Eflornithine Hydrochloride Monohydrate

Eflornithine Hydrochloride Monohydrate is a topical cream indicated for the reduction of unwanted facial hair in women. It irreversibly binds to ornithine decarboxylase (ODC), inhibiting the anagen phase of hair production. Apply twice daily at least 8 hours apart to affected areas (face and under chin). Improvement may be noticed within 8 weeks of starting treatment. Continued treatment is necessary to maintain beneficial effects. Side effects include acne, itching, skin redness, hair loss, burning, dry skin, rash and folliculitis. Contraindicated in hypersensitivity. Use with caution in severe renal impairment.

• Reduction of unwanted facial hair (facial hirsutism) in women

Eflornithine irreversibly binds to ornithine decarboxylase (ODC), inhibiting the anagen phase of hair production. ODC catalyzes biosynthesis of intracellular polyamines required for cell division and differentiation.

Eflornithine irreversibly binds to ornithine decarboxylase (ODC), inhibiting the anagen phase of hair production, thereby slowing hair growth.

Adult Dose (Topical): Apply twice daily, at least 8 hours apart to affected areas.

Child Dose (>12 years): Apply twice daily, at least 8 hours apart to affected areas.

For external use only. Apply a thin layer to clean, dry skin and rub in thoroughly. Wash hands after application. Avoid contact with eyes, nose or mouth. Do not cleanse the treated area within 4 hours of application. Do not apply within 5 minutes of waxing or shaving.

If you miss a dose of Eflornithine Hydrochloride Monohydrate, apply it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular schedule.

Common Side Effects:

• Acne
• Itching
• Hair loss
• Burning sensation
• Dry skin
• Rash
• Paresthesia
• Irritation
• Folliculitis
• Headache
• Dizziness
• Erythema

• For external use only. Avoid contact with eyes, nose or mouth.
• If skin irritation develops, reduce frequency to once daily temporarily. If irritation continues, discontinue treatment and consult doctor.
• Do not apply within 5 minutes of waxing or shaving (may increase stinging/burning).
• Do not cleanse treated area within 4 hours of application.
• Wait at least 5 minutes after application before applying makeup or sunscreen.
• Excessive hair growth may result from serious underlying disorders (e.g., PCOS, androgen-secreting neoplasm).

• Hypersensitivity to eflornithine or any ingredient

No interaction studies have been performed.

No interaction found/established.

Eflornithine Hydrochloride Monohydrate may be unsafe during pregnancy. Animal studies have shown harmful effects. Doctor will weigh benefits and risks.

Probably safe during breastfeeding. Limited human data suggests no significant risk to the baby. However, data on use during lactation is limited.

Safety and efficacy in children aged 0 to 18 years have not been established.

(>65 years) No dosage adjustment is necessary.

Renal impairment: Caution required in severe renal impairment.

Hepatic impairment: Safety not established. Caution required.

Overdose is highly unlikely due to minimal cutaneous penetration. Intravenous therapeutic doses (400 mg/kg/day) may cause: hair loss, facial swelling, seizures, hearing impairment, GI disturbance, loss of appetite, headache, weakness, dizziness, anemia, thrombocytopenia and leucopenia.

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

Eflornithine Hydrochloride Monohydrate