Monday, 23 July 2012

Fleet Pain Relief Pad


Generic Name: pramoxine topical (pra MOX een TOP i kal)

Brand Names: Anest Hemor, Blistex Pro Relief, Calaclear, Caladryl Clear, Callergy Clear, Curasore, Fleet Pain Relief Pad, Gold Bond Anti-Itch, Itch-X, PrameGel, Pramox, Prax, Proctofoam, Proctozone-P, Sarna Sensitive, Sarna Sensitive Eczema Itch Relief, Sarna Ultra, Soothe-It Plus Hemmorhoidal Pad, Summers Eve Anti-Itch, Tronolane


What is Fleet Pain Relief Pad (pramoxine topical)?

Pramoxine is an anesthetic, or "numbing medicine." It works by interfering with pain signals sent from the nerves to the brain.


Pramoxine topical (for the skin) is used to treat pain or itching caused by insect bites, minor burns or scrapes, hemorrhoids, and minor skin rash, dryness, or itching. Pramoxine topical is also used to treat chapped lips, and pain or skin irritation caused by coming into contact with poison ivy, poison oak, or poison sumac.


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


What is the most important information I should know about Fleet Pain Relief Pad (pramoxine topical)?


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


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.

Less serious side effects are more likely, and you may have none at all.


What should I discuss with my health care provider before using Fleet Pain Relief Pad (pramoxine topical)?


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

Ask a doctor or pharmacist if it is safe for you to take this medicine if you are allergic to any drugs or any other numbing medicines.


FDA pregnancy category C. It is not known whether pramoxine topical will harm an unborn baby. Do not use this medication without medical advice if you are pregnant. It is not known whether pramoxine topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without medical advice if you are breast-feeding a baby.

How should I use Fleet Pain Relief Pad (pramoxine topical)?


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


Pramoxine is usually applied to the affected area 3 to 5 times daily, depending on which form of this medication you use. Follow the label directions or your doctor's instructions about how much medication to use and how often.


Pramoxine hemorrhoid cream, lotion, foam, or medicated wipe may be used on the rectum after each bowel movement to treat hemorrhoid pain and itching.


Wash your hands before and after applying pramoxine topical. Wash the affected skin area with warm water and a mild soap. Rinse and dry the area thoroughly.

To use pramoxine on the skin, (spray, lotion, gel, or stick), apply just enough of the medication to cover the area to be treated.


To use the pramoxine medicated wipe to treat the hemorrhoid area, apply the medication by patting the wipe onto the rectal area. Avoid harsh rubbing. You may fold the wipe and leave it in place for up to 15 minutes. Each pramoxine medicated wipe is for one use only. Throw the wipe away after using.


Shake the pramoxine rectal foam before each use. Squirt only a small amount of the medicine onto a clean tissue and apply it to your rectum. Do not insert this medication or the medicated wipe into your rectum. Use pramoxine topical only on the outside of the area.

Stop using pramoxine and call your doctor if your symptoms do not improve after 7 days of treatment, or if your condition clears up and then comes back.


Store at room temperature away from moisture and heat.

What happens if I miss a dose?


Since pramoxine topical is used on an as needed basis, you are not likely to miss a dose.


What happens if I overdose?


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

What should I avoid while using Fleet Pain Relief Pad (pramoxine topical)?


Avoid getting this medication in your eyes or nose. If this does happen, rinse with water. Do not use pramoxine topical on deep skin wounds, blistered skin, severe burns, or large skin areas. Seek medical attention for more severe skin irritation or injury.

Avoid using other medications on the areas you treat with pramoxine topical unless you doctor tells you to.


Fleet Pain Relief Pad (pramoxine topical) 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 pramoxine topical and call your doctor at once if you have a serious side effect such as:

  • any new redness or swelling where the medicine was applied; or




  • severe pain, burning, or stinging where the medicine is applied.



Less serious side effects are more likely, and you may have none at all.


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 Fleet Pain Relief Pad (pramoxine topical)?


It is not likely that other drugs you take orally or inject will have an effect on topically applied pramoxine. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.



More Fleet Pain Relief Pad resources


  • Fleet Pain Relief Pad Side Effects (in more detail)
  • Fleet Pain Relief Pad Use in Pregnancy & Breastfeeding
  • Fleet Pain Relief Pad Support Group
  • 1 Review for Fleet Pain Relief - Add your own review/rating


  • Caladryl Clear MedFacts Consumer Leaflet (Wolters Kluwer)

  • Itch-X Foam MedFacts Consumer Leaflet (Wolters Kluwer)

  • PrameGel Gel MedFacts Consumer Leaflet (Wolters Kluwer)

  • Pramoxine Hydrochloride Monograph (AHFS DI)

  • Prax Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Proctofoam Foam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Sarna Sensitive Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

  • Tronolane Cream MedFacts Consumer Leaflet (Wolters Kluwer)



Compare Fleet Pain Relief Pad with other medications


  • Hemorrhoids


Where can I get more information?


  • Your pharmacist can provide more information about pramoxine topical.

See also: Fleet Pain Relief side effects (in more detail)


Clindamycin/Benzoyl Peroxide Gel


Pronunciation: KLIN-da-MYE-sin/BEN-zoe-il per-OX-ide
Generic Name: Clindamycin/Benzoyl Peroxide
Brand Name: BenzaClin Care Kit


Clindamycin/Benzoyl Peroxide Gel is used for:

Treating acne.


Clindamycin/Benzoyl Peroxide Gel is an antibiotic and drying agent combination. It works by stopping the bacterial infection that causes acne. The moisturizing serum works by providing moisture to the skin.


