Eflornithine Hydrochloride cream, 13.9% is indicated for the reduction of unwanted facial hair in women. Eflornithine Hydrochloride has only been studied on the face and adjacent involved areas under the chin of affected individuals. Usage should be limited to these areas of involvement.
Eflornithine prevents hair growth by inhibiting the anagen phase of hair production. This occurs by eflornithine irreversibly binding (also called suicide inhibition) to ornithine decarboxylase (ODC) and physically preventing the natural substrate ornithine from accessing the active site.
Adults: Apply a thin layer of Eflornithine cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. The patient should continue to use hair removal techniques as needed in conjunction with Eflornithine (Wonica should be applied at least 5 minutes after hair removal). Cosmetics or sunscreens may be applied over treated areas after cream has dried. Elderly: No apparent differences in safety were observed between older patients and younger patients. Children: The safety and effectiveness of this product have not been established in pediatric patients less than 12 years of age.
No interaction studies have been performed.
Eflornithine is contraindicated in patients with a history of sensitivity to any components of the preparation. For external use only. Transient stinging or burning may occur when applied to abraded or broken skin.
Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of Eflornithine. Side effects can include acne, barbae, pseudofolliculitis, stinging skin, headache, burning skin, dry skin, erythema (redness), pruritus (itching), tingling skin, dyspepsia, skin irritation, rash, alopecia, dizziness, folliculitis, hair ingrown, facial edema, anorexia, nausea, asthenia, vertigo.
Pregnancy Category C. It is not known whether or not Eflornithine Hydrochloride is excreted in human milk. Caution should be exercised when Eflornithine is administered to a nursing woman.
Given the minimal cutaneous penetration of Eflornithine, overdose is highly unlikely. However, should very high dose cutaneous administration or accidental oral ingestion occur, attention should be paid to the effects seen with therapeutic doses of intravenous eflornithine (400 mg/kg/day or approximately 24 g/day). This dose of Eflornithine in intravenous route is used in the treatment of Trypanosoma brucei gambiense infection (African sleeping sickness). The symptoms of this disease are: hair loss, facial swelling, seizures, hearing impairment, gastrointestinal disturbance, loss of appetite, headache, weakness, dizziness, anaemia, thrombocytopenia and leucopenia. If symptoms of overdose occur the use of the medicinal product should be stopped.
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
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