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Isotretinoin (Claravis, Amnesteem, Sotret)
What is Isotretinoin?
Isotretinoin is the closest thing to a cure for severe acne that has been invented thus far. isotretinoin is a vitamin A derivative that has been found to be very effective in severe acne and several other conditions.
In most cases it will improve acne to an impressive degree, and many adult patients are permanently cured, needing no further acne therapy. Others will require mild topical therapy for maintenance, and a small minority (about 7-10%) will require a second course of isotretinoin. Very rarely a third course is needed. The permanent success rate is lower for women, but still very high.
Why does Isotretinoin work for acne?
Exactly why isotretinoin is so effective is not completely clear. It seems that this medication shuts down the functioning oil gland and loosens the plugs in the pores emptying them out during the five or six months the medication is used.
Can I get the brand name, Accutane?
The branded version of isotretinoin, Accutane is no longer made, but other generics are available (Claravis, Amnesteem, Sotret).
Can anyone receive Isotretinoin?
Isotretinoin is prescribed by dermatologists for patients with severe acne. This medication is so strong that both patients and dermatologists must follow careful guidelines during its use. In order for patients to use the Isotretinoin treatment regimen, they much participate in the government iPLEDGE program to ensure that all risks are minimized.
What is iPLEDGE?
iPLEDGE is a US government regulated program. Participation is required in order to receive treatment with isotretinoin in the United States. The program was started to help insure that no one gets pregnant while taking isotretinoin, and that no one shares pills or donates blood.
For women, part of the program is requirements for contraceptive use if they are sexually active, and for monthly pregnancy tests before, during, and after medication treatment. For both men and women the program requires registration and reminders not to share pills or donate blood for one year after completion of isotretinoin. You cannot receive isotretinoin in the United States without participating in iPLEDGE.
How long will I be on isotretinoin?
Length of use of medication is approximately 16-20 weeks at standard dose. In more severe cases, or at lower doses, it may be used longer. The dose is based on body weight.
Do I have to do blood tests on isotretinoin?
Yes, monthly blood tests are required while taking isotretinoin.
How is isotretinoin treatment different for women?
The only differences for women are that they are required to use two forms of birth control if they are sexually active and they must do monthly pregnancy tests in order to receive isotretinoin.
- Follow-up visits are now always every 30 days under iPLEDGE, a government-mandated program designed to prevent female patients “of child bearing potential” from becoming pregnant if they are taking the drug.
- Dispense – You will be provided with only 30 days’ worth of the isotretinoin at a time.
What Patients need to know about this drug
1. There are drug interactions with isotretinoin. Do not take this with tetracycline, minocycline or doxycycline. Other antibiotics are safe, as are vitamin preparations containing regular doses of vitamin A.
2. Isotretinoin must be taken with food, preferably fatty food. To help absorb the drug, you could eat a tablespoon of peanut butter with each capsule, but any type of fatty food is fine.
3. Note that acne may worsen and sometimes flares during the third to fifth week on the medication. Intermittent flares will occur during the course of treatment as the deeper spots come to the surface.
4. Wash gently with unscented mild cleansers like Dove or Cetaphil cleanser.
5. Do not scrub your face. Wash gently with your hands.
What are the side effects from isotretinoin?
This medication has many side effects at higher doses, but most of them are mild at the lower doses we now use and can be readily managed through the period on the isotretinoin. Overall this drug is very safe when used correctly. Dr. Jennifer Janiga encourages her patients to read all the information in the isotretinoin book and package insert that come with your prescription, and on the web site www.ipledgeprogram.com. These sources will ensure that you are aware of all possible side effects.
What are some of the common side effects with isotretinoin?
- Chapped lips – cheilitis – occurs in almost all patients and can be quite sever at higher doses. It seems to get better with time. Simple Vaseline Petroleum Jelly, Vaseline with sun block, Aquaphor or plain lanolin is often enough to control this.
- Dryness - use Vaseline Petroleum Jelly or Aquaphor after wetting with water. A moisturizer like Cetaphil Moisturizing Cream, Nutraderm, or Vanicream may be enough. If you are still having problems, consult with Dr. Janiga.
- Itching – as the skin gets drier, you may feel itching that will be improved by the use of a moisturizer. In rare cases Dr. Janiga may have to prescribe a medication to help alleviate the condition.
- Eye Problems – if the eyelids get dry, there can be irritation of this area. Blepharoconjunctivits, which is rare, may be a problem in those who are wearing contact lenses. Try saline drops multiple times per day to combat this dryness. This may persist after isotretinoin is stopped. A decrease in night vision, though rare, can also occur, making night driving dangerous. Spontaneous recovery normally occurs once off isotretinoin. Cloudiness in the cornea of the eyes is rare and resolves spontaneously.