Do NOT use Clindamycin/Benzoyl Peroxide Gel if:


  • you are allergic to any ingredient in Clindamycin/Benzoyl Peroxide Gel or to lincomycin

  • you have a history of Crohn disease, inflammation of the colon caused by antibiotics, pseudomembranous colitis, regional enteritis, or ulcerative colitis

  • you are using a product that contains erythromycin or an ammonium salt (eg, benzalkonium chloride)

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



Before using Clindamycin/Benzoyl Peroxide Gel:


Some medical conditions may interact with Clindamycin/Benzoyl Peroxide Gel. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

  • if you have allergies to medicines, foods, or other substances

  • if you have a stomach or intestinal disease

Some MEDICINES MAY INTERACT with Clindamycin/Benzoyl Peroxide Gel. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Products that contain ammonium salts (eg, benzalkonium chloride) because they may decrease Clindamycin/Benzoyl Peroxide Gel's effectiveness

  • Products that contain erythromycin because their effectiveness may be decreased by Clindamycin/Benzoyl Peroxide Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if Clindamycin/Benzoyl Peroxide Gel 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 Clindamycin/Benzoyl Peroxide Gel:


Use Clindamycin/Benzoyl Peroxide Gel as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Use Clindamycin/Benzoyl Peroxide Gel on a regular schedule to get the most benefit from it.

  • Before applying Clindamycin/Benzoyl Peroxide Gel to the affected areas, gently wash and rinse the skin with warm water and pat dry. Apply a thin film of medicine to the affected skin and rub in as directed by your doctor. Wash your hands immediately after using Clindamycin/Benzoyl Peroxide Gel.

  • To use the moisturizing serum: Twist the cap off of one ampule. Squeeze the serum onto your skin and rub in completely. Throw away any serum left in the ampule after one use.

  • Continue to use Clindamycin/Benzoyl Peroxide Gel even if your condition improves. Do not miss any doses.

  • If you miss a dose of Clindamycin/Benzoyl Peroxide Gel, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use Clindamycin/Benzoyl Peroxide Gel.



Important safety information:


  • Clindamycin/Benzoyl Peroxide Gel is for external use only. Do not get it in your eyes, nose, or mouth, or in the vagina. If you get it in any of these areas, rinse immediately with cool water.

  • Clindamycin/Benzoyl Peroxide Gel may bleach hair or colored fabric. Avoid getting Clindamycin/Benzoyl Peroxide Gel in your hair or on your clothes.

  • Once you begin using Clindamycin/Benzoyl Peroxide Gel, it may take several weeks before you begin to see improvement. If your symptoms do not improve by 11 weeks or if they become worse, check with your doctor.

  • Talk with your doctor before you use any other topical acne medicines or cleansers on your skin.

  • Do not use Clindamycin/Benzoyl Peroxide Gel for other conditions at a later time.

  • Clindamycin/Benzoyl Peroxide Gel may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Clindamycin/Benzoyl Peroxide Gel. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Long-term or repeated use of Clindamycin/Benzoyl Peroxide Gel may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.

  • Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur during treatment or within several months after treatment with Clindamycin/Benzoyl Peroxide Gel. Do not treat diarrhea without first checking with your doctor.

  • Clindamycin/Benzoyl Peroxide Gel should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Clindamycin/Benzoyl Peroxide Gel while you are pregnant. It is not known if Clindamycin/Benzoyl Peroxide Gel is found in breast milk after topical use. Do not breast-feed while using Clindamycin/Benzoyl Peroxide Gel.


Possible side effects of Clindamycin/Benzoyl Peroxide Gel:


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:



Dry skin; flushing; itching; redness.



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); bloody stools; burning, peeling, or irritation at the application site; severe diarrhea; stomach cramps or pain.



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. Clindamycin/Benzoyl Peroxide Gel may be harmful if swallowed.


Proper storage of Clindamycin/Benzoyl Peroxide Gel:

Store Clindamycin/Benzoyl Peroxide Gel at room temperature, below 77 degrees F (25 degrees C). Do not freeze. Store away from heat, moisture, and light. Do not store in the bathroom. Keep tightly closed. Throw away any unused portion after 3 months. Keep Clindamycin/Benzoyl Peroxide Gel out of the reach of children and away from pets.


General information:


  • If you have any questions about Clindamycin/Benzoyl Peroxide Gel, please talk with your doctor, pharmacist, or other health care provider.

  • Clindamycin/Benzoyl Peroxide Gel 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 Clindamycin/Benzoyl Peroxide Gel. 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 Clindamycin/Benzoyl Peroxide resources


  • Clindamycin/Benzoyl Peroxide Use in Pregnancy & Breastfeeding
  • Clindamycin/Benzoyl Peroxide Drug Interactions
  • Clindamycin/Benzoyl Peroxide Support Group
  • 53 Reviews for Clindamycin/Benzoyl Peroxide - Add your own review/rating


Compare Clindamycin/Benzoyl Peroxide with other medications


  • Acne

Sunday, 22 July 2012

PreviDent 5000 Sensitive


Pronunciation: SOE-dee-um FLUR-ide/po-TAS-ee-um NYE-trate
Generic Name: Sodium Fluoride/Potassium Nitrate
Brand Name: PreviDent 5000 Sensitive


PreviDent 5000 Sensitive is used for:

Preventing tooth decay. It is also used to help reduce painful sensitivity of the teeth to touch; sweets; or hot, cold, or acidic substances.


PreviDent 5000 Sensitive is a topical fluoride toothpaste. It works by strengthening the tooth enamel.


Do NOT use PreviDent 5000 Sensitive if:


  • you are allergic to any ingredient in PreviDent 5000 Sensitive

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



Before using PreviDent 5000 Sensitive:


Some medical conditions may interact with PreviDent 5000 Sensitive. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


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

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

  • if you have allergies to medicines, foods, or other substances

  • if you have kidney problems

Some MEDICINES MAY INTERACT with PreviDent 5000 Sensitive. However, no specific interactions with PreviDent 5000 Sensitive are known at this time.


Ask your health care provider if PreviDent 5000 Sensitive 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 PreviDent 5000 Sensitive:


Use PreviDent 5000 Sensitive as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Use PreviDent 5000 Sensitive in place of your regular toothpaste unless your doctor tells you otherwise.

  • Place at least a 1-inch strip of the paste onto a soft bristle toothbrush.

  • Brush the teeth thoroughly for at least 1 minute, then spit out the paste. Do NOT swallow. Rinse the mouth well. Spit out the rinse water.

  • Be sure to brush all sensitive areas of the teeth.

