Introduction

Halcinonide Cream is indicated for contact eczema, atopic dermatitis, neurodermatitis, psoriasis with a small area, sclerosing atrophic lichen, lichen planus, discoid lupus erythematosus, seborrheic dermatitis (excluding the face), and hypertrophic scars.

Details

【Drug Name】

Generic Name: Halcinonide Cream

English Name: Halcinonide Cream

【Ingredients】Halcinonide.

Chemical Name: 16α,17 - [(1 - methylethylidene)bis(oxy)] - 11尾 - hydroxy - 21 - chloro - 9 - fluoropregna - 4 - ene - 3,20 - dione

Chemical Structural Formula:

Molecular Formula: C₂₄H₃₂ClFO₅

Molecular Weight: 454.97

【Properties】A white cream.
【Indications】Contact eczema, atopic dermatitis, neurodermatitis, psoriasis with a small area, sclerosing atrophic lichen, lichen planus, discoid lupus erythematosus, seborrheic dermatitis (non-facial area), hypertrophic scar.

【Specifications】10g:10mg

【Usage and Dosage】Apply externally to the affected area, once in the morning and once in the evening every day.

【Adverse Reactions】In a few patients, the skin at the application site may experience burning, stinging, and temporary itching. Long-term use may lead to skin capillary dilation (especially on the face), skin atrophy, striae atrophicae (more likely to occur in adolescents), secondary purpura and ecchymosis after skin atrophy, skin fragility, hirsutism, folliculitis, milia, skin depigmentation, and delayed ulcer healing. When using the occlusive method, secondary fungal infections are likely to occur in skin folds. When absorbed through the skin in large amounts, systemic adverse reactions may occur (see Precautions).

【Contraindications】Patients allergic to this drug. Primary skin lesions caused by bacteria, fungi, viruses, and parasites. Ulcerative lesions. Acne, rosacea. Use of the drug on the eyelids (risk of causing glaucoma). Exudative skin diseases.

【Precautions】Large-area and high-dose use or the occlusive method may lead to increased percutaneous absorption and systemic reactions, especially in young children and infants, including reversible Cushing's syndrome and growth retardation. Abrupt withdrawal may cause acute adrenocortical insufficiency. In case of local intolerance, stop using the drug and find the cause. Be vigilant that the drug remaining in skin folds and diapers may be absorbed into the body.

【Use in Pregnant and Lactating Women】There is no research on the teratogenic effect of local use of this drug in humans. It should be used with caution during pregnancy. When a large amount is absorbed through the skin after external use, it can be excreted in breast milk, so it should be used with caution during lactation.

【Use in Children】It should be used on a small area for a short period. Once the symptoms subside, stop using the drug promptly. Children under one year old should try not to use this drug. Avoid long-term and large-area occlusive administration.

【Use in Elderly Patients】Avoid long-term and large-area occlusive administration.

【Drug Interactions】Not clear.

【Overdose】Not clear.

【Pharmacology and Toxicology】

Pharmacology:

1. Anti-inflammatory effect: This product is a topical drug, a highly effective corticosteroid containing fluorine and chlorine, with anti-inflammatory, anti-itching, and vasoconstrictive effects. Based on the triamcinolone skeleton, the 21-hydroxyl group is replaced by a chlorine atom. The anti - inflammatory potency multiple determined by the vasoconstriction test is 360. There is evidence that the intensity of the vasoconstriction test is consistent with the curative effect. The mechanism of its anti - inflammatory and anti - itching effects is to increase the reactivity of 尾 - receptors to catecholamines. By activating adenylate cyclase, the production of cAMP is increased, and by inhibiting phosphodiesterase, the destruction of cAMP is reduced. As a result, the concentration of cAMP in cells is increased, and at the same time, the release of histamine is inhibited. The effect of this product in inhibiting granuloma hyperplasia in rats and mice is similar to that of dexamethasone. Observed by the method of inducing hind-foot swelling in mice and rats with formaldehyde, both this product and dexamethasone have obvious inhibitory effects, while hydrocortisone at a 5-fold higher dose has no inhibitory effect. This product has a significant weight - reducing effect on the thymus and spleen.

2. Selective pharmacological effects on various cells: It reduces the number of T-lymphocytes, monocytes, and eosinophils, inhibits lymphocyte proliferation and cytokine production, inhibits macrophage differentiation and phagocytic activity, inhibits neutrophil adhesion, reduces the permeability of vascular endothelial cells, inhibits fibroblast proliferation and collagen synthesis, and inhibits sebaceous gland cell activity.

3. Anti-proliferative effect: This product has an anti-mitotic effect. It reduces RNA transcription, thus reducing DNA synthesis and also affecting DNA repair. As a result, the epidermis becomes thinner, especially having the greatest impact on collagen synthesis.

4. Immunosuppressive effect: This product binds to the cytoplasmic corticosteroid receptor, triggering a series of reactions, activating the expression of "lysosomal genes" in cells; it induces the cleavage of nuclear DNA in lymphocytes, directly killing lymphocytes.

Toxicity:

Acute toxicity test: The LD₅₀ for intramuscular injection in female mice is 84mg/kg, and in male mice is 35mg/kg; theLD₅₀ for intraperitoneal injection in male mice is 215mg/kg; intragastric administration at doses from 250 to 1500mg/kg, no animal deaths were observed .

Sub - acute toxicity test: The main manifestations are damage to the thymus and lymphocytes.

There is no research on the teratogenicity of local external use of this product, but oral use in humans has not shown a higher teratogenic risk than the general population.

When this product is applied in large areas and large amounts or by the occlusive method, it has an inhibitory effect on the hypothalamic-pituitary-adrenal axis (HPA axis).

【Pharmacokinetics】 Multiple factors, including the preparation matrix, the integrity of the epidermal barrier, and occlusion, determine the percutaneous absorption of this topical product. It can be absorbed through normal and intact skin, and the percutaneous absorption is increased in inflamed skin or other skin diseases. After percutaneous absorption, its pharmacokinetic is the same as that of systemic application. That is, it binds to plasma proteins to varying degrees, is mainly metabolized by the liver and then excreted by the kidneys, and some is also excreted through the bile.

【Storage】Store in a sealed container in a cool place (not exceeding 20℃).

【Packaging】Packed in medicinal cream aluminum tubes. Each tube contains 10g, and each box contains 1 tube.

【Expiry Date】36 months