- Sun sensitivity- means you are more likely to get sunburned in a short period of time. This can be very marked and it is essential that sun avoidance, proper clothing and full spectrum UVA/UVB sunscreens be used during sun exposure. A lotion or cream sunscreen or block with a sun protection factor (SPF) of 50 or greater is essential. Always wear a broad brimmed hat. Alcohol based spray sunscreens are not recommended because they dry out the skin even further.
- Hair Thinning – this is quite uncommon, temporary, and usually reversible once isotretinoin has been discontinued.
- Dry Nose and nosebleeds- as lips dry, nose lining can dry too. One can develop nosebleeds easily. Again, lots of Vaseline Petroleum jelly is necessary, apply inside of the nose with a Q-tip. Let Dr. Janiga know if you have frequent nosebleeds.
- Pyogenic granuloma – at sites of broken skin such as hang-nails or even open acne cysts, one can develop small red heaped-up areas of skin that can persist during the course of medication. These require local removal or super potent steroid ointment if they persist.
- Acne flare ups- occur usually at about weeks 3 through 5. Intra-lesional injection of cysts with a dilute cortisone solution may be needed. Call the office if you have a significant flare-up, Dr. Janiga will examine you and see if additional treatments are necessary.
- Skin Fragility – Totally avoid waxing for hair removal. Do not “pick” blemishes.
General Side Effects
- Headache occurs in 5% of patients. This is most commonly seen when, by mistake, patients have stayed on their tetracycline, doxycycline, or minocycline, or been given a prescription of these for something else.
- Acute depression, crying, irritability – Acne of various degrees is associated with depressed mood, and understandably so. There have been reports of worsening depression and even rare suicides in patients on isotretinoin.
- Anthralgia, myalgia, bone pain – These joint, muscle, bone aches and pains usually occur patients with previous injuries or arthritis or those involved in contact sports. Uncommonly this can occur in normally healthy people.
- Elevation in blood fats (cholesterol and triglycerides) (50%) - Isotretinoin seems to mobilize stores of fat in susceptible individuals so that there are mild elevations in these particular blood lipids or fats. Usually this is of no consequence. This lipid/triglyceride alteration is aggravated by alcohol, so alcohol consumption should be limited during isotretinoin therapy.
- Blood sugar abnormalities (rare) - Diabetics or pre-diabetics may have difficulty with control of blood sugar. You should report any personal or family history of diabetes.
- Blood in urine or stool – Blood in urine or stool must be reported to Dr. Janiga immediately.
- Hepatitis – This can occur rarely. Report any pale stool, dark urine or color change of the skin to Dr. Janiga.
- Inflammatory Bowel Disease- There have been rare reports of induction of cases of inflammatory bowel disease by isotretinoin. If you have a family history of one of these diseases you should discuss that with Dr. Janiga before starting isotretinoin.
- Miscellaneous – Patients who experience hearing impairments like ringing in ears, or any changes in hearing, should stop the medication and call Dr. Jennifer Janiga for assessment.
- The following side effects have rarely been reported – pancreatitis (inflammation of the pancreas associated with elevated lipids-blood fats), bronchospasm, stroke and vascular thrombotic disease. Allergic reactions such as rashes are also rare.
This medication is absolutely forbidden for patients who are pregnant or could get pregnant.
Birth Defects – There is absolutely no doubt that isotretinoin causes major deforming birth defects, but it has an effect only on a growing fetus. One month after the isotretinoin has been stopped; it is out of the system and will have no effect at all on pregnancy and the development of a baby.
Birth Control Requirement – Before isotretinoin is used, female patients must be on birth control ( usually “the pill”) for 1 month before they start the medication and for the whole time they are on the isotretinoin, and for one month after they have stopped the isotretinoin. Two negative pregnancy tests must be obtained before starting the isotretinoin and must be rechecked monthly while on the medication and again 1 month after completing the treatment.
Government require program regarding isotretinoin:
Do you see patients for Isotretinoin treatment in your Reno office?
Yes. We evaluate and treat patients with severe acne and who may be candidates for isotretinoin treatment. Appointment length varies and depends on severity of condition and other contributing factors, as well as completion of required tests, but is usually not more than 30 minutes in duration.
For more information, or to set up a consultation with Dr. Jennifer Janiga for your isotretinoin treatment and evaluation in our Reno/Tahoe dermatology offices, please send us an email or call 775-398-4600.
Jennifer J. Janiga, MD, FAAD
Dr. Janiga enjoys taking care of both adults and children. Her extensive training and years of experience in medical dermatology, lasers, and cosmetic procedures allows her to treat her patients with the comprehensive attention they deserve.
Dr. Janiga listens attentively to what patients have to say, and works with them in planning the right course of action on an individual basis. Honest talk, humility and a fresh perspective paired with years of experience and education all contribute to the effectiveness of her straightforward care.