  • Use PreviDent 5000 Sensitive on a regular schedule to get the most benefit from it.

  • Using PreviDent 5000 Sensitive at the same time each day will help you remember to use it.

  • If you miss a dose of PreviDent 5000 Sensitive, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use PreviDent 5000 Sensitive.



Important safety information:


  • Do NOT use more than the recommended dose or use for longer than 4 weeks without checking with your doctor.

  • If your symptoms do not get better or if they get worse, check with your doctor.

  • PreviDent 5000 Sensitive may cause harm if a large amount is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.

  • PreviDent 5000 Sensitive should not be used in CHILDREN younger than 12 years old without checking with your doctor or dentist; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using PreviDent 5000 Sensitive while you are pregnant. It is not known if PreviDent 5000 Sensitive is found in breast milk after topical use. If you are or will be breast-feeding while you use PreviDent 5000 Sensitive, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of PreviDent 5000 Sensitive:


All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with this product. 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).



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.


See also: PreviDent 5000 Sensitive side effects (in more detail)


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 bloody vomit; burning in the mouth; diarrhea; drooling; nausea; sore tongue; stomach pain or cramping; or vomiting.


Proper storage of PreviDent 5000 Sensitive:

Store PreviDent 5000 Sensitive at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep PreviDent 5000 Sensitive out of the reach of children and away from pets.


General information:


  • If you have any questions about PreviDent 5000 Sensitive, please talk with your doctor, pharmacist, or other health care provider.

  • PreviDent 5000 Sensitive 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 PreviDent 5000 Sensitive. 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 PreviDent 5000 Sensitive resources


  • PreviDent 5000 Sensitive Side Effects (in more detail)
  • PreviDent 5000 Sensitive Use in Pregnancy & Breastfeeding
  • 0 Reviews for PreviDent 5000 Sensitive - Add your own review/rating


  • APF Gel Advanced Consumer (Micromedex) - Includes Dosage Information

  • Prevident 5000 Booster Prescribing Information (FDA)

  • Prevident 5000 Dry Mouth Prescribing Information (FDA)

  • Prevident 5000 Enamel Protect Prescribing Information (FDA)

  • Prevident 5000 Sensitive Prescribing Information (FDA)

  • Prevident 5000 Sensitive Concise Consumer Information (Cerner Multum)



Compare PreviDent 5000 Sensitive with other medications


  • Prevention of Dental Caries

Saturday, 21 July 2012

FML Ointment


Pronunciation: flure-oh-METH-oh-lone
Generic Name: Fluorometholone
Brand Name: FML


FML Ointment is used for:

Treating inflammation (swelling, warmth, redness, pain) of the eyes and eyelids.


FML Ointment is a corticosteroid. Exactly how FML Ointment works is unknown.


Do NOT use FML Ointment if:


  • you are allergic to any ingredient in FML Ointment

  • you have a viral infection of the eye (eg, herpes), a fungal or tuberculosis infection of the eye, certain untreated eye infections (eg, infections producing pus or discharge), or vaccinia or chickenpox infection

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



Before using FML Ointment:


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


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

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

  • if you have allergies to medicines, foods, or other substances

  • if you have thinning of the eye tissues (eg, cornea, sclera), other eye problems (eg, glaucoma, cataracts, nerve damage), or diabetes

  • if you have recently had cataract surgery

Some MEDICINES MAY INTERACT with FML Ointment. Because little, if any, of FML Ointment is absorbed into the blood, the risk of it interacting with another medicine is low.


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


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


  • FML Ointment may be used around the eye or in the eye. To use FML Ointment in the eye, first, wash your hands. Using your index finger, pull the lower eyelid away from your eye to form a pouch. Squeeze a thin strip of ointment into the pouch. After using FML Ointment, gently close your eyes for 1 to 2 minutes. Wash your hands to remove any medicine that may be on them. Wipe the applicator tip with a clean, dry tissue. To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.

  • Do not wear soft contact lenses while you are using FML Ointment. Sterilize contact lenses according to the manufacturer's directions and check with your doctor before using them.

  • If your doctor prescribed more than 1 eye medicine, find out the best order for using each medicine.

  • If you miss a dose of FML Ointment, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use FML Ointment.



Important safety information:


  • FML Ointment may cause blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to FML Ointment.

  • If your condition does not improve within 2 days or if it becomes worse, check with your doctor.

  • LAB TESTS, including eye pressure, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.

  • Use FML Ointment with extreme caution in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using FML Ointment during pregnancy. It is unknown if FML Ointment is excreted in breast milk after use in the eye. If you are or will be breast-feeding while you are using FML Ointment, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of FML Ointment:


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



Blurred vision; taste changes; temporary burning or stinging.



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

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; continuing blurred vision; discharge from eyes; eye pain, itching, redness, swelling, irritation, or sores not present when you began using FML Ointment.



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.


See also: FML side effects (in more detail)


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.


Proper storage of FML Ointment:

Store FML Ointment below 77 degrees F (25 degrees C). Avoid temperatures above 105 degrees F (40 degrees C). Store away from heat, moisture, and light. Do not freeze. Do not store in the bathroom. Keep FML Ointment out of the reach of children and away from pets.


General information:


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

  • FML Ointment 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 FML Ointment. 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 FML resources


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


Compare FML with other medications


  • Eye Dryness/Redness
  • Eye Redness/Itching
  • Eyelash Hypotrichosis

Friday, 20 July 2012

Fexmid


Generic Name: cyclobenzaprine (Oral route)

sye-kloe-BEN-za-preen

Commonly used brand name(s)

In the U.S.


  • Amrix

  • Fexmid

  • Flexeril

  • FusePaq Tabradol

Available Dosage Forms:


  • Capsule, Extended Release

  • Tablet

  • Suspension

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting


Uses For Fexmid


Cyclobenzaprine is used to help relax certain muscles in your body. It helps relieve the pain, stiffness, and discomfort caused by strains, sprains, or injuries to your muscles. However, this medicine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem. Cyclobenzaprine acts on the central nervous system (CNS) to produce its muscle relaxant effects. Its actions on the CNS may also cause some of this medicine's side effects.


