Roaccutane capsules 10mg №30

Dosage form

Capsules

Packaging

30 pieces

Mechanism of action

Roaccutane - regeneration stimulator, retinoid for systemic treatment of acne
Isotretinoin, the active ingredient of Roaccutane, the stereoisomer of all-trans-retinoic acid (tretinoin).
It has a specific anti-seborrheic action in severe forms of acne (acne) that are not amenable to other types of therapy. The mechanism of action of the drug is not fully elucidated, but it has been established that the improvement in the clinical picture of the disease is associated with a dose-dependent decrease in the activity of the sebaceous glands and a decrease in their size, which is confirmed by histological studies. In addition, isotretinoin has an anti-inflammatory effect on the skin.

Severe acne (nodular / cystic, conglobate acne or acne with the risk of scarring).
Acne, not amenable to other therapies.

Contraindications

Pregnancy, lactation, liver failure, hypervitaminosis A, severe hyperlipidemia, concomitant Tetracycline therapy.
Hypersensitivity to the drug or its components.
Children's age up to 12 years.

Dosage and administration

Standard dosing regimen
Inside, with a meal 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 per 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. It is proved that the frequency of remission and prevention of recurrence is 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 very poorly tolerate the recommended dose, 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.

Dosing in special cases
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 the maximum tolerated.

Adverse reactions

Most of the side effects of Roaccutane are dose dependent. As a rule, when prescribing the recommended doses, the ratio of benefits and risks, taking into account the severity of the disease, is acceptable for the patient. Usually, side effects are reversible after dose adjustment or drug withdrawal, but some may persist after stopping treatment.
Symptoms associated with hypervitaminosis A: dry skin, mucous membranes, incl. lips (cheilitis), nasal cavity (bleeding), laryngopharynx (hoarseness), eyes (conjunctivitis, reversible corneal clouding and intolerance to contact lenses).
Skin and its appendages: rash, pruritus, erythema of the face / dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased proliferation of granulation tissue, persistent hair thinning, reversible hair loss, fulminant acne, hirsutism, hyperpigmentation, photosensitization, photoallergy, photoaltimization, photoallergy, acalysis At the beginning of treatment, acne may worsen, lasting for several weeks.
Musculoskeletal system: muscle pain with increased levels of CK in serum or without it, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, other bone changes, tendinitis.
Central nervous system and mental health: behavioral disorders, depression, headache, increased intracranial pressure (“brain pseudotumor”: headache, nausea, vomiting, visual disturbances, optic nerve edema), seizures.
Sense organs: isolated cases of visual acuity, photophobia, impaired dark adaptation (reduction in the severity of twilight vision), rarely - color disturbance (taking place after drug withdrawal), lenticular cataract, keratitis, blepharitis, conjunctivitis, eye irritation, swelling of the optic nerve (as a manifestation of intracranial hypertension); hearing loss at certain sound frequencies.
Gastrointestinal tract: nausea, diarrhea, inflammatory bowel disease (colitis, ileitis), bleeding; pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg / dL). Rare cases of pancreatitis with a fatal outcome have been described. Transient and reversible increase in liver transaminase activity, isolated cases of hepatitis. In many of these cases, the changes did not go beyond the limits of the norm and returned to the original indicators in the course of treatment, but in some situations it was necessary to reduce the dose or cancel Roaccutane.
Respiratory system: rarely - bronchospasm (more often in patients with bronchial asthma in history).
Blood system: anemia, decrease in hematocrit, leukopenia, neutropenia, increase or decrease in the number of platelets, accelerated ESR.
Laboratory values: hypertriglyceridemia, hypercholesterolemia, hyperuricemia, a decrease in the level of high-density lipoproteins, rarely - hyperglycemia. In the course of taking Roaccutane, cases of newly diagnosed diabetes were reported. In some patients, especially those engaged in intense physical activity, isolated cases of an increase in the activity of CK in serum have been described.
The immune system: local or systemic infections caused by gram-positive pathogens (Staphylococcus aureus).
Other: lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener's granulomatosis, allergic vasculitis), systemic hypersensitivity reactions, glomerulonephritis.

Special notes

Roaccutane should be prescribed only by physicians, preferably dermatologists, who are experienced in using systemic retinoids and who are aware of the risk of drug teratogenicity. Patients, both female and male, need to issue a copy of the patient information leaflet.
In order to avoid accidental effects of the drug on the body of other people, patients who receive or shortly before this (1 month) received Roaccutane, you can not take donated blood.
It is recommended to monitor liver function and liver enzymes before treatment, 1 month after its onset, and then every 3 months or as indicated. A transient and reversible increase in hepatic transaminases is noted, in most cases within normal limits.If the level of liver transaminases exceeds the norm, it is necessary to reduce the dose of the drug or cancel it.
You should also determine the level of lipids in the serum on an empty stomach before treatment, 1 month after the start, and then every 3 months or according to indications. Usually, lipid concentrations are normalized after dose reduction or withdrawal of the drug, as well as diet. It is necessary to control the clinically significant increase in triglycerides, since their elevation above 800 mg / dL or 9 mmol / L may be accompanied by the development of acute pancreatitis, possibly with a fatal outcome. If persistent hypertriglyceridemia or symptoms of pancreatitis, Roaccutane should be canceled.
In rare cases, patients treated with Roaccutane described depression, psychotic symptoms and, very rarely, suicidal attempts. Although their causal relationship with the use of the drug has not been established, special care must be taken in patients with depression in history and all patients should be monitored 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, acne exacerbation is noted, which disappears within 7–10 days without a dose adjustment.
A few years after Roaccutane was used to treat dyskeratosis, bone changes developed with a total dose rate and duration of therapy higher than those recommended for acne therapy.including premature closure of epiphyseal growth zones, hyperostosis, calcification of ligaments and tendons. Therefore, when prescribing a drug to any patient, you should first carefully evaluate the ratio of possible benefits and risks.
Patients receiving Roaccutane are recommended to use moisturizing ointment or body cream, lip balm to reduce dryness of the skin and mucous membranes at the beginning of therapy.
During post-marketing follow-up with Roaccutane, cases of severe skin reactions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis are described. These phenomena can be serious and lead to disability, life-threatening conditions, hospitalization or fatal outcome. Patients receiving Roaccutane need to be carefully monitored to identify severe skin reactions and, if necessary, decide on the abolition of the drug.
While taking Roaccutane, there may be pain in muscles and joints, an increase in serum creatinine phosphokinase, which may be accompanied by a decrease in tolerance to intense exercise.
Deep chemical dermoabrasion and laser treatment in patients receiving Roaccutane should be avoided, as well as within 5-6 months after the end of treatment due to the possibility of enhanced scarring in atypical sites and the occurrence of hyperpigmentation and hypopigmentation.During treatment with Roaccutane and for 6 months after it, epilation cannot be performed using wax applications because of the risk of epidermis detachment, scar development and dermatitis.
Since some patients may experience a decrease in visual acuity at night, which sometimes persists even after the end of therapy, patients should be informed about the possibility of this condition, recommending that they be careful when driving a car at night. The state of visual acuity must be carefully monitored.
Dry conjunctival eyes, corneal opacities, blurred night vision and keratitis usually disappear after discontinuation of the drug. In case of dryness of the mucous membrane of the eyes, you can use applications of moisturizing eye ointment or an artificial tear preparation. It is necessary to observe patients with dry conjunctiva for possible development of keratitis. Patients complaining of vision should be referred to an ophthalmologist and consider the appropriateness of canceling Roaccutane. If contact lenses are intolerant, glasses should be used at the time of therapy.
Exposure to sunlight and UV rays should be limited. If necessary, use a sunscreen with a high protective factor of at least 15 SPF.
Rare cases of the development of benign intracranial hypertension ("brain pseudotumor"), including when combined with tetracyclines.In such patients, Roaccutane should be discontinued immediately.
With Roaccutane therapy, an inflammatory bowel disease may occur. In patients with severe hemorrhagic diarrhea, Roaccutane should be discontinued immediately.
Rare cases of Anaphylactic reactions that occurred only after previous external use of retinoids have been described. Severe allergic reactions dictate the need to discontinue the drug and closely monitor the patient.
High-risk patients (with diabetes, obesity, chronic alcoholism or impaired fat metabolism) may need more frequent laboratory monitoring of glucose and lipids in Roaccutane treatment.
If diabetes is present or suspected, a more frequent determination of glycemia is recommended.

Because of the possible increase in symptoms of hypervitaminosis A, the 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 can weaken the effectiveness of Progesterone drugs, 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.

In case of an overdose, signs of hypervitaminosis A may appear. In the first few hours after the overdose, gastric lavage may be necessary.

Store at a temperature not exceeding 25 ° C, protected from light and moisture.
Keep out of the reach of children.

3 years.