Brand Information

Strength	Rate	Packing Style
20%	0.00	Tab

Drug Interaction:

Reports not available

Indication:

New drugs approved For Marketing by Drug Controller General of India(DCGI )

during the period January 1988 to November 2014

(Ref- IDMA Annual Publication 2015)

Name of Drug Indication Date of Approval

Azelaic acid Anti-acne 06-07-2003

Acne vulgaris

Adverse Reaction:

Most common adverse reactions

Puritus 5%

Others Erythema, dryness, rash, peeling, irritation , contact dermatitis reported in less than 1% of cases

Contra-Indications:

Hypersensitivity

Special precautions

Hypopigmentation- isolated reports

Hypersensitivity - if sensitivity or severe irritation develop treatment should be discontinued and appropiate therapy instituted

Pregnancy- Drug should be used during pregnancy only if clearly needed

Lactation- Caution should be excercised when azelic acid is administered to a nursing mother

Children- Safety and efficacy in pediatric patients under 12 years of age have not been establised

Dosages/ Overdosage Etc:

Indication-

Acne vulgaris

Dosage-

Apply to the previously washed and patted dry skin, a thin film of azelic acid, should be gently but throughly massaged into affected areas twice daily in the morning and evening

Patient Information:

Azelaic acid- Topical

Patients should be told-

1. To use azelic acid for the full prescribed period

2. To avoid use of occlusive dressings or wrapping

3. To keep azelic acid away from mouth, eyes, and other mucous membranes ,

If it does come in contact with the eyes, they should wash their eyes with large amounts of water and consult their physician ifirritation persists

4. If they have dark complexions, to report any abnormal changes in skin color to their physician

5. Due in part to the low pH of azelic acid, temporory skin irritation ( pruritis, burning, or stinging ) may occur when azelic acid is applied to broken or inflammed skin, usually at start of treatment. If it continue it should be applied only once a day, or treatment should be stopped until these effcts have subsided

6. If troublesome irritation persists use should be discontinued and patients should consult their physician

7.Allergies-

Tell your doctor if you are have ever had any unusual or allergic reaction to

azelic acid. Also tell your healthcare care professional if you are allergic to any other

substances such as foods. preservatives or dyes.

8.Pregnancy-

Azelaic acid has not been studied in pregnant woman

9. Breast-feeding-

Small amounts of azelaic acid are absorbed through the skin into the blood stream.

It is possible that tiny amounts of this medicine may pass into the breast milk.

However, this medicine has not been reported to cause any problems in nursing

babies.

10.Children-

Studies of thie medicine has been done only in adult patients and there is no specific

information comparing azelaic acid in children with use in other age groups.

11.Older adults-

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way than they do in younger adults, or if they cause different side effects or problems in older people. There is no specific information comparing use of azelaic acid in the elderly with use in other age groups

12. Other medicines-

Although certain medicines should not be used together at all, in other cases two

different medicines may be used together even if an interaction might occur. in such

cases your doctor may want to change the dose, or other precautions may be necessary.

Tell your doctor if you are using any other topical prescription of prescription or

non-prescription (Over-the counter) OTC medicine that is to be applied to the same

area of the skin.

Pregnancy and lactation:

Pregnancy-

Drug should be used during pregnancy only if clearly needed

Lactation-

Caution should be excercised when azelic acid is administered to a nursing mother

Children-

Safety and efficacy in pediatric patients under 12 years of age have not been establised

AZELEX *

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pregnancy and lactation