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


Cyclobenzaprine is available only with your doctor's prescription.


Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, cyclobenzaprine is used in certain patients with fibromyalgia syndrome (also called fibrositis or fibrositis syndrome).


Before Using Fexmid


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 cyclobenzaprine 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 use of cyclobenzaprine tablets in the elderly with use in other age groups.


Because of the possibility of higher blood levels in the elderly as compared to younger adults, use of cyclobenzaprine extended-release capsules is not recommended in the elderly .


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


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


Interactions with Medicines


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


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


  • Brofaromine

  • Clorgyline

  • Furazolidone

  • Iproniazid

  • Isocarboxazid

  • Lazabemide

  • Linezolid

  • Moclobemide

  • Nialamide

  • Pargyline

  • Phenelzine

  • Procarbazine

  • Rasagiline

  • Selegiline

  • Toloxatone

  • Tranylcypromine

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


  • Duloxetine

  • Tramadol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Escitalopram

  • Fluoxetine

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:


  • Glaucoma or

  • Problems with urination—Cyclobenzaprine can make your condition worse.

  • Heart or blood vessel disease or

  • Overactive thyroid—The chance of side effects may be increased.

  • Liver disease—Higher blood levels of cyclobenzaprine may occur, increasing the chance of side effects .

Proper Use of cyclobenzaprine

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


Take this medicine only as directed by your doctor. Do not take more of it and do not take it more often than your doctor ordered. To do so may increase the chance of serious side effects.


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 relaxing stiff muscles:
    • For the oral dosage form (tablets):
      • Adults and teenagers 15 years of age and older—The usual dose is 10 milligrams (mg) three times a day. The largest amount should be no more than 60 mg (six 10-mg tablets) a day.

      • Children and teenagers up to 15 years of age—Dose must be determined by your doctor.


    • For the oral dosage form (extended-release capsules):
      • Adults—The usual dose is 15 mg once a day. Some patients may require up to 30 mg (one 30 mg capsule or two 15 mg capsules) per day.

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



Missed Dose


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


Storage


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


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


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Fexmid


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


This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.


You should NOT use the extended-release capsules if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days .


This medicine may cause some people to have blurred vision or to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well.


Cyclobenzaprine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.


If your condition does not improve within two or three weeks, or if it becomes worse, check with your doctor .


Fexmid 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.


Stop taking this medicine and get emergency help immediately if any of the following effects occur:


Rare
  • Changes in the skin color of the face

  • fast or irregular breathing

  • large swellings that look like hives on the face, eyelids, mouth, lips, and/or tongue

  • puffiness or swelling of the eyelids or the area around the eyes

  • shortness of breath, troubled breathing, tightness in chest, and/or wheezing

  • skin rash, hives, or itching

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


Rare
  • Fainting

Symptoms of overdose
  • Convulsions (seizures)

  • drowsiness (severe)

  • dry, hot, flushed skin

  • fast or irregular heartbeat

  • hallucinations (seeing, hearing, or feeling things that are not there)

  • increase or decrease in body temperature

  • troubled breathing

  • unexplained muscle stiffness

  • unusual nervousness or restlessness (severe)

  • vomiting (occurring together with other symptoms of overdose)

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


Rare
  • Clumsiness or unsteadiness

  • confusion

  • mental depression or other mood or mental changes

  • problems in urinating

  • ringing or buzzing in the ears

  • skin rash, hives, or itching occurring without other symptoms of an allergic reaction listed above

  • unusual thoughts or dreams

  • yellow eyes or skin

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


More common
  • Blurred vision

  • dizziness or lightheadedness

  • drowsiness

  • dryness of mouth

Less common or rare
  • Bloated feeling or gas, indigestion, nausea or vomiting, or stomach cramps or pain

  • constipation

  • diarrhea

  • excitement or nervousness

  • frequent urination

  • general feeling of discomfort or illness

  • headache

  • muscle twitching

  • numbness, tingling, pain, or weakness in hands or feet

  • pounding heartbeat

  • problems in speaking

  • trembling

  • trouble in sleeping

  • unpleasant taste or other taste changes

  • unusual muscle weakness

  • unusual tiredness

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: Fexmid 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 Fexmid resources


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


  • Fexmid Prescribing Information (FDA)

  • Cyclobenzaprine Prescribing Information (FDA)

  • Cyclobenzaprine Monograph (AHFS DI)

  • Cyclobenzaprine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Amrix Extended-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

  • Amrix Prescribing Information (FDA)

  • Flexeril Prescribing Information (FDA)

  • Flexeril Consumer Overview



Compare Fexmid with other medications


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Wednesday, 18 July 2012

Eraxis


Generic Name: Anidulafungin
Class: Echinocandins
VA Class: AM700
Chemical Name: 1 - [(4R,5R) - 4,5 - dihydroxy - N2 - [[4″ - (pentyloxy)[1,1′:4′,1″ - terphenyl] - 4 - yl]carbonyl] - l - ornithine] Echinocandin B
Molecular Formula: C58H73N7O17
CAS Number: CAS-166663-25-8

Introduction

Antifungal; echinocandin; lipopeptide synthesized from a fermentation product of Aspergillus nidulans.1 2 4 5 7


Uses for Eraxis


Candidemia and Other Invasive Candida Infections


Treatment of candidemia and certain other invasive Candida infections (intra-abdominal abscess, peritonitis).1 5 8 19 21 24 A drug of choice.21 24


For treatment of candidemia in nonneutropenic patients or for empiric treatment of suspected invasive candidiasis in such patients, IDSA recommends fluconazole or an echinocandin (caspofungin, micafungin, anidulafungin) for initial therapy;24 amphotericin B (conventional or lipid formulation) is the preferred alternative.24 An echinocandin may be preferred for initial treatment in those who have moderately severe to severe candidemia, are allergic to or intolerant of azole antifungals, have recently received an azole, or have or are likely to have infections caused by Candida glabrata or C. krusei.24 Fluconazole may be preferred for initial treatment in those who are less critically ill and have not recently received an azole and for infections caused by C. parapsilosis.24 If an echinocandin is used initially, transition to fluconazole is recommended for patients who are clinically stable and have isolates likely to be susceptible to fluconazole (e.g., C. albicans).24


