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Sun Pharmaceutical Industries Ltd

Eflora Cream 15gm

Hirsutism
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    Introduction About EFLORA CREAM

    EFLORA CREAM contains Eflornithine, which belongs to the group of medicines called Ornithine decarboxylase inhibitors. It is used in the management of facial hirsutism in women. Facial Hirsutism is a condition with unwanted excessive hair growth on the chin, mouth and other parts of the face in women which is distributed in a manner like that of a man as a result of hormonal imbalance (due to an increase in androgen hormone level), Polycystic ovary syndrome, tumor in the adrenal gland or ovary, Cushing’s syndrome etc.

    Before applying EFLORA CREAM, inform your doctor if you have or ever had a kidney, or liver problems such as renal or hepatic impairment. EFLORA CREAM is not recommended for use if you are allergic to eflornithine. EFLORA CREAM should be used with caution by pregnant and breastfeeding women. EFLORA CREAM should be used with caution in children and adolescents (below 18 years). Consult your doctor before applying EFLORA CREAM.

    The most common side effects of using EFLORA CREAM are pimples, razor bumps, burning, stinging, or tingling sensations in the skin, itching, dry skin, hair loss, skin redness, irritation, inflammation, and skin rash. Contact your doctor if any of the symptoms worsen.

    Uses Of EFLORA CREAM

    • Manage facial hirsutism in women to slow the growth of unwanted facial hair in the affected women

    How EFLORA CREAM Works

    EFLORA CREAM works by blocking a certain natural substance (an enzyme) that is needed for hair growth in the skin which results in slowing the hair growth and making the hair grow finer and lighter thereby hair growth in the affected part of the women especially face.

    How to use EFLORA CREAM

    Always apply EFLORA CREAM as directed by your physician. It is for external use only. Apply a thin layer of this medicine to the affected area. Managed areas on the face should not be washed for at least 4 hours after application. It should remain applied to the face for 5 minutes after hair removal. Do not cover the applied area with a plaster or bandage. Avoid applying this medicine around your eyes.

    Side Effects Of EFLORA CREAM

    Common

    • pimples
    • razor bumps
    • burning, stinging, and tingling sensation on the skin
    • itching
    • dry skin
    • hair loss
    • skin redness, irritation, and inflammation
    • skin rash
    • headache
    • indigestion
    • dizziness
    • folliculitis (inflammation of hair follicle)
    • ingrown hair
    • facial swelling
    • anorexia (eating disorder)
    • nausea
    • weakness
    • internal or external spinning sensation

    Uncommon

    • bleeding skin
    • inflammation of the lips
    • red, itchy skin rash
    • swelling of face, mouth, and lips
    • signs of herpes simplex such as sores, blisters, and itching at the affected site
    • numbness and rosacea (pus-filled bumps on face)

    Rare

    Stop taking EFLORA CREAM and contact your doctor immediately if you experience any of the following side effects:

    • signs of allergic skin reactions (hypersensitivity) such as red itchy spots on the skin, and rash

    How To Manage Side Effects

    Dizziness:

    Get up and move around to feel awake, and take small naps to edge off the sleepiness. Give your eyes a break to avoid fatigue and eat healthy foods to boost energy. Consult your doctor if the symptom does not improve.

    Nausea:

    Try taking this medicine with or after a meal or snack. Stick to simple meals. Avoid eating rich or spicy food. Consult your doctor if the symptom does not improve.

    Warning & Precautions

    Pregnancy

    EFLORA CREAM should be used with caution in pregnant women only if it is necessary. Consult your doctor before taking it.

    Breastfeeding

    EFLORA CREAM should be used with caution only if it is necessary. Consult your doctor before taking it.

    Kidney

    EFLORA CREAM should be used with caution in patients with renal impairment. Consult your doctor before taking it.

    Liver

    EFLORA CREAM should be used with caution in patients with hepatic impairment. Consult your doctor before taking it.

    Allergy

    Do not take EFLORA CREAM if you are allergic to eflornithine or any of the other ingredients of this medicine.

    Others

    Use in pediatrics:

    EFLORA CREAM should be used with caution in children and adolescents (below 18 years) as safety and effectiveness are unknown. Consult your doctor before taking it.

    Use in geriatrics:

    EFLORA CREAM should be used with caution in elderly patients (aged above 65 years). Consult your doctor before taking it.

