Roaccutane from acne: instructions for use

Roaccutane is a means of a new generation that must be taken internally by courses. His activity is aimed at temporarily suppressing the work of the sebaceous glands. This drug perfectly copes with acne.

The main active component of capsules Roaccutane isotretinoin is a 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 drug, it has an anti-inflammatory and anti-seborrheic therapeutic effect.

Clinical and pharmacological group

The drug for acne treatment. Retinoid.

Terms of sale from pharmacies

It is possible to buy under the prescription of the doctor.

Price

How much does Roaccutane cost in pharmacies? The average price is at the level of1 800 rubles for 10 capsules.

.

Composition and form of release

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

The active substance of the drug is isotretinoin in a dosage of 10 or 20 mg. The auxiliary ingredients include beeswax, soybean oil, gelatin, dyes.

pharmachologic effect

The active component of the drug is isotretinoin. It has anti-inflammatory and antimicrobial effects. The substance is capable of normalizing the functioning of the regenerative, reducing and oxidizing processes. The component destroys the expression of genes responsible for protein production, positively affects 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 contaminated. Isotretinoin is successfully used both in dermatology and in cosmetology.

The drug is a systemic retinoid. This group of medicines restores skin regeneration and inhibits excess amount of skin fat. The drug has an effect on the genitourinary, nervous, musculoskeletal system, as well as on the stomach and intestines.

Indications for use

Roaccutane is prescribed for the treatment of vulgar acne of severe genesis and course (with the formation of scars, pigment spots, pustules, hemorrhages) that can not be treated by other methods.

The medication is indicated for the violation of the keratinization process: red fibrous pityriasis, palmar-plantar form of keratoderma, ichthyosis, follicular keratosis. Tablets are effective in purulent hydradenitis, folliculitis (if the pathogen belongs to the gram-negative flora), rosacea (severe variant of the course).

Contraindications

At some pathological and physiological conditions of an organism reception of capsules Roakkutan is counter-indicative, to them concern:

1. Simultaneous reception of antibiotics of the tetracycline group.
2. Pregnancy at any time and lactation period (breastfeeding).
3. Age of child under 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 an elevated level of lipids (fats) in the blood.
7. Hypersensitivity to any of the components of the drug.

With care capsules Roaccutane is used in diabetes mellitus, depression (long-term depression of mood), including past, alcoholism, obesity. Before using the drug, you should make sure that there are no contraindications.

Intended use for 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 defects development.

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

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 treatment Roaccutane, within one month after it and urgent consultation in case of suspected onset 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 for a month after its termination (see. section "Interaction with other drugs"); 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 onset drug administration; a pregnancy test is strongly recommended to be performed monthly during treatment and 5 weeks after completion 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 before treatment with Roaccutane, during treatment and within a month after its completion, as well as undergo the same reliable test for pregnancy;
• 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.

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

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 before taking the drug, during therapy and 5 weeks after the end of therapy; The dates and results of the pregnancy test are document;
• the patient uses at least 1, preferably 2 effective methods of contraception, including the barrier method, within one month prior to the initiation of Roaccutane treatment, during treatment and within a month after it endings;
• 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.

Pregnancy test

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

Before the start of therapy:

To exclude a possible pregnancy before the application of contraception, the result and the date of the initial pregnancy test must be recorded by the doctor. In patients with irregular menstruation, the timing of the pregnancy test depends on sexual activity, it should be performed 3 weeks after unprotected intercourse. The doctor should inform the patient about the methods of contraception.

The pregnancy test is carried out on the day of administration of the drug Roaccutane® or 3 days before the patient's visit to the doctor. The specialist should register the test results. The drug can be prescribed only to patients receiving effective contraception at least 1 month before starting therapy with Roaccutane®.

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 the sexual activity preceding the menstrual cycle disorders. 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:

After 5 weeks after the end of therapy, a test is performed to exclude pregnancy.

The recipe for Roaccutane® for a woman capable of childbearing 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 a pharmacy should be performed only within 7 days of the prescription.
To help doctors, pharmacists and patients avoid the risk of exposure to Roaccutane® on the fetus, the manufacturing company created a " pregnancy aimed at preventing the teratogenicity of the drug and emphasizing the absolutely mandatory use of reliable contraceptive measures by women of childbearing age. The program contains the following materials:

To male patients

Existing evidence suggests that in women, the exposure of the drug from the seed and semen of men taking Roacutane is not sufficient for the appearance of teratogenic effects 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, the pregnancy has nevertheless occurred, there is a high risk of very severe fetal malformations (in particular, from the central nervous system, heart and large blood vessels 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.

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

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.

Dosage and route of administration

As indicated in the instructions for use, take Roacutane inside, during 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 body weight / 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 / day. It is proved that the frequency of remission and the prevention of relapses are optimal when using a course dose of 120-150 mg / kg (for treatment), 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.

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

Side effect

Most of the resulting side effects of Roaccutane depend on the dose. As a rule, side effects occur after withdrawal of the drug or correction of the dose taken, but some may persist even after discontinuation of treatment.

