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Isotretinoin Ipledge

isotretinoin ipledge

Why is this medication prescribed?

Isotretinoin is used to treat severe recalcitrant nodular acne (a certain type of severe acne) that has not been helped by other treatments, such as antibiotics. Isotretinoin is in a class of medications called retinoids. It works by slowing the production of certain natural substances that can cause acne.

How should this medicine be used?

Isotretinoin comes as a capsule to take by mouth. Isotretinoin is usually taken twice a day with meals for 4 to 5 months at a time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take isotretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole with a full glass of liquid. Do not chew, crush, or suck on the capsules.

Your doctor will probably start you on an average dose of isotretinoin and increase or decrease your dose depending on how well you respond to the medication and the side effects you experience. Follow these directions carefully and ask your doctor or pharmacist if you are not sure how much isotretinoin you should take.

It may take several weeks or longer for you to feel the full benefit of isotretinoin. Your acne may get worse during the beginning of your treatment with isotretinoin. This is normal and does not mean that the medication is not working. Your acne may continue to improve even after you finish your treatment with isotretinoin.

A Decrease in Prescriptions

Nearly 6 months into the program that’s been called confusing at best and inordinately complex and cumbersome at worst, dermatologists are either putting up with the hassles or opting out. Certain early technical and logistical problems, such as long telephone wait times — more than an hour, in some cases — to reach the iPLEDGE call center and conflicting responses from representatives to inquiries, have been largely resolved. But the rigidity of the requirements (even the FDA acknowledges that iPLEDGE’s complexity is unprecedented) and time consumed in complying with those requirements, have prompted some dermatologists to say “no thanks” to iPLEDGE — which went into effect March 1 despite requests from the AAD and others to delay its implementation.

“There are some dermatologists who are no longer prescribing isotretinoin because of the difficulties encountered with the system and the problems with timing office visits,” says Diane Thiboutot, M.D., who chairs the American Academy of Dermatology’s Ad Hoc Task Force on Isotretinoin and practices in a 24-dermatologist group practice at Pennsylvania State University in Hershey, PA.

What is iPledge?

The iPledge program aims to inform patients about the teratogenic effects of isotretinoin (Accutane). All patients must be enrolled in the iPledge program prior to starting treatment. Females must be on two forms of birth control or choose abstinence one month before the start date and stay on the chosen method throughout the duration of treatment.

What side effects can this medication cause?

Isotretinoin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • red, cracked, and sore lips
  • dry skin, eyes, mouth, or nose
  • nosebleeds
  • changes in skin color
  • peeling skin on the palms of the hands and soles of the feet
  • changes in the nails
  • slowed healing of cuts or sores
  • bleeding or swollen gums
  • hair loss or unwanted hair growth
  • sweating
  • flushing
  • voice changes
  • tiredness
  • cold symptoms

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