Roakkutan

Roakkutan – the medicine with antiseborrheal, antiinflammatory action applied at treatment of an acne.

Form of release and structure

Dosage form of release of Roakkutan – the capsule: oval, opaque; contents of capsules – suspension of a homogeneous consistence from dark yellow till yellow color; on 10 mg – brown-red, on a surface a text of "ROA 10" black ink; on 20 mg – one half brown-red, another – white, on a surface a text of "ROA 20" black ink (in blisters on 10 pieces, in a cardboard pack of 3 or 10 blisters).

Structure of 1 capsule:

• active agent: изотретиноин – 10 or 20 mg;
• auxiliary components (10/20 mg): bee yellow wax – 7,68/15,36 mg, oil of soybeans – 107,92/215,84 mg, the hydrogenated oil of soybeans – 7,68/15,36 mg, partially hydrogenated oil of soybeans – 30,72/61,44 mg;
• capsule cover (10/20 mg): gelatin – 75,64/120,66 mg, глицерол 85% – 31,275/49,835 mg, Karionum 83 (Mannitolum, the potato hydrolyzed starch, sorbitol) – 8,065/12,86 mg, dye red iron oxide (E172) – 0,185/0,145 mg, titanium dioxide (E171) – 1,185/1,97 mg;
• ink: shellac, dye oxide black iron (E172); use of ready Opacode Black S-1-27794 ink is admissible.

Indications to use

• acne in severe forms (konglobatnye/uzelkovo-cystous or with risk of formation of hems);
• acne at inefficiency of other types of treatment.

Contraindications

Absolute:

• liver failure;
• the expressed lipidemia;
• hypervitaminosis And;
• the combined use with tetracyclines;
• pregnancy (at emergence of pregnancy during therapy or for a month after its termination there is very high probability of the birth of the child with heavy malformations) and the lactation period;
• age up to 12 years;
• hypersensitivity to drug components.

Relative (Roakkutan it is necessary to apply with care at the following states / diseases):

• alcoholism;
• diabetes mellitus;
• depression (anamnestic data);
• disturbances of lipidic exchange;
• obesity.

Route of administration and dosage

Roakkutan accept inside, it is more preferable – along with food.

Frequency rate of reception – 1-2 times a day.

The doctor selects a dose individually. Efficiency of therapy and side reactions have dozozavisimy character and vary at different patients.

The recommended initial daily dose – 0,5 mg/kg.

In most cases the daily dose is in limits of 0,5-1 mg/kg, at very heavy disease and in cases of treatment of an acne of a trunk its increase up to 2 mg/kg is possible.

Optimum course dose – 120-150 mg/kg (is the basis for calculation of duration of treatment). Often full remission of an acne manages to be achieved in 16-24 weeks of use of Roakkutan. At very bad portability of drug decrease in a daily dose and increase in duration of a course is possible.

In most cases after carrying out a single course of treatment of an acne disappear completely. At an explicit recurrence repetition of a course is shown. It is appointed not earlier, than in 2 months after the termination of the first course (the period during which improvement can continue).

At a heavy renal failure therapy needs to be begun with a smaller dose (for example, 10 mg a day). Further it is increased to 1 mg/kg a day or the greatest transferable.

Side effects

Side reactions, as a rule, have reversible character (after decrease in dose/cancellation of therapy), but in certain cases they can remain after the termination of reception of Roakkutan. In most cases disturbances depend on a dose.

Possible side reactions:

• alimentary system: nausea, diarrhea, inflammatory diseases of intestines (ileitis/colitis), bleedings, pancreatitis (in particular at the accompanying gipertriglitseridemiya it is higher than 800 mg/dl, in rare instances – with a fatal outcome), reversible / транзиторное increase in activity of hepatic transaminases; in some cases – hepatitis (most often changes did not overstep the bounds of norm and in the course of treatment were returned to initial indicators, however dose adjustment or cancellation of treatment sometimes was required);
• central nervous system and mental sphere: headache, depression, behavior disorder, convulsive attacks, increase in intracranial pressure ("brain pseudoneoplasm": vision disorder, headache, vomiting, nausea, hypostasis of an optic nerve);
• respiratory system: seldom – a bronchospasm (is more often at bronchial asthma in the anamnesis);
• hemopoietic system: neutropenia, acceleration of SOE, decrease in a hematocrit, anemia, leukopenia, change of number of thrombocytes;
• skeletal and muscular system: muscular pains with/without increase in level of a serumal kreatinfosfokinaza, joint pains, tendinites, arthritis, a hyperostosis, calcification of sinews/sheaves, other changes of bones;
• immune system: the system/local infections caused by gram-positive activators (Staphylococcus aureus);
• sense bodys: in some cases – a photophobia, visual acuity disturbances, disturbance of dark adaptation (decrease in sharpness of twilight sight); seldom – disturbance of color perception (passes after therapy cancellation), conjunctivitis, a lentikulyarny cataract, a blepharitis, a keratitis, hypostasis of an optic nerve (is display of intracranial hypertensia), irritation of eyes, a hearing disorder at certain acoustical frequencys;
• the disturbances connected with a hypervitaminosis And: a xeroderma, mucous membranes, including a cheilitis, bleedings of a nasal cavity, hoarseness of a voice, conjunctivitis, intolerance of contact lenses, reversible opacification of a cornea;
• laboratory indicators: lowering of the level of lipoproteins of high density, gipertriglitseridemiya, hyperuricemia, hypercholesterolemia; seldom – a hyperglycemia, the diabetes mellitus (revealed for the first time), increase in activity of a serumal kreatinfosfokinaza (in particular at intensive exercise stresses);
• dermatological reactions: an itch, rash, fulminantny forms of an acne, an erythema face/dermatitis, paronychias, perspiration, a piogenic granuloma, permanent thinning of hair, onikhodistrofiya, the strengthened growth of granulyatsionny fabric, a reversible hair loss, a photoallergy, a hirsutism, a photosensitization, a hyperpegmentation, an easy travmiruyemost of skin; at the beginning of therapy the exacerbation of an acne throughout several weeks is possible;
• others: proteinuria, glomerulonephritis, system reactions of hypersensitivity, hamaturia, lymphadenopathy, vasculitis (Wegener's granulomatosis, allergic vasculitis).

