Erase or Roaccutane - which drug is better and what is the difference between them?

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.

Roaccutane and Sotret: similarities and differences

Roaccutane is a drug from the Swiss company Roche, intended for the treatment of complex forms of acne: nodular cystic and atypical acne, rashes with a tendency to scarring.

Another criterion is the area of ​​the lesion - the involvement in the process of not only the facial skin, but also other parts of the body.

The drug is available in the form of capsules - 30 pieces per package. The active ingredient is isotretinoin (vitamin A) in a dosage of 10 or 20 mg.

Sotrat is an Indian generic (analogue) of Roaccutane, produced by Ranbaxy. Sold in the same form and dosage.

Compound

The difference between Sotret and Roaccutane in the chemical formula is almost invisible . They use soybean oil as regulators. However, Roaccutane contains a little more of it, and, on the contrary, less gelatin.

The beeswax in Sotret is white, not yellow like the original. Roaccutane additionally contains starch and polyhydric alcohols, which are not found in Sotret.

Effect of drugs

Isotretinoin blocks the sebaceous glands , and their production of sebum is reduced. While you are taking the drug (the recommended course of treatment is 6–9 months), the sebaceous glands decrease in size and no longer increase.

This explains the stable results of the treatment. Your skin type will also change – from oily to normal.

Isotretinoin is completely eliminated from the body by the liver in 2–4 weeks. Therefore, violation of its functions is one of the main contraindications .

What is the danger?

Taking the drugs is prohibited without medical supervision, even in small doses , as there are a number of restrictions on use, in addition, quite serious side effects may occur:

• dryness and flaking of the skin;
• increased sensitivity to the sun;
• hair loss;
• dry mouth;
• joint pain;
• high fatigue, depression.

Isotretinoin treatment is strictly prohibited for some people. Contraindications :

1. Pregnancy and lactation period. Sotret and Roaccutane belong to the group of the most highly teratogenic drugs - they can cause malformations of the embryo. It is not recommended to take the medicine if you are planning a pregnancy (within several months before conception). During treatment it is necessary to carefully protect yourself.
2. Acute liver failure. Sometimes patients are prescribed parallel medications to improve liver function.
3. Childhood. Treatment with Roaccutane and Sotret is prohibited for children under 13 years of age.
4. Therapy is prescribed with extreme caution for diabetes and depression.

While taking medications, it is necessary to monitor liver tests, urea, blood glucose levels, and retinol density every month.

The comparison between Roaccutane and Sotret is also based on the main difference between the medications: Roaccutane is an original drug, Sotret is a generic . There is no consensus on the effectiveness of originals and analogues.

They are believed to have approximately the same effect . You may have your own opinion on this issue. To do this, it is enough to understand the definitions.

Originals or generics?

An original medicine (in our case it is Roaccutane) is a drug that is developed by a pharmaceutical company through molecular synthesis. Then the drug is tested on animals and special artificial organisms.

The third stage lasts about 10 years - the medicine is tested on humans . The cost of such research is very high - more than $1 billion. After testing, the drug is patented and supplied to pharmacies.

The duration of patents is about 10 years . During this time, the pharmaceutical company must recoup its development costs.

After 8–10 years, the license to produce the drug is sold to everyone . Competing companies are beginning to produce exact copies of the medicine - generics, which are much more affordable than the originals.

When choosing from analogues, give preference to drugs manufactured in Europe and America. They are considered the best in quality.

So what should you choose?

You can hear both positive and negative reviews from patients about all the proposed drugs. When prescribing treatment, dermatologists rely on reliable facts.

Roaccutane

Advantages:

1. Reliability - original drugs have been tested by time and numerous tests; analogues are usually not tested.
2. Quality – only the highest quality components are used in the originals.

Disadvantages : high price.

Will erase

Advantages : affordable price - if the economic component of therapy plays a decisive role, feel free to choose Erast.

Disadvantages : Treatment may be more difficult to tolerate and take longer.

Aknekutan

Advantages : best price-quality ratio.

Disadvantages : special studies on the use of Acnecutane have not been conducted.

Systemic retinoid therapy often works wonders for patients' skin. But it is necessary to weigh the effectiveness of the drug against the risk of its effect on the body.

Only a correctly prescribed drug is safe . Don't try to heal yourself! You can change your life for the better only if the recovery process takes place under the supervision of a qualified specialist.

Or or. There is no third?

Recently, another analogue of Roaccutane has gone on sale - the Belgian drug Acnecutane . Or rather, it’s not even entirely analogous.

Acnekutan is produced using a different, more modern technology. The drug has very significant advantages :

1. Innovative Lidose (“solid solution”) technology and two additional components increase the bioavailability of isotretinoin by 20%. It turns out that 16 mg of Acnecutane is equivalent to 20 mg of Roaccutane. The amount of isotretinoin entering the body is reduced by 20%. The results of treatment are maintained, and the number of side effects is reduced.
2. Acnecutane is better absorbed without food. Roaccutane is taken with meals; it must be “snacked” with fatty foods. This is not always convenient.
3. The quality of Aknekutan meets the best European standards.
4. Acnecutane is cheaper than Roaccutane. But the price difference is not as great as that of Sotret.