EFLORA
Manufacturer Details
SUN PHARMA
Compositions:
Eflornithine hydrochloride 13.9% cream,
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Strength
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Rate
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Packing Style
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13.9% cream
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710.00
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15g cream
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List of Related Indications:
List Of Drugs:
- Eflornithine Hydrochloride -@- Dermatological agent -(Mar 2006)
Indication Type Description:
Drug Interaction:
Reports not available
Indication:
LIST OF DRUGS DURING 2006
Sr.No- 28
Name of the Drug- Eflornithine HCL Cream (139mg/gm) Pharmacological Classification- For reduction of unwanted facial hair in women
Date of Approval- 22-03-2006
Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List- 2006)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Eflornithine Hcl cream 139mg/gm 22-03-2006
For the reduction of unwanted facial hair in women
Removal of facial hair in women
Treatment of Facial hirusutism in women
Adverse Reaction:
Acne. local irritation - discontinue if severe
Pseudofolliculitis barbae 16% Acne 21%
Burning skin 4% Alopecia 1.5%
Dizziness 1.5% Dry skin 1.8%
Dyspepsisa 2.5% Erythema (redness ) 1%
Headache 3.8% Pruritus ( itching ) 3.5%
Contra-Indications:
Pregnancy
Lactation,
Severe renal impairment
Special precautions-
Consider other causes of hirsutism before starting treatment
Avoid eyes and mucous membranes abraded or broken skin
Reduce frequency if irritation or intolrence develops.
Hepatic or renal impairment
Dosages/ Overdosage Etc:
Indication-
Treatment of facial hirsutism in women
Dosage-
Apply thin layer of cream to affected area of face and chin twice daily
Rub the cream throughly
Max- 30g monthly
Discontinue after 4 months if no improvement is noticed
Children- Not recommened
Patient Information:
1. Allergy- patients who are allergic to the drug should not use the cream
2. Cream - Not to be used by those younger than 12 years
3. Consult your doctor if you are pregnant or by those hoping to become pregnant
4. Not to be used by breast feeding mothers
5. Can produce temporary redness, stinging, burning, tinglinng or rash, in areas where the cream is applied. Consult your doctor if these persists
Pregnancy and lactation:
Pregnancy-
No clinical studies performed in pregnant women. Consult your doctor if you are pregnant or hoping to become pregnant
Lactation-
Not known whether Eflorithine is passed to infants through breast milk. Consult your Doctor before use.
