Roaccutane - 35 reviews, instructions for use

Compound

Components of the drug:

the main substance is isotretinoin;
soybean oil (fully and partially hydrogenated);
beekeeping product - wax.

The shell consists of:

glycerol;
gelatin;
sorbitol;
mannitol;
hydrolyzed potato starch;
titanium dioxide;
the coloring component is red iron oxide.

Ink is applied to the shell. They consist of a dye - black iron oxide and shellac. Sometimes a ready-made pigment is used - Opacode Black S-1-27794.

Contraindicated

Vagility and period of breastfeeding; the unknown of all minds “Programs for the advance of gestation” for women of the reproductive age; increased sensitivity to isotretinoin and to any components of the drug; liver failure; hyperlipidemia is evident; hypervitaminosis A; adjunctive therapy with tetracyclines. Let's talk about Roaccutane ®

Mix soybean oil, partially hydrogenated soybean oil and hydrogenated soybean oil, a drug contraindicated for use in patients with allergies to peanuts and soybeans.

Forms of release and cost

Roaccutane (the instructions for use indicate that the drug is available in capsule form) has 2 release forms, based on the concentration of the main substance:

The terracotta-colored, oval-shaped capsules have an inscription on a black dye shell. Isotretinoin content – 10 mg. It contains a homogeneous powder, the tone of which varies from yellow to dark yellow.
The capsule is divided in half into 2 colors: terracotta and white. The design remains the same, the presence of isotretinoin changes - 20 mg.

Roaccutane is dispensed in blister packs, which are placed in cardboard packs.

Price range – 2000 to 4000 rubles. The cost depends on pharmacies and region.

Price

The drug is available to buy in Moscow at a pharmacy or online store.

In the second case, you can save a little; a home delivery service is also provided.

The average cost of the product is 1600-1800 rubles .

This drug is dispensed upon presentation of a prescription.

Indications for use

The drug is prescribed for the following forms of acne:

nodular cystic;
with the risk of scarring;
conglobate.

Roaccutane is prescribed in certain cases when acne cannot be cured by other means.

Contraindications

Roaccutane (the instructions for use included in the package describe a number of contraindications) is prohibited in the following cases:

Lactation period.
Carrying a child.
Children under 12 years old.
Allergic reaction to the components of the drug.
Elevated levels of lipids in the blood.
Excessive intake of vitamin A into the body.
Treatment with an antibiotic from the tetracycline group.
Liver dysfunction.

Take with caution when:

diabetes mellitus;
drinking alcoholic beverages;
overweight;
depressive disorders;
disturbances in the production and breakdown of fats in the liver and adipose tissue.

When treating with Roaccutane, UVR-ultraviolet irradiation therapy is contraindicated.

Precautionary measures

The drug should not be taken by persons:

under 12 years of age;
pregnant women and breastfeeding women;
having individual intolerance and sensitivity to the medicinal components included in Roaccutane;
having hypervitaminosis A, liver failure.
taking tetracycline. Both drugs increase intracranial pressure;
taking vitamin A. Since hypervitaminosis may occur;
who use contraceptives that contain progesterone, because Roaccutane reduces its effect.

Prescription of the drug to persons with diabetes mellitus, alcoholism, obesity, and those prone to depressive and suicidal conditions is carried out with extreme caution and under the constant supervision of the course of treatment by a specialist.

When taking Roaccutane, the following rules should be followed:

do not stay in direct sunlight, and if you cannot avoid exposure, use strong sunscreens;
do not perform hair removal procedures or other cosmetic procedures (during treatment and a year after completion);
avoid laser and surgical procedures;
do not become a blood donor (including a month after the end of treatment), there may be an accidental effect of the drug substance on the body of other people;
control the functioning of the liver and its enzymes;
moisturize the skin of the face, lips and body with balms, creams, gels;
avoid driving a car at night;
monitor changes in vision, visit an ophthalmologist regularly;
wear glasses instead of contact lenses, use moisturizing eye drops or ointments;
refrain from drinking alcoholic beverages, as the drug and alcohol have a dangerous, serious effect on the liver and kidneys;
women need to visit a gynecologist every month and take a pregnancy test;
women who are sexually active must use 2 contraceptives during treatment and a month after completion;
do not perform dermabrasion;
Avoid intense physical activity and active sports.

