butoconazole (Rx, OTC)

Brand and Other Names:Femstat 3, Gynazole 1
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

vaginal cream

  • 2%

Candidiasis

Gynazole: 1 applicatorful of cream (approximately 5 g of the cream) intravaginally as single dose; may need to extend use for 6 days in pregnant women (2nd and 3rd trimester only)

Safety & efficacy not established

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Adverse Effects

Frequency Not Defined

Pelvic/abdominal pain or cramping

Vulvar/vaginal irritation, soreness, and swelling

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Warnings

Contraindications

Hypersensitivity to drug

1st trimester of pregnancy

Cautions

Hypersensitivity to other azoles

Contains mineral oil, which may weaken latex or rubber products

Consider HIV infection in sexually active women with difficult to eradicate recurrent yeast infection

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Pregnancy & Lactation

Pregnancy Category: C

Lactation: not known if excreted in breast milk; use caution

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Imidazole; alters fungal cell membrane permeability

Peak Plasma Time: 12-24 hr

Absorption: systemic (1.7%)

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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Gynazole-1 vaginal
-
2 % cream

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
butoconazole nitrate vaginal

BUTOCONAZOLE NITRATE CREAM - VAGINAL

(BUE-toe-KON-a-zole NYE-trate)

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

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: 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: 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 this medication has been prescribed because your doctor 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: 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. 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.

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: 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.

NOTES: Do not share this medication with others.To help prevent vaginal yeast infections, dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.If your sexual partner experiences symptoms, they should contact their doctor right away.

MISSED DOSE: Not applicable. This medication is usually given as one dose only.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

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.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.