What Are the Most Common Uses for Erythromycin Gel?

It is used for local treatment of mild and moderate acne vulgaris, and is effective for both inflammatory and non-inflammatory skin lesions.

Drug Name: Isotretinoin erythromycin gel

Drug type: prescription

Isotretinoin Erythromycin Gel Ingredients

This product is a compound preparation, and its components are 0.5 mg isotretinoin and 20,000 units of erythromycin per gram of gel.

Isotretinoin Erythromycin Gel Properties

This product is light yellow-green, uniform, delicate, transparent or translucent viscous body.

Isotretinoin Erythromycin Gel Indication

This product is used for local treatment of mild and moderate acne vulgaris, and is effective for both inflammatory and non-inflammatory skin lesions.

Isotretinoin Erythromycin Gel Specifications

(1) 10g: 5mg isotretinoin and 200,000 units of erythromycin (2) 30g: 15mg isotretinoin and 600,000 units of erythromycin

Isotretinoin Erythromycin Gel Usage and Dosage

Adults: Take an appropriate amount of this product and apply it to the entire affected area, once or twice a day. In some cases, it takes 6 to 8 weeks to have a significant effect.

Isotretinoin Erythromycin Gel Adverse Reaction

The application site may have a tingling and burning sensation, and may also have erythema and peeling. These local symptoms will disappear automatically with continued medication. If severe irritation occurs, the medication should be temporarily stopped, and the medication should be continued after the irritation response is reduced. If the irritation response continues to occur, treatment should be stopped. The treatment is terminated and the stimulus response will be alleviated.

Isotretinoin Erythromycin Gel Contraindications

Those who are known to be allergic to any of the ingredients in this product are contraindicated.

Isotretinoin Erythromycin Gel Precautions

Avoid contact with mouth, eyes, mucous membranes and damaged or eczema skin. Use caution on skin on sensitive areas such as the neck. This product can increase the sensitivity to light. Avoid or minimize exposure to sunlight or light. Combination with other topical medications should be used with caution, as they may produce cumulative irritation.

Isotretinoin erythromycin gel for pregnant and lactating women

The safety of pregnant women for external use is not clear. Animal experiments show that this product has no direct or indirect damage to the fetus or embryo, and to the pregnancy process and prenatal and postnatal periods. Isotretinoin may have teratogenic effects when administered systemically. However, reproductive research trials in rabbits have shown that external application of 60 times the human therapeutic dose is not harmful to the fetus. The erythromycin component in this product is not significantly dangerous to pregnant women. Pregnant women or women who are planning to become pregnant should avoid using this product. The absorption of isotretinoin from this product through the skin can be ignored, but it is unknown whether isotretinoin is secreted into human milk, so this product should not be used during lactation.

Isotretinoin Erythromycin Gel for Children

Pre-pubertal children rarely develop acne vulgaris, and their medication is unclear.

Isotretinoin Erythromycin Gel for Elderly

Because older people do not suffer from acne vulgaris, there is no clear recommendation.

Isotretinoin Erythromycin Gel Drug Interactions

still uncertain

Isotretinoin Erythromycin Gel Overdose

Acute overdose of this product has not been reported. Isotretinoin and erythromycin components do not cause problems with the uptake of this product.