For treatment of candidemia in neutropenic patients, IDSA recommends an echinocandin (caspofungin, micafungin, anidulafungin) or amphotericin B (a lipid formulation) for initial therapy;24 fluconazole is the preferred alternative in those who are less critically ill or have not recently received an azole;24 voriconazole can be used as an alternative when broader antifungal coverage is required.24 An echinocandin is preferred for C. glabrata infections;24 fluconazole or amphotericin B (a lipid formulation) is preferred for C. parapsilosis infections;24 an echinocandin, amphotericin B (a lipid formulation), or voriconazole is recommended for C. krusei infections.24 For initial empiric treatment of suspected invasive candidiasis in neutropenic patients, amphotericin B (a lipid formulation), caspofungin, or voriconazole is recommended;24 alternatives are fluconazole or itraconazole.24


Safety and efficacy not established for treatment of endocarditis, osteomyelitis, or meningitis caused by Candida.1


Manufacturer states efficacy data are insufficient to date regarding use of anidulafungin for treatment of candidemia or other invasive Candida infections in neutropenic patients.1


Esophageal Candidiasis


Treatment of esophageal candidiasis.1 3 5 11 21 24 26 A drug of choice.21 24


Esophageal candidiasis requires treatment with a systemic antifungal (not a topical antifungal).24 26


IDSA recommends oral fluconazole as the preferred drug of choice for the treatment of esophageal candidiasis;24 if oral therapy is not tolerated, IV fluconazole, IV amphotericin B (conventional formulation), or an IV echinocandin (caspofungin, micafungin, anidulafungin) is recommended.24 For fluconazole-refractory infections, preferred alternatives are itraconazole oral solution, oral posaconazole, or IV or oral voriconazole;24 other alternatives are an IV echinocandin (caspofungin, micafungin, anidulafungin) or IV amphotericin B (conventional formulation).24


For treatment of esophageal candidiasis in HIV-infected adults and adolescents, CDC, National Institute of Health (NIH), and IDSA recommend IV or oral fluconazole as the preferred drug of choice and itraconazole oral solution as the preferred alternative.26 Other alternatives include an IV echinocandin (caspofungin, micafungin, anidulafungin), oral or IV voriconazole, oral posaconazole, or IV amphotericin B (conventional formulation).26 For refractory esophageal candidiasis, including fluconazole-refractory infections, itraconazole oral solution or oral posaconazole is preferred;26 alternatives include IV amphotericin B (conventional or lipid formulation), an IV echinocandin (caspofungin, micafungin, anidulafungin), or oral or IV voriconazole.26


Patients with frequent or severe recurrences of esophageal candidiasis, including HIV-infected patients, may benefit from long-term suppressive or maintenance therapy (secondary prophylaxis) with oral fluconazole or oral posaconazole; however, the potential for azole resistance should be considered.1 3 24 26 Echinocandins not included in recommendations for secondary prophylaxis of esophageal candidiasis.24 26 Patients with fluconazole-refractory esophageal candidiasis who responded to an echinocandin should receive voriconazole or posaconazole for secondary prophylaxis until antiretroviral therapy produces immune reconstitution.26


Oropharyngeal Candidiasis


Treatment of oropharyngeal candidiasis.21 24 26 Considered an alternative, not a drug of choice.24 26


IDSA recommends topical clotrimazole or topical nystatin for mild oropharyngeal candidiasis;24 oral fluconazole is recommended for moderate to severe disease.24 For refractory oropharyngeal candidiasis, including fluconazole-refractory infections, itraconazole oral solution, oral posaconazole, or oral voriconazole is recommended.24 An IV echinocandin (caspofungin, micafungin, anidulafungin) or IV amphotericin B (conventional formulation) also are recommended as alternatives for refractory infections.24


For treatment of oropharyngeal candidiasis in HIV-infected adults and adolescents, CDC, NIH, and IDSA recommend oral fluconazole as the preferred drug of choice for initial episodes;26 alternatives for initial episodes include topical clotrimazole or topical nystatin.26 For fluconazole-refractory infections, itraconazole oral solution or oral posaconazole is preferred;26 alternatives include IV amphotericin B (conventional or lipid formulation), an IV echinocandin (caspofungin, micafungin, anidulafungin), or oral or IV voriconazole.26


Patients with frequent or severe recurrences of oropharyngeal candidiasis, including HIV-infected patients, may benefit from long-term suppressive or maintenance therapy (secondary prophylaxis) with oral fluconazole or itraconazole oral solution; however, the potential for azole resistance should be considered.24 26 Echinocandins not included in recommendations for secondary prophylaxis of oropharyngeal candidiasis.24 26 Patients with fluconazole-refractory oropharyngeal candidiasis who responded to an echinocandin should receive voriconazole or posaconazole for secondary prophylaxis until antiretroviral therapy produces immune reconstitution.26


Eraxis Dosage and Administration


Administration


IV Administration


Administer by slow IV infusion.1 Do not administer by rapid IV injection.1


Do not admix or infuse concomitantly with other drugs.1


Reconstitution

Reconstitute 50- or 100-mg vials of lyophilized anidulafungin with 15 or 30 mL, respectively, of sterile water for injection to provide a solution containing 3.33 mg/mL.1


Dilution

Dilute total contents of the required number of reconstituted vials in 50, 100, or 200 mL of 5% dextrose injection or 0.9% sodium chloride injection as directed to provide an IV infusion solution containing 0.77 mg/mL.1 (See Table.)


Use strict aseptic technique since drug contains no preservative.1























Instructions for Diluting Reconstituted Vials of Anidulafungin1

Anidulafungin Dose Indicated



Number of Reconstituted Vials Required



Required Volume of Diluent (5% Dextrose Injection or 0.9% Sodium Chloride Injection)



Total Infusion Volume of 0.77-mg/mL Solution



Minimum Duration of Infusion (minutes)



50 mg



One 50-mg vial



50 mL



65 mL



45



100 mg



Two 50-mg vials or one 100-mg vial



100 mL



130 mL



90



200 mg



Four 50-mg vials or two 100-mg vials



200 mL



260 mL



180


Rate of Administration

Administer IV infusions at a rate not exceeding 1.1 mg/minute (1.4 mL/minute).1 More rapid infusion may increase risk of histamine-mediated reactions.1 (See Histamine-mediated Reactions under Cautions.)


