En DE FR ES PL
Roaccutane - instructions for use, analogs, reviews and release forms (capsules or tablets 10 mg and 20 mg) of a drug for the treatment of acne or acne in adults, children and pregnancy. Composition

Roaccutane - instructions for use, analogs, reviews and release forms (capsules or tablets 10 mg and 20 mg) of a drug for the treatment of acne or acne in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Roaccutane. There are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors specialists on the use of Roaccutane in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Roaccutane in the presence of existing structural analogues. Use for the treatment of acne or acne in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

 

Roaccutane - retinoid for systemic therapy of acne.

 

The exact mechanism of action of Roaccutane has not yet been elucidated, however, it found that the improvement in the clinical picture of severe acne is associated with suppression of sebaceous gland activity and a histologically confirmed decrease in their size. In addition, the anti-inflammatory effect of isotretinoin on the skin has been proven.

 

Hyperkeratosis of epithelial cells of hair follicles and sebaceous glands leads to shedding of corneocytes into the duct and gland plugging last keratin and excess sebaceous secretion. This is followed by the formation of a comedon and, in some cases, the attachment of an inflammatory process. Roaccutane suppresses the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation. Skin fat is the main substrate for the growth of Propionibacterium acnes, so reducing the formation of sebum suppresses the bacterial colonization of the duct.

 

Composition

 

Isotretinoin + auxiliary substances.

 

Pharmacokinetics

 

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

 

The intake of isotretinoin with food increases bioavailability by 2 times compared with fasting. After ingestion, three major metabolites are detected in the plasma: 4-oxo-isotretinoin, Tretinoin (fully trans retinoic acid), and 4-oxo-retinoin. The main metabolite is 4-oxo-isotretinoin, plasma concentrations of which in the equilibrium state are 2.5 times higher than the concentrations of the initial preparation. There are also less significant metabolites, including also glucuronides, but the structure of not all metabolites is established.

 

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

 

After ingestion of radiolabeled isotretinoin in urine and feces, approximately the same amount is found.

 

Isotretinoin refers to natural (physiological) retinoids.Endogenous concentrations of retinoids are restored approximately 2 weeks after the end of Roaccutane intake.

 

Indications

  • severe acne (nodular-cystic, conglobate acne or acne with risk of scarring);
  • acne, not amenable to other types of therapy.

 

Forms of release

 

Capsules 10 mg and 20 mg (sometimes mistakenly called tablets).

 

Other forms of the drug, such as ointment or gel, do not exist.

 

Instructions for use and dosage

 

Inside, with meals once or twice a day.

 

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

 

Treatment with Roaccutane should begin with a dose of 0.5 mg / kg of body weight per day. In most patients, the dose varies from 0.5 to 1.0 mg / kg of body weight per day. Patients with very serious forms of disease or with acne of the trunk may need higher daily doses - up to 2.0 mg / kg per day. It has been proved that the frequency of remission and the prevention of relapses are optimal when using a course dose of 120-150 mg / kg (per treatment course), so the duration of therapy in specific patients varies depending on the daily dose. Complete remission of acne is often achieved in 16-24 weeks of treatment.In patients who are very poorly tolerated the recommended dose, treatment can continue at a lower dose, but spend it longer.

 

In most patients, acne completely disappears after a single course of treatment. With a clear relapse, a second course of Roaccutane treatment is shown at the same daily and exchange rate as the first. Since the improvement can continue up to 8 weeks after drug withdrawal, the repeated course should be appointed no earlier than the end of this period.

