Aknekutan

Aknekutan – means from eels; oppresses activity and proliferation of sebaceous glands and promotes reduction of their sizes, suppressing bacterial colonization of a channel, recovering normal process of a differentiation of cells, stimulating regeneration, having antiinflammatory effect on skin.

Form of release and structure

Dosage form – gelatinous solid capsules: 8 mg – the size No. 3, brown color, 16 mg – the size No. 1, a lid green and the case of white color; contents of capsules – orange-yellow waxy paste (on 10 pieces in the blister, in a cardboard pack of 2, 3, 5, 6, 9 or 10 blisters; on 14 pieces in the blister, in a cardboard pack on 1, 2, 4 or 7 blisters).

Aknekutan contains in 1 capsule:

• Active ingredient: изотретиноин – 8 or 16 mg;
• Auxiliary components: the oil soy purified Gelyutsir 50/13 (mix of ethers of stearic acid of a glitserol and poly(ethylene oxide)), Span 80 (sorbitan oleate – mixed ethers of sorbite and oleic acid);
• Case and lid of capsules: titanium dioxide (E171), gelatin; No. 3/№1 – dye ferrous oxide red (E172)/indigo carmine (E132), dye ferrous oxide yellow (E172).

Indications to use

• Konglobatny, nodular and cystous and other severe forms of acne rash, including with risk of formation of hems;
• The eels who are not giving in to other methods of therapy.

Contraindications

• A hypervitaminosis;
• Severe form of a lipidemia;
• Liver failure;
• Simultaneous use of tetracyclines;
• Breastfeeding period;
• The pregnancy established or planned (the probability of embriotoksichesky and teratogenic action is high);
• Age up to 12 years;
• Individual intolerance of components of drug.

Emergence of pregnancy during use or within the first month after end of a course of therapy poses potential threat of heavy malformations at the newborn.

To women of childbearing age therapy by Aknekutan is allowed only in at the expressed form of the acne which is not giving in to usual methods of treatment. At the same time the woman has to:

• To understand and to unconditionally follow all instructions of the doctor;
• To obtain information from the doctor on danger of approach of pregnancy in the course of therapy, for 1 month after it and need of urgent consultation in case of suspicion on pregnancy;
• To confirm understanding of need of precautionary measures and degree of responsibility;
• To obtain information on possible inefficiency of contraceptives;
• To understand need and to constantly use the most effective ways of contraception for 1 month before therapy by Aknekutan, in the course of treatment and for 1 month after its end;
• To use (whenever possible) at the same time two various methods of contraception, including barrier;
• To receive a negative take of the authentic test for pregnancy in 11 days prior to administration of drug;
• To carry out the test for pregnancy monthly in the course of treatment and 5 weeks later upon termination of therapy;
• To begin therapy only in 2-3 days after the beginning of a normal menstrual cycle;
• To realize need every month it is obligatory to visit the doctor;
• To use the same effective methods of contraception at therapy of a recurrence of a disease, for 1 month before therapy, in the course of treatment and for 1 month after its end and to take the same authentic test for pregnancy;
• To understand need of precautionary measures and to confirm the understanding and desire to use the reliable methods of protection recommended by the doctor.

It is necessary to use contraceptives according to the above-stated recommendations during therapy izotretinoiny even to women who usually do not apply contraception because of an amenorrhea, infertility (an exception – the patients who transferred a hysterectomy) or reporting that they have no sex.

With care Aknekutan sick with a diabetes mellitus, obesity, disturbance of lipidic exchange is recommended to appoint, at a depression in the anamnesis, alcoholism.

Route of administration and dosage

Capsules accept orally 1-2 times a day, it is preferable during food.

The doctor appoints a drug dose individually, considering a therapeutic effectiveness and existence of side effects at the patient.

The recommended dosing: an initial dose – from calculation for 0,4 mg on 1 kg of weight of the patient a day, if necessary appointment on 0,8 mg to 1 kg a day is possible. For treatment of an acne of a trunk or severe forms of a disease the dose can make 2 mg on 1 kg a day.

Optimum cumulative dose on a course of therapy of 100-120 mg on 1 kg of weight. Achievement of full remission usually requires 4-6 months.

Patients with bad portability of Aknekutan can lower the recommended daily dose, having prolonged the therapy period.

Usually acne rash completely disappears after one course of treatment.

In case of a recurrence it is possible to appoint a repeated course not earlier, than in 2 months after the end of treatment as symptoms of improvement can be a little delayed. The second year is conducted in an initial daily and cumulative dose.

Patients with the expressed chronic renal failure should reduce an initial dose to 8 mg a day.