Side effects

The occurrence of side effects depends on the dosage. They are eliminated after adjusting the dose or stopping the medication. Sometimes unpleasant symptoms remain even after therapy.

Scheme of action of the drug Roaccutane.

List of possible side effects:

Pain in the head.
Nausea and vomiting.
Fear of light.
Visual impairment.
Hearing loss.
Frequent loose stools.
Inflammation of the pancreas.
Bleeding from the mucous membranes of the nose.
Decreased hemoglobin concentration.
Reduction of red bodies, leukocytes, neutrophilic granulocytes in the blood.
Bronchospastic syndrome (usually in people with bronchial asthma).
Muscle pain, inflammation in joints, ligaments.
Inflammation and degeneration of tendon tissue.
Increased growth of bone tissue in an excessive form.
Hives, itching.
Hyperhidrosis – excessive sweating.
Hair loss.
Pathological changes in the nail plates.
Inflammation of the nail fold.
Excessive hair growth in women, characteristic of men.
Particular sensitivity of the skin and mucous membranes to ultraviolet radiation and the sun.
Dry skin and mucous membranes.
Various allergic reactions.

Scientific studies have shown that most often after consuming Roaccutane, facial dermatitis and cheilitis appear - an inflammatory process that affects the skin, mucous membrane and red border of the lips.

Side effects

Any side effects of isotretinoin vary depending on the dose. Adverse reactions may be reversed after dose adjustment or administration of the drug, but these actions may be avoided after treatment. The symptoms most often reported with isotretinoin ingestion are dry skin, mucous membranes, including lips (cheilitis), nasal passages (nosebleeds), and eyes (conjunctivitis).

To describe the frequency of adverse reactions, the following categories are used: very broad (≥ 1/10), very wide (≥ 1/100, < 1/10), rarely wide (≥ 1/10000, < 1/1000), very rare (< 1/10000) and the frequency is unknown (cannot be insured on the basis of actual data). In the skin group, by frequency and class of organ systems, adverse reactions are presented in order of decreasing severity.

Infections:

Very rarely, gram-positive bacterial infections of the skin and mucous membranes are widespread.

Disorders on the side of the blood and lymphatic systems:

even more widespread - anemia, accelerated cervical renal failure, thrombocytopenia, thrombocytosis; wider – neutropenia; very rarely widened - lymphadenopathy.

Deal with the immune system:

Rarely, allergic reactions on the side of the skin, anaphylactic reactions, hypersensitivity reactions.

Soothe the metabolism of speech and metabolism:

Very rarely, it is broadened – blood diabetes, hyperuricemia.

Mental disorders:

rarely widened – depression, increased depression, tendency to aggression, anxiety, change of mood; Very rarely are they broadened – behavioral disturbances, psychotic disorders, attempts at self-destruction, self-destruction.

Disorders on the side of the nervous system:

wider – headache; Rarely are they broadened – mild internal cranial hypertension, seizures, drowsiness, confusion.

Relax behind the eyes of the organs:

very wide – blepharitis, conjunctivitis, dry eyes, teasing eyes; even rarely widened - blurred vision, cataracts, impaired color perception, intolerance to contact lenses, cloudy corneas, decreased sharpness of the diurnal vision, keratitis, swelling of the nipple of the visual nerve (as a result of good internal cranial hypertension), photophobia, impaired vision.

Discover the organs of hearing and the labyrinth:

Very rarely widened - hearing loss.

Judgment's discord:

even more rarely – vasculitis (for example, Wegener’s granulomatosis, allergic vasculitis).

Loosen the sides of the respiratory organs, chest and mediastinum:

wider – nosebleeds, dry nose, nasopharyngitis; very rarely - bronchospasm (especially in patients with asthma), dysphonia.

