Wonica 0.139

INDICATIONS

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.

PHARMACOLOGY

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.

DOSAGE & ADMINISTRATION

Eflornithine cream should be applied to the affected area twice daily, at least eight hours apart. Efficacy has only been demonstrated for affected areas of the face and under the chin. The application should be limited to these areas. Maximal applied doses used safely in clinical trials were up to 30 grams per month. Improvement in the condition may be noticed within eight weeks of starting treatment. Continued treatment may result in further improvement and is necessary to maintain beneficial effects. The condition may return to pre-treatment levels within eight weeks following discontinuation of treatment. Use should be discontinued if no beneficial effects are noticed within four months of commencing therapy. Patients may need to continue to use a hair removal method (e.g. shaving or plucking) in conjunction with Eflornithine cream. In that case, the cream should be applied no sooner than five minutes after shaving or use of other hair removal methods, as increased stinging or burning may otherwise occur.Elderly: (>65 years) No dosage adjustment is necessary.Pediatric population: The safety and efficacy of Eflornithine in children aged 0 to 18 years has not been established. There is no data available to support use in this age group.Hepatic/renal impairment: The safety and efficacy of Eflornithine in women with hepatic or renal impairment have not been established. As the safety of Eflornithine has not been studied in patients with severe renal impairment, caution should be used when prescribing Eflornithine cream for these patients. A thin layer of the cream should be applied to clean and dry affected areas. The cream should be rubbed in thoroughly. The medicinal product should be applied such that no visual residual product remains on the treated areas after rub-in. Hands should be washed after applying this medicinal product. For maximal efficacy, the treated area should not be cleansed within four hours of application. Cosmetics (including sunscreens) can be applied over the treated areas, but no sooner than five minutes after application.

INTERACTION

No interaction studies have been performed.

SIDE EFFECTS

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 & LACTATION

pregnancy: Throughout clinical trials data from a limited number of exposed pregnancies (22) indicate that there is no clinical evidence that treatment with Eflornithine adversely affects mothers or foetuses. Among the 22 pregnancies that occurred during the trials, only 19 pregnancies occurred while the patient was using Eflornithine. Of these 19 pregnancies, there were 9 healthy infants, 5 elective abortions, 4 spontaneous abortions and 1 birth defect (Down’s Syndrome to a 35 year old). Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Therefore, women who are pregnant or planning pregnancy should use an alternative means to manage facial hair.Lactation: It is not known whether eflornithine/metabolites are excreted in human milk. Women should not use Eflornithine whilst breastfeeding.

PRECAUTIONS & WARNINGS

If skin irritation or intolerance develops, the frequency of application should be reduced temporarily to once a day. If irritation continues, treatment should be discontinued and the physician consulted.

THERAPEUTIC CLASS

Hair Growth Inhibitor

STORAGE CONDITIONS

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.