BUTOCONAZOLE NITRATE CREAM - VAGINAL

BUTOCONAZOLE NITRATE CREAM - VAGINAL

PHONETIC PRONUNCIATION: (BUE-toe-KON-a-zole NYE-trate)

COMMON BRAND NAME(S): Gynazole-1, Mycelex

GENERIC NAME(S): butoconazole nitrate

Uses

USES: This medication is used to treat vaginal yeast infections. Butoconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.


How to use BUTOCONAZOLE NITRATE CREAM - VAGINAL

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using butoconazole, and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. This product is for vaginal use only. Wash your hands before and after use. Avoid contact of this cream with your eyes. If it gets into your eyes, wash them right away with plenty of water. Call your doctor if eye irritation persists. Use this product as directed by your doctor, usually given as a single dose. Learn all preparation and usage instructions in the product package. Lie on your back with your knees toward your chest. Insert the applicator filled with medication into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator in to apply the full dose of the cream. Do not use tampons or douches while using this medication. Unscented sanitary napkins may be used for your menstrual period or to protect your clothing from leakage of the medication. Tell your doctor if your condition does not improve or if it returns within 2 months. You may need a different or additional medication to treat your condition.

Side Effects

SIDE EFFECTS: Increased vaginal/urethral burning/itching/pain, or mild abdominal cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A different type of infection (bacterial vaginosis) or a more serious condition (Pelvic Inflammatory Disease-PID) may require different treatment. Tell your doctor right away if you have any of the following symptoms: flu-like symptoms (including fever/chills), foul-smelling discharge from the vagina, stomach/abdominal pain. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDS), frequent vaginal yeast infections (more than 4 per year). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Ask your doctor whether you can have sexual intercourse while using this product. This product may weaken rubber products (such as latex condoms, diaphragms, cervical caps) and lead to failure. This can result in pregnancy. Therefore, do not use these products during treatment with this medication and for 3 days after treatment is over. Consult your doctor about other forms of barrier protection/birth control (such as polyurethane condoms) during this time. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnant women should use extra care when using the vaginal applicator. Follow your doctor's instructions closely on how to insert the medication using the applicator. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may increase the risk of vaginal yeast infections include antibiotics, corticosteroids (such as prednisone), and drugs that suppress the immune system (such as cyclosporine, methotrexate). Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

Overdose

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Faq for BUTOCONAZOLE NITRATE CREAM - VAGINAL

Butoconazole nitrate cream is used to treat vaginal yeast infections caused by the Candida fungus. It relieves itching, burning, and discharge associated with the infection.

Wash your hands before and after applying the cream. Using the applicator provided, insert the cream into the vagina as directed by your doctor or the product instructions. It is usually recommended to apply the cream at bedtime for the best results. Follow the full course of treatment, even if symptoms improve.

Common side effects may include itching or burning sensation, vaginal discomfort, and headache. If these side effects persist or worsen, consult your doctor. Serious allergic reactions are rare but seek medical attention if you experience rash, itching/swelling, severe dizziness, or trouble breathing.

It is recommended to consult your doctor before using this medication during pregnancy, as they will weigh the benefits against potential risks. Butoconazole nitrate cream is generally considered safe to use during the second and third trimesters of pregnancy.

Usually, it takes about 3 days for the symptoms to improve. However, it is important to complete the full course of treatment as prescribed by your doctor, even if symptoms disappear. If symptoms do not improve after 7 days, consult your healthcare provider.

It is recommended to avoid sexual activity while using butoconazole nitrate cream since it may weaken latex condoms, diaphragms, and cervical caps, making them less effective as contraception.

Limited data suggests that using butoconazole nitrate cream while breastfeeding is unlikely to harm the nursing infant. However, it is always best to consult with your healthcare provider before using any medication while breastfeeding.

If you miss a dose, apply it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not apply a double dose to make up for a missed one.

Butoconazole nitrate cream is specifically designed for vaginal use and is not intended for use by men. It is only recommended for the treatment of vaginal yeast infections in women.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.