Rozladi on the side of the scolio-intestinal tract:

very rarely - colitis, ulceration, dry throat, gut bleeding, hemorrhagic diarrhea, inflammatory bowel disease, fatigue, pancreatitis. Episodes of severe diarrhea were also reported (section “Peculiarities of diarrhea”).

Hepatobiliary disorders:

even wider – transaminases (div. section “Peculiarities of stagnation”); It is very rarely broadened – hepatitis.

Loosen the side of the skin and the underside of the skin:

very wide – cheilitis, dermatitis, dry skin, localized peeling, itching, erythematous sagging, traumatic skin (risk of rash when rubbing); rarely wider – alopecia; very rarely widespread - fulminant forms of acne, acute acne (acne hyperemia), erythema (exposing), exanthema, side hair disorders, hirsutism, onychodystrophy, paronychia, photosensitivity, pyogenic granules oma, hyperpigmentation of the skin, increased sweating; frequency unknown - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Place a side of brushes, meats and rich fabric:

even wider – arthralgia, myalgia, back pain (especially in children and young children); very rarely widened - arthritis, calcification (calcification of ligaments and tendons), premature closure of epiphyseal growth zones, exostosis, hyperostosis, changes in the thickness of bone tissue, tendonitis; frequency unknown – rhabdomyolysis.

Dissolve the side of the sectovid system:

very rarely wider – glomerulonephritis.

Disorders on the side of the reproductive system and thoracic cavity:

The frequency is unknown - impaired physical function, including erectile dysfunction and decreased libido, gynecomastia.

Zagalni discord:

very rarely expanded - tissue granulation (advanced molding), incl.

Laboratory displays:

even wider – hypertriglyceridemia, decreased level of high-density lipoproteins; wider – hypercholesterolemia, hyperglycemia, hematuria, proteinuria; Rarely is the increase in CPK levels in the blood.

How the drug works

Roaccutane belongs to the vitamin A group of drugs.

The instructions for use indicate that Roaccutane has the following range of actions:

Suppresses the activity of the sebaceous glands.
Relieves inflammation.
Reduces the stratum corneum.
Increases microcirculation.
Eliminates seborrhea.
Destroys bacteria.
Cleanses the skin.
Tightens pores.
Removes acne without leaving marks.
Prevents the recurrence of acne.
Inhibits the formation of horny plug.

Instructions for use for acne

Side effects and the effect of the drug depend on the individual characteristics of the person and the prescribed dosage. Roaccutane is taken with meals, 1-2 times a day.

There are several dosage options:

initial – 0.5 mg per 1 kg of weight (maximum daily norm);
average – from 0.5 to 1 mg;
high – 2 mg (for particularly severe cases of the disease).

It has been established that the duration of therapy depends on the prescribed dosage. Treatment is prolonged for patients who do not tolerate the drug, but the dose is reduced.

According to statistics, Roaccutane helps after 1 course of treatment. When acne appears again, repeated therapy with a similar dosage regimen is indicated.

After treatment, Roaccutane has a beneficial effect on the skin for 8 weeks, so it is recommended to repeat the course after this period. If a person has impaired all renal functions, the minimum daily dosage is 10 mg per day. The dose is slowly increased to 1 mg per 1 kg of weight.

Pharmacology

The dermatological product is intended for systemic treatment of acne.

The improvement in the clinical picture when using Roaccutane capsules is explained by the ability of the active substance to regulate the function of the sebaceous glands and reduce their secretion.

In addition, the product has an anti-inflammatory effect on the skin.

The mechanism of action of the drug includes the following processes:

inhibition of sebocyte proliferation;
reduction of sebum formation;
suppression of bacterial colonization of the stream;
restoration of normal differentiation of epidermal cells.

Use during pregnancy and breastfeeding

Based on the studies conducted, it has been established that the use of Roaccutane during pregnancy and lactation is strictly prohibited. The main substance, isotretinoin, damages the embryo, which leads to the development of defects in the child. The likelihood of such an outcome is very high.

