Erase (Sotrat)
Pregnancy is an absolute contraindication for therapy with Sotret, the active substance of which is isotretinoin. Isotretinoin has a strong teratogenic effect. If pregnancy occurs, despite warnings, during treatment with isotretinoin (orally, at any dose, and even for a short time) or within a month after the end of therapy, there is a very high risk of giving birth to a child with severe malformations.
Pregnancy Prevention Program
The drug Sotret is contraindicated in women of childbearing age, unless the woman’s condition meets all of the following criteria:
- she must have severe acne that is resistant to conventional treatments;
- she must clearly understand the need for careful monthly medical supervision and follow the doctor’s instructions;
- she is informed by the doctor about the danger of pregnancy during treatment with Sotret and within one month after treatment, and about the need for urgent consultation if there is a risk of pregnancy;
- she should be warned about the possible ineffectiveness of contraceptives;
— she must confirm that she understands and understands the risk factors and the essence of precautionary measures;
- she understands the need to use and must continuously use effective methods of contraception for one month before treatment with Sotret, during treatment and for a month after the end of treatment; it is advisable to use 2 different methods of contraception at the same time, including barrier;
- the patient understands and accepts that a pregnancy test must be performed monthly during treatment and 5 weeks after the end of therapy;
- she should begin treatment with Sotret only on the 2-3 day of the next normal menstrual cycle;
- when being treated for a relapse of the disease, she must constantly use the same effective methods of contraception for one month before starting treatment with Sotret, during treatment and for a month after its completion, as well as undergo the same reliable pregnancy test;
- she fully understands the need for precautions and confirms her understanding and desire to use reliable methods of contraception, which the doctor explained to her;
- even if there is amenorrhea, the patient should follow all recommendations for effective contraception.
Use of contraception as directed above during treatment with isotretinoin should be recommended even in women who do not routinely use contraception due to infertility (except in patients who have had a hysterectomy), amenorrhea, or who report not being sexually active.
The doctor must be sure that:
— the patient suffers from a severe form of acne (nodulocystic, conglobate acne or acne with a risk of scarring); acne that does not respond to other types of therapy;
- a negative result from a reliable pregnancy test was obtained before starting the drug, during therapy and 5 weeks after the end of therapy; the dates and results of the pregnancy test must be documented;
- the patient uses at least 1, preferably 2 effective methods of contraception, including a barrier method, for at least one month before starting treatment with Sotret, during treatment and for a month after its completion;
— the patient is able to understand and fulfill all of the above requirements for pregnancy protection;
— the patient meets all of the above conditions;
— the patient confirmed her understanding of the above conditions and agreement with them.
Contraception
Female patients should be provided with comprehensive information on preventing pregnancy and receive contraceptive advice if they are not using effective contraceptive methods.
The minimum requirement for patients with a potential risk of pregnancy is the use of at least one method of contraception. It is better for the patient to use two complementary methods of contraception, including a barrier method. The use of contraception, even in patients with amenorrhea, should be continued for at least 1 month after discontinuation of isotretinoin.
Pregnancy test
According to current practice, a pregnancy test with a minimum sensitivity of 25 mIU/ml should be performed in the first 3 days of the menstrual cycle: Before starting therapy:
— To exclude possible pregnancy, before starting contraception, the result and date of the initial pregnancy test must be recorded by a doctor. In patients with irregular menstruation, the timing of a pregnancy test depends on sexual activity and should be performed 3 weeks after unprotected intercourse. The doctor should inform the patient about contraceptive methods.
— A pregnancy test is carried out on the day of prescription of the drug Erase or 3 days before
patient's visit to the doctor. The specialist should record the results
testing. The drug can only be prescribed to patients receiving
effective contraception for at least 1 month before starting therapy with Sotret.
During therapy:
— The patient must visit the doctor every 28 days. The need for monthly pregnancy testing is determined in accordance with local practice and taking into account sexual activity and previous menstrual irregularities. If indicated, a pregnancy test is performed on the day of the visit or three days before the visit to the doctor, the test results must be recorded.
End of therapy:
- 5 weeks after the end of therapy, a test is performed to exclude pregnancy. A prescription for the drug Sotret for a woman capable of childbearing can be issued only for 30 days of treatment; continuation of therapy requires a new prescription of the drug by a doctor. It is recommended that a pregnancy test, writing a prescription and receiving the drug be carried out on the same day.
The drug Sotret should be dispensed at the pharmacy only within 7 days from the date of issuing the prescription.