Dosage


Adults


Candidemia and Other Invasive Candida Infections (Intra-abdominal Abscess, Peritonitis)

IV

A single 200-mg loading dose on day 1, followed by 100 mg once daily.1 21 24


Duration of treatment is based on clinical response.1 Manufacturer recommends anidulafungin be continued for at least 14 days after last positive culture.1 IDSA and others recommend that antifungal treatment for candidemia (without persistent fungemia or metastatic complications) be continued for 14 days after first negative blood culture and resolution of signs and symptoms of candidemia.21 24


Esophageal Candidiasis

IV

A single 100-mg loading dose on day 1, followed by 50 mg once daily is recommended by the manufacturer and some clinicians.1 21 IDSA recommends a single 200-mg loading dose on day 1, followed by 100 mg once daily.24


HIV-infected adults: A single 100-mg loading dose on day 1, followed by 50 mg once daily.26


Duration of treatment is based on clinical response.1 Manufacturer recommends a minimum of 14 days and at least 7 days following resolution of symptoms.1 IDSA and others recommend that antifungal treatment be continued for 14–21 days.21 24 26


Oropharyngeal Candidiasis

IV

Some clinicians recommend a single 100-mg loading dose on day 1, followed by 50 mg once daily.21 IDSA recommends a single 200-mg loading dose on day 1, followed by 100 mg once daily.24


HIV-infected adults: A single 100-mg loading dose on day 1, followed by 50 mg once daily.26


IDSA and others recommend that antifungal treatment be continued for 7–14 days.24 26


Special Populations


Hepatic Impairment


Dosage adjustment not required in adults with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).1


Renal Impairment


Dosage adjustment not required.1 Not dialyzable; may administer without regard to dialysis timing.1 2 4 5 7 11


Geriatric Patients


Dosage adjustment not required in adults ≥65 years of age.1 7 11


Cautions for Eraxis


Contraindications



  • Known hypersensitivity to anidulafungin, other echinocandin antifungals (e.g., caspofungin, micafungin), or any ingredient in the formulation.1



Warnings/Precautions


Sensitivity Reactions


Hypersensitivity Reactions

Possible histamine-mediated symptoms (e.g., rash, urticaria, flushing, pruritus, dyspnea, hypotension).1 6 12 Reported infrequently when infusion rate does not exceed 1.1 mg/minute.1


Hepatic Effects


Abnormal liver function test results reported.1 Clinically important hepatic dysfunction, hepatitis, or worsening hepatic failure reported in patients with serious underlying conditions receiving multiple drugs concomitantly; causal relationship not established.1


If abnormal liver function test results occur, monitor for evidence of worsening hepatic function and evaluate benefits versus risks of continuing therapy.1


Selection and Use of Antifungals


Obtain specimens for fungal culture and other relevant laboratory studies (e.g., histopathology) prior to initiation of therapy.1 Therapy may be started pending results; adjust therapy as needed when results available.1


Specific Populations


Pregnancy

Category C.1


Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 Use only if potential benefits outweigh risks.1


Pediatric Use

Safety and efficacy not established in pediatric patients.1


Has been used in a limited number of neutropenic children 2–17 years of age without unusual adverse effects.18


Some experts state data are insufficient to date to recommend use of anidulafungin for first-line treatment of invasive candidiasis or for treatment of esophageal or oropharyngeal candidiasis in children (including HIV-infected children).25


Common Adverse Effects


GI effects (diarrhea,1 nausea1 3 5 6 8 ), phlebitis/thrombophlebitis,3 5 6 hypokalemia,1 8 12 increased ALT,1 3 increased alkaline phosphatase,1 increased γ-glutamyltransferase (GGT, γ-glutamyl transpeptidase, GGPT),1 3 7 12 headache,1 3 5 6 8 rash,1 3 neutropenia.1 3 5 6


Interactions for Eraxis


Does not inhibit or induce and is not a substrate for CYP isoenzymes.1 5 6 7 9 11 27 28


Drugs Metabolized by Hepatic Microsomal Enzymes


Pharmacokinetic interactions unlikely with drugs metabolized by CYP isoenzymes 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A.1 7 28


Drugs Affecting or Affected by P-glycoprotein Transport


Not an inhibitor or substrate of the P-glycoprotein transport system; pharmacokinetic interactions unlikely.11 27 30


Specific Drugs






























Drug



Interaction



Comments



Amphotericin B



No clinically important pharmacokinetic interactions1


In vitro evidence of additive antifungal effects against Candida, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis22


In vitro evidence of antagonism against some strains of Aspergillus flavus and A. terreus; in vitro evidence of synergism against some strains of A. fumigatus16



Anidulafungin dosage adjustment not necessary1


Clinical importance of in vitro studies unclear16 22



Fluconazole



In vitro evidence of additive or indifferent antifungal effects against C. albicans, C. glabrata; in vitro evidence of indifference against C. krusei, C. parapsilosis, C. tropicalis22



Clinical importance of in vitro studies unclear22



Flucytosine



In vitro evidence of additive or indifferent antifungal affects against C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis22



Clinical importance of in vitro studies unclear22



Immunosuppressive agents (cyclosporine, tacrolimus)



Cyclosporine: Increased anidulafungin AUC at steady state but no clinically important change in anidulafungin steady-state peak plasma concentrations; no effect on cyclosporine pharmacokinetics1 5 9 11


Tacrolimus: No clinically important pharmacokinetic interactions with oral tacrolimus1 14



Cyclosporine: Anidulafungin and cyclosporine dosage adjustments not necessary1 9 11


Tacrolimus: Anidulafungin and tacrolimus dosage adjustments not necessary1



Itraconazole



In vitro evidence of additive or indifferent antifungal effects against Candida, including C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. tropicalis22


