fluids).1


Generally contraindicated in patients with known hypersensitivity to teniposide or polyoxyl 35 castor oil; however, may consider cautious administration when the antileukemic benefit already demonstrated clearly outweighs the possible risk.1 When reinitiating therapy in a patient who previously developed a hypersensitivity reaction, pretreat with a corticosteroid and antihistamine and observe patient carefully during and after infusion.1


Appropriate equipment and agents (e.g., epinephrine, antihistamines, corticosteroids, IV fluids, oxygen) should be readily available.1


No evidence of cross-sensitization between teniposide and etoposide.1


General Precautions


Toxicity

Administer only under constant supervision by clinicians experienced in therapy with cytotoxic agents and only when the potential benefits outweigh the possible risks.1


Most adverse effects are reversible if detected early.1


Discontinue or reduce dosage and institute appropriate measures as necessary when severe adverse effects occur.1


Reinstitute therapy with caution, considering further need for the drug and possible toxicity recurrence.1


Local Effects

Extravasation may result in local tissue necrosis and/or thrombophlebitis.1


Dermatologic Effects

Alopecia reported; usually reversible but sometimes may progress to total baldness.1


Carcinogenicity

Secondary acute myeloid (myelogenous, nonlymphocytic) leukemia (AML, ANLL), with or without a preleukemic phase, reported in patients receiving maintenance therapy with teniposide in combination with other antineoplastic agents.1 10 Assess potential benefit versus risks of therapy.1 10


Animal studies to determine the carcinogenic potential of teniposide have not been performed to date; however, the drug should be considered a potential carcinogen.1


Specific Populations


Pregnancy

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


Lactation

Not known whether teniposide is distributed into milk.1 Discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy established only for combination therapy of refractory childhood ALL.1 6 In an analysis of data from 7 studies involving 303 patients ranging in age from 0.5 months to 20 years who received teniposide as a single agent for a variety of hematologic malignancies and solid tumors, no age-related difference in tolerance was reported.27 f


Each mL of teniposide concentrate for injection contains 30 mg of benzyl alcohol.1 Although a causal relationship has not been established, injections preserved with benzyl alcohol have been associated with toxicity in neonates.a b c d e


Hepatic Impairment

Use with caution.1 (See Elimination: Special Populations, under Pharmacokinetics.)


Patients with Down’s Syndrome

Possible increased sensitivity to myelosuppressive chemotherapy.1 Dosage adjustments necessary.1 (See Down's Syndrome under Dosage and Administration.)


Patients with Hypoalbuminemia

Careful monitoring recommended.1 (See Distribution: Special Populations, under Pharmacokinetics.)


Common Adverse Effects


Neutropenia, leukopenia, anemia, thrombocytopenia, myelosuppression (nonspecified), mucositis, diarrhea, nausea, vomiting, infection, alopecia, bleeding, hypersensitivity reactions, rash, fever, hypotension.1


Interactions for Teniposide


Specific Drugs





















Drug



Interaction



Comments



Antiemetic agents



Possible CNS depression when used concomitantly with higher than recommended dosages of teniposide1



Methotrexate



Possible increased methotrexate clearance1



Sodium salicylate



Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1



Use concomitantly with caution1



Sulfamethizole



Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1



Use concomitantly with caution1



Tolbutamide



Possibility of substantially increased plasma teniposide concentrations and potential for increased toxicity1



Use concomitantly with caution1


Teniposide Pharmacokinetics


Distribution


Extent


Limited distribution throughout the body because of extensive protein binding.1 Limited distribution into the brain; however, CSF concentrations are higher in patients with brain tumors.1


Concentrations in saliva, CSF, and malignant ascites fluid are low relative to those in plasma.1


Plasma Protein Binding


>99%.1


Special Populations


Volume of distribution increases with decreasing albumin concentrations.1 (See Patients with Hypoalbuminemia under Cautions.)


Elimination


Elimination Route


44% of dose is excreted in urine within 120 hours after dosing (with only 4–12% excreted as unchanged drug); 0–10% of dose is excreted in feces within 72 hours.1


Half-life


5 hours.1


Special Populations


Possible association between increased concentrations of serum alkaline phosphatase or γ-glutamyltransferase (γ-glutamyltranspeptidase, GT, GGTP) and a decrease in plasma teniposide clearance.1 (See Hepatic Impairment under Cautions.)


Stability


Storage


Parenteral


Injection

2–8°C; protect from light.1


Store diluted solutions at room temperature; do not refrigerate.1 Diluted solutions at concentrations of 0.1, 0.2, or 0.4 mg/mL are stable for up to 24 hours at room temperature.1 Diluted solutions at concentration of 1 mg/mL should be administered within 4 hours to reduce potential for precipitation.1 Stability and use times are identical for solutions prepared in glass or plastic containers.1


Compatibility


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


Parenteral


Possible precipitation of diluted solutions.1 Precipitation reported during 24-hour infusions of teniposide diluted to concentrations of 0.1–0.2 mg/mL, resulting in occlusion of central venous access catheters.1 17 (See IV Administration under Dosage and Administration.) To minimize precipitation, avoid agitation, decrease storage time prior to administration, and avoid contact with other drugs or fluids.1


Solution CompatibilityHID






Compatible



Dextrose 5% in water



Ringer’s injection, lactated



Sodium chloride 0.9%


Drug Compatibility





































































































Y-Site CompatibilityHID

Compatible



Acyclovir sodium



Allopurinol



Amifostine



Amikacin sulfate



Aminophylline



Amphotericin B



Ampicillin sodium



Ampicillin sodium–sulbactam sodium



Aztreonam



Bleomycin sulfate



Bumetanide



Buprenorphine HCl



Butorphanol tartrate



Calcium gluconate



Carboplatin



Carmustine



Cefazolin sodium



Cefotaxime sodium



Cefoxitin sodium



Ceftazidime



Ceftizoxime sodium



Ceftriaxone sodium



Cefuroxime sodium



Chlorpromazine HCl



Cimetidine HCl



Ciprofloxacin



Cisplatin



Cladribine



Clindamycin phosphate



Co-trimoxazole



Cyclophosphamide



Cytarabine



Dacarbazine



Dactinomycin



Daunorubicin HCl



Dexamethasone sodium phosphate



Diphenhydramine HCl



Doxorubicin HCl



Doxycycline hyclate



Droperidol



Enalaprilat



Etoposide



Etoposide phosphate



Famotidine



Floxuridine



Fluconazole



Fludarabine phosphate



Fluorouracil



Furosemide



Gallium nitrate



Ganciclovir sodium



Gemcitabine HCl



Gentamicin sulfate



Granisetron HCl



Haloperidol lactate



Hydrocortisone sodium phosphate



Hydrocortisone sodium succinate



Hydromorphone HCl



Hydroxyzine HCl



Ifosfamide



Imipenem–cilastatin sodium



Leucovorin calcium



Lorazepam



Mannitol



Mechlorethamine HCl



Melphalan HCl



Meperidine HCl



Mesna



Methotrexate sodium



Methylprednisolone sodium succinate



Metoclopramide HCl



Metronidazole



Minocycline HCl



Mitomycin



Mitoxantrone HCl



Morphine sulfate



Nalbuphine HCl



Netilmicin sulfate



Ondansetron HCl



Potassium chloride



Prochlorperazine edisylate



Promethazine HCl



Ranitidine HCl



Sargramostim



Sodium bicarbonate



Streptozocin



Thiotepa



Ticarcillin disodium



Ticarcillin disodium–clavulanate potassium



Tobramycin sulfate



Vancomycin HCl



Vinblastine sulfate



Vincristine sulfate



Vinorelbine tartrate



Zidovudine



Incompatible



Heparin1



Idarubicin HCl


ActionsActions



  • Exact mechanism(s) of action not known; apparently produces cytotoxic effects by damaging DNA and thereby inhibiting or altering DNA synthesis.1 6 7




