Roaccutane for acne: instructions for use

Roaccutane is a new generation tool that needs to be ingested by courses. Its activity is aimed at the temporary suppression of the sebaceous glands. This drug copes with acne.

The main active component of Roaccutane isotretinoin capsules is the stereoisomer of vitamin A. It changes the activity of metabolic (metabolic) processes in the sebaceous glands of the skin, which causes a decrease in their functional activity.

Against the background of the use of the drug, it has anti-inflammatory and antiseborrheic therapeutic effect.

Clinico-pharmacological group

The drug for the treatment of acne. Retinoid.

Terms of sale from pharmacies

You can buy by prescription.

Price

How much does Roaccutane cost in pharmacies? The average price is at the level of 1 800 rubles for 10 capsules.

Composition and release form

Roaccutane is produced in the form of oval opaque capsules. The composition of this tool is a homogeneous suspension.

The active ingredient of the drug is isotretinoin at a dosage of 10 or 20 mg. Auxiliary ingredients include beeswax, soybean oil, gelatin, dyes.

Pharmachologic effect

The active ingredient of the drug is isotretinoin. It has anti-inflammatory and antimicrobial effects. The substance can lead to normal functioning of the regeneration, reduction and oxidation processes. The component destroys the expression of genes responsible for protein production, has a positive effect on the microflora and prevents infectious diseases.

The action of the drug stops the production of sebum, so that the skin remains clean for a long period of time, and the pores are not polluted. Isotretinoin is successfully used both in dermatology and in cosmetology.

The drug is a systemic retinoid. This group of medications restores skin regeneration and inhibits excess fat from the skin. The drug affects the urogenital, nervous, musculoskeletal system, as well as the stomach and intestines.

Indications for use

Roaccutane is prescribed for the treatment of severe acne vulgaris and course (with the formation of scars, pigment spots, pustules, hemorrhages), which are not amenable to treatment by other methods.

The drug is shown in violation of the process of keratinization: red hairy pitiriasis, palm-plantar form of keratoderma, ichthyosis, follicular keratosis. Tablets are effective for purulent hydradenitis, folliculitis (if the pathogen belongs to the gram-negative flora), pink acne (heavy version of the flow).

Contraindications

In some pathological and physiological states of the body, Roakkutan capsules are contraindicated, these include:

  1. Simultaneous administration of tetracycline antibiotics.
  2. Pregnancy at any time and lactation period (breastfeeding).
  3. Age of child up to 12 years.
  4. Hypervitaminosis (increased intake and accumulation in it) of vitamin A.
  5. Severe insufficiency of the functional activity of the liver.
  6. Hyperlipidemia is a condition characterized by elevated levels of lipids (fats) in the blood.
  7. Hypersensitivity to any of the components of the drug.

With care, Roaccutane capsules will be used for diabetes, depression (prolonged decrease in mood), including past, alcoholism, obesity. Before starting the drug should make sure there are no contraindications.

Appointment during pregnancy and lactation

Pregnancy is an absolute contraindication for Roaccutane therapy. If pregnancy occurs, despite the warnings, during treatment or within a month after the end of therapy, there is a very high risk of having a baby with severe developmental defects.

Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs at a time when a woman orally takes isotretinoin (at any dose or even a short time), there is a very high risk of having a baby with developmental disabilities.

Roaccutane is contraindicated in women of childbearing age, unless a woman’s condition satisfies all of the following criteria:

  • she must suffer from severe acne that is resistant to conventional treatments;
  • she must surely understand and follow the instructions of the doctor;
  • she should be informed by a doctor about the danger of pregnancy during Roaccutane treatment, within one month after it and urgent consultation if a pregnancy is suspected;
  • she should be warned about the possible ineffectiveness of contraception;
  • she must confirm that she understands the essence of the precautions;
  • she must understand the need and continuously use effective methods of contraception for one month before Roaccutane treatment, during treatment and for one month after its termination (see the section "Interaction with other drugs"); it is desirable to use simultaneously 2 different methods of contraception, including barrier; she must have received a negative result of a reliable pregnancy test within 11 days before the start of the drug; pregnancy test is strongly recommended to be carried out monthly during treatment and 5 weeks after the end of therapy;
  • she should begin Roaccutane treatment only on day 2–3 of the next normal menstrual cycle;
  • she must understand the necessity of compulsory visits to the doctor every month;
  • when treating for the recurrence of the disease, she should constantly use the same effective methods of contraception for one month before starting treatment with Roaccutane, during treatment and for one month after its completion, as well as undergo the same reliable pregnancy test;
  • She must fully understand the need for precautions and confirm her understanding and desire to use reliable contraceptive methods that the doctor explained to her.