Synergistic or indifferent antifungal effects against Aspergillus; indifferent effects against Fusarium16



Clinical importance of in vitro studies unclear16



Ketoconazole



In vitro evidence of additive or indifferent antifungal effects against C. albicans, C. glabrata, C. krusei, C. parapsilosis; in vitro evidence of antagonism against C. tropicalis22



Clinical importance of in vitro studies unclear16



Rifampin



No clinically important pharmacokinetic interactions1 6 11



Anidulafungin dosage adjustment not necessary1



Voriconazole



No clinically important pharmacokinetic interactions with oral voriconazole1 7 17



Anidulafungin and voriconazole dosage adjustments not necessary1 7


Eraxis Pharmacokinetics


Absorption


Plasma Concentrations


Linear relationship between dose and peak plasma concentration and AUC.30 31


Steady state achieved on the first day after an IV loading dose.1


Distribution


Extent


Crosses placenta in rats and detected in rat fetal plasma;1 not known whether crosses placenta in humans.1


Distributed into milk of lactating rats;1 not known whether distributed into human milk.1


Plasma Protein Binding


>99%.1


Elimination


Metabolism


Slow chemical degradation at physiologic temperature and pH; metabolite exhibits no antifungal activity.1 5 6 7 12


Elimination Route


Eliminated principally in feces via the biliary tract.5 28 30 Following a single IV dose, 30% recovered in feces over 9 days (<10% as unchanged drug); <1% excreted in urine.1 5 7 28


Half-life


Distribution half-life is 0.5–1 hour;1 terminal elimination half-life is 27–52 hours.1 5 28


Special Populations


Geriatric adults: Median clearance in adults ≥65 years of age slightly less than that in younger adults; dosage adjustments not required.1


Hepatic impairment: Not metabolized in the liver;1 6 7 9 concentrations not increased in adults with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).1


Renal impairment or end-stage renal disease: Negligible renal clearance; pharmacokinetics not affected by mild, moderate, or severe renal impairment.1


Not removed by hemodialysis.1


Stability


Storage


Parenteral


Powder for IV Infusion

2–8°C;1 do not freeze.1


Following reconstitution with sterile water for injection, store at 2–8°C for ≤1 hour;1 do not freeze.1 Following further dilution in 5% dextrose injection or 0.9% sodium chloride injection to a concentration of 0.77 mg/mL, store at 2–8°C and administer within 24 hours of preparation.1 Do not freeze.1


Compatibility


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


Parenteral


Solution Compatibility





Compatible



Dextrose 5%



Sodium chloride 0.9%


Actions and SpectrumActions



  • Echinocandins (e.g., caspofungin, micafungin, anidulafungin) differ structurally and pharmacologically from other available antifungals.1 2 4 5 6 7 11




  • Inhibits synthesis of β-d-glucan, an essential component of fungal cell walls that is not present in mammalian cells.1 2 3 4 5 7




  • May be fungistatic or fungicidal in action.1 2 3 4 5 7 13




  • Active in vitro against Candida, including C. albicans,1 10 11 29 C. dubliniensis,11 23 C. glabrata,1 10 11 13 C. guilliermondii,1 10 C. keyfri,10 C. krusei,1 10 11 C. lusitaniae,10 C. metapsilosis,37 C. orthopsilosis,37 C. parapsilosis,1 10 37 and C. tropicalis.1 10 11 27 30 31




  • Active against some strains of fluconazole-resistant C. albicans,1 10 C. glabrata,10 29 and C. krusei.10




  • Active in vitro against Aspergillus, including A. fumigatus, A. flavus, A. niger, and A. terreus.2 4 5 6 7 11 12 27 29 30 31




  • Like other echinocandins, not active against Cryptococcus neoformans,2 4 5 11 27 29 30 31 Trichosporon,2 29 31 33 Fusarium,2 4 11 27 31 33 or zygomycetes.2 4 29 30 31 33




  • Potential for development of resistance or for cross-resistance with other echinocandins (caspofungin, micafungin) not known.1 2 6 11 12




  • Active against some strains of C. glabrata resistant to caspofungin13 and C. parapsilosis resistant to caspofungin and micafungin.36



Advice to Patients



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




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.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.


















Anidulafungin

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Parenteral



For injection, for IV infusion



50 mg



Eraxis



Pfizer



100 mg



Eraxis



Pfizer



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 November 2009. 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. Pfizer Inc. Eraxis (anidulafungin) for injection prescribing information. New York, NY; 2009 Jun.



2. Denning DW. Echinocandin antifungal drugs. Lancet. 2003; 362:1142-51. [IDIS 504895] [PubMed 14550704]



3. Krause DS, Simjee AE, van Rensburg C et al. A randomized, double-blind trial of anidulafungin versus fluconazole for the treatment of esophageal candidiasis. Clin Infect Dis. 2004; 39:770-5. [PubMed 15472806]



4. Zaas AK, Alexander BD. Echinocandins: role in antifungal therapy, 2005. Expert Opin Pharmacother. 2005; 6:1657-68. [PubMed 16086652]



5. Murdoch D, Plosker GL. Anidulafungin. Drugs. 2004; 64:2249-58. [PubMed 15456342]



6. Vazquez JA. Anidulafungin: a new echinocandin with a novel profile. Clin Ther. 2005; 27:657-73. [PubMed 16117974]



7. Raasch RH. Anidulafungin: review of a new echinocandin antifungal agent. Expert Rev Anti Infect Ther. 2004; 2:499-508. [PubMed 15482216]



8. Krause DS, Reinhardt J, Vazquez JA et al. Phase 2, randomized, dose-ranging study evaluating the safety and efficacy of anidulafungin in invasive candidiasis and candidemia. Antimicrob Agents Chemother. 2004; 48:2021-4. [PubMed 15155194]



9. Dowell JA, Stogniew M, Krause D et al. Assessment of the safety and pharmacokinetics of anidulafungin when administered with cyclosporine. J Clin Pharmacol. 2005; 45:227-33. [PubMed 15647416]