Full information about teratogenic risk and strict adherence to pregnancy prevention measures should be provided to both men and women.
For male patients
Current evidence suggests that in women, exposure to isotretinoin from the semen and seminal fluid of men taking isotretinoin is not sufficient to produce the teratogenic effects of isotretinoin. Male patients should be reminded that they should not share their medicine with anyone, especially women.
In case of pregnancy
If during treatment with Sotret or within a month after its end, despite the precautions described in the pregnancy prevention program, the patient still becomes pregnant, there is a high risk of very severe fetal malformations (in particular, from the central nervous system , heart and large blood vessels). In addition, the risk of spontaneous miscarriage increases.
If pregnancy occurs, therapy with Sotret is discontinued. The advisability of maintaining it should be discussed with a doctor specializing in teratology. Severe congenital malformations of the human fetus have been documented associated with isotretinoin, including hydrocephalus, microcephaly, cerebellar malformations, external ear anomalies (microtia, narrowing or absence of the external auditory canal, absent external ear), microphthalmia, cardiovascular anomalies (tetrad Fallot, transposition of the great vessels, septal defects), malformations of the face (cleft palate), thymus gland, pathology of the parathyroid glands.
Because isotretinoin is highly lipophilic, it is very likely that it passes into breast milk. Due to possible side effects, isotretinoin should not be prescribed to nursing mothers.
Retinoids (in-depth review)
Acnecutane, Roaccutane, Erase
Acnecutane, Roaccutane, Erase
Systemic retinoids contain the active ingredient isotretinoin. This substance has been used in world medicine for almost 40 years and is the gold standard for the treatment of acne and acne.
What kind of substance is this? This is trans-retinoic acid and it very powerfully suppresses the activity of the sebaceous glands.
When does acne occur?
Acne occurs when, under the influence of excessive effects of the hormone testosterone on the sebaceous gland, powerful production of sebum in large quantities is stimulated.
How do systemic retinoids work?
Systemic retinoids act on the sebaceous gland receptors, joining the sebaceous gland receptors, they inhibit the activity of sebum secretion from the gland and acne goes away.
The most frequently prescribed drugs from systemic retinoids (approved in the Russian Federation):
- Roaccutane
- Aknekutan
- Will erase
Comment from cosmetologist, dermatologist Yuliana Shiyan:
When I prescribe one of these drugs, I am asked why this particular drug and what is the difference between retinoids? All these drugs have one substance in common: Isotretinoin. Roaccutane was the very first to appear. This is the original drug, and all other drugs are its *generics. All generics of isotretinoin have their own registration certificates and are approved in Russia.
*GENERIC - approved copy of the original drug
Roaccutane and Sotret practically do not differ from each other either in formula or dose. When assigning them, there is no difference and the choice in favor of one or the other is immaterial. Acnecutane contains the same substance, but its formula is slightly different from Roaccutane and Sotret.
Why is Acnecutane more interesting for a cosmetologist and the patient himself, as a choice for treatment and how to understand which retinoid drug is better?
Isotretinoin is a fat-soluble substance. It is absorbed by the body only in combination with absorbed fats. If you take Roaccutane and wash it down with plain water, you will absorb less than 40% of it. If you take Acnecutan and drink it with plain water, it will be absorbed by the body by about 70%.
When prescribing Acnecutane, the doctor insures patients against their own mistakes. Patients may neglect fatty foods while taking Roaccutane and Sotret, forget to eat anything fatty or fatty foods are forbidden to them (on a diet), and the required dose of the drug must enter the body! Necessary, not a small part of it! Therefore, the drug Acnekutan is more preferable for the patient; a lack of fat when taking it is less likely to affect the outcome of treatment.
Its daily dose is regulated by the doctor, but there is also a cumulative dosage of the drug that the patient’s body must accumulate. It is when it is achieved that we can talk about a high chance of stable remission in the patient.
Due to the fact that Acnecutane is better absorbed, the manufacturer made slightly less active ingredient in one dose, which means: The working dose is 20 mg. Roaccutane corresponds to the working dose of Acnecutane with 16 milligrams of Isotretinoin.
The conclusion is simple: if less isotretinoin accumulates in the body, then the risks of side effects are also reduced. This is very good for the patient!
For ardent supporters of all original and original drugs, Roaccutane is recommended. But all other retinoids will be useful for you, provided that they are prescribed by a dermatologist, and you, in turn, comply with all the conditions for taking retinoids.
