Ezanic C1G

Topical application of Azelaic acid cream caused marked reduction in the densities of cutaneous micrococcaceae and intrafollicular propionibacterium Sp.

And decrease the fatty acid content of skin surface lipids.
Topical Azelaic acid cream also showed an antikeratinising effect on acne affected skin which was related to decreased synthesis of filaggrin. (Keratin filament aggregating protein), hence a reduction in follicular hyperkeratosis may partly underlie the drug’s anti-acne action.

Since Azelaic acid affects the cornification process of the epidermal cells, it exerts a therapeutically positive effect on the formation of comedones. Azelaic acid also inhibits the release of oxygen radical from neutrophilic granulocytes and thus may have a clinically relevant anti inflammatory action in acne.

Following a single application of azelaic acid cream to human skin in vitro, azelaic acid penetrates into the stratum corneum (approximately 3 to 5% of the applied dose) and other viable skin layers (up to 10% of the dose is found in the epidermis and dermis). Negligible cutaneous metabolism occurs after topical application. Approximately 4% of the topically applied azelaic acid is systemically absorbed. Azelaic acid is mainly excreted unchanged in the urine but undergoes some -oxidation to shorter chain dicarboxylic acids.

The observed half-lives in healthy subjects are approximately 45 minutes after oral dosing and 12 hours after topical dosing, indicating percutaneous absorption rate-limited kinetics.

Azelaic acid is a dietary constituent (whole grain cereals and animal products), and can be formed endogenously from longer-chain dicarboxylic acids, metabolism of oleic acid, and w-oxidation of monocarboxylic acids. Endogenous plasma concentration (20 to 80 n/mL) and daily urinary excretion (4 to 28 mg) of azelaic acid are highly dependent on dietary intake. After topical treatment with azelaic acid cream in humans, plasma concentration and urinary excretion of azelaic acid are not significantly different from baseline levels.

INDICATION

EZANIC C1G CREAM is effective for the topical treatment of mild-to-moderate inflammatory acne vulgaris. Azelaic acid is also effective in against Hyperpigmentary disorders (Such as Melasma, Post inflammatory melanoderma, lentigo maligna).

DOSE AND METHOD OF ADMINISTRATION

After the skin is thoroughly washed and patted dry, a thin film of azelaic acid cream should be gently but thoroughly massaged into the affected areas twice daily, in the morning and evening or as directed by the physician. The hands should be washed following application. The duration of use of EZANIC C1G CREAM can vary from person to person and depends on the severity of the acne. Improvement of the condition occurs in the majority of patients with inflammatory lesions within four weeks.

WARNINGS AND PRECAUTIONS

• Cream is for dermatologic use only and not for ophthalmic use.
• There have been isolated reports of hypopigmentation after use of azelaic acid. Since. Azelaic acid has not been well studied in patients with dark complexions; these patients should be monitored for early signs of hypopigmentation.
• If sensitivity or severe irritation develops with the use of EZANIC C1G CREAM, treatment should be discontinued and appropriate therapy instituted.
• FOR EXTERNAL USE ONLY
• TO BE USED UNDER MEDICAL SUPERVISION ONLY

Information for Patients

To use azelaic acid cream for the full prescribed treatment period.
To keep azelaic acid cream away from the mouth, eyes and other mucous membranes. If it does come in contact with the eves, they should wash their eyes with large amounts of water and consult a physician if eye irritation persists.
If they have dark complexions, to report abnormal changes in skin color to their physician.
Due in part to the low pH of azelaic acid, temporary skin irritation (pruritus, burning, or stinging) may occur when EZANIC C1G CREAM is applied to broken or inflamed skin. Usually at the start of treatment. However, this irritation commonlv subsides if treatment is continued. If it continues, EZANIC C1G CREAM should be applied only once-a-day, or the treatment should be stopped until these effects have subsided. If troublesome irritation persists. use should be discontinued, and patients should consult their physician.