Product Overview
【Drug Name】
Generic Name: Miconazole Nitrate Powder
Brand Name: Daktarin Miconazole Nitrate Powder 1g: 20mg*40g
Pinyin Code: DaKeNing XiaoSuanZuoKangZuoSan 1g: 20mg*40g
【Main Ingredients】
Each gram of this product contains 20 mg of miconazole nitrate as the main ingredient. Excipients include talc, microcrystalline silica gel, and zinc oxide.
【Appearance】
This product is a white powder.
【Indications/Main Functions】
Used for tinea interdigital and groin tinea, and diaper rash caused by fungi and yeasts. Generally used in combination with creams and alternately. Additionally, applying it to shoes and socks can prevent athlete's foot.
【Specifications】
1g: 20mg*40g
【Dosage and Administration】
For external use. Apply an appropriate amount of powder to the affected area. Twice daily. If used in combination with a cream, apply the powder and cream once daily. For preventative application to shoes and socks, apply once daily. The course of treatment may be 2–6 weeks, depending on the site of infection and the patient's sensitivity to the drug. Continue treatment for one week after all symptoms have disappeared to prevent recurrence.
【Adverse Reactions】
Occasionally, allergic reactions, blisters, burning sensation, congestion, itching, or other skin irritation may occur. Very rarely, angioedema, urticaria, eczema, contact dermatitis, erythema, and discomfort at the application site may occur.
【Contraindications】
Contraindicated in patients with known hypersensitivity to miconazole nitrate or any other component of this product.
【Precautions】
1. Avoid contact with eyes and other mucous membranes (such as mouth, nose, etc.).
2. Use with caution in pregnant and lactating women.
3. If burning sensation, redness, or swelling occurs at the application site, discontinue use and wash the area thoroughly. Consult a physician if necessary.
4. Contraindicated in patients with known hypersensitivity to this product; use with caution in patients with allergic constitution.
5. Do not use this product if its appearance changes.
6. Keep this product out of reach of children.
7. Children must use this product under adult supervision.
8. If you are using other medications, consult your doctor or pharmacist before using this product.
9. If an allergic or sensitive reaction occurs, discontinue use immediately and consult a doctor promptly.
10. Pay attention to hygiene and control factors that may lead to infection or reinfection.
11. This product contains talcum powder, whose good hygroscopic properties help keep the skin dry, but avoid inhalation to prevent tracheal irritation. Use caution when treating infants and children to prevent inhalation.
12. This product is for topical use only and should not be taken orally. In case of accidental large ingestion, appropriate gastric emptying measures may be taken if necessary. Accidental large inhalation of this product may cause airway obstruction. Treat sleep apnea with supportive therapy and oxygen therapy. If respiratory depression occurs, endotracheal intubation should be considered to remove obstructive substances and provide assisted ventilation.
【Drug Interactions】
1. Consult your doctor or pharmacist before using this product if you are currently using other medications.
2. Systemic formulations of miconazole nitrate are known to inhibit CYP3A4/2C9. Given the limited systemic absorption of this product via vaginal administration, clinically significant drug interactions are very rare. Use with caution in patients taking oral anticoagulants (e.g., warfarin) and monitor for anticoagulation effects.
3. Concomitant use of miconazole drugs with other oral hypoglycemic agents or phenytoin may increase the effects and side effects of the other drugs; caution should be exercised.
【Pediatric Use】
No adverse reactions have been observed in children, but caution should be exercised when using this product.
【Use in Elderly Patients】
Not yet clear.
【Use in Pregnant and Lactating Women】
Systemic absorption of this product after topical administration is minimal (bioavailability less than 1%). Although there is no evidence of embryotoxicity or teratogenicity of miconazole in animals, the therapeutic benefits and potential risks of use in pregnant women should be weighed. Systemic absorption of topical miconazole is minimal, and it is unknown whether miconazole is excreted in human breast milk. Caution should be exercised when using miconazole in lactating women.
【Overdosage】
Not yet clear.
【Pharmacology and Toxicology】
This product is a broad-spectrum antifungal drug. Its mechanism of action is to inhibit fungal cell membrane synthesis and affect their metabolic processes. It has antifungal activity against dermatophytes, Candida, etc., and also has some efficacy against certain Gram-positive cocci.
【Storage】
Protect from light and store in a sealed container.
【Packaging】
Plastic bottles, 20g/bottle/box, 40g/bottle/box
【Shelf Life】
36 months
【Approval Number】
National Drug Approval Number H10930213
【Manufacturer】
Xi'an Janssen Pharmaceutical Co., Ltd.
