Uses

This kit contains 2 medications: one fluconazole capsule and a tube of clotrimazole cream. Fluconazole is an azole antifungal taken by mouth to treat vaginal yeast infections. The clotrimazole cream is also an azole antifungal. It is used on the skin in and around the vaginal area to reduce symptoms such as burning, itching, and redness that may occur with a vaginal yeast infection. Both medications work by stopping the growth of yeast (fungus) that causes the infection.

Ask your doctor before using this medication for self-treatment if this is your first vaginal infection. This product only works for vaginal yeast infections. You may have a different type of infection (such as bacterial vaginosis) and may need a different medication.

If you have fever, chills, flu-like symptoms, stomach/abdominal pain, or a bad-smelling vaginal discharge, do not use this medication. Contact your doctor right away because these may be signs of a more serious infection.

How To Use

If you are using the over-the counter product to self-treat, read and follow all directions on the product package before using this medication. If your doctor has prescribed this medication, follow your doctor's directions. Read the Patient Information Leaflet available with this product. Ask your doctor or pharmacist if you have any questions.

Take the fluconazole capsule by mouth with or without food as directed by your doctor, usually as a one-time only dose. Dosage is based on your medical condition and response to treatment.

If you have itching/burning in or around the vaginal area, apply a small amount of the cream to that area usually once or twice daily for no more than 7 days. Wash your hands before and after use. Avoid contact of this product with your eyes. If it gets into your eyes, wash them right away with plenty of water. Call your doctor if eye irritation lasts.

You should see some improvement in your symptoms within 1 day of taking the fluconazole. Tell your doctor if your condition does not improve after 3 days or lasts more than 7 days. Tell your doctor if your infection returns within 2 months. You may need a different or additional medication to treat your infection.

Side Effects

Nausea, stomach/abdominal pain, dizziness, or headache may occur with fluconazole. Clotrimazