Thursday, 29 September 2016

Erythra-Derm




In the US, Erythra-Derm (erythromycin topical) is a member of the following drug classes: topical acne agents, topical antibiotics and is used to treat Acne and Perioral Dermatitis.

US matches:

  • Erythra-Derm

Ingredient matches for Erythra-Derm



Erythromycin

Erythromycin is reported as an ingredient of Erythra-Derm in the following countries:


  • United States

International Drug Name Search

Wednesday, 28 September 2016

Veregen topical


Generic Name: sinecatechins (topical) (SYNE e KAT e kins TOP i kal)

Brand Names: Veregen


What is kunecatechins?

Kunecatechins is an herbal product made from green tea leaves.


Kunecatechins is used to treat external (on the outside of the body) genital and anal warts in adult patients.


Kunecatechins will not cure genital or anal warts, and will not keep you from spreading the warts to other people through sexual intercourse or skin-to-skin contact. Kunecatechins will not treat genital warts that are caused by the human papilloma virus (HPV).

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


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


Before using kunecatechins, tell your doctor if you have human papilloma virus (HPV), HIV or AIDS, or a weak immune system (from disease or medications such as steroids, chemotherapy, or radiation treatments).


Kunecatechins will not cure genital or anal warts, and will not keep you from spreading the warts to other people through sexual intercourse or skin-to-skin contact. Kunecatechins will not treat genital warts that are caused by the human papilloma virus (HPV).

Keep using kunecatechins until your warts have completely cleared. Do not use this medication for longer than 16 weeks without your doctor's advice.


Call your doctor if your warts do not clear up, or if they go away and then come back after treatment.

Talk with your doctor about safe methods of preventing transmission of genital warts during sex.


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


Using this medication will not prevent you from passing genital warts to another person during skin-to-skin contact or sexual intercourse. Talk with your doctor about safe methods of preventing transmission of genital warts during sex.


Do not use this medication if you are allergic to green tea.

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



  • human papilloma virus (HPV);




  • HIV or AIDS; or




  • a weak immune system (from disease or medications such as steroids, chemotherapy, or radiation treatments).



If you have any of these conditions, you may not be able to use kunecatechins, or you may need a dosage 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 kunecatechins passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take kunecatechins?


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


This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Wash your hands before and after applying this medicine.

Kunecatechins is usually applied 3 times daily. Apply enough ointment to cover each wart, leaving a thin layer of ointment on the skin surface.


Do not wash the treated skin area just after applying this medication. Reapply the ointment after you swim, bathe, or shower.


Women using this medication should wash the ointment off before inserting a tampon into the vagina. You may accidentally get some of the medicine into your vagina if you insert a tampon while the ointment is on the outside of your vagina. Men using this medication on an uncircumcised penis should wash underneath the foreskin each day.

Keep using kunecatechins until your warts have completely cleared. Do not use this medication for longer than 16 weeks without your doctor's advice.


Call your doctor if your warts do not clear up, or if they go away and then come back after treatment.

Kunecatechins ointment can stain clothing or bed sheets. Avoid getting the medicine on these surfaces. You may want to wear dark-colored clothing to prevent unwanted staining. Do not use a sanitary napkin or other protective barrier without your doctor's advice.


Store this medication in the refrigerator and do not allow it to freeze.

What happens if I miss a dose?


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


What happens if I overdose?


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

An overdose of applied kunecatechins applied to the skin is not expected to produce life-threatening symptoms.


What should I avoid while taking kunecatechins?


Avoid sexual intercourse while you have this medication on your skin. Wash the ointment off before having intercourse, even if you are using a condom. Kunecatechins can weaken the latex in a rubber condom, and an unintended pregnancy could occur.


Avoid touching the treated skin areas, or allowing another person to touch your treated skin after you have applied the ointment.


Kunecatechins is for use only on the outside of the body. Avoid getting this medication in your eyes, nose, or mouth or into your rectum, vagina, or the opening to your bladder.

Do not apply this medication to an open wound or broken skin.


Avoid exposing treated skin to sunlight or artificial UV rays (sunlamps or tanning beds).

Kunecatechins 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. Wash off the ointment with mild soap and water and call your doctor at once if you have any of these serious side effects:

  • severe redness, burning, or itching of treated skin;




  • swelling, blisters, sores, or skin changes where the medicine was applied;




  • hardening of the treated skin areas; or




  • bleeding of treated skin.



Less serious side effects may include mild stinging, itching, or irritation.


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 kunecatechins?


Before using kunecatechins, tell your doctor about all other genital wart treatments you have used or are still using.


There may be other drugs that can affect kunecatechins. 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 Veregen resources


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


Compare Veregen with other medications


  • Condylomata Acuminata


Where can I get more information?


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

See also: Veregen side effects (in more detail)


Vitafol-One


Pronunciation: pree-NATE-al muhl-tee-VYE-ta-mins/MIN-er-als/EYE-urn/FOE-lik AS-id
Generic Name: Prenatal Multivitamin with Minerals, Iron, Folic Acid, and DHA
Brand Name: Vitafol-One

Accidental overdose of products that contain iron is a leading cause of fatal poisoning in children younger than 6 years old. Keep this and all medicines out of the reach of children. In case of accidental ingestion, call the poison control center or doctor at once.





Vitafol-One is used for:

Treating or preventing a lack of vitamins or minerals before and during pregnancy, and after pregnancy while breast-feeding. It may also be used for other conditions as determined by your doctor.


Vitafol-One is a vitamin, mineral, and omega-3 fatty acid combination. It works by providing vitamins and minerals to the body to help meet nutritional requirements.


Do NOT use Vitafol-One if:


  • you are allergic to any ingredient in Vitafol-One or to cobalt

  • you have cirrhosis of the liver, hemochromatosis (a disorder of iron metabolism), high blood iron levels, or certain types of anemia (eg, chronic, hemolytic anemia; untreated pernicious anemia)

  • you are taking acitretin

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



Before using Vitafol-One:


Some medical conditions may interact with Vitafol-One. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances (including soy)

  • if you have a peptic ulcer or other stomach or bowel problems (eg, colitis, Crohn disease, diverticulitis), pernicious anemia or other blood problems (eg, anemia, porphyria), bleeding problems (eg, hemophilia), high blood calcium levels, liver problems, an overactive parathyroid gland, or an overactive thyroid

  • if you have had multiple blood transfusions

  • if you have a history of kidney stones

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


  • Anticoagulants (eg, warfarin) because the risk of bleeding may be increased by Vitafol-One

  • Acitretin, anti-thyroid medicines (eg, methimazole), cation exchange resins (eg, sodium polystyrene sulfonate), or fluorouracil because the risk of their side effects may be increased by Vitafol-One

  • Doxycycline, hydantoins (eg, phenytoin), methotrexate, penicillamine, or thyroid hormones (eg, levothyroxine) because their effectiveness may be decreased by Vitafol-One

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


How to use Vitafol-One:


Use Vitafol-One as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Check with your doctor or pharmacist to see if you should take Vitafol-One with food or on an empty stomach. If stomach upset occurs, take with food to reduce stomach irritation.

  • Take Vitafol-One by mouth with a full glass of water (8 oz/240 mL).

  • Do not take an antacid within 1 hour before or 2 hours after you take Vitafol-One.

  • Avoid taking Vitafol-One with dairy products; they may interfere with the absorption of the iron in Vitafol-One.

  • Many medicines (eg, used for infection, blood pressure, immune system suppression, low blood platelets, osteoporosis, thyroid problems, cancer) should not be taken at the same time as Vitafol-One; their effectiveness may be decreased. Ask your doctor or pharmacist if your dose of Vitafol-One should be separated from your dose of any of your other medicines.

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

Ask your health care provider any questions you may have about how to use Vitafol-One.



Important safety information:


  • Do not take more than the recommended dose of Vitafol-One without checking with your doctor.

  • Do not take large doses of vitamins while you are taking Vitafol-One unless your doctor tells you to.

  • Vitafol-One may discolor the stools. This is normal and not a cause for concern.

  • Vitafol-One has many vitamins, minerals, iron, folic acid, and DHA in it. Before you start any new medicine, check the label to see if it has these ingredients in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Vitafol-One has iron in it. Iron overdose is a leading cause of fatal poisoning in children younger than 6 years old. In case of an overdose, call a doctor or poison control center right away.

  • PREGNANCY and BREAST-FEEDING: Vitafol-One is intended for use during pregnancy and breast-feeding. If you are or will be breast-feeding while you use Vitafol-One, check with your doctor.


Possible side effects of Vitafol-One:


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



Constipation; dark or discolored stools; diarrhea; nausea; stomach upset; vomiting.



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

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



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.



If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include black, tarry stools; chest pain; lack of feeling alert; loss of balance; seizure; severe nausea, vomiting, diarrhea, or stomach pain; shortness of breath; sluggishness; trouble breathing; unusual tiredness or weakness; unusually pale skin; weak pulse.


Proper storage of Vitafol-One:

Store Vitafol-One at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Vitafol-One out of the reach of children and away from pets.


General information:


  • If you have any questions about Vitafol-One, please talk with your doctor, pharmacist, or other health care provider.

  • Vitafol-One is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

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



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Vitafol-One resources


  • Vitafol-One Use in Pregnancy & Breastfeeding
  • Drug Images
  • Vitafol-One Drug Interactions
  • Vitafol-One Support Group
  • 21 Reviews for Vitafol-One - Add your own review/rating


  • Advance Care Plus Concise Consumer Information (Cerner Multum)

  • CitraNatal Assure Prescribing Information (FDA)

  • CitraNatal Harmony Prescribing Information (FDA)

  • Concept DHA Prescribing Information (FDA)

  • Docosavit Prescribing Information (FDA)

  • Folcal DHA Prescribing Information (FDA)

  • Folcaps Care One Prescribing Information (FDA)

  • Gesticare DHA Prescribing Information (FDA)

  • Inatal Advance Prescribing Information (FDA)

  • Inatal Ultra Prescribing Information (FDA)

  • Multi-Nate DHA Prescribing Information (FDA)

  • Multi-Nate DHA Extra Prescribing Information (FDA)

  • Multifol Plus Concise Consumer Information (Cerner Multum)

  • Natelle One Prescribing Information (FDA)

  • Paire OB Plus DHA Prescribing Information (FDA)

  • PreNexa Prescribing Information (FDA)

  • PreferaOB Prescribing Information (FDA)

  • Prenatal Plus Prescribing Information (FDA)

  • Prenatal Plus Iron Prescribing Information (FDA)

  • Prenate Elite tablets

  • Prenate Elite Prescribing Information (FDA)

  • Prenate Essential Prescribing Information (FDA)

  • PrimaCare ONE capsules

  • Renate DHA Prescribing Information (FDA)

  • Se-Natal 19 Prescribing Information (FDA)

  • Tandem DHA Prescribing Information (FDA)

  • Tandem OB Prescribing Information (FDA)

  • TriAdvance Prescribing Information (FDA)

  • Triveen-PRx RNF Prescribing Information (FDA)

  • UltimateCare ONE NF Prescribing Information (FDA)

  • Vinate AZ Prescribing Information (FDA)

  • Zatean-CH Prescribing Information (FDA)



Compare Vitafol-One with other medications


  • Vitamin/Mineral Supplementation during Pregnancy/Lactation

Phendiet


Generic Name: phendimetrazine (fen di MEH tra zeen)

Brand Names: Adipost, Bontril PDM, Bontril Slow Release, Melfiat


What is Phendiet (phendimetrazine)?

Phendimetrazine is similar to an amphetamine. Phendimetrazine stimulates the central nervous system (nerves and brain), which increases your heart rate and blood pressure and decreases your appetite.


Phendimetrazine is used as a short-term supplement to diet and exercise in the treatment of obesity.


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


What is the most important information I should know about Phendiet (phendimetrazine)?


Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly. Phendimetrazine may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine. Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

What should I discuss with my healthcare provider before taking Phendiet (phendimetrazine)?


Do not use phendimetrazine if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects. You should not use this medication if you are allergic to phendimetrazine, or if you have:

  • coronary artery disease (hardening of the arteries);




  • heart disease;




  • severe or uncontrolled high blood pressure;




  • heart murmur or heart valve disorder;




  • pulmonary arterial hypertension (PAH);




  • overactive thyroid;




  • glaucoma;




  • severe agitation or nervousness;




  • if you have a history of drug or alcohol abuse; or




  • if you are allergic to other diet pills, amphetamines, stimulants, or cold medications.



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



  • high blood pressure;




  • diabetes;




  • an anxiety disorder;




  • epilepsy or seizure disorder; or




  • if you have used other diet pills in the past year (prescription, over-the-counter, or herbal products).




It is not known whether phendimetrazine will harm an unborn baby. Do not take phendimetrazine without first talking to your doctor if you are pregnant. It is also not known whether phendimetrazine passes into breast milk. Do not take phendimetrazine without first talking to your doctor if you are breast-feeding a baby.

How should I take Phendiet (phendimetrazine)?


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. Phendimetrazine should be taken only for a short time, such as a few weeks.


Phendimetrazine is usually taken once daily. Follow your doctor's instructions.


Take phendimetrazine on an empty stomach, 30 to 60 minutes before your morning meal. Do not crush, chew, break, or open the extended-release capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time. You should lose at least 4 pounds during the first 4 weeks of taking phendimetrazine and eating a low calorie diet. Tell your doctor if you do not lose at least 4 pounds after taking the medication for 4 weeks. Do not stop using phendimetrazine suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using phendimetrazine. Never take more of this medication than is prescribed for you. Too much phendimetrazine could be very dangerous to your health. Talk with your doctor if you have increased hunger or if you otherwise think the medication is not working properly. Taking more of this medication will not make it more effective and can cause serious, life-threatening side effects. Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

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.


A dose taken too late in the day will cause insomnia.

What happens if I overdose?


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

Overdose symptoms of a phendimetrazine overdose include nausea, vomiting, diarrhea, stomach cramps, confusion, panic, hallucinations, extreme restlessness, feeling tired or depressed, ringing in your ears, chest pain, slow heart rate, weak pulse, fainting, seizure, or slow breathing (breathing may stop).


What should I avoid while taking Phendiet (phendimetrazine)?


Phendimetrazine may cause blurred vision or impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Phendiet (phendimetrazine) 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 phendimetrazine and call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;




  • chest pain, feeling like you might pass out;




  • swelling in your ankles or feet;




  • pounding heartbeats or fluttering in your chest;




  • confusion or irritability, unusual thoughts or behavior;




  • feelings of extreme happiness or sadness; or




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



Less serious side effects may include:



  • feeling restless or hyperactive;




  • headache, dizziness, tremors;




  • sleep problems (insomnia);




  • flushing (warmth, redness, or tingly feeling);




  • dry mouth;




  • diarrhea or constipation, upset stomach; or




  • increased or decreased interest in sex, impotence.



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 Phendiet (phendimetrazine)?


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



  • insulin; or




  • any other diet pills.



This list is not complete and other drugs may interact with phendimetrazine. 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 Phendiet resources


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


  • Phendiet Advanced Consumer (Micromedex) - Includes Dosage Information

  • Phendimetrazine Prescribing Information (FDA)

  • Bontril PDM MedFacts Consumer Leaflet (Wolters Kluwer)

  • Phendimetrazine Tartrate Monograph (AHFS DI)



Compare Phendiet with other medications


  • Obesity


Where can I get more information?


  • Your pharmacist can provide more information about phendimetrazine.

See also: Phendiet side effects (in more detail)


Bezaterio SR




Bezaterio SR may be available in the countries listed below.


Ingredient matches for Bezaterio SR



Bezafibrate

Bezafibrate is reported as an ingredient of Bezaterio SR in the following countries:


  • Japan

International Drug Name Search

Tuesday, 27 September 2016

Vantas


Generic Name: Histrelin
Class: Antineoplastic Agents
Chemical Name: 6-[1-phenylmethyl)-d-histidine]-9-(N-ethyl-l-prolinamide)-10-deglycinamide-luteinizing hormone-releasing factor (pig)
Molecular Formula: C66H86N18O12
CAS Number: 76712-82-8


Special Alerts:


[Posted 10/20/2010] ISSUE: Gonadotropin-Releasing Hormone (GnRH) agonists will have new safety information added to the Warnings and Precautions section of the drug labels. This new information warns about increased risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer.


BACKGROUND: GnRH agonists are approved to treat the symptoms (palliative treatment) of advanced prostate cancer. The benefits of GnRH agonist use for earlier stages of prostate cancer that have not spread (non-metastatic prostate cancer) have not been established. FDA’s notification to manufacturers of GnRH agonists to add this safety information is based on the Agency’s review of several published studies. Most of the studies reviewed by FDA reported small but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists.


RECOMMENDATIONS: Healthcare professionals should evaluate patients for risk factors for these diseases and carefully weigh the benefits and risks of using GnRH agonists before determining appropriate treatment for prostate cancer. Patients who are receiving treatment with GnRH agonists should undergo periodic monitoring of blood glucose and/or glycosylated hemoglobin (HbA1c). Healthcare professionals should also monitor patients for signs and symptoms suggestive of development of cardiovascular disease and manage according to current clinical practice. For more information visit the FDA website at: and .


[Posted 05/03/2010] FDA notified healthcare professionals and patients of FDA’s preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists, drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.


Most of the studies reviewed by FDA reported small, but statistically significant increased risks of diabetes and/or cardiovascular events in patients receiving GnRH agonists. FDA’s review is ongoing and the agency has not made any conclusions about GnRH agonists and whether they increase the risk of diabetes and cardiovascular disease in patients receiving these medications for prostate cancer.


Healthcare professionals and patients should be aware of these potential safety issues and carefully weigh the benefits and risks of GnRH agonists when determining treatment choices. FDA recommends that patients receiving GnRH agonists should be monitored for development of diabetes and cardiovascular disease. Patients should not stop their treatment with GnRH agonists unless told to do so by their healthcare professional.


Some GnRH agonists are also used in women and in children for other indications than those above. There are no known comparable studies that have evaluated the risk of diabetes and heart disease in women and children taking GnRH agonists. For more information visit the FDA website at: and .



Introduction

Antineoplastic agent; a synthetic nonapeptide analog of gonadotropin-releasing hormone (GnRH, luteinizing hormone-releasing hormone [LHRH], gonadorelin).1


Uses for Vantas


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Prostate Cancer


Palliative treatment of advanced prostate cancer.1


Vantas Dosage and Administration


Administration


Sub-Q Administration


Administer sub-Q as an implant; insert implant in inner aspect of upper arm.1 Consult manufacturer’s labeling for proper methods of inserting and removing implants.1


Dosage


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Available as histrelin acetate; dosage expressed in terms of the salt.1


Adults


Prostate Cancer

Sub-Q

One 50-mg implant every 12 months.1


Remove implant 12 months after insertion.1 At time of implant removal, may insert another implant to continue therapy.1 In limited clinical studies, treatment remains effective for up to 2 years.1 3


Prescribing Limits


Adults


Prostate Cancer

Sub-Q

Use of 2 or 4 implants provides no additional benefit beyond that produced by a single implant.1 2


Special Populations


Renal Impairment


No dosage adjustment required.1 (See Special Populations under Pharmacokinetics.)


Cautions for Vantas


Contraindications



  • Women or pediatric patients.1 May cause fetal harm when administered to a pregnant woman.1




  • Known hypersensitivity to histrelin or any ingredient in the formulation, other GnRH agonists, or GnRH.1



Warnings/Precautions


Warnings


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Endocrine Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Possible transient increase in serum testosterone concentrations during first week of treatment.1 Worsening of signs and/or symptoms of prostate cancer and/or development of new manifestations (e.g., bone pain, neuropathy, hematuria, ureteral or bladder outlet obstruction) may occur during first few weeks of therapy.1


Ureteral obstruction and spinal cord compression (which may contribute to paralysis with or without fatal complications) reported with GnRH agonists.1 Observe patients with metastatic vertebral lesions and/or urinary tract obstruction closely during first few weeks of therapy.1 If spinal cord compression or renal impairment develops, institute standard treatment.1


No acute increase in serum testosterone concentration observed following removal of first implant (after 1 year of therapy) and insertion of second implant.1


Sensitivity Reactions


Hypersensitivity Reactions

Anaphylactic reactions reported with synthetic GnRH or GnRH agonists.1


Major Toxicities


Renal Effects

Renal impairment reported.1 Some patients had a single occurrence of mild impairment (Clcr of 30–59 mL/minute) that returned to normal by the next visit.1


General Precautions


Laboratory Monitoring

To monitor response, measure serum concentrations of testosterone and PSA periodically.1


Implant Complications

Implant insertion or removal is a surgical procedure.1 Carefully follow recommended procedures for insertion and removal of implant to minimize potential for complications or for implant expulsion.1


Implants are not radio-opaque and, therefore, will not be visible on radiographs.1 If implant is difficult to locate by palpation, may use ultrasound and computed tomography (CT) scan.1


Decrease in Bone Mineral Density

Decrease in bone mineral density possible following long-term therapy with GnRH antagonists and agonists.1 3


Specific Populations


Pregnancy

Category X.1 (See Contraindications under Cautions.)


Lactation

Contraindicated in women.1 (See Contraindications under Cautions.)


Pediatric Use

Contraindicated in pediatric patients.1 (See Contraindications under Cautions.)


Geriatric Use

Studies conducted principally in patients ≥65 years of age,1 since prostate cancer occurs mainly in an older patient population.3


Common Adverse Effects


Local or insertion site reactions (e.g., bruising, pain/soreness/tenderness, erythema), hot flushes (flashes), testicular atrophy, gynecomastia, erectile dysfunction, decreased libido, fatigue, renal impairment, constipation, headache, insomnia, weight loss.1


Interactions for Vantas


No formal drug interaction studies to date.1


Vantas Pharmacokinetics


Absorption


Bioavailability


Following sub-Q insertion, peak serum concentrations occurred at a median of 12 hours.1


Drug is delivered continuously at rate of 50–60 mcg daily over 12 months.1


Special Populations


Serum histrelin concentrations are 50% higher in patients with mild to severe renal impairment (Clcr of 15–60 mL/minute).1 However, increased exposure not considered clinically relevant; dosage adjustment not required.1


Distribution


Plasma Protein Binding


Approximately 70%.3


Elimination


Elimination Route


No excretion studies to date.1


Half-life


Approximately 3.92 hours following sub-Q injection of a 500-mcg dose.3


Stability


Storage


Sub-Q


Implant

2–8°C in unopened glass vial, overwrapped in amber plastic pouch and carton.1 Do not freeze.1 Protect from light.1


ActionsActions



  • Antineoplastic agent; a synthetic nonapeptide analog of GnRH (LHRH, gonadorelin).1




  • Causes a transient surge in circulating concentrations of LH, FSH, and gonadal steroids (testosterone and dihydrotestosterone in males) following initial administration.1 Following long-term and continuous administration (generally, 2–4 weeks after initiation of therapy), secretion of LH and FSH is decreased, resulting in marked reduction in serum testosterone concentrations.1




  • Reductions in serum testosterone concentrations following histrelin therapy comparable to those achieved after surgical castration (i.e., <50 ng/dL).1




  • Commercially available as nonbiodegradable, diffusion-controlled implant.1




  • Not active when given orally.1



Advice to Patients


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.



  • Importance of reading and understanding the manufacturer’s patient information leaflet.1 3




  • Importance of protecting the arm in which the implant was inserted from moisture for 24 hours and refraining from heavy lifting or strenuous exertion with that arm for 7 days after implant insertion.1




  • Importance of understanding required monitoring procedures.1




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




  • 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.













Histrelin Acetate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



Implants



50 mg



Vantas



Valera



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 December 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Valera Pharmaceutical Inc. Vantas (histrelin implant) prescribing information. Cranbury, NJ; 2004 Oct.



2. Schlegel PN, Kuzma P, Frick J et al. Effective long-term androgen suppression in men with prostate cancer using a hydrogel implant with the GnRH agonist histrelin. Urology. 2001; 58:578-82. [PubMed 11597543]



3. Valera Pharmaceuticals Inc., Cranbury, NJ: Personal communication.



More Vantas resources


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


  • Vantas Prescribing Information (FDA)

  • Vantas Advanced Consumer (Micromedex) - Includes Dosage Information

  • Vantas Implant MedFacts Consumer Leaflet (Wolters Kluwer)

  • Vantas Consumer Overview

  • Supprelin LA Implant MedFacts Consumer Leaflet (Wolters Kluwer)

  • Supprelin LA Prescribing Information (FDA)



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