The use of contraceptives according to the above instructions during treatment with isotretinoin should be recommended even to women who usually do not use contraceptive methods due to infertility (except for patients who have undergone hysterectomy), amenorrhea, or who report that they are not sexually active.

The physician must be sure that:

  • the patient suffers from severe acne (nodular-cystic, conglobate acne or acne with the risk of scarring); acne that is not amenable to other therapies;
  • a negative result was obtained from a reliable pregnancy test before the start of the drug intake, 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, within one month before starting treatment with Roaccutane, during treatment and within a month after its termination;
  • the patient is able to understand and fulfill all the above requirements for the prevention of pregnancy;
  • the patient meets all of the above conditions.

Pregnancy test

In accordance with current practice, a pregnancy test with a minimum sensitivity of 25 mME / ml should be carried out in the first 3 days of the menstrual cycle:

Before initiating therapy:

To exclude possible pregnancy before the start of contraception, the result and the date of the initial pregnancy test must be registered by a doctor. In patients with irregular menstruation, the time of the pregnancy test depends on sexual activity, it should be carried out 3 weeks after unprotected intercourse. The physician should inform the patient about contraceptive methods.

A pregnancy test is performed on the day Roakkutan is prescribed or 3 days before the patient's visit to the doctor. The specialist should register the test results. The drug can be administered only to patients who receive effective contraception for at least 1 month before starting therapy with Roaccutane®.

During therapy:

The patient should 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, previous violations of the menstrual cycle. If there is evidence, a pregnancy test is conducted 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 rule out pregnancy.

A prescription for Roaccutane® for a woman capable of childbearing can be prescribed only for 30 days of treatment, the continuation of therapy requires a new prescription of the drug by a doctor. We recommend a pregnancy test, prescription and receiving the drug in one day.

The delivery of Roaccutane® at the pharmacy should be carried out only within 7 days from the date of prescription.
To help doctors, pharmacists and patients avoid the risk of Roaccutan® exposure to the fetus, the manufacturing company created a Pregnancy Protection Program, aimed at warning of the drug's teratogenicity and emphasizing the absolutely obligatory use of reliable contraceptive measures for women of childbearing age. The program contains the following materials:

Male patients

Existing evidence suggests that in women, exposure to the drug, taken from the semen and seminal fluid of men taking Roaccutane, is not sufficient for the appearance of the teratogenic effects of Roaccutane.

Men should exclude the possibility of taking the drug by other persons, especially women.

If, despite the precautions taken, during Roaccutane treatment or within a month after its termination, the pregnancy nevertheless occurred, 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 miscarriage increases.

When pregnancy occurs, Roaccutane therapy is stopped. It is necessary to discuss the feasibility of its preservation with a physician specializing in teratology.

The severe congenital malformations of the fetus in humans associated with the appointment of Roaccutane have been documented, including hydrocephalus, microcephaly, cerebellar malformations, anomalies of the external ear (microtia, narrowing or absence of external auditory canal), microphthalmia, cardiovascular anomalies (Fallot tetrade, transposition of great vessels, septal defects), facial malformations (cleft palate), thymus gland, parathyroid gland pathology.

Since isotretinoin has a high lipophilicity, it is very likely that it passes into breast milk. Due to possible side effects, Roaccutane cannot be prescribed to nursing mothers.

Dosage and method of use

As indicated in the instructions for use take Roaccutane by mouth, with meals once or twice a day.

The therapeutic efficacy of Roaccutane and its side effects are dose dependent and vary in different patients. This dictates the need for individual dose selection during treatment.

