Treatment of excessive facial hair in women (hirsutism).
Composition:
1 g of cream contains 115 mg eflornithine (as monohydrate hydrochloride). The preparation contains cetostearyl alcohol, stearyl alcohol, methyl parahydroxybenzoate and propyl parahydroxybenzoate.
Action:
Hair loss reducing preparation. Irreversibly inhibits the action of ornithine decarboxylase - an enzyme involved in the production of the hair shaft by hair follicles. At steady-state, percutaneous penetration of eflornithine from the preparation used on the face skin of shaving women is about 0.8%. T0,5 drug is about 8 hours. The steady state is reached after 4 days. Eflornithine is not metabolised. It is mainly excreted in the urine.
Contraindications:
Hypersensitivity to eflornithine or to any of the excipients.
Precautions:
The cause of hypertrichosis may be a serious disease (eg polycystic ovarian syndrome, androgen-secreting cancer) or some active substances (eg cyclosporine, glucocorticoids, minoxidil, phenobarbitone, phenytoin, hormone replacement estrogen-androgen therapy). These factors should be taken into account in the general treatment of patients who are advised to use the preparation. Avoid contact with eyes and mucous membranes (eg nose or mouth). Applying the cream on the abraded or cut skin may cause a transient burning sensation or skin burning. If skin irritation or intolerance to the drug occurs, temporarily reduce the frequency of application of the cream by applying the medicine once a day. If skin irritation persists, stop treatment and seek medical advice. Caution should be exercised when prescribing to patients with severe renal impairment (no study). The preparation contains cetostearyl alcohol and stearyl alcohol, which can cause local skin reactions (eg contact dermatitis), and methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause (possibly delayed) allergic reactions. The safety and efficacy of the preparation in children aged 0-18 has not been established. There is no data available to support the use in this age group.
Pregnancy and lactation:
Do not use during pregnancy and breast-feeding.
Side effects:
Very often: acne. Common: chronic folliculitis, alopecia, skin burning, dry skin, pruritus, erythema, tingling of the skin, skin irritation, rash, folliculitis. Uncommon: hair growth, swelling of the face, dermatitis, edema of the mouth, follicular rash, skin bleeds, herpes simplex, eczema, inflammation of the lips, impermeability, contact dermatitis, abnormal hair structure, abnormal hair growth, hypopigmentation, redness of the skin, numbness lips, soreness of the skin. Rare: rosacea, seborrheic dermatitis, skin cancer, maculopapular rash, skin cysts, vesiculic bladder rash, skin disorders, hirsutism, skin tightness.
Dosage:
Outwardly. The cream should be applied to the face in a place covered with excessive hair twice a day, separated by at least 8 hours. The effectiveness of the drug was demonstrated only in relation to facial hair and chin. Use of the drug should be limited to these places. The safety of maximal use up to 30 g / month has been demonstrated in clinical trials. The improvement can be seen within 8 weeks after starting treatment. Continuing treatment can bring further improvement and is necessary to maintain beneficial results. After discontinuation of treatment, the hair may return to the condition that occurred before treatment within 8 weeks. If there are no beneficial results within 4 months of the start of treatment, treatment should be discontinued. At the same time, other methods of hair removal (eg, shaving or plucking) can be used with the treatment. In such cases, the cream should not be applied before 5 minutes after shaving the skin hair or using a different method of depilation, as this may cause increased burning or burning of the skin.Elderly patients (> 65 years) do not need to adjust the dose.Method of administration. A thin layer of cream should be applied to clean and dry facial skin in places covered with excessive hair. The cream should be carefully rubbed into the skin. The product should be applied in such a way that after being rubbed into the skin, no traces of cream were visible. Wash your hands after using the product. For best results, treated skin should not be cleaned within 4 hours after application. Cosmetics (also containing sunscreen) may be used on the treated skin, but not earlier than 5 minutes after application.
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