Wintevi cream, developed by Italian pharmaceutical company Cassiopea S.p.A., is an innovative local androgen receptor inhibitor.

1、 Drug name

1. Common name: Clascoterone cream

2. Product Name: WINLEVI ®

2、 Indications

Used for local treatment of acne vulgaris in patients aged 12 and above.

3、 Specifications and characteristics

1. Specification: Cream 1% (containing 10mg of claricotone per gram)

2. Appearance: White to nearly white cream.

4、 Main components

Active ingredient: Ketone

5、 Usage and dosage

1. Usage: For topical application.

2. Dosage: Take a thin layer (about 1 gram) twice a day (once in the morning and once in the evening) and apply it to the affected area.

3. Gently clean and dry the skin before use; Avoid contact with eyes, mouth, and mucous membranes; Only for skin use, not for ophthalmic, oral or vaginal use.

6、 Dose adjustment

1. No clear recommended dosage adjustment plan. If there is local irritation (itching, burning, redness or flaking of the skin), the frequency of medication can be reduced or stopped.

2. If hypothalamic pituitary adrenal axis inhibition occurs, the medication should be attempted to be discontinued.

7、 Medication precautions

1. Before and after meals: No special requirements.

2. Missed administration: It should be reapplied as soon as possible. If it is close to the next medication time, skip that time and continue using according to the original plan.

3. Vomiting: Not mentioned, this product is an external preparation and usually does not affect.

4. Avoid using on damaged skin (such as cuts, abrasions), eczema, or sunburned areas.

5. Avoid using other products that may irritate the skin at the same time, such as medicated or frosted soaps, strong drying cosmetics, high concentration alcohol products, astringents, fragrances, or lime products.

6. If accidentally in contact with mucous membranes, rinse thoroughly with clean water immediately.

8、 Medication for special populations

1. Pregnant women: No human data available, animal experiments show risks, caution should be exercised when necessary.

2. Breastfeeding period: There is no data indicating whether it enters breast milk, and the pros and cons should be weighed when using it.

3. Children: Safety and efficacy have been established for patients aged 12 and above; The patient under 12 years old has not been identified yet. Children may be more susceptible to systemic toxicity.

4. Elderly individuals: Clinical research data is insufficient and should be used with caution.

9、 Adverse reactions

1. The most common adverse reactions (incidence rate 7% -12%) are erythema/redness, itching, desquamation/dryness.

2. Other common reactions (>3%): edema, stabbing pain, burning sensation (similar to the incidence of excipient cream).

3. Serious adverse reactions: local skin reactions, hypothalamic pituitary adrenal axis inhibition, hyperkalemia (observed in clinical trials).

4. Other reported reactions: polycystic ovary syndrome, amenorrhea.

10、 Contraindications

There are no known contraindications.

11、 Drug interactions

1. No drug interaction studies have been conducted clinically.

2. In vitro studies have shown that claricotone has no significant inhibitory or inducing effect on CYP450 enzymes, and no clinically significant interactions are expected.

12、 Storage method

1. Before mixing: Refrigerate at 2 ° C to 8 ° C (36 ° F to 46 ° F), do not freeze.

2. After preparation (during patient use): Store at room temperature between 20 ° C and 25 ° C (68 ° F and 77 ° F), do not freeze.

3. Discard time: 180 days after blending or 1 month after first opening, whichever is earlier.

Winleviinformation