    Interactions

    A. Drug-Drug interactions:

    Before taking EFLORA CREAM, inform your doctor if you are taking any prescription, non-prescription or any other herbal medicines.

    Overdosage:

    If you or anyone else accidentally take too much of EFLORA CREAM or swallowed this medicine, consult your doctor immediately or visit the nearby hospital.

    Synopsis

    Drug :   Eflornithine
    Pharmacological Category :   Ornithine decarboxylase inhibitors
    Therapeutic Indication :   Facial hirsutism, Adjunct to any hair removal technique (With limited use in the neck of the affected women)     
    Dosage Forms :   Cream

    More Information

    • Keep EFLORA CREAM out of reach from children
    • Store at a temperature, not more than 25°C

    FAQs About EFLORA CREAM

    What is the use of EFLORA CREAM?

    EFLORA CREAM is used in the management of facial hirsutism in women; it reduces and slows the growth of unwanted facial hair. It is also used as an adjunct to any hair removal technique, but only on the affected women's face and neck.

    Is it safe for children to use EFLORA CREAM?

    EFLORA CREAM should be used with caution in children and adolescents (those under the age of 18) due to unknown safety and effectiveness. If EFLORA CREAM is accidentally ingested by a child or adolescent, go to the hospital immediately and consult the doctor for further management. Consult your doctor before taking it.

    What happens if I use more EFLORA CREAM?

    If too much cream is applied to your skin, it is unlikely to harm you. If you or anyone else accidentally swallows EFLORA CREAM, contact your doctor immediately.

    How to use EFLORA CREAM

    Always apply EFLORA CREAM as directed by your physician. It is for external use only. Apply a thin layer of this medicine to the affected area. Managed areas on the face should not be washed for at least 4 hours after application. It should remain applied to the face for 5 minutes after hair removal. Do not cover the applied area with a plaster or bandage. Avoid applying this medicine around your eyes and eyelids.

    Is it safe to use EFLORA CREAM while pregnant or nursing?

    EFLORA CREAM should only be used in pregnant or breastfeeding women if it is indicated or necessary. Consult your doctor before taking it.

    What are the common side effects of EFLORA CREAM?

    The most common side effects of using EFLORA CREAM are pimples, razor bumps, burning, stinging, or tingling sensations in the skin, itching, dry skin, hair loss, skin redness, irritation, and skin rash. Contact your doctor if any of the symptoms worsen.

    References

    1. Howard I. Maibach. Treatment of Hirsutism (Medical Interventions). Evidence Based Dermatology. 2nd Edition. 2011. Page – 532.

    2. Iltefat Hamzavi, MD, Eileen Tan, MD, Jerry Shapiro, MD, FRCPC, Harvey Lui, MD, FRCPC.  A randomized bilateral vehicle-controlled study of eflornithine cream combined with laser treatment versus laser treatment alone for facial hirsutism in women. journal of American Academy of Dermatology. February 2007. [Accessed 10th June 2022] https://www.jaad.org/article/S0190-9622(06)02590-4/fulltext

    3. Eflornithine. NIH National Library of Medicine. National Center for Biotechnology Information. July 2022. [Accessed on 10th June 2022] https://pubchem.ncbi.nlm.nih.gov/compound/Eflornithine#section=MeSH-Pharmacological-Classification

    4. Cipher Pharmaceuticals Inc. Drug and Health Product Register (HRES). [Revised in July 2015] [Accessed on 20th June 2022] https://pdf.hres.ca/dpd_pm/00031219.PDF

    5. Bristol-Myers Squibb Company. US Food and Drug Administration (FDA). [Revised in July 2000] [Accessed on 10th June 2022] https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21145lbl.pdf

    Useful Diagnostic Tests

    • Follicle Stimulating Hormone
    • Luteinising Hormone
    • Thyroid Stimulating Hormone, T4 test
    • USG
    • CT/MRI scan
    • serum testosterone level
    • progesterone level
    • DHEAS test
    • Serum estradiol
    • Serum prolactin
    • Serum adrenocorticotropic hormone level
    • Serum B-human chorionic gonadotropin
    • Urinalysis
    • Potassium levels

    Author Details

    Written By Dr. Dhivakaran R - BDS
    Reviewed For Accuracy By Dr. Janet. C - Pharm.D
    Last updated on 06 Dec 2022 | 05:08 PM(IST)
    Lab updated