Treatment with Roaccutane should be started with a dose of 0.5 mg / kg body weight / day. In most patients, the dose ranges from 0.5 to 1.0 mg / kg of body weight per day. Patients with very severe forms of the disease or with acne torso may require higher daily doses - up to 2.0 mg / kg / day. It is proved that the frequency of remission and prevention of relapse are optimal when using a course dose of 120-150 mg / kg (per course of treatment), therefore the duration of therapy in specific patients varies depending on the daily dose. Complete acne remission can often be achieved within 16-24 weeks of treatment. In patients who tolerate the recommended dose very poorly, treatment can be continued at a lower dose, but it can be carried out longer.

In most patients, acne completely disappears after a single course of treatment. With a clear relapse, a repeated course of treatment with Roaccutane is indicated in the same daily and course dose as the first. Since the improvement can continue up to 8 weeks after discontinuation of the drug, a second course should be prescribed not earlier than the end of this period.

In patients with severe renal insufficiency, treatment should begin with a lower dose (for example, 10 mg / day) and further increase to 1 mg / kg / day or maximum tolerated.

Side effect

Most of the side effects of Roaccutane are dose dependent. As a rule, side effects disappear after drug withdrawal or dose adjustment, but some may persist even after treatment is discontinued.

Violations can manifest as:

  • Hematopoietic system: decrease in hematocrit, anemia, neutropenia, decrease or increase in the number of platelets, leukopenia, accelerated ESR;
  • Musculoskeletal system: pains in the joints and muscles with increased serum CK levels in serum or without it, tendinitis, hyperostosis, calcification of tendons and ligaments, arthritis, other bone changes;
  • Mental Sphere and Central Nervous System: Depression, Behavioral Disorder, Headache, Seizures, Increased Intracranial Pressure (“Pseudotumor of the Brain”: Impaired Vision, Nausea, Headache, Vomiting, Edema of the Optic Nerve);
  • Respiratory system: rarely - bronchospasm (more often in patients with a history of bronchial asthma);
  • Immune system: systemic or local infections caused by gram-positive pathogens (Staphylococcus aureus);
  • Sense organs: photophobia, isolated cases of visual acuity, violation of dark adaptation (reduction of the severity of twilight vision); rarely - irritation of the eyes, impaired color perception (disappears after discontinuation of the drug), keratitis, lenticular cataract, conjunctivitis, blepharitis, hearing loss at certain sound frequencies, swelling of the optic nerve (associated with intracranial hypertension);
  • Effects due to hypervitaminosis A: dry hypopharynx (hoarseness of voice), mucous membranes (cheilitis), skin, nasal cavity (bleeding), eyes (reversible corneal clouding, conjunctivitis, intolerance to contact lenses);
  • Dermatological reactions: fulminant forms of acne, persistent thinning of hair, paronychia, slight trauma to the skin, itching, rash, sweating, erythema of the face / dermatitis, pyogenic granuloma, increased proliferation of granulation tissue, they are difficult to dystrophy, reversible hair loss, hyperpigmentation, Icy, Icy, myocardiosis, recurrent hair loss, hyperpigmentation, Icy, Icy, Icytrosis Acne exacerbation may persist at the beginning of therapy and persists for several weeks;
  • Digestive system: diarrhea, nausea, inflammatory bowel disease (ileitis, colitis), bleeding, pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dL), reversible and transient increase in liver transaminase activity. Individual cases of the development of hepatitis and pancreatitis with a fatal outcome have been described.Often, these violations do not go beyond the normal range and return to baseline during therapy, but sometimes there is a need to reduce the dose of Roaccutane or cancel it;
  • Laboratory indicators: hyperuricemia, hypercholesterolemia, hypertriglyceridemia, a decrease in the level of high-density lipoproteins; rarely - hyperglycemia. Individual cases of newly diagnosed diabetes were reported. In some patients, especially those with intense physical exertion, there have been some isolated cases of an increase in serum CK activity;
  • Other: hematuria, lymphadenopathy, proteinuria, systemic hypersensitivity reactions, vasculitis (Wegener's granulomatosis, allergic vasculitis), glomerulonephritis.

In post-marketing observations when Roaccutane was taken, cases of severe skin reactions were described: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Overdose

The same symptoms appear as with an excess of vitamin A in the body. In the beginning it may be necessary to flush the stomach.

Special instructions

Roaccutane should only be taken as directed by a physician, preferably a dermatologist, who has experience with systemic retinoids and is aware of the risk of their teratogenicity. The drug can be appointed only after a careful assessment of the ratio of benefits and possible risks to the patient.

Each person should be given a copy of the patient information leaflet when Roakutana is prescribed.

Before the administration of the drug, 1 month after the start of treatment, then every 3 months or, if indicated, it is recommended to monitor liver enzymes and liver function. If the level of liver transaminases exceeds the norm, you need to reduce the dose of the drug, or cancel it altogether.

At the same intervals, fasting serum lipids should be determined. In case of exceeding the norm, it is also necessary to reduce the dose of the drug or cancel it. In some cases, the normalization of lipid concentrations can be achieved through diet.

In addition, during treatment, it is necessary to control the clinically significant increase in triglyceride levels, since their increase in more than 800 mg / dL or 9 mmol / l can lead to the development of acute pancreatitis and even death. With persistent hypertriglyceridemia or the appearance of pancreatitis symptoms, Roaccutane is canceled.

In order to avoid accidental exposure of isotretinoin to the body of other people, don’t donate blood for 1 month after the end of treatment.

In rare cases, patients who received Roaccutane developed psychotic symptoms, depression, and very rarely - suicidal attempts. And although the causal relationship with the use of retinoid has not been established, patients with a history of depression should be under close medical supervision. Moreover, the abolition of the drug does not always lead to the disappearance of symptoms, therefore, further observation and treatment by a specialist may be required.

At the beginning of therapy, lip balm, moisturizer or body ointment is recommended for patients to reduce dryness of the mucous membranes and skin.

During treatment with Roaccutane and for 5-6 months after its termination, patients should not be given laser therapy and deep chemical dermoabrasion (associated with the risk of hyper- and hypopigmentation, increased scarring in atypical places), and also waxing hair removal (the risk of detachment increases epidermis, dermatitis and scar development).

In connection with the likelihood of a decrease in visual acuity during treatment, it is recommended to use caution when driving in the evening. Visual acuity must be carefully monitored.

Deterioration of night vision, corneal opacity, keratitis and dry conjunctiva of the eyes usually disappear after Roaccutane is canceled. For dryness of the mucous membrane of the eye, preparations of artificial tears or application of moisturizing eye ointment can be used. In the case of complaints of vision, the patient should be referred for consultation to an ophthalmologist.

If contact lenses are intolerant, glasses should be used during treatment.

During the period of therapy, it is necessary to limit exposure to sun and ultraviolet rays, in extreme cases - to use sunscreen with a high protective factor (SPF of at least 15).

With the development of severe hemorrhagic diarrhea, Roaccutane is immediately discontinued.

Severe allergic reactions are also indications for immediate discontinuation of the drug.

In the presence or suspicion of diabetes, it is more often to determine the glycemia.

Patients at risk (with impaired fat metabolism, obesity, diabetes, chronic alcoholism) during therapy may require more frequent laboratory monitoring of lipid levels and glucose.

Pregnancy is an absolute contraindication to Roaccutane. If, despite all the warnings, pregnancy occurs during treatment or within a month after it ends, there is a very high risk of giving birth to a child with severe developmental defects.

Such severe congenital malformations of the fetus associated with Roaccutane are documented, including microphthalmia, cerebellar malformations, microcephaly, hydrocephalus, cardiovascular anomalies (transposition of the great vessels, tetrapus Fallo, septal defects), anomalies of the external ear (absence or narrowing external auditory canal, microtia), the pathology of the parathyroid glands, malformations of the thymus gland and face (cleft palate).

For this reason, women of childbearing age are prescribed Roaccutane only if they suffer severe forms of acne that are resistant to conventional therapies. In this case, the woman should be informed about all the risks and warned about the possible ineffectiveness of contraceptives. The woman should confirm that she understands the essence of all precautions, the need to strictly follow the instructions of the doctor and use reliable methods of contraception (at least one, and preferably two, including barrier) all the period of treatment with a retinoid and 1 month after its termination.

The drug can be prescribed only to those patients who have used effective methods of contraception for at least 1 month prior to the use of Roaccutane. Treatment begins on day 2-3 of the next normal menstrual cycle after receiving a negative result of a reliable pregnancy test. In addition, a pregnancy test is recommended to be done monthly during the entire course of treatment and 5 weeks after its termination. Every 28 days the patient must visit the doctor.

The use of effective contraceptives is recommended even for women who report that they do not have sex, usually do not use contraception because of amenorrhea or infertility (except for patients who have undergone hysterectomy).

In connection with the foregoing, a prescription for Roaccutane to a woman of childbearing age is written only for 30 days. If continuation of therapy is required, a new prescription of the drug by a doctor is necessary. It is recommended to do a pregnancy test, write a prescription and get the drug in one day.

The issuance of the drug in pharmacies is carried out only within 7 days from the date of prescription.

To help patients, doctors and pharmacists to prevent the negative effects of isotretinoin on the fetus, Roaccutane's manufacturer has created a Pregnancy Protection Program, which aims to prevent the drug's teratogenicity and emphasize the absolutely obligatory use of effective contraceptive measures for women capable of childbirth. It contains the following materials:

  • for medical professionals: a guide for prescribing doctor Roaccutane for women, a form for recording the prescription of a drug for women, a form of informed consent for the patient;
  • for patients: what you need to know about contraception, information leaflet for the patient;
  • for the pharmacist: a guide for the pharmacist for dispensing Roaccutane.

Complete information about the teratogenic effect of isotretinoin and the need for strict adherence to measures to prevent pregnancy should be provided not only to women but also to men.

Interaction with other drugs

When using the drug, you must consider the interaction with other drugs:

  1. Because of the possible increase in symptoms of hypervitaminosis A, the simultaneous administration of Roaccutane and vitamin A should be avoided.
  2. Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with Roaccutane is contraindicated.
  3. Combined use with local keratolytic or exfoliative drugs for the treatment of acne is contraindicated because of the possible increase in local irritation.
  4. Isotretinoin can weaken the effectiveness of progesterone drugs, so do not use contraceptives containing small doses of progesterone.

Reviews

We offer you to read the reviews of people who used the drug Roaccutane:

  1. Sasha. Thank you and God bless all those who invented this pill, thanks to my doctor Pavlova E.V. (Dermatovenerologic Dispensary, Surgut, 70 Beregova St.) for prescribing the right treatment for me, yet the doctor’s literacy is very important, I would not have coped, thanks to her and everyone who created this pill, thanks to them I got rid of acne that I had been suffering for 13 years, all possible treatments, talkers, creams, ointments, procedures, diets, tests, were retrained, everything went to failure. Now I happy, I got rid of this byaki. Guys, the main thing is to find a doctor professional and follow his prescribed treatment. All healthy and clear skin!
  2. Alla A good remedy for wrinkles. The composition contains vitamin A in its special form, so the effect is much more interesting than from expensive imported creams, which cost many times more than Roaccutane, and in fact just moisturize, but do not affect skin collagen, which should stretch the skin. Roaccutane affects, therefore, periodically smear courses several times a year.
  3. Catherine. Long struggled with severe acne on my face. It's terrible when you hesitate to talk to the person who you like when you have it on your face. I was told that this was due to the activity of the sebaceous glands and was advised to take this medication to reduce acne size. Honestly, I am pleased with the result. The skin became cleaner, black spots disappeared.
Roaccutane: photo before and after treatment.

Analogs

Structural analogues of the active substance:

  • 13-cis-Retinoic acid;
  • Aknekutan;
  • Isotretinoin;
  • Retasol;
  • Retinoic ointment 0.01%;
  • Retinoic ointment 0.05 and 0.1%;
  • Will erase.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

To store in protected from light and moisture, the place, inaccessible for children, at a temperature not above 25 ° C. Shelf life - 3 years.

Watch the video: Accutane. Roaccutane. Accutane Side Effects. Isotretinoin Helpful Tips (April 2020).

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