Azelec Cream
Azelaic Acid 20% topical
20%
Acme Laboratories Ltd.
| Pack size | 5gm,10gm tube |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 30.19,75.51 AED |
Indications
Azelec Cream is used for:
Acne vulgaris, Rosacea, Rosacea melasma, Post inflammatory hyperpigmentation
Adult Dose
Topical
Acne vulgaris
Adult: As 20% cream: Apply into the affected areas bid (morning and evening). Improvement may be detectable w/n 4 wk. Duration of treatment: Up to 6 mth.
Rosacea
Adult: Apply into the affected areas bid (morning and evening). Improvement occurs in 4-8 wk.
Child Dose
Topical
Acne vulgaris, Rosacea
Child: >12 yr Massage a thin layer into the affected areas on the face q12hr
<12 years: Safety and efficacy not established
Renal Dose
Administration
Cleanse affected area with mild soap or soapless cleansing lotion and pat dry before applying. Apply thinly into the affected areas bid (morning and evening) after cleansing.
Contra Indications
Hypersensitivity to any of the ingredients.
Precautions
In case of known hypersensitivity to any component of the gel, avoid the use of gel dosage form; if hypersensitivity develops during treatment, discontinue and institute appropriate therapy
For dermatologic use only
Therapy has been reported to cause irritation of eyes; avoid contact with eyes and mucous membranes; if medication comes in contact with eyes, wash eyes with large amounts of water and consult a physician if eye irritation persists
Isolated cases of hypopigmentation reported after azelaic acid use; monitor patients with dark complexion for early signs of hypopigmentation
Skin irritation (i.e. pruritus, burning or stinging) may occur, usually during first few weeks of treatment; if sensitivity or severe irritation develops and persists, discontinue treatment and institute appropriate therapy
Do not wax treated area or apply topical products that may further irritate skin (eg, astringents, abrasive soaps and cleansers, exfoliants)
Avoid any foods and beverages that provoke erythema, flushing, and blushing (eg, alcoholic beverages, spicy food, hot drinks such as hot coffee and tea)
Pregnancy-Lactation
Pregnancy
Azelaic acid is minimally absorbed systemically following topical route of administration; maternal use not expected to result in fetal exposure to drug
Animal data
In animal reproduction studies, embryofetal toxicity was noted when azelaic acid was administered orally during period of organogenesis at doses 162, 19, and 65 times maximum recommended human dose (MRHD) in rats, rabbits, and monkeys, respectively; maternal toxicity was noted at these doses but no malformations were observed in these embryofetal developmental studies
Lactation
Azelaic acid is naturally present in human milk; when used as prescribed, azelaic acid is unlikely to be absorbed through skin in clinically relevant amounts to cause a change in azelaic acid concentration in milk or milk production; therefore, breastfeeding is not expected to result in exposure of infant to drug
The developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Interactions
There have been no formal studies of the interaction of Azelaic Acid Gel with other drugs.
Adverse Effects
Side effects of Azelaic Acid 20% topical :
>10%
Burning/ stinging/ tingling (4-16%)
1-10%
Pruritus (1-6%),Scaling/ dry skin/ xerosis (1-5%),Erythema/ irritation (1-2%)
<1%
Contact dermatitis,Edema,Acne
Mechanism of Action
Azelaic acid is a naturally-occurring aliphatic dicarboxylic acid. The exact mechanism of action in treatment of acne vulgaries has not been fully established. It is believed to inhibit the growth of susceptible organisms (mainly Propionibacteria Acnes) on the skin surface, and inhibits follicular keratinisation thus restricts the development of comedones. Mechanism of action in the treatment of rosacea is unknown.
Note
Azelec 20% Cream manufactured by Acme Laboratories Ltd.. Its generic name is Azelaic Acid 20% topical. Azelec is availble in Bangladesh.
Farmaco BD drug index information on Azelec Cream is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.