Zonyra 0.005%15 gm

Zonyra 0.005% 15 gm cream is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Topical application of Zonyra 0.005% 15 gm cream is not expected to affect the circulating concentrations of oral hormonal contraceptives containing ethinylestradiol and levonorgestrel.

Most common adverse reactions (incidence >1%) in patients treated with Zonyra 0.005% 15 gm cream were application site irritation, application site pruritus, and sunburn.

Skin irritation: Patients using Zonyra 0.005% 15 gm cream may experience erythema, scaling, dryness and stinging/burning. Maximum severity of these reactions typically occurred within the first 4 weeks of treatment, and severity decreased with continued use of the medication. Depending upon the severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of application of Zonyra 0.005% 15 gm cream, or suspend use temporarily. If severe reactions persist the treatment may be discontinued. Avoid application of Zonyra 0.005% 15 gm cream to cuts, abrasions, or eczematous or sunburned skin. Use of "waxing" as a depilatory method should be avoided on skin treated with Zonyra 0.005% 15 gm cream. Ultraviolet Light and Environmental Exposure: Minimize unprotected exposure to ultraviolet rays (including sunlight and sunlamps) during treatment with Zonyra 0.005% 15 gm cream. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided.

Do not store above 25°C. Protect from light. Keep out of reach of children.

Topical retinoid and related preparations

Zonyra 0.005% 15 gm is an agonist of retinoic acid receptors (RAR), with particular activity at the gamma subtype of RAR. Stimulation of RAR results in modulation of target genes which are associated with various processes, including cell differentiation and mediation of inflammation. The exact process by which Zonyra 0.005% 15 gm ameliorates acne is unknown.

Pregnancy Category C. Available data from clinical trials with Zonyra 0.005% 15 gm cream use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Zonyra 0.005% 15 gm cream and any potential adverse effects on the breastfed infant from Zonyra 0.005% 15 gm cream or from the underlying maternal condition.

Pediatric Use: Safety and effectiveness of Zonyra 0.005% 15 gm cream have not been established in pediatric patients below the age of 9 years.Geriatric Use: Clinical trials of Zonyra 0.005% 15 gm cream did not include any subjects aged 65 years and over to determine whether they respond differently than younger subjects.