Violations can occur as:

• The hemopoietic system: a decrease in hematocrit, anemia, neutropenia, a decrease or increase in the number of platelets, leukopenia, acceleration of ESR;
• Musculoskeletal system: joint and muscle pain with or without elevation of serum CK, tendonitis, hyperostosis, calcification of tendons and ligaments, arthritis, other bone changes;
• Psychic and central nervous system: depression, behavioral disorders, headache, seizures, increased intracranial pressure ("pseudotumor brain visual impairment, nausea, headache, vomiting, edema of the eye nerve);
• Respiratory system: rarely - bronchospasm (more often in patients with bronchial asthma in the anamnesis);
• Immune system: systemic or local infections caused by Gram-positive pathogens (Staphylococcus aureus);
• Organs of senses: photophobia, isolated cases of visual impairment, disturbance of dark adaptation (reduction of sharpness of twilight vision); rarely - eye irritation, color perception disorder (occurs after drug discontinuation), keratitis, lenticular cataract, conjunctivitis, blepharitis, hearing impairment at certain sound frequencies, edema of the optic nerve (associated with intracranial hypertension);
• Effects caused by hypervitaminosis A: dryness of the laryngopharynx (hoarseness of the voice), mucous membranes (cheilitis), skin, nasal cavity (bleeding), eyes (reversible corneal opacity, conjunctivitis, intolerance of contact lenses);
• Dermatological reactions: fulminant forms of acne, persistent thinning of hair, paronychia, slight trauma of the skin, itching, rash, sweating, face erythema / dermatitis, pyogenic granuloma, increased proliferation of granulation tissue, onychodystrophy, reversible hair loss, hyperpigmentation, hirsutism, photo allergy, photosensitization. At the beginning of therapy, there may be an exacerbation of acne that persists for several weeks;
• Digestive system: diarrhea, nausea, inflammatory bowel disease (ileitis, colitis), bleeding, pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dL), a reversible and transient increase in hepatic activity transaminase. Individual cases of the development of hepatitis and pancreatitis with a fatal outcome are described. Often these disorders do not go beyond the limits of the norm and return to the baseline during therapy, but sometimes it becomes necessary to lower the dose of Roaccutane or to cancel it;
• Laboratory indicators: hyperuricemia, hypercholesterolemia, hypertriglyceridemia, lowering of high-density lipoproteins; rarely - hyperglycemia. Individual cases of newly diagnosed diabetes mellitus have been reported. In some patients, especially those with intensive physical activity, there are individual cases of increased activity of CK in the serum;
• Other: hematuria, lymphadenopathy, proteinuria, systemic hypersensitivity reactions, vasculitis (Wegener's granulomatosis, allergic vasculitis), glomerulonephritis.

In post-marketing observations with the administration of Roaccutane, cases of development of severe skin reactions have been described: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome.

Overdose

There are the same symptoms as with an excess of vitamin A in the body. In the beginning, it may be necessary to rinse the stomach.

special instructions

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

Each person should be given a copy of a brochure with information for the patient when administering Roaccutane.

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

With the same intervals should determine the level of lipids in blood serum on an empty stomach. In case of excess of the norm, it is also necessary to reduce the dose of the drug or to cancel it. In some cases, the normalization of lipid concentration can be achieved through diet compliance.

In addition, during treatment it is necessary to monitor a clinically significant increase in the level of triglycerides, their increase of more than 800 mg / dL or 9 mmol / l may lead to the development of acute pancreatitis and even lethal outcome. With persistent hypertriglyceridemia or the appearance of symptoms of pancreatitis, Roaccutane is canceled.

To avoid accidental exposure of isotretinoin to the body of other people, donors blood can not be taken / taken within 1 month after the end of treatment.

In rare cases, patients treated with Roaccutane experienced psychotic symptoms, depression, and very rarely suicidal attempts. And although the cause-and-effect relationship with the use of retinoid is not established, patients with a history of depression should be under careful medical control. Moreover, the discontinuation of the drug does not always lead to the disappearance of symptoms, so further monitoring and treatment with a specialist may be required.

At the beginning of therapy, to reduce the dryness of mucous membranes and skin, patients are advised to use a lip balm, moisturizing cream or ointment for the body.

During treatment with Roaccutane and within 5-6 months after its end, patients should not undergo laser therapy and deep chemical dermoabrasion (associated with risk the emergence of hyper and hypopigmentation, increased scarring in atypical sites), as well as wax epilation (increases the risk of detachment of the epidermis, development of dermatitis and scars).

In connection with the probability of reducing the acuity of night vision during treatment, it is recommended to use caution when driving a car in the evening. Visual acuity needs to be carefully monitored.

Deterioration of night vision, corneal opacity, keratitis and dryness of the conjunctiva of the eye usually pass after the cancellation of Roaccutane. If the mucous eye is dry, artificial teardrops or moisturizing eye ointments can be applied. In case of complaints about vision, the patient should be referred for consultation to an ophthalmologist.

