Isotretinoin - A-vitamin-like drug from the group of retinoids with anti-acne, anti-inflammatory, anti-seborrheic and dermato-protective action.
Release form and composition
Dosage forms of the drug - tablets and capsules for oral administration of 10 mg and 20 mg.
The active component of isotretinoin is a substance of the same name.
Indications for use
Isotretinoin is used in the treatment of:
- Severe forms of acne (conglobate, nodular-cystic and acne with the risk of scarring;
- Acne, not amenable to other therapies.
Isotretinoin is contraindicated:
- During pregnancy;
- During pregnancy planning;
- In severe hyperlipidemia;
- Breastfeeding women;
- Patients with severe liver failure;
- Simultaneously with tetracyclines and other retinoids;
- When hypervitaminosis A;
- In case of hypersensitivity to the drug.
It is possible to use the product, but with extreme caution when:
- Renal failure;
- Depression in history;
- Lipid metabolism disorders;
Dosing and Administration
The drug should be taken orally during meals. The dosage is chosen individually, since the effectiveness of Isotretinoin and its side effects are dose-dependent in nature and may have different degrees of severity in different patients.
The initial dose is usually 0.1 mg per kilogram of patient weight. After 4 weeks, depending on the effectiveness and tolerability of the drug, it is increased by 0.1-1 mg / kg / day.
The average therapeutic dosage is 0.4-0.5 mg / kg / day, divided into two doses. In severe cases of the disease, as well as in case of acne lesions of the trunk, the daily dose is increased to 2 mg / kg.
The maximum allowable dosage for patients with severe chronic renal failure is 10 mg / day.
Taking into account the response to the therapy and / or severity of side effects, the dose is adjusted in the course of treatment.
The duration of Isotretinoin is 16-24 weeks. If during this time the number of lesions decreased by at least 70%, the therapy is stopped. In the case of persistent or recurrent disease, repeat courses of treatment are prescribed at intervals of at least 2 months.
When using isotretinoin, the following side effects may occur:
- On the part of the digestive tract: bleeding from the gums, dryness of the oral mucosa, inflammation of the gums, diarrhea, nausea, bleeding, inflammatory bowel disease (ileitis, colitis); rarely - pancreatitis (especially in patients with concomitant hypertriglyceridemia above 800 mg / dL), very rarely - pancreatitis with a fatal outcome, hepatitis, a transient and reversible increase in the activity of hepatic transaminases;
- From the nervous system and sensory organs: photophobia, headache, excessive fatigue, brain pseudotumor (manifested by optic nerve edema, nausea, vomiting, headache, visual impairment), xerophthalmia, decreased visual acuity (especially twilight), convulsive fits; rarely - blepharitis, keratitis, conjunctivitis, eye irritation, color perception, optic neuritis, lenticular cataract, hearing impairment at certain sound frequencies, psychosis, depression, suicidal thoughts;
- On the part of the musculoskeletal system: pain in muscles and joints, arthritis, tendonitis, calcification of ligaments and tendons, hyperostosis;
- On the part of the hematopoietic system: neutropenia, leukopenia, anemia, accelerated ESR, an increase or decrease in the number of platelets, a decrease in hematocrit;
- On the part of the respiratory system: very rarely - bronchospasm (more often in patients with bronchial asthma in history);
- For the skin: facial erythema or dermatitis, fulminant forms of acne, increased proliferation of granulation tissue, desquamation of the skin of the palms and soles, onychodystrophy, pyogenic granuloma, sweating, paronychia, itching, persistent hair thinning, hyperpigmentation, reversible hair loss, hirsutism, photosensitivity, rash, mild skin trauma. At the beginning of treatment, possible exacerbation of acne, persisting for several weeks;
- Others: systemic hypersensitivity reactions, proteinuria, hematuria, vasculitis, lymphadenopathy, glomerulonephritis, hypertriglyceridemia, hyperuricemia, reduction of high-density lipoprotein levels, hypercholesterolemia, local and systemic infections caused by Staphylococcus aureus; rarely - hyperglycemia.
In the case of prolonged use of Isotretinoin and / or in high doses, hypervitaminosis A may develop, manifested by nasal bleeding, cheilitis, reversible corneal opacification, conjunctivitis, contact lens intolerance, dry skin, larynx and pharynx, voice hoarseness.
In accordance with the classification by the FDA (exposure of the drug to the fetus), Isotretinoin belongs to the category X - drugs that are characterized by a high risk of persistent damage to the fetus and the development of congenital anomalies. For this reason, the remedy is contraindicated during pregnancy and at the planning stage. In this regard, before starting therapy, women of childbearing age are recommended to do a test to exclude pregnancy, and 1 month before the start of treatment, its entire period and within 4 weeks after termination should use reliable contraceptive methods. If during the use of Isotretinoin the pregnancy is still there, it is interrupted for medical reasons.
In case of visual impairment, the occurrence of colitis or symptoms of brain pseudotumor, treatment should be discontinued. If a pseudo-tumor is suspected, a neurological examination is prescribed.
During the treatment period:
- It is necessary to control liver function, lipid levels, and glucose, especially in patients with diabetes mellitus;
- Increased insolation, including UV therapy, should be avoided;
- Avoid epilation using wax applications, as this is fraught with epidermis detachment, scar formation and the development of dermatitis;
- You should not take other drugs from the group of retinoids at the same time. possible development of hypervitaminosis A;
- Care must be taken when driving vehicles, especially in the evening;
- You should not take drugs that increase photosensitivity (including thiazide diuretics, tetracyclines and sulfonamides), because increases the risk of sunburn.
With the use of isotretinoin, intolerance to contact lenses is possible. In the case of any side effects from the organ of vision should be used glasses.
Isotretinoin can reduce the effectiveness of progesterone, it should take into account women taking oral contraceptives.
Accutane, 13-cis-Retinoic acid, Aknekutan, Retinoic ointment, Erase, Retasol, Roaccutane.
Terms and conditions of storage
Isotretinoin should be stored in a place protected from the penetration of sunlight at a temperature of up to 25 ºC. Shelf life - 4 years.