达克宁硝酸咪康唑, Daktarin Miconazole Nitrate Cream, Anti-fungal Infection, Xiaosuan Mikangzuo Rugao,2%, 20g

Drug Name
Miconazole Nitrate Cream
Xiaosuan Mikangzuo Rugao

Ingredients
Each gram of this product contains 20 milligrams of the main ingredient, Miconazole Nitrate. The excipients include Carbomer 934P, Triethanolamine, Disodium Edetate, Propylene Glycol, Benzoic Acid, and Purified Water.

Appearance
This product is a white or nearly white cream.

Category
This product is a non-prescription drug for dermatological and gynecological use.

Indications

1. Skin and nail infections caused by dermatophytes, yeasts, and other fungi, such as tinea corporis, tinea pedis, tinea manuum, tinea versicolor, tinea capitis, tinea barbae, and onychomycosis; cutaneous and nail candidiasis; angular cheilitis, and otitis externa. Due to its antibacterial effect on Gram-positive bacteria, it can be used for secondary infections caused by these bacteria.
2. Vaginal infections and secondary infections caused by yeasts (such as Candida) and Gram-positive bacteria.

Specification
Each gram contains 20 milligrams of Miconazole Nitrate (2%).

Dosage and Administration

1. Skin infections:
   Apply externally to the cleaned affected area, once in the morning and once in the evening. Continue using the medication for 10 days after symptoms disappear (usually requires 2 to 5 weeks) to prevent recurrence.
2. Nail infections:
   Trim the affected nails as much as possible and apply the cream to the affected area once a day. Continue using the medication until new nails begin to grow after the affected nails loosen (approximately 2 to 3 weeks). Visible efficacy usually requires about 7 months.
3. Candidal vaginitis:
   Before bedtime, use an applicator to insert approximately 5 grams of the cream deep into the vagina. Continuous use for 2 weeks is required. The medication can be used during menstruation. It is still effective for secondary recurrences.

Adverse Reactions

1. Occasionally, allergies, blisters, burning sensations, hyperemia, pruritus, or other skin irritation symptoms may occur. Very rare post-marketing adverse reactions also include hypersensitivity (including anaphylactic reactions and anaphylactoid reactions), angioedema, urticaria, contact dermatitis, rash, erythema, reactions at the application site (including application site irritation) and vaginal irritation.
2. The following described adverse reactions are based on a comprehensive assessment of the obtained adverse events and are considered to be related to the use of Miconazole Nitrate/Miconazole. The causality between Miconazole Nitrate/Miconazole and these adverse reactions cannot be established solely based on individual cases. Moreover, since clinical trials are conducted in diverse situations, the incidence of adverse reactions observed in one drug in clinical studies cannot be directly compared with the incidence of adverse reactions of another drug in clinical studies, nor can it reflect the incidence of adverse reactions observed in clinical practice.
3. Clinical trial data:
   Safety evaluations were conducted on 426 subjects in a total of 21 clinical trials of topical administration of this product. The reported adverse reactions include skin burning sensation, skin inflammation, skin hypopigmentation, application site irritation, application site burning, application site warmth, application site pruritus, and application site reaction (unspecified).
   Safety evaluations were conducted on 265 subjects in 2 clinical trials of 7-day vaginal administration of this product. The reported adverse reactions with an incidence of greater than or equal to 1% include female genital pruritus, vaginal burning sensation, vulvovaginal discomfort, headache, dysmenorrhea, abdominal pain, upper abdominal pain, nausea; the reported adverse reactions with an incidence of less than 1% include vaginal discharge, vaginal bleeding, vaginal pain, urinary tract infection, rash, dysuria, pruritus.

Contraindications
This product is contraindicated in patients with known hypersensitivity to Miconazole/Miconazole Nitrate, other ingredients of this product, or other imidazole derivatives.

Precautions

1. Avoid contact with the eyes and other mucous membranes (such as the mouth and nose).
2. Pregnant and lactating women should use this product with caution.
3. For the treatment of candidiasis, avoid sealing and bandaging, as it may promote the growth of pathogens.
4. If there is a burning sensation, redness, or other discomfort at the application site, discontinue use and wash the local area with water. Consult a physician if necessary.
5. When used for gynecological conditions: Women without a sexual history should use this product under the guidance of a physician; during medication use, pay attention to personal hygiene to prevent reinfection.
6. Patients who are allergic to this product should not use it, and those with allergic constitutions should use it with caution.
7. Do not use this product if its appearance has changed.
8. Keep this product out of the reach of children.
9. Children must use this product under adult supervision.
10. If you are using other medications, consult your physician or pharmacist before using this product.
11. There have been reports of severe hypersensitivity reactions, including anaphylactic reactions and angioedema, when using Miconazole Nitrate Cream or other miconazole-based topical treatments (see Adverse Reactions for details). If sensitivity or allergic reactions occur, discontinue use immediately and consult a physician promptly.
12. When sexual partners are infected, appropriate treatment should also be given.
13. This product is for topical use only and should not be taken orally. Excessive use may cause skin irritation, and symptoms usually disappear after discontinuation. If accidentally ingested in large amounts, appropriate supportive therapy should be adopted.
14. The safety and effectiveness of vaginal administration of this product in children and adolescents under 18 years of age have not been studied.
15. The simultaneous use of latex condoms (or diaphragms) and vaginal anti-infective products may reduce the efficacy of latex contraceptive products. Therefore, this product should not be used simultaneously with latex condoms or latex diaphragms. Since the ingredients of this product can damage latex products, avoid contact between this product and latex contraceptive diaphragms, condoms, etc.
16. The systemic absorption of topical Miconazole is minimal (bioavailability is less than 1%). There is no evidence to suggest that Miconazole has embryotoxicity or teratogenicity in animals. When using this product during pregnancy, the expected therapeutic benefit should be weighed against the potential risks. Even though the vaginal absorption of this product is limited, it should only be used during the first trimester of pregnancy when the potential benefit is judged to outweigh the possible risk by a physician.
17. The systemic absorption of topical Miconazole is minimal, and it is not known whether Miconazole Nitrate is excreted in human milk. Lactating women should use this product with caution.

Drug Interactions

1. If used concurrently with other medications, drug interactions may occur. Consult your physician or pharmacist for details.
2. It is known that systemic formulations of Miconazole can inhibit CYP3A4 and CYP2C9. Given the limited systemic absorption of this product with topical administration, clinically significant drug interactions are very rare. Patients taking oral anticoagulants (such as warfarin) should use with caution and monitor anticoagulant effects.
3. The concurrent use of miconazole-based drugs with other medications such as oral hypoglycemic agents or phenytoin may increase the effects and adverse reactions of these medications, and caution should be exercised.

Pharmacological Action
This product is a broad-spectrum antifungal agent. Its mechanism of action is to inhibit the synthesis of fungal cell membranes and affect their metabolic processes. It has antibacterial effects against dermatophytes and Candida, and also has certain efficacy against some Gram-positive cocci.

Storage
Store in a sealed container.

Packaging
Aluminum tube packaging, 20 grams per tube, one tube per box.

Expiration
60 months