  • Induces single- and double-stranded DNA breaks and also induces DNA-protein cross-links,1 2 5 possibly through inhibition of type II topoisomerase.1 6




  • Cell-cycle specific, inducing G2-phase arrest and preferentially killing cells in the G2 and late S phases.1 2 5



Advice to Patients



  • Importance of advising patients and/or their parents or guardians of adverse effects and associated manifestations.1




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




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and to advise pregnant women of risk to the fetus.1




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



Preparations


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













Teniposide

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection concentrate, for IV infusion only



10 mg/mL



Vumon (with dehydrated alcohol 42.7% and benzyl alcohol 30 mg and polyoxyl 35 castor oil 500 mg per mL)



Bristol-Myers Squibb



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 June 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


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




References



1. Bristol-Myers Squibb Oncology Division. Vumon (teniposide injection) prescribing information. Princeton, NJ: 1998 Oct.



2. National Cancer Institute Cancer Therapy Evaluation Program. Group C treatment protocol: VM-26 in combination with Ara-C for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. NCI protocol No. 188-16. Bethesda, MD: National Cancer Institute; 1988 Aug 15.



3. Strife J, Jardine I. Analysis of the anticancer drugs VP 16-213 and VM 26 and their metabolites by high-performance liquid chromatography. J Chromatogr. 1980; 182:211-20. [IDIS 178818] [PubMed 7380913]



4. Grem JL, Hoth DF, Leyland-Jones B et al. Teniposide in the treatment of leukemia: a case study of conflicting priorities in the development of drugs for fatal diseases. J Clin Oncol. 1988; 6:351-79. [PubMed 3276827]



5. National Cancer Institute Therapy Evaluation Program. Group C treatment protocol: VM-26 in combination with Ara-C for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia. NCI protocol No. 188-0016. Bethesda, MD: National Cancer Institute; 1989 Jan 25.



6. Anon. Teniposide for acute lymphoblastic leukemia. Med Lett Drugs Ther. 1992; 34:105-6. [PubMed 1435505]



7. Krishan A, Paika K, Frei E III. Cytofluorometric studies on the action of podophyllotoxin and epipodophyllotoxins (VM-26, VP-16-213) on the cell cycle traverse on human lymphoblasts. J Cell Biol. 1975; 66:521-30. [PubMed 1057547]



8. O’Dwyer PJ, Alonso MT, Leyland-Jones B et al. Teniposide: a review of 12 years of experience. Cancer Treat Rep. 1984; 68:1455-66. [IDIS 195977] [PubMed 6391663]



9. Bristol-Myers Squibb Oncology Division. Vumon (teniposide) concentrate for injection formulary guide. Princeton, NJ; 1992.



10. Pui CH, Ribeiro RC, Hancock ML et al. Acute myeloid leukemia in children treated with epipodophyllotoxins for acute lymphoblastic leukemia. N Engl J Med. 1991; 325:1682-7. [IDIS 288970] [PubMed 1944468]



11. McLeod HL, Baker DK Jr, Pui CH et al. Somnolence, hypotension, and metabolic acidosis following high-dose teniposide treatment in children with leukemia. Cancer Chemother Pharmacol. 1991; 29:150-4. [PubMed 1760858]



12. Razon-Veronesi S. Cardiovascular toxic effects of VM26 in the treatment of acute lymphatic leukemia: presentation of two cases. Tumori. 1982; 68:253-5. [PubMed 6958114]



13. Shimizu H, Frankel LS, Culbert SJ. Severe hypertensive reactions to teniposide (VM-26) in infants with congenital leukemia. Am J Pediatr Hematol/Oncol. 1987; 9:239-41.



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