Isotretinoin Erythromycin Gel Clinical Trial

A multi-center, randomized, blinded, parallel controlled clinical trial of positive drugs was used to evaluate the efficacy and safety of isotretinoin erythromycin gel in the treatment of mild and poisonous acne vulgaris. A total of 240 patients were enrolled. The control was vitamin A acid cream. Both the test and control drugs are applied once a day. Before going to bed, apply an appropriate amount of the drug evenly to all affected areas. Wash the affected area with warm water before applying and wipe dry.
Validity results: 1. Comprehensive efficacy: FAS analysis, the effective rates of the experimental group and the control group were 84.48% (98/116) and 80.51% (95/118), there was no statistical significance between the two groups (P> 0.05): According to PPS analysis, the effective rates of the experimental group and the control group were 87.39% (97/111) and 81.74% (94/115), respectively. There was no significant difference between the two groups (P> 0.05). 2. Classification of skin lesions: FAS analysis, for non-inflammatory skin lesions, the effective rates of the experimental group and the control group were 71.17% (79/111) and 69.30% (79/114) respectively, and the difference between the two groups was not statistically significant ( P> 0.05); for inflammatory skin lesions, the effective rates of the experimental group and the control group were 82.76% (96/116) and 75.44% (86/114), respectively. There was no significant difference between the two groups (P> 0.05), PPS For analysis and analysis of non-inflammatory skin lesions, the effective rates of the experimental group and the control group were 73.58% (78/106) and 70.27% (78/111), respectively. The difference between the two groups was not statistically significant (P> 0.05): for inflammatory For skin lesions, the effective rates of the experimental group and the control group were 85.59% (95/111) and 76.58% (85/111). There was no significant difference between the two groups (P> 0.05), but for the inflammatory rash, the test The effective rates of the group and the control group were 85.59% (95/111) and 73.87% (82/111) respectively, and the differences between the two groups were statistically significant (P <0.05). 3. The total number of skin lesions at each follow-up point improved: FAS and PPS analysis, the experimental group and the control group were significantly different from baseline at 2, 4, 6, and 8 weeks of treatment, respectively, and the number of skin lesions was significantly reduced (P <0.05). Safety results: The incidence of adverse reactions in the experimental group and the control group was 10.17% (12/118) and 7.56% (9/119). There was no significant difference between the two groups (P> 0.05). The drug-related adverse reactions in the test group were erythema, tight skin pain, tingling, desquamation, dryness, mild to moderate, and alleviated after stopping the drug or reducing the dose. No serious adverse events occurred in either group. Laboratory tests (liver and kidney function, routine hematuria) did not show clinically significant abnormalities related to the test drug.

Isotretinoin Erythromycin Gel Pharmacology and Toxicology

Isotretinoin is similar in structure and pharmacology to vitamin A and can regulate epithelial cell growth and differentiation. Its mechanism of action has not been fully elucidated. When used systemically, it can inhibit the activity of sebaceous glands and reduce sebum secretion; it can also reduce the generation of acne, keratinization of tissue capsules, inhibit P. acnes and reduce the occurrence of inflammation. Animal model studies show that topical isotretinoin has similar activity. Studies in the ears and flank of Syrian rats suggest that topical isotretinoin can inhibit sebum production. Isotretinoin is applied to the ears for 15 days. Can reduce the volume of fat glands by 50%, and apply to the lateral abdomen can reduce the volume of fat glands by 40%. Topical isotretinoin has also been shown to have a differentiating effect on the epidermis of nasal skin in mice.
It is generally believed that topical isotretinoin can promote mitosis of epithelial cells, reduce basal layer keratinocyte binding, inhibit keratinization of acne vulgaris, promote desquamation, and prevent skin lesions from forming. Isotretinoin treatment can reduce the volume of small cysts or surface cysts that develop into small cysts. This volume reduction has also been used to quantify antikeratosis. Isotretinoin has a local anti-inflammatory effect. Topical isotretinoin has a significant inhibitory effect on acne, while tretinoin has only a weak inhibitory effect. Compared with tretinoin, topical isotretinoin has a smaller rebound effect.
Erythromycin is a macrolide antibiotic, which works by reversibly binding to riboprotein subunits to interfere with the synthesis of bacterial proteins. Erythromycin can inhibit the migration of aminoacyl transfer ribonucleic acid and inhibit the synthesis of polypeptides. In the treatment of acne, erythromycin works by reducing the release of P. acnes and preventing the release of inflammatory regulatory substances from P. acnes. P. acnes may be resistant to external erythromycin, but there is evidence that the combination of erythromycin and isotretinoin is effective against P. acnes-resistant erythromycin-resistant strains. Isotretinoin is effective for the treatment of blackheads, while erythromycin is effective for mild to moderate inflammatory acne vulgaris. Since most cases have both blackheads and inflammatory conditions, isotretinoin and erythromycin are combined for topical use. Is reasonable.
Toxicity studies:
Non-clinical safety studies have not been performed for this product. Local human irritation shows that the irritation of this product is similar to the application of any of its individual components. The irritation of this product is small and can be tolerated.

Isotretinoin Erythromycin Gel Pharmacokinetics

Topical erythromycin is rarely absorbed into the blood, and the metabolism, distribution, and elimination of any trace isotretinoin through the skin are consistent with the oral route, and long-term topical isotretinoin through the skin can be ignored.

Isotretinoin Erythromycin Gel Storage

Sealed and stored in a cool place (not exceeding 20 ° C).

Isotretinoin Erythromycin Gel Packaging

Medical aluminum tube, 10g / piece, 30g / piece.

Isotretinoin Erythromycin Gel Expiration Date

24 months

Isotretinoin Erythromycin Gel Implementation Standard

State Food and Drug Administration Standard YBH06912008 ^[1]