miconazole nitrate
Drug Details
- Generic Name
- miconazole nitrate
- Brand Names
- miconazole 3, HERS Miconazole 3, Topco Miconazole 3, GOOD SENSE MICONAZOLE 3, Miconazole, signature care miconazole 7, fungoid tincture, basic care miconazole 3, Medline
- Application Number
- ANDA091366
- Sponsor
- FDC Limited
- NDC Codes
- 13
- Dosage Forms
- POWDER, CREAM, KIT, TINCTURE, SUPPOSITORY
- Routes
- VAGINAL, TOPICAL
- Active Ingredients
- MICONAZOLE NITRATE
Indications and Usage
Uses • treats vaginal yeast infections • relieves external itching and irritation due to a vaginal yeast infection
Warnings
Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have • vaginal itching and discomfort for the first time • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. • been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur. When using this product • do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). • do not have vaginal intercourse • mild increase in vaginal burning, itching or irritation may occur • if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if • symptoms do not get better in 3 days • symptoms last more than 7 days • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).