Miconazole Nitrate Cream for Skin and nail infections caused by dermatophytes as athlete’s foot

Description

【Drug Name】
Generic name: Dacnin Cream 20mg/g
Product name: Dakenin
English name: Miconazole Nitrate Cream
Chinese Pinyin: Xiaosuan Mikangzuo Rugao
【Ingredients】 This product contains 0.02g of miconazole nitrate per gram. The excipients are: glyceryl monostearate, stearic acid, triethanolamine, stearyl alcohol, glycerin, ethyl hydroxyphenyl ester, white petrolatum, liquid paraffin, and purified water.
【Character】This product is white or off-white cream
【Indications】
1.Skin and nail infections caused by dermatophytes, yeasts and other fungi, such as tinea cruris, tinea pedis, tinea versicolor, tinea capitis, tinea barbae, and onychomycosis; skin, finger (toe) infections Candidiasis, angular stomatitis, and otitis externa. Since this product has antibacterial effects on Gram-positive bacteria, it can be used for secondary infections caused by such bacteria.
2.Vaginal infections and secondary infections caused by yeast (such as Candida, etc.) and Gram-positive bacteria.
【Dosage】
1.For external use on skin infections, apply to the dry and clean affected area once in the morning and once in the evening. After the symptoms disappear (usually 2 to 5 weeks), the medication should be continued for 10 days to prevent recurrence.
2.For finger (toe) nail infection, try to cut off the affected nail as much as possible, apply this product to the affected area, once a day. After the affected nail is loosened (about 2 to 3 weeks), continue to use the medicine until new nail begins to grow. It usually takes about 7 months to see effective results.
3.For Candida vaginitis, use an applicator to squeeze the ointment (about 5 grams) deep into the vagina every day before going to bed. It must be used continuously for 2 weeks. It can also be used during menstruation. It is still effective if used again after a second recurrence.
【Adverse reactions】Occasionally, symptoms of allergies, blisters, burning, congestion, itching, or other skin irritation may occur. Very rarely angioedema, urticaria, eczema, contact dermatitis, erythema, pelvic pain (cramping), vaginal irritation, vaginal discharge, and administration site discomfort.
【Contraindications】This product is contraindicated by those who are known to be allergic to miconazole nitrate or other ingredients of this product.
【Precautions】
1.Avoid contact with eyes and other mucous membranes (such as mouth, nose, etc.).
2.Pregnant and lactating women should use with caution.
3.When treating candidiasis, sealing and bandaging must be avoided, otherwise it may promote the growth of pathogenic bacteria.
4.If there is a burning sensation, redness, or swelling at the medication site, the medication should be discontinued, the local medication should be washed, and if necessary, consult a physician.
5.When used for gynecological diseases: Women with no sexual history should use it under the guidance of a physician; pay attention to personal hygiene during medication to prevent repeated infections.
6.People who are allergic to this product should not use it, and people with allergies should use it with caution.
7.It is forbidden to use this product when its properties change.
8.Please keep this product out of reach of children.
9.Children must use it under adult supervision.
10.If you are using other drugs, please consult your physician or pharmacist before using this product.
11.If local sensitivity or allergic reaction occurs, you should stop taking the medicine immediately and consult a doctor in time.
12.Sexual partners should also be given appropriate treatment when they are infected.
13.This product is for local use and must not be taken orally. If large amounts are accidentally orally administered, use appropriate gastric emptying measures if necessary.
【Drug use for special groups】 Note for children: Children must use under adult supervision. Precautions during pregnancy and lactation:
1.Precautions during pregnancy and lactation: Animal tests have shown that miconazole is toxic to the fetus, so this product is contraindicated in pregnant women.
2.It is not clear whether this product will be secreted into breast milk, so it is not recommended for lactating women to use this product. Precautions for the elderly: Not yet clear
【medicine interactions】
1.Drug interactions may occur if used together with other drugs. Please consult a physician or pharmacist for details.
2.Systemic administration formulations of miconazole nitrate are known to inhibit CYP3A4/2C9. Given the limited systemic absorption of topical administration of this product, clinically significant drug interactions are rare. Patients taking oral anticoagulants (e.g., warfarin) should be used with caution and monitored for anticoagulant effects.
3.Taking miconazole drugs together with other drugs such as oral hypoglycemic drugs or phenytoin can increase the effects and side effects of other drugs and should be used with caution.
4.Since the ingredients of this product can cause damage to latex products such as contraceptive diaphragms and condoms, contact between this product and such products should be avoided.
【Pharmacological effects】 This product is a broad-spectrum antifungal drug. Its mechanism of action is to inhibit the synthesis of fungal cell membranes and affect its metabolic process. It has antibacterial effects on dermatophytes, Candida, etc., and also has certain curative effects on certain Gram-positive cocci.
【Storage】Seal and store.
【Specification】Contains miconazole nitrate 0.02g (2%) per g
【Packaging specifications】 Aluminum tube packaging, 15g/piece/box, 20g/piece/box.
【Validity period】60 months
【Execution Standard】”Chinese Pharmacopoeia” 2020 Edition Part 2
【Approval number】National drug approval number H61020001
【Instruction Revision Date】2020/10/28
【manufacturer】
Company name: Xi’an Janssen Pharmaceutical Co., Ltd.