Carpronium Chloride Solution for External Use 5% "CH" 30mL × 12 Carpronium Chloride Solution for External Use 5% Alopecia Dry Seborrheic Leukoplakia Vulgaris

1. Basic information of the drug

1. Common name: Carpronium chloride
2. English Name: Carpronium Chloride Solution
3. Product name: Carpronium Chloride External Solution 5% "CH" (Carpronium Chloride External Solution 5% "CH")
4. Dosage form: liquid for external use
5. Indications:
   • Preventing hair loss and promoting hair growth in patients with alopecia (including alopecia areata, multiple alopecia areata, malignant alopecia, pityriasis, diffuse alopecia, senile alopecia, symptomatic alopecia, etc.);
   • Dry grease leakage;
   • Leukoplakia vulgaris.
6. Element:
   • Active ingredient: 1mL contains 50mg of carpronium chloride;
   • Additives: ethanol, sodium citrate, hydrochloric acid, yellow No. 4 (tar yellow), cyan No. 1, fragrance.
7. Appearance: Green clear liquid

2. Usage and Dosage

• Alopecia, dry seborrheic dermatitis: Apply an appropriate amount to the affected area 2 to 3 times a day, or sprinkle on the entire scalp and massage gently.
• Leukoplakia vulgaris: Apply appropriate amount to the affected area 3 to 4 times a day.

3. Taboo

IV. Precautions

1. Special Populations:
   • Use with caution in patients with a history of allergy to the ingredients of this drug;
   • Pregnant women: Use only when the benefits of treatment outweigh the potential risks;
   • Lactating women: We need to weigh the benefits of treatment against the nutrition of breast milk and consider whether to continue breastfeeding;
   • Children: No clinical studies have been conducted on children;
   • Elderly people: Because their physiological functions are mostly reduced, they need to pay attention to reducing the dosage.
2. Medication Instructions:
   • For external use only, avoid contact with eyes; if contact with eyes occurs, rinse immediately with clean water;
   • If you experience abnormalities such as sweating, chills, shivering, nausea, vomiting, etc. after applying the medicine, stop taking the medicine immediately and rinse the affected area with water;
   • Using it after decoction may aggravate the side effects. If side effects occur, rinse the affected area.
3. Drug storage: Store at room temperature.

5. Adverse Reactions

1. Allergic reaction: Transient redness and itching may occur (incidence 0.1%~5%).
2. Other reactions: Irritation pain, local sweating, heat sensation, generalized sweating and associated chills, shivering, nausea, and vomiting (frequency unknown) may occur.

6. Drug Interactions

7. Pharmacological Action

1. Local vasodilation effect: The intensity is about 10 times that of acetylcholine. It is used to prevent hair loss, promote hair growth, and treat dry seborrheic dermatitis and vitiligo vulgaris.
2. Action characteristics: good skin permeability, resistance to cholinesterase, and lasting action.

8. Pharmacokinetics

1. Absorption: 1 mL of alcohol solution containing 10 mg of carpronium chloride (1/5 times the concentration of 5% of this agent) was applied to the forearm of a healthy adult. The percutaneous absorption rate was 5.4% after 1 hour and 15.3% after 3 hours. It is biologically equivalent to 5% Fluoron topical solution and has a similar percutaneous absorption rate.

IX. Clinical Research

1. Alopecia:
   • Domestic single-blind controlled trial: Apply to the affected area at least 4 times a day for more than 1 to 2 months, the effective rate for circular, multiple, malignant, and diffuse alopecia is 62.5% (25/40).
   • Domestic double-blind controlled trial: Apply to the affected area at least 3 times a day for more than 1 month (more than 1 week for alopecia pityriasis), the effective rate for round, multiple, malignant, and alopecia pityriasis is 75.9% (66/87).
2. Leukoplakia vulgaris:
   • Domestic single-blind controlled trial: Apply to the affected area at least 4 times a day for more than 1 to 2 months, with an effective rate of 45.0% (9/20).

10. Packaging specifications

11. Production Information

Manufacturer: Choseido Pharmaceutical Co., Ltd.