Eflornithine Hydrochloride

N/A

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.

N/A

Eflornithine is contraindicated in patients with a history of sensitivity to any components of the preparation.

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.

It is not known whether Eflornithine has any interaction with other topically applied drug products.

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

Overdosage information with Eflornithine is unavailable. However, if very high topical doses (e.g., multiple tubes per day) or oral ingestion has been encountered (a 30 gm tube contains 4.2 gm of Eflornithine Hydrochloride), the patient should be monitored, and appropriate supportive measures should be administered as necessary.

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.

For external use only. Transient stinging or burning may occur when applied to abraded or broken skin.