10. Pfaller MA, Boyken L, Hollis RJ et al. In vitro activities of anidulafungin against more than 2,500 clinical isolates of Candida spp., including 315 isolates resistant to fluconazole. J Clin Microbiol. 2005; 43:5425-7. [PubMed 16272464]



11. Cappelletty D, Eiselstein-McKitrick K. The echinocandins. Pharmacotherapy. 2007; 27:369-88. [PubMed 17316149]



12. Vazquez JA, Sobel JD. Anidulafungin: a novel echinocandin. Clin Infect Dis. 2006; 43:215-22. [PubMed 16779750]



13. Cota J, Carden M, Graybill JR et al. In vitro pharmacodynamics of anidulafungin and caspofungin against Candida glabrata isolates, including strains with decreased caspofungin susceptibility. Antimicrob Agents Chemother. 2006; 50:3926-8. [PubMed 16940061]



14. Dowell JA, Stogniew M, Krause D et al. Lack of pharmacokinetic interaction between anidulafungin and tacrolimus. J Clin Pharmacol. 2007; 47:305-14. [PubMed 17322142]



15. Dowell JA, Stogniew M, Krause D et al. Anidulafungin does not require dosage adjustment in subjects with varying degrees of hepatic or renal impairment. J Clin Pharmacol. 2007; 47:461-70. [PubMed 17389555]



16. Philip A, Odabasi Z, Rodriguez J et al. In vitro synergy testing of anidulafungin with itraconazole, voriconazole, and amphotericin B against Aspergillus spp. and Fusarium spp. Antimicrob Agents Chemother. 2005; 49:3572-4. [PubMed 16048988]



17. Dowell JA, Schranz J, Baruch A et al. Safety and pharmacokinetics of coadministered voriconazole and anidulafungin. J Clin Pharmacol. 2005; 45:1373-82. [PubMed 16291712]



18. Benjamin DK, Driscoll T, Seibel NL et al. Safety and pharmacokinetics of intravenous anidulafungin in children with neutropenia at high risk for invasive fungal infections. Antimicrob Agents Chemother. 2006; 50:632-8. [PubMed 16436720]



19. Reboli AC, Rotstein C, Pappas PG et al. Anidulafungin versus fluconazole for invasive candidiasis. N Engl J Med. 2007; 356:2472-82. [PubMed 17568028]



21. Anon. Antifungal drugs. Treat Guidel Med Lett. 2008; 6:1-8. [PubMed 18157085]



22. Karlowsky JA, Hoban DJ, Zhanel GG et al. In vitro interactions of anidulafungin with azole antifungals, amphotericin B and 5-fluorocytosine against Candida species. Int J Antimicrob Agents. 2006; 27:174-7. [PubMed 16414247]



23. Jacobsen MD, Whyte JA, Odds FC. Candida albicans and Candida dubliniensis respond differently to echinocandin antifungal agents in vitro. Antimicrob Agents Chemother. 2007; 51:1882-4. [PubMed 17307974]



24. Pappas PG, Kauffman CA, Andes D et al. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009; 48:503-35. [PubMed 19191635]



25. Mofenson LM, Brady MT, Danner SP et al. Guidelines for the Prevention and Treatment of Opportunistic Infections among HIV-exposed and HIV-infected children: recommendations from CDC, the National Institutes of Health, the HIV Medicine Association of the Infectious Diseases Society of America, the Pediatric Infectious Diseases Society, and the American Academy of Pediatrics. MMWR Recomm Rep. 2009; 58:1-166. [PubMed 19730409]



26. Kaplan JE, Benson C, Holmes KH et al. Guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. MMWR Recomm Rep. 2009; 58:1-207; quiz CE1-4. [PubMed 19357635]



27. Estes KE, Penzak SR, Calis KA et al. Pharmacology and antifungal properties of anidulafungin, a new echinocandin. Pharmacotherapy. 2009; 29:17-30. [PubMed 19113794]



28. Damle BD, Dowell JA, Walsky RL et al. In vitro and in vivo studies to characterize the clearance mechanism and potential cytochrome P450 interactions of anidulafungin. Antimicrob Agents Chemother. 2009; 53:1149-56. [PubMed 19029327]



29. Morris MI, Villmann M. Echinocandins in the management of invasive fungal infections, part 1. Am J Health Syst Pharm. 2006; 63:1693-703. [PubMed 16960253]



30. Kauffman CA, Carver PL. Update on echinocandin antifungals. Semin Respir Crit Care Med. 2008; 29:211-9. [PubMed 18366002]



31. Kim R, Khachikian D, Reboli AC. A comparative evaluation of properties and clinical efficacy of the echinocandins. Expert Opin Pharmacother. 2007; 8:1479-92. [PubMed 17661730]



32. Juang P. Update on new antifungal therapy. AACN Adv Crit Care. 2007 Jul-Sep; 18:253-60; quiz 261-2.



33. de la Torre P, Meyer DK, Reboli AC. Anidulafungin: a novel echinocandin for candida infections. Future Microbiol. 2008; 3:593-601. [PubMed 19072176]



34. Vazquez JA, Schranz JA, Clark K et al. A phase 2, open-label study of the safety and efficacy of intravenous anidulafungin as a treatment for azole-refractory mucosal candidiasis. J Acquir Immune Defic Syndr. 2008; 48:304-9. [PubMed 18545153]



35. Eschenauer G, Depestel DD, Carver PL. Comparison of echinocandin antifungals. Ther Clin Risk Manag. 2007; 3:71-97. [PubMed 18360617]



36. Moudgal V, Little T, Boikov D et al. Multiechinocandin- and multiazole-resistant Candida parapsilosis isolates serially obtained during therapy for prosthetic valve endocarditis. Antimicrob Agents Chemother. 2005; 49:767-9. [PubMed 15673762]



37. Lockhart SR, Messer SA, Pfaller MA et al. Geographic distribution and antifungal susceptibility of the newly described species Candida orthopsilosis and Candida metapsilosis in comparison to the closely related species Candida parapsilosis. J Clin Microbiol. 2008; 46:2659-64. [PubMed 18562582]



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