Severe forms of acne (such as nodular acne, acne acne or acne with the risk of permanent scarring) resistant to standardized standard treatment of general antimicrobials and topical medications.
Composition:
1 softcapsule contains 10 mg or 20 mg isotretinoin. The preparation contains sorbitol.
Action:
Preparation from the retinoid group, a synthetic derivative of vit. A (all-trans-retinoic acid stereoisomer). It inhibits the activity of sebaceous glands and reduces their size. It has anti-inflammatory effects on the skin. Bioavailability increases when isotretinoin is given with food. It is highly bound to plasma proteins (99.9%). Isotretinoin concentrations in the epidermis are half as high as in the blood serum. It is metabolized in the liver to 4-oxo-isotretinoin and tretinoin by a series of CYP enzymes. T0,5 isotretinoin is on average 19 h, and its metabolite (4-oxo-isotretinoin) - an average of 29 h.
Contraindications:
Hypersensitivity to isotretinoin, soybean oil, soy, peanut or any of the excipients. Pregnancy, breast-feeding. Isotretinoin is contraindicated in women who could become pregnant unless all conditions of the Pregnancy Prevention Program are met. Liver failure. Significantly increased blood lipids. Hypervitaminosis A. Simultaneous use of tetracyclines.
Precautions:
Due to the strong teratogenic effect, the preparation can be used in women of childbearing age only in the severe form of refractory acne and only after confirming that the patient is not pregnant (negative pregnancy test before starting treatment) and provided that effective contraception is used 1 month before, during and for at least 1 month after the end of therapy. The patient must be aware of teratogenic effects, adhere to the Pregnancy Prevention Program and have a monthly medical check up. Pregnancy tests (with a sensitivity of at least 25 mIU / ml) should be carried out in the first 3 days of the cycle; they are performed before treatment, during and for 5 weeks after its completion. If during pregnancy a woman becomes pregnant, treatment should be discontinued and the patient should be referred to a specialist or teratology specialist. It is not recommended for children under 12 years of age. Particularly cautiously use in patients with a history of depression. Exposure to intense solar or UV radiation should be avoided, if necessary, products containing UV filters of at least SPF 15 should be used. During treatment and up to 5-6 months afterwards, aggressive chemical dermabrasion and laser skin treatment should be avoided. (risk of scars, discoloration and discoloration). At least 6 months after the end of treatment, waxing should not be used (risk of rupture of the epidermis). The concomitant use of isotretinoin with topically administered keratolytic agents or exfoliating products used in the treatment of acne should be avoided due to the risk of excessive skin irritation. Patients should be advised about the possibility of severe skin reactions (eg erythema multiforme, Stevens-Johnson syndrome, toxic epidermal fat cell) and to carry out a detailed observation of patients for these reactions. If a severe skin reaction is suspected, treatment with isotretinoin should be discontinued. Some patients may experience worsening of vision in the dark, sometimes this symptom may occur suddenly; ophthalmologic consultation is recommended, it may be necessary to discontinue the medicine. The preparation should be immediately discontinued if mild intracranial hypertension, severe diarrhea (haemorrhagic) or severe allergic reactions appear. For long-term and clinically significant increases in serum transaminases, a dose reduction or discontinuation should be considered. In patients with renal failure, treatment starts with a lower dose and gradually increases to the maximum tolerated.Treatment with isotretinoin should be discontinued if hypertriglyceridemia can not be stabilized until plasma triglyceride levels are achieved or when symptoms of pancreatitis occur. In patients with diabetes, alcoholism, obesity, and patients with lipid metabolism disorders, it may be necessary to monitor blood lipids and Glucose more frequently. The preparation contains sorbitol, therefore it should not be used in patients with hereditary fructose intolerance. The preparation also contains soybean oil and cochineal cochlil, which can cause allergic reactions.
Pregnancy and lactation:
Use during pregnancy is absolutely contraindicated (teratogenic). Use while breastfeeding is contraindicated.
Side effects:
Very common: anemia, accelerated fall of red blood cells, thrombocytopenia, thrombocytosis; blepharitis, conjunctivitis, dry eye syndrome, eye irritation; increase in aminotransferases; inflammation of the lips, dermatitis, dry skin, local exfoliation, pruritus, erythematous rash on the skin, skin sensitivity to damage (risk of abrasions); joint pain, muscle pain, back pain (especially in puberty patients); increase in serum triglycerides, decrease in high-density lipoprotein. Common: neutropenia; Headache; nosebleeds, dryness of the nasal mucous membrane, nasopharyngeal inflammation; increased serum cholesterol, increased blood Glucose, hematuria, proteinuria. Very rare: skin and mucous membrane infections caused by Gram-positive bacteria; lymphadenopathy; diabetes, hyperuricemia; behavioral disorders, psychotic disorders, suicidal thoughts, suicide attempts, suicide; benign intracranial hypertension, convulsions, drowsiness; blurred vision, cataracts, color blindness, contact lens intolerance, corneal opacity, reduced night vision, keratitis, optic nerve edema (as a symptom of benign intracranial hypertension), photophobia; hearing impairment; vasculitis (e.g., Wegener's granulomatosis, allergic vasculitis); bronchospasm (especially in patients with asthma), hoarseness; colitis, ileitis, dry mucous pharynx, gastrointestinal haemorrhages, haemorrhagic diarrhea, inflammatory bowel diseases, nausea, pancreatitis; hepatitis; acne fulminant, exacerbation of acne (acne relapse), erythema (on the face), eruptions, hair disorders, hirsutism, nausea dystrophy, nausea, hypersensitivity reaction to the light, pyogenic granuloma, hyperpigmentation of the skin, increased sweating; arthritis, calcification, premature bone root growth, bone growth, bone hypertrophy, reduction in bone density, tendinitis; glomerulonephritis; excessive formation of granulomatous tissue, malaise; increase in creatine kinase in the blood. Not known (can not be estimated from the available data) erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Dosage:
Orally. Isotretinoin can only be prescribed by a physician who has experience in the use of generally active retinoids in the course of severe forms of acne and a full knowledge of the risks associated with the use of isotretinoin and the requirements for monitoring the patient during the use of the drug. Treatment must be under the supervision of a doctor who meets these conditions. Adults, including adolescents and the elderly: treatment should be started at a dose of 0.5 mg / kg. per day. Response to treatment and some adverse reactions depend on dose and vary in individual patients. Therefore, individual dose adjustments are required during therapy. For most patients, the appropriate dose is in the range of 0.5-1 mg / kg. per day. Long-term remission and the rate of relapse depend more on the total dose than on the treatment or daily dose. It was demonstrated that exceeding the cumulative dose of 120-150 mg / kg does not bring significant additional benefits. The duration of treatment depends on the individual daily dose. Usually, treatment for 16 to 24 weeks is sufficient for remission. In most patients, the symptoms of acne disappear completely after one treatment cycle.In the event of a relapse, a re-cycle of isotretinoin treatment may be considered using the same daily and cumulative dose. Due to the fact that further acne disappearance may occur within 8 weeks after the end of treatment, a recurrence of treatment should not be considered before this time. In patients with severe renal impairment, treatment should be started with a lower dose (eg 10 mg daily). The dose should then be increased to 1 mg / kg. daily or up to the maximum dose tolerated by the patient. Isotretinoin is not indicated for the treatment of pre-pubescent acne and is not recommended for use in children under 12 years of age. In patients with severe intolerance, the recommended dose may be continued with a lower dose. It is associated with a longer treatment time and a greater risk of relapse. In order to obtain the highest possible treatment effectiveness, the highest dose tolerated by the patient should be continued. Capsules should be taken with food.