Roaccutane is prescribed based on special nuances:

a woman has a complex degree of acne that is not respondable to other treatment methods. Usually these are nodular cystic acne with the threat of scarring or a conglobate form;
it is important to strictly comply with all admission requirements;
the doctor must explain all the dangers in the event of possible conception during treatment with Roaccutane;
During treatment, it is necessary to take precautions responsibly. It is recommended to choose at least 2 options: pills + condoms or female diaphragms;
It is worth paying attention to the reaction in the community with other drugs, which will be indicated below;
protection should be continuous 4 weeks before treatment, throughout the entire treatment period and for 4 weeks after completion of therapy;
a hCG test is done 11 days before starting to take Roaccutane to eliminate the risk of fertilization. The possibility of pregnancy will have to be checked every month during therapy and after completion after 5 weeks;
You need to visit a doctor monthly;
It is recommended to start taking Roaccutane on the 2-3rd day of the next normal monthly cycle;
there is a chance of relapse, so it is important to use proper and systematic protection;
Women who have had their uterus removed, do not have a monthly cycle (amenorrhea) or are not sexually active do not need to take contraceptives.

The doctor is responsible for the patient’s health, so he must be sure that:

The procedure to check for the fact of pregnancy did not give a positive result.
The woman strictly complies with the requirements and recommendations.
The patient uses several effective methods of contraception, as recommended in 2 variations.
The form of acne is one of the most complex (nodular cystic, with the threat of scarring or conglobate).

Testing for conception is carried out in the first 72 hours of the monthly cycle:

4 weeks before therapy, a test is performed to rule out possible pregnancy. The doctor must record all results. If a woman’s “lunar” cycle is disrupted, a pregnancy test is done 21 days after sexual intercourse. The hCG level is checked on the day of the appointment or 3 days before visiting the doctor. Roaccutane is prescribed to patients who have used contraceptives 4 weeks before starting the medication.
During treatment, you must visit your doctor monthly. Testing is carried out on the day of the appointment or 3 days before the consultation.
After treatment - 5 weeks after finishing taking Roaccutane, a repeat pregnancy test is done. A prescription for the drug is issued for 30 days. To obtain a new permit for admission, a repeated check is made to determine the possibility of conception. It is advisable to conduct a test, write a prescription and buy the drug on the same day.

Roaccutane can be purchased within a week from the date the prescription is issued. If pregnancy occurs, stop taking the medication.

List of possible fetal defects when using Roaccutane:

hydrocele is a disease in which fluid accumulates in certain areas of the brain;
reduction of the skull and brain to a significant extent;
disorders in the formation of the cerebellum - Joubert, Payne, Arnold-Chiari, Gillespie (which is characterized by loss of coordination, mental retardation and uncontrolled muscle hypertonicity);
narrowed or absent ear canal;
reduction in the size of the auricle, its deformation or complete absence;
reduction in the size of the eyes and cornea;
“blue” heart defect – the right side of the heart develops incorrectly. With the disease, the right stomach, interventricular septum, and pulmonary valve are abnormally formed. In such children, the mucous membranes and skin have a bluish tint;
transposition of the great arteries - the aorta arises from the right ventricle, the pulmonary artery from the left. The central vessels do not depart from the heart correctly, which leads to poor circulation in the body, and oxygen begins to flow poorly to the tissues;
cleft palate (cleft palate) – a gap in the middle part of the palate;
abnormalities in the development of the thymus;
disorders associated with the parathyroid glands.

Each patient is required to sign written informed consent, since Roaccutane is dangerous for an unborn child.

Reviews from doctors

Marchenko Stepan Antonovich, dermatologist:

I have been using Roaccutane for a long time. During the entire period, there were no complaints about side effects. Only once was a case of severe drying of the skin and mucous membranes recorded, which was explained by physical predisposition. Acne problems were resolved with the help of medication in the vast majority of patients.

The product minimizes the risks of tissue scarring, regulates the production of sebaceous secretion, tightens pores, and promotes the removal of toxins.

Taking capsules on your own is prohibited; a therapeutic effect is possible only with an adjusted daily dosage.