 

Side effect

  • impaired behavior;
  • depression;
  • headache;
  • increased intracranial pressure ("pseudotumor brain": headache, nausea, vomiting, impaired vision, edema of the optic nerve);
  • convulsive seizures;
  • individual cases of visual impairment;
  • photophobia;
  • disturbance of dark adaptation (reduction of sharpness of twilight vision);
  • violation of color perception (passing after withdrawal of the drug);
  • keratitis;
  • blepharitis;
  • conjunctivitis;
  • eye irritation;
  • edema of the optic nerve (as a manifestation of intracranial hypertension);
  • hearing impairment at certain sound frequencies;
  • nausea;
  • diarrhea;
  • inflammatory bowel disease (colitis, ileitis);
  • anemia, leukopenia, neutropenia, increase or decrease in the number of platelets, acceleration of ESR;
  • bronchospasm (more often in patients with bronchial asthma in anamnesis);
  • arthritis;
  • calcification of ligaments and tendons;
  • rash;
  • itching;
  • sweating;
  • paronychia;
  • they are not built;
  • persistent thinning of hair;
  • reversible hair loss;
  • hirsutism;
  • hyperpigmentation;
  • photosensitization;
  • photo allergy;
  • dry skin;
  • reversible opacity of the cornea;
  • intolerance to contact lenses;
  • local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus);
  • vasculitis (Wegener's granulomatosis, allergic vasculitis);
  • systemic hypersensitivity reactions;
  • glomerulonephritis.

 

Contraindications

  • liver failure;
  • hypervitaminosis A;
  • severe hyperlipidemia;
  • concomitant therapy with tetracyclines;
  • pregnancy;
  • the period of breastfeeding;
  • children's age till 12 years;
  • hypersensitivity to the drug or its components.

 

Application in pregnancy and lactation

 

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

 

Isotretinoin is a drug with a strong teratogenic effect. If a pregnancy occurs at a time when a woman is taking orally taking isotretinoin (at any dose and even for a short time), there is a very high risk of a child with developmental defects.

 

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

  • she must suffer a severe form of acne, resistant to conventional methods of treatment;
  • she must certainly understand and follow the doctor's instructions;
  • she should be informed by the doctor about the dangers of pregnancy during Roaccutan treatment, within one month after it and urgent consultation in case of suspected pregnancy;
  • she should be warned about the possible ineffectiveness of contraceptives;
  • she must confirm that she understands the nature of precautions;
  • she must understand the need and continuously use effective methods of contraception within one month prior to treatment with Roaccutane,during treatment and within a month after its termination; It is desirable to use at the same time 2 different methods of contraception, including barrier;
  • she should receive a negative result of a valid pregnancy test within 11 days before the drug is taken; a pregnancy test is strongly recommended to be performed monthly during treatment and 5 weeks after the end of therapy;
  • she should begin treatment with Rojkutan only on the 2-3 day of the next normal menstrual cycle;
  • she must understand the need for a compulsory visit to the doctor every month;
  • when treating for a relapse of the disease, she must constantly use the same effective methods of contraception within one month prior to the beginning of Roaccutane treatment, during treatment and within a month after its completion, and also undergo the same reliable pregnancy test;
  • she must fully understand the need for precautionary measures and confirm her understanding and desire to apply reliable methods of contraception, which the doctor explained to her.

 

Use of contraceptives according to the above instructions during treatment with isotretinoin shouldrecommend even those women who do not usually use contraceptive methods because of infertility (except for patients who underwent a hysterectomy), amenorrhea, or who report that they do not have sex.

 

The doctor should be sure that:

  • the patient suffers from severe acne (nodular-cystic, conglobate acne or acne with the risk of scarring); acne, not amenable to other types of therapy;
  • a negative result of a valid pregnancy test was obtained prior to taking 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 the barrier method, within one month prior to initiation of Roaccutane treatment, during treatment and for a month after its termination;
  • the patient is able to understand and fulfill all of the above requirements for protection from pregnancy;
  • the patient meets all of the above conditions.

 

The recipe for Roaccutane is a woman capable of childbirth can be discharged 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, a prescription and preparation be conducted on the same day.

 

The delivery of Roaccutane in the pharmacy should be carried out only within 7 days of the receipt of the prescription.

 

Complete information on teratogenic risk and strict adherence to measures to prevent pregnancy should be provided to both men and women.

 

To male patients

 

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

 

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

 

If, in spite of the precautionary measures taken, during the treatment with Roaccutane or within a month after its termination, pregnancy does occur, there is a high risk of very serious fetal malformations (in particular, from the central nervous system, heart and large blood vessels). In addition, the risk of spontaneous miscarriages increases.

 

When a pregnancy occurs, Roaccutane is discontinued.It should be discussed the expediency of its preservation with a doctor specializing in teratology.

 

Heavy congenital malformations of the fetus in humans associated with the administration of Roaccutane, including hydrocephalus, microcephaly, malformations of the cerebellum, anomalies of the external ear (microtia, narrowing or absence of the external auditory canal), microphthalmia, cardiovascular anomalies (tetralogy of Fallot, transposition of the main vessels, defects of the septa), developmental defects of the face (wolf mouth), thymus gland, parathyroid gland pathology.

 

Since isotretinoin has a high lipophilicity, it is very likely that it enters the breast milk. Due to possible side effects, Roaccutane can not be administered to nursing mothers.

 

special instructions

 

Roaccutane should be prescribed only by physicians, preferably dermatologists who have experience with systemic retinoids and who are aware of the risk of teratogenicity of the drug.

 

In order to avoid accidental exposure of the drug to the body of other people, in patients who receive or shortly before this (1 month) received Roaccutane, you can not take donor blood.

 

It is recommended to monitor liver function and hepatic enzymes before treatment, 1 month after its onset, and then every 3 months or according to indications. There was a transient and reversible increase in hepatic transaminases, in most cases within normal values. If the level of hepatic transaminases exceeds the norm, it is necessary to reduce the dose of the drug or to cancel it.

 

The level of serum lipids in the fasting serum should be determined before the treatment, 1 month after the start, and then every 3 months or according to the indications. Usually lipid concentrations are normalized after dose reduction or drug withdrawal, as well as dieting. It is necessary to monitor a clinically significant increase in triglyceride levels, since their elevation above 800 mg / dl or 9 mmol / l may be accompanied by the development of acute pancreatitis, possibly fatal. With persistent hypertriglyceridemia or symptoms of pancreatitis, Roaccutane should be discontinued.

 

In rare cases, patients treated with Roaccutane are described for depression, psychotic symptoms and very rarely suicidal attempts. Although their causal relationship with the use of the drug is not established,special care should be taken in patients with a history of depression and observe all patients for depression during treatment with the drug, if necessary, referring them to the appropriate specialist. However, the cancellation of Roaccutane may not lead to the disappearance of symptoms and may require further observation and treatment by a specialist.

 

In rare cases, at the beginning of therapy, there is an exacerbation of acne, which occurs within 7-10 days without correction of the dose of the drug.

 

A few years after the administration of Roaccutane for the treatment of dyskeratoses with a total exchange rate and duration of therapy higher than those recommended for acne therapy, bone changes developed, including premature closure of epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons. Therefore, when prescribing the drug to any patient, you should first carefully evaluate the ratio of possible benefits and risks.

 

Patients receiving Roaccutane, it is recommended to use moisturizing ointment or body cream, lip balm to reduce dry skin and mucous membranes at the beginning of therapy.

 

During the post-marketing observation, the cases of development of severe skin reactions, such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, are described with the use of Roaccutane. These phenomena can be serious and lead to loss of ability to work, life-threatening conditions, hospitalization or fatal outcome. Patients receiving Roaccutane need careful monitoring to identify severe skin reactions and, if necessary, to decide whether to discontinue the drug.

 

Against the background of taking Roaccutane, pains in the muscles and joints, an increase in serum creatinine phosphokinase, which may be accompanied by a decrease in the tolerance of intensive physical activity, are possible.

 

It should avoid deep chemical dermabrasion and laser treatment in patients receiving Roaccutane, and also within 5-6 months after the end of treatment because of the possibility of increased scarring in atypical sites and the occurrence of hyper and hypopigmentation. During treatment with Roaccutane and within 6 months after it, hair removal with wax applications can not be carried out because of the risk of detachment of the epidermis, development of scarring and dermatitis.

 

Since some patients may have a decrease in visual acuity, which sometimes persists after the end of therapy, patients should be informed about the possibility of this condition, recommending them to use caution when driving a car at night. The state of visual acuity needs to be carefully monitored.

 

Dryness of the conjunctiva of the eyes, opacity of the cornea, worsening of night vision and keratitis usually pass after drug withdrawal. With dry eye mucosa, you can use moisturizing ointment applications or artificial tears. It is necessary to observe patients with dryness of the conjunctiva for possible development of keratitis. Patients presenting complaints of vision should be referred to an ophthalmologist and consider whether it is advisable to cancel Roaccutane. If intolerance of contact lenses for the duration of therapy should be used glasses.

 

Limit exposure to sunlight and UV rays. If necessary, use a sunscreen with a high protective factor of at least 15 SPF.

 

Rare cases of development of benign intracranial hypertension ("pseudocarcinoma of the brain") are described, including.when combined with tetracyclines. These patients should immediately cancel Roaccutane.

 

With Roaccutane therapy, inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, Roaccutane should be immediately discontinued.

 

Rare cases of anaphylactic reactions, which occurred only after the previous external application of retinoids, are described. Severe allergic reactions dictate the need to discontinue the drug and carefully monitor the patient.

 

Patients in the high-risk group (with diabetes, obesity, chronic alcoholism, or fat metabolism disorders) may need more frequent laboratory monitoring of glucose and lipid levels when taking Rojkutan.

 

In the presence of diabetes or suspected of it, a more frequent definition of glycemia is recommended.

 

Drug Interactions

 

Because of the possible increase in symptoms of hypervitaminosis A, simultaneous administration of Roaccutane and vitamin A should be avoided.

 

Since tetracyclines can also cause an increase in intracranial pressure, their use in combination with Roaccutane is contraindicated.

 

Isotretinoin may impair the effectiveness of Progesterone preparations, so do not use contraceptives containing small doses of progesterone.

 

Combined use with local keratolytic or exfoliative drugs for the treatment of acne is contraindicated because of the possible increase in local irritation.

 

Analogues of Roaccutane

 

Structural analogs for the active substance:

  • 13-cis-Retinoic acid;
  • Acnekutan;
  • Isotretinoin;
  • Retasol;
  • Retinoic ointment 0.01%;
  • Retinoic ointment 0.05 and 0.1%;
  • Wipe off.

Similar medicines:

Other medicines:

Reviews (7):
Guests
Of the world
Roaccutane is a drug that blocks the work of the sebaceous glands, preventing the appearance of acne. I bought it for my son. Girls, I would advise to look for another remedy, because during the treatment of the son began to drop hair and dry skin. The boy will survive, although there is not much to enjoy either. Girls will be more difficult.

Now about the pleasant. Acne still passed. Now they appear extremely rarely and not in such quantity. We treated Roakkutan more than six months. It must be taken depending on its weight. The drug is expensive, the treatment, in general, was expensive. But I'm glad that Roaccutane helped his son get rid of pimples and complexes.No money is not a pity, but the drug still has a lot of drugs!
Guests
Indies
I'm forbidden in the Directory to offer visitors to buy medicines from their hands. It's illegal and I think it's immoral. Do not do this again. Thank you.
admin
Guests
Alla
A good remedy for wrinkles. In the composition contains vitamin A in its special form, so the effect is much more interesting than from expensive imported creams that are several times more expensive than roaccutane, but actually just moisturize, but do not affect the skin collagen, which should stretch the skin. Roaccutane works, so I periodically smear on courses several times a year.
Visitors
NelfFyl
Question. When taking this medication it is considered normal: pressure reduction, there is a constant flow of blood from the nose, headache, fever?
Administrators
admin
NelfFylSuch symptoms can not be recognized as normal when taking any medications, not just Roaccutane.Contact your doctor who prescribes this medication to change the treatment regimen or cancel the medication.
Guests
Nodir
What time of day should I take Roaccutane?
Administrators
admin
Nodir, No difference. Usually taken in the morning. Solar radiation should still be avoided for the duration of the drug treatment.

Rules for publishing reviews and visitor questions