Verokutan capsules 10 mg, 30 pcs.

Contraindications

• hepatic insufficiency;
• hypervitaminosis A;
• concomitant therapy with tetracyclines;
• children under 12 years of age;
• expressed hyperlipidemia;
• pregnancy established and planned;
• period of breastfeeding;
• high sensitivity to isotretinoin and any other component of the drug.

With caution: history of depression, diabetes, obesity, lipid metabolism disorders, alcoholism.

Side effects

Most side effects of isotretinoin are dose-dependent. Generally, the benefit/risk ratio is acceptable to the patient, given the severity of the disease, when prescribing the recommended doses. Usually the side effects are reversible after adjusting the dose or withdrawing the drug, but some may persist after discontinuation of treatment.

Skin and subcutaneous fatty tissue system side effects: rash, itching, facial erythema/dermatitis, sweating, pyogenic granuloma, paronychia, onychodystrophy, increased granulation tissue overgrowth, persistent hair thinning, reversible hair loss, fulminant forms of acne, hirsutism, hyperpigmentation, photosensitization, photoallergy, mild skin injury, skin flaking of palms and soles. At the beginning of treatment acne aggravation may occur that lasts for several weeks.

Symptoms associated with hypervitaminosis A: dry skin, mucous membranes, including the lips (cheilitis), nasal cavity (bleeding), larynx, pharynx (hoarseness of voice), eyes (conjunctivitis, reversible corneal opacity, intolerance of contact lenses).

Senses: visual acuity disorders, photophobia, decreased visual acuity, color vision disorders (resolving after drug withdrawal), lenticular cataract, keratitis, blepharitis, conjunctivitis, xerophthalmia, eye irritation, optic edema (as manifestation of intracranial hypertension); hearing impairment at certain sound frequencies.

Musculoskeletal system: muscle pain, joint pain, hyperostosis, arthritis, calcification of ligaments and tendons, other bone changes, tendinitis, decreased bone density, premature closure of epiphyseal growth zones.

Central nervous system: behavioral disorders, depression, headache, increased intracranial pressure (“pseudotumor of the brain”: headache, nausea, vomiting, visual disturbance, optic nerve edema), seizures. Dizziness, drowsiness, sleep disturbance, lethargy, anxiety, nervousness, paresthesias, syncope, weakness, excessive fatigue.

Mental sphere: suicidal thoughts, suicide attempts, suicide, depression, aggression, emotional lability, psychosis.
Reproductive system: Menstrual disorders.

Respiratory system: bronchospasm (especially in patients with a history of bronchial asthma).

Digestive system: nausea, diarrhea, dry oral mucosa, bleeding gums, inflammatory bowel diseases (colitis, ileitis), bleeding, esophagitis, esophageal ulcers, pancreatitis (especially with concomitant hypertriglyceridemia above 800 mg/dL), including with fatal outcome. Transient and reversible increase of activity of “hepatic” transaminases, hepatitis. In these cases the changes were within normal limits and returned to baseline values during treatment, but in some situations it was necessary to reduce the dose or cancel isotretinoin.

Laboratory parameters: increased concentration of triglycerides (TG), cholesterol, uric acid, decreased concentration of high density lipoproteins (HDL) in plasma, hyperglycemia. Cases of newly diagnosed diabetes mellitus have been described during isotretinoin administration. In some patients, especially those engaged in intensive physical activity, cases of increased creatine phosphokinase activity have been described.

Blood system, hematopoietic organs: anemia, decreased number of leukocytes, neutrophils, decreased hematocrit, increased or decreased number of platelets, accelerated sedimentation rate of red blood cells (SLE).

Immune system disorders: local or systemic infections caused by Gram-positive pathogens (Staphylococcus aureus).

Other:
lymphadenopathy, hematuria, proteinuria, vasculitis (Wegener’s granulomatosis, allergic vasculitis), systemic hypersensitivity reactions, glomerulonephritis, back pain. Post-marketing surveillance Cases of severe skin reactions, such as erythema multiforme exudative, Stevens-Johnson syndrome, toxic epidermal necrolysis, have been described during post-marketing surveillance when using isotretinoin.

Overdose

Symptoms: In case of overdose there may be signs of hypervitaminosis A (dizziness, headache, drowsiness, nausea, vomiting, irritability).

Treatment: In the first few hours after an overdose the gastric lavage may be required. In most cases these phenomena are reversible and do not require treatment.

Pregnancy use

Pregnancy is an absolute contraindication for isotretinoin therapy. Isotretinoin is a drug with a strong teratogenic effect. If pregnancy occurs while a woman is taking isotretinoin orally (in any dose, even for a short period of time), there is a very high risk of a child being born with malformations. Isotretinoin is contraindicated in women of childbearing age unless the woman meets all of the following criteria:

• Severe acne that is resistant to conventional treatments.
• The patient must understand and follow the doctor’s instructions.
• The patient should be informed by the physician of the risk of pregnancy during treatment with isotretinoin, for one month thereafter, and urgent consultation if pregnancy is suspected.
• The patient should be warned of the possible ineffectiveness of contraception.
• The patient must confirm that she understands the precautions.
• The patient must understand the need for and continuously use effective contraception for one month before, during, and one month after treatment with isotretinoin; preferably 2 different contraceptive methods, including barrier contraception, should be used simultaneously. The use of contraception during isotretinoin treatment should be recommended even for women who are not usually using contraception because of infertility (except for patients who have had a hysterectomy), amenorrhea, or who report not being sexually active.

Pregnancy test According to current practice, a pregnancy test with a minimum sensitivity of 25 mEU/mL should be performed in the first 3 days of the menstrual cycle:
Before starting therapy

• To rule out possible pregnancy before starting contraception, the result and date of the initial pregnancy test should be recorded by the physician. In patients with irregular menstrual periods, the timing of the pregnancy test depends on sexual activity and should be performed 3 weeks after unprotected intercourse. The doctor must inform the patient about the contraceptive methods.
• Pregnancy test is performed on the day of use of VeroCutan or 3 days before the patient’s visit to the doctor. The specialist should record the results of the test. The drug may only be used by patients who received effective contraception for at least 1 month before starting therapy with Verokutan. During therapy
• Patient should see her doctor every 28 days. The need for monthly pregnancy testing is determined according to local practice and taking into account sexual activity, previous menstrual irregularities. If indicated, a pregnancy test is performed on the day of the visit or three days before the visit to the physician, and the results of the test must be recorded. End of therapy
• Five weeks after the end of therapy, a pregnancy test is performed to rule out pregnancy.
• Prescription for Verokutan for women capable of childbearing may only be prescribed for 30 days of treatment, continuation of therapy requires a new prescription by the doctor. It is recommended that the pregnancy test, prescription, and medication pick up be done on the same day.
• Dispense Verokutan at the pharmacy only within 7 days of issuing the prescription.

Male patients