Ignatov Igor Alekseevich, dermatologist:

Roaccutane is an effective remedy for acne, as evidenced by reviews of treated patients. In my practice, there were cases when acne covered the skin on almost all parts of the body. The medicine works flawlessly with a properly developed treatment regimen.

When using a dermatological product, some patients complain of flaking of the skin and a sharp deterioration in its condition at the initial stage of treatment. This fact is indicated in the instructions as a normal phenomenon that goes away within 2-4 weeks.

To reduce the risk of negative manifestations, it is recommended to use high-quality nutritional and moisturizing agents during therapy, and consume a vitamin complex that includes a large amount of minerals and trace elements.

It is also important to consider that pregnancy and Roaccutane are incompatible. The active component has a detrimental effect on the development of the fetus, which leads to the birth of a child with severe intrauterine pathologies.

Interaction with other drugs

Roaccutane (the instructions for use describe which drugs the drug is not compatible with) should not be taken with:

Retinol, since Roaccutane is a retinoid drug, an overdose is possible;
antibiotics from the tetracycline group - they increase pressure in the cranial cavity and may increase the body’s sensitivity to ultraviolet and visible radiation;
contraceptives containing progesterone - isotretinoin weakens the effect of such drugs;
medications that soften and dissolve the stratum corneum of the skin;
peelings for deep cleansing of the skin - irritation may occur.

Efficacy of the drug

Once the desired course dose is achieved, the treatment result can be stable and there will be no relapse. In patients with conglobate acne (rashes on the face and torso), after 8 months of treatment, the effectiveness reached 92%. In 6% of people in the group, the disease returned.

Based on clinical studies, the following results were collected:

reduction in signs of seborrhea after 1-2 weeks of treatment;
reduction in the number of ulcers, nodules and inflammatory processes after 3-4 weeks;
reduction in the number of subcutaneous acne after 1-2 months of therapy.

In 91% of patients, the disease recurred after treatment. Within 1 week of treatment, 50% of patients developed a side effect - cheilitis, which was temporary.

If you follow the recommendations and use the drug correctly, a complete recovery is possible in 16-24 weeks. Roaccutane has a prolonged anti-acne effect, so 1 course of treatment is usually enough.

Pharmacokinetics

Since the kinetics of isotretinoin and its metabolites is linear, its plasma concentrations during therapy can be predicted based on data obtained after a single dose. This property of the drug also suggests that it does not affect the activity of liver enzymes involved in the metabolism of drugs.

Suction

Absorption of isotretinoin from the gastrointestinal tract varies. The absolute bioavailability of isotretinoin was not determined, since there is no release form of the drug for intravenous use in humans. However, extrapolation of data obtained in an experiment in dogs suggests a rather low and variable systemic bioavailability. In patients with acne, maximum plasma concentrations (Cmax) at steady state after administration of 80 mg isotretinoin on an empty stomach were 310 ng/ml (range 188-473 ng/ml) and were achieved after 2-4 hours. Plasma concentrations of isotretinoin are approximately 1.7 times higher than blood concentrations due to poor penetration of isotretinoin into red blood cells.

Taking isotretinoin with food increases bioavailability by 2 times compared to taking it on an empty stomach.

Distribution

Isotretinoin binds to a high degree (99.9%) with plasma proteins, mainly with albumin, therefore, over a wide range of therapeutic concentrations, the content of the free (pharmacologically active) fraction of the drug is less than 0.1% of its total amount.

The volume of distribution of isotretinoin in humans has not been determined because there is no dosage form available for intravenous administration.

Equilibrium concentrations of isotretinoin in the blood (C ss min) in patients with severe acne who took 40 mg of the drug 2 times a day ranged from 120 to 200 ng/ml.

The concentrations of 4-oxo-isotretinoin in these patients were 2.5 times higher than those of isotretinoin. There is insufficient data on the penetration of isotretinoin into tissues in humans. Concentrations of isotretinoin in the epidermis are two times lower than in serum.

