Isotretinoin with its brand name Tretizen is a retinoid for the systemic treatment of acne. Improvement of the clinical picture of severe forms of acne is associated with the suppression of the activity of the sebaceous glands and a decrease in their size, deprivation of Propionibacterium acnes of the main substrate for growth.
The drug inhibits the proliferation of sebocytes and acts on acne, restoring the normal process of cell differentiation.
The anti-inflammatory effect of isotretinoin on the skin has been proven.
The kinetics of isotretinoin and its metabolites is linear; it does not affect the activity of hepatic enzymes involved in drug metabolism.
In patients with acne, the maximum plasma concentrations in an equilibrium state after taking 80 mg of isotretinoin on an empty stomach were 310 ng/ml and were reached after 2-4 hours. Plasma concentrations of isotretinoin are approximately 1.7 times higher than those in blood, due to poor penetration of isotretinoin into erythrocytes.
Isotretinoin is 99.9% bound to plasma proteins. After oral administration, three major metabolites are found in plasma: 4-oxo-isotretinoin, tretinoin (all-trans-retinoic acid), and 4-oxo-retinoin. After oral administration of radioactively labeled isotretinoin, approximately the same amount is found in urine and feces. The terminal phase elimination half-life for the unchanged drug in patients with acne averages 19 hours.
It is used for the treatment of severe forms of acne (nodular-cystic, conglobatic acne, or acne with a risk of scarring) and acne that is not amenable to other types of therapy.
– Breastfeeding period
– Liver failure
– Hypervitaminosis A
– Severe hyperlipidemia
– Concomitant tetracyclines therapy
– Hypersensitivity to the drug or its components (including soy).
– Children up to age 12.
To be used Carefully
– History of depression
– Lipid metabolism disorders
– Pregnancy and lactation:
FDA recommendations – category X. Contraindicated during pregnancy and lactation, teratogenic.
Women taking isotretinoin should use effective contraception for the entire period of drug treatment and 1 month after the end of treatment.
Method of administration and dosage of Isotretinoin
Inside, with meals, once or twice a day.
Recommended daily doses range from 0.4 to 1 mg/kg body weight. Patients with very severe forms of the disease or with acne of the trunk may require higher daily doses – up to 2.0 mg/kg. The course dose is from 100 to 150 mg/kg, the duration of therapy in specific patients varies depending on the daily dose.
Highest daily dose: 2.0 mg/kg.
Hematopoietic system: anemia, neutropenia, increased erythrocyte sedimentation rate, nosebleeds.
Digestive system: nausea, colitis, in rare cases – hepatitis.
Musculoskeletal system: myalgia, arthralgia, rarely hyperostosis. Dermatological reactions: skin rash, dermatitis, dry mucous membranes, erythema, sweating, paronychia, nail dystrophy, increased tissue granulation in the affected areas, rarely – photosensitivity, vasculitis, hair thinning. Sense organs: photophobia, conjunctivitis, corneal opacity, decreased visual acuity at twilight, hearing impairment.
Central and peripheral nervous system: often headache, rarely depression, suicidal tendencies, seizures.
Signs of hypervitaminosis A.
Treatment is symptomatic.
Since tetracyclines can cause an increase in intracranial pressure, their use in combination with the drug is contraindicated.
Isotretinoin can weaken the effectiveness of progesterone medications, so you should not use contraceptives containing small doses of progesterone.
Combined use with topical keratolytic or exfoliative drugs for the treatment of acne is contraindicated due to the possible increase in local irritation.
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