Side effects

• Alimentary system: nausea, diarrhea, a xerostomia, an inflammation of gums, an odontorrhagia, intestinal bleedings, inflammatory pathologies of intestines (an ileitis, colitis), pancreatitis, including with a lethal outcome (is more often at a gipertriglitseridemiya higher than 800 mg/dl); in some cases – hepatitis, reversible tranzitorny increase in activity of liver enzymes;
• Dermatological reactions: for the several first weeks of use the exacerbation of an acne is possible; a peeling of skin of soles and palms, an itch, rash, dermatitis or an erythema of the person, perspiration, paronychias, a piogenic granuloma, onikhodistrofiya, permanent thinning of hair, the strengthened growth of granulyatsionny fabric, a reversible hair loss, a hirsutism, fulminantny forms of an acne, a photosensitization, a hyperpegmentation, an easy travmiruyemost of skin;
• Nervous system: headache, increased fatigue, increase in intracranial pressure (brain pseudoneoplasm: nausea, vomiting, headache, hypostasis of an optic nerve, vision disorder), convulsive attacks; seldom – psychosis, a depression, suicide thoughts;
• Musculoskeletal system: joint pains, muscle pains (with increase in level of activity of a kreatinfosfokinaza in blood serum or without it), arthritis, a hyperostosis, tendinites, calcification of sinews and sheaves;
• Sense bodys: photophobia, visual acuity disturbances (separate cases), xerophthalmia, disturbance of dark adaptation (decrease in sharpness of twilight sight); seldom – passing disturbance of color perception (after cancellation it is recovered independently), an optic neuritis, a keratitis, a lentikulyarny cataract, conjunctivitis, a blepharitis, irritation of eyes, hypostasis of an optic nerve (as display of intracranial hypertensia), at patients with contact lenses is difficulties in carrying, disturbance of acoustical perception of certain acoustical frequencys;
• System of a hemopoiesis: decrease in a hematocrit, anemia, leukopenia, neutropenia, change of number of thrombocytes, acceleration of a blood sedimentation rate;
• Respiratory system: seldom – a bronchospasm (is more often at bronchial asthma in the anamnesis);
• Laboratory indicators: hypercholesterolemia, gipertriglitseridemiya, decrease in level of lipoproteins of high density, hyperuricemia; seldom – a hyperglycemia; cases for the first time the revealed diabetes mellitus; more often at an intensive exercise stress – increases in activity of a kreatinfosfokinaza in serum; the system or local infections caused by Staphylococcus aureus (gram-positive activators);
• Others: a proteinuria, a hamaturia, a lymphadenopathy, a vasculitis (including an allergic etiology, Wegener's granulomatosis), a glomerulonephritis, system reactions of hypersensitivity.

The symptoms connected with A hypervitaminosis: dryness of mucous membranes of a throat and throat (hoarseness of a voice), lips (cheilitis), eye (reversible opacification of a cornea, conjunctivitis, intolerance of contact lenses), nasal cavity (bleeding), skin.

Embriotoksichesky and teratogenic action of Aknekutan: inborn uglinesses – hydrocephaly, a nanocephalia, a microphthalmia, an underdevelopment of cranial nerves, malformations of epithelial bodies and cardiovascular system, disturbance of formation of a skeleton (an underdevelopment of a skull, manual phalanxes, cervical vertebrae, anklebones, a femur, forearm bones, a wolf mouth, a facial skull), an underdevelopment and/or a low arrangement of auricles, total absence or an underdevelopment of outside acoustical pass, hernia back and a brain, an union of toes and hands, bone unions, disturbances of development of a thymus, death of a fruit during the perinatal period, an abortion, premature birth, early closing of epiphyseal regions of growth, in experiments on animals – a pheochromocytoma.

Special instructions

Purpose of drug to each patient has to be carried out after careful preliminary estimate of a ratio of estimated advantage and potential risk.

Drug is not shown for treatment of acne rash of the period of puberty.

Aknekutan's use demands carrying out regular control of function of a liver and liver enzymes before treatment, after one month of therapy, further every 3 month. At exceeding of norm of level of hepatic transaminases it is necessary to lower a dose of drug or to stop reception.

 Besides, prior to treatment at the patient it is necessary to determine the level of lipids in blood serum, then, after one month of use, and every 3 month or by indications. Usually the maintenance of lipids is normalized a dose decline, observance of a diet or drug withdrawal.

As increase in level of triglycerides over 9 mmol/l or 800 mg/dl can cause development of acute pancreatitis, including with a lethal outcome, the patient needs to control their contents. In case of a steady gipertriglitseridemiya or emergence of symptoms of pancreatitis use of drug should be stopped.

Because of risk of emergence of psychotic symptomatology, a depression, suicide attempts with extra care it is recommended to appoint drug at a depression in the anamnesis and to control emergence of symptoms of a depression in all patients.

The exacerbation of an acne which arose at the beginning of therapy without dose adjustment passes within 7-10 days.

At the beginning of therapy for reduction of a xeroderma it is recommended to use the moisturizing cream or body ointment, lip balm.

As effect of drug can cause decrease in sharpness of a scotopia (sometimes remaining and after the end of reception), the doctor has to inform the patient on a possibility of such state, recommend to it when driving the car at night to be careful. Dryness of a conjunctiva can cause development of a keratitis therefore for moistening of a mucous membrane of eyes it is recommended to use the drugs of an artificial tear moisturizing oculentums. At an aggravation of symptoms of visual acuity it is necessary to address the ophthalmologist.

It is necessary to avoid ultra-violet therapy and influence of direct sunshine, it is recommended to use cream with high value of a sun-protection factor (15 SPF and more).

At emergence of an inflammatory disease of intestines it is necessary to see a doctor. In case of the expressed hemorrhagic diarrhea administration of drug needs to be stopped immediately.

Because of risk of the strengthened scarring, emergence hypo - and hyperpegmentations, treatment by the laser and carrying out a deep chemical dermoabraziya both during Aknekutan's reception, and within 5-6 months after the end of therapy is contraindicated to patients.

There is a risk of amotio of epidermis, emergence of dermatitis and hems when carrying out an epilation by means of wax applications. Procedures cannot be carried out during therapy and for six months after drug withdrawal.

Heavy allergic reactions are the basis for immediate cancellation of capsules.

Patients with obesity, a diabetes mellitus, an alcoholism, disturbance of a lipometabolism need more frequent carrying out laboratory control of level of lipids and glucose.

It is impossible to make blood sampling at potential donors during therapy izotretinoiny, and also within 1 month after completion of treatment.

During Aknekutan's use by the patient it is necessary to be careful at control of vehicles and work with difficult mechanisms.

Medicinal interaction

Before simultaneous use of Aknekutan with other medicines it is necessary to consult with the attending physician to avoid development of side effects.

Terms and storage conditions

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

Period of validity – 2 years.