Metabolism

Following oral administration, three major metabolites are found in plasma: 4-oxo-isotretinoin, tretinoin (all-trans retinoic acid) and 4-oxo-retinoin. The main metabolite is 4-oxo-isotretinoin, whose plasma concentrations at steady state are 2.5 times higher than the concentrations of the parent drug. Less significant metabolites have also been discovered, including glucuronides, but the structure of not all metabolites has been established.

Isotretinoin metabolites have biological activity confirmed in several laboratory tests. Thus, the clinical effects of the drug in patients may be the result of the pharmacological activity of isotretinoin and its metabolites.

Because isotretinoin and tretinoin (all-trans retinoic acid) are reversibly converted into each other in vivo, the metabolism of tretinoin is related to the metabolism of isotretinoin. 20-30% of the isotretinoin dose is metabolized by isomerization.

Enterohepatic circulation may play a significant role in the pharmacokinetics of isotretinoin in humans.

In vitro metabolism studies have shown that several CYP enzymes are involved in the conversion of isotretinoin to 4-oxo-isotretinoin and tretinoin. Apparently, none of the isoforms plays a dominant role in this case. Roaccutane and its metabolites do not have a significant effect on the activity of enzymes of the CYP system.

Removal

After oral administration of radioactively labeled isotretinoin, approximately equal amounts are found in urine and feces. The terminal phase half-life for unchanged drug in patients with acne averages 19 hours. The terminal phase half-life for 4-oxo-isotretinoin appears to be longer, averaging 29 hours.

Isotretinoin is a natural (physiological) retinoid. Endogenous concentrations of retinoids are restored approximately 2 weeks after the end of taking Roaccutane .

Pharmacokinetics in special clinical situations

Since isotretinoin is contraindicated in patients with impaired liver function, data on the pharmacokinetics of the drug in this group of patients are limited.

Kidney failure

does not affect the pharmacokinetics of isotretinoin.

Analogues of Roaccutane

Similar in composition and effect are:

Retasol is an Indian-made drug, the main component is isotretinoin propylene glycol. Average price – 500 rub. Used orally, rectally and applied to the skin in a thin layer.
Erase - Indian analogue. Costs up to 2000 rubles. The main component is isotretinoin.
Acnecutane is a drug produced in Croatia, the price is close to Roaccutane. The capsules contain isotretinoin.
Dermoretin is a Russian drug produced in the form of capsules and rectal suppositories. The main component is isotretinoin. The price starts from 120 rubles.
Retinoic ointment is a domestic product. Available in tubes of 10 g. Costs about 250 rubles. The ointment acts locally, relieving inflammation and healing wounds.
Verocutan is a Russian drug produced in capsule form. Costs from 760 rubles. Has a similar active ingredient.
Isotrexin - produced in the union of Ireland, Great Britain, Ukraine. Available in aluminum tubes in the form of cream and gel. Costs from 100 to 300 rubles. per package. Contains isotretinoin and erythromycin.

special instructions

Only a highly specialized specialist - a dermatologist - can prescribe treatment with Roaccutane. To prevent the drug from getting into the blood of other people, you should not become a donor during the treatment period.

To prevent the development of other diseases, it is necessary to constantly check the condition of the kidneys, liver and the whole body by taking a blood test.
To minimize the appearance of dryness on the mucous membranes and skin of the lips, it is necessary to use products with a moisturizing effect: creams, balms.
While taking Roaccutane, people involved in active sports may experience muscle and joint pain.
While taking the medication, it is advisable to avoid direct sun exposure and protect the skin with a cream with a high protection factor.
Some patients experience an exacerbation of acne, which goes away after a week without changing the dosage.
To prevent the mucous membranes of the eyes from suffering from dryness, purchase a moisturizing gel, for example, Korneregel or Systane Ultra drops, Hilocomod.
Sometimes, while taking Roaccutane, it is advisable to use glasses, abandoning the optical device - lenses.

A modern and potent remedy - Roaccutane is sold only after providing a prescription form. The instructions for use contain all the necessary information. The drug should be stored in a cool, dark place at a temperature of no more than 25 °C. Valid for 36 months.