If intolerance of contact lenses during treatment should be used glasses.

In the period of therapy, it is necessary to limit exposure to sunlight and ultraviolet rays, in the extreme case - to use sunscreen with a high value of the protective factor (SPF not less than 15).

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

Severe allergic reactions are also an indication for immediate withdrawal of the drug.

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

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

Pregnancy is an absolute contraindication to the appointment of Roakkutan. If, despite all warnings, pregnancy occurs during treatment or within a month after its termination, there is a very high risk of a child with severe developmental defects.

Documented are, among other things, such severe congenital malformations of the fetus associated with Roaccutane: microphthalmia, malformations cerebellum, microcephaly, hydrocephalus, cardiovascular anomalies (transposition of the main vessels, tetralogy of Fallot, defects of partitions), anomalies external ear (absence or narrowing of the external auditory canal, microtia), pathology of the parathyroid glands, malformations of the thymus gland and face (cleft palate).

For this reason, women of childbearing age Roaccutane are prescribed only if they suffer severe acne, resistant to conventional therapies. At the same time, a woman should be informed of all the risks and be warned about the possible ineffectiveness of contraceptives. The woman must confirm that she understands the essence of all precautionary measures, the need to strictly follow the doctor's instructions and use reliable methods of contraception (at least one, and preferably two, including the barrier) the entire period of retinoid treatment and 1 month after it endings.

The drug can be prescribed only to those patients who have used effective methods of contraception at least 1 month before the application of Roaccutane. Treatment begins on day 2-3 of the next normal menstrual cycle after receiving a negative result of a valid pregnancy test. In addition, a pregnancy test is recommended to be done monthly throughout the course of treatment and 5 weeks after the end of the course. Every 28 days a patient should visit a doctor.

The use of effective contraceptives is recommended even for those women who report that they do not live sexually life, usually do not use contraceptive methods because of amenorrhea or infertility (except for patients who have undergone hysterectomy).

In connection with the above, the prescription for Roakkutan to a woman of childbearing age is prescribed only for 30 days. If continuation of therapy is required, a new prescription of the drug by a doctor is necessary. Do a pregnancy test, prescribe and receive the drug is recommended in one day.

The drug is dispensed in pharmacies only within 7 days from the date of prescription.

To help patients, doctors and pharmacists prevent the negative impact of isotretinoin on the fetus, the manufacturer Roaccutane has created a " pregnancy the purpose of which is to prevent teratogenicity of the drug and to emphasize the absolutely mandatory use of effective contraceptive measures by women capable of procreation. It contains the following materials:

• for medical specialists: guidance for a doctor on the appointment of Roaccutane to women, a form of accounting for the prescription of the drug to women, a form of informed consent for the patient;
• for patients: what you need to know about contraception, an informational brochure for the patient;
• for the pharmacist: a guide for the pharmacist on the release of Roaccutane.

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

Interaction with other drugs

When using the drug, it is necessary to take into account the interaction with other drugs:

1. Because of the possible increase in symptoms of hypervitaminosis A, 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 may impair the effectiveness of progesterone preparations, so do not use contraceptives containing small doses of progesterone.

Reviews

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

1. Sasha. Thank you and God forbid health to all those, then came up with this pill, thank my doctor Pavlova EV (Skin and Venereal Dispensary Surgu, L. Beregova 70) that she prescribed the right treatment for me, but the literacy of the doctor is very important, I would not be able to do it, I thank her and everyone who created this pill, Thanks to them I got rid of acne with which I suffered 13 le, all possible treatments, oltushk, rem, az, rotserud, iet, nasal futility. Now I'm happy, got rid of this byaka. Robe, it's best to find a professional doctor and follow his appointed treatment. All healthy and clean 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 that cost in times more expensive roakkutana, but in fact just moisturize, but do not affect the skin collagen, which should stretch skin. Roaccutane works, so I periodically smear on courses several times a year.
3. Catherine. Long struggled with the severe form of acne on my face. It's terrible when you're embarrassed to talk to someone you like, when you have it on your face. I was told that this is due to the activity of the sebaceous glands and to reduce the size of acne advised to take this drug. Honestly, I'm happy with the result. The skin has become purer, black dots have disappeared.

Roaccutane: before and after treatment.

Analogues

Structural analogs for the active substance:

• 13-cis-Retinoic acid;
• Acnekutan;
• Isotretinoin;
• Retasol;
• Retinoic ointment, 1%;
• Retinoic ointment, 5 and,%;
• Wipe off.

Before buying an analogue, consult your doctor.

Shelf life and storage conditions

Store in a place protected from light and moisture, inaccessible to children, at a temperature of no higher than 25 ° C. Shelf life - 3 years.

How to choose probiotics for the intestine: a list of drugs.

Effective and inexpensive cough syrups for children and adults.

Modern non-steroidal anti-inflammatory drugs.

Review of tablets from the increased pressure of the new generation.

Antiviral drugs are inexpensive and effective.