When carrying out post-marketing observations cases of emergence of such heavy skin reactions as Stephens-Johnson's syndrome, a multiformny erythema, a toxic epidermal necrolysis were recorded.

Special instructions

Roakkutan has to be appointed the doctor, it is desirable – the dermatologist having experience of use of system retinoids and aware of risk of its teratogenecity. Patients of women's and male have to be informed and have about it the copy of the brochure with information.

To avoid unintentional influence of Roakkutan on an organism of other people, to take donor blood from patients who receive or received drug shortly before it (within 30 days), it is impossible.

Control of function of a liver and liver enzymes it is recommended to spend prior to therapy, in 1 month from the moment of its beginning, and further each 3 months or according to indications. As a rule, increase in hepatic transaminases has passing and reversible character and is in limits of normal values. At exceeding of norm the dose decline or cancellation of treatment is shown.

With the same frequency it is necessary to determine the serumal level of lipids on an empty stomach. As a rule, normalization of concentration of lipids happens after reduction of a dose, cancellation of therapy and at observance of a diet. It is necessary to exercise control of clinically significant increase in level of triglycerides. Their raising of over 9 mmol/l or 800 mg/dl can proceed with developing of acute pancreatitis, in certain cases – with a lethal outcome. Therapy is cancelled at a resistant gipertriglitseridemiya or at development of symptoms of pancreatitis.

In rare instances during treatment there is a psychotic symptomatology, a depression, is very rare – suicide attempts. In spite of the fact that relationship of cause and effect Roakkutana is not established with reception, patients need to observe extra care at purpose of drug with a depression in the anamnesis. It is also necessary to observe all patients regarding development of a depression during administration of drug (consultation of the specialist can be required). If cancellation of therapy does not lead to disappearance of symptoms, further observation and treatment at the specialist is necessary.

At the beginning of therapy the exacerbation of an acne which passes without dose adjustment of drug for 7-10 days was in rare instances noted.

In several years after carrying out a medical course of dyskeratoses by Roakkutan at the general course dose and duration of therapy exceeding the acnes recommended for therapy there were bone changes, including a hyperostosis, premature closing of epiphyseal regions of growth, calcification of sinews/sheaves. In this regard at Roakkutan's appointment any patient needs previously to estimate carefully an advantage ratio with risk.

At the beginning of therapy for reduction of dryness of mucous membranes and skin by the patient use of the moisturizing ointments or body creams, lip balm is recommended.

Patients during Roakkutan's reception for identification of development of heavy skin reactions need careful observation (in case of need treatment is cancelled).

Treatment by the laser and holding a procedure of deep chemical dermabrasion during therapy, and also for 5-6 months after the termination of a medical course it is necessary to avoid (possibly strengthening of scarring in atypical places and development hypo - and hyperpegmentations). During administration of drug and within half a year after its termination it is not necessary to carry out an epilation by means of wax applications (there is a probability of amotio of epidermis, emergence of dermatitis and hems).

As a rule, opacifications of a cornea, dryness of a conjunctiva of eyes, a keratitis and deterioration in a scotopia after drug withdrawal take place. At dryness of a mucous membrane of eyes use of the moistening oculentums or drugs of an artificial tear is possible. At dryness of a conjunctiva control regarding probable development of a keratitis is necessary. At emergence of complaints to sight it is necessary to consult at the ophthalmologist (drug withdrawal is possible). In cases of intolerance of contact lenses during Roakkutan's reception it is necessary to use points.

During treatment it is necessary to limit influence of solar/ultraviolet rays. Use of sunblock creams with high value of a protective factor (not less than 15 SPF) is recommended.

At development of benign intracranial hypertensia, including at the combined use with tetracyclines, Roakkutan immediately cancel. Also immediate cancellation of therapy is shown in cases of developing of the expressed hemorrhagic diarrhea.

During therapy carrying out more frequent laboratory researches of level of glucose and lipids can be required by the patients belonging to group of high risk (at a diabetes mellitus, obesity, an alcoholism or disturbances of a lipometabolism). At the diabetes (confirmed or at suspicion) more frequent definition of a glycemia is recommended.

At some patients during therapy decrease in sharpness of a scotopia which in certain cases remains also after the termination of a course can be observed. In this regard patients are recommended to be careful when driving at night (careful control of a condition of visual acuity is necessary).

Medicinal interaction

At the combined use of Roakkutan with some medicinal means / substances the following effects can develop:

• vitamin A: strengthening of symptoms of a hypervitaminosis And (the combination is not recommended);
• tetracyclines: increase in intracranial pressure (the combination is contraindicated);
• progesterone drugs: decrease in their efficiency;
• local exfoliative/keratolytic drugs for treatment of an acne: strengthening of local irritation (the combination is contraindicated).

Terms and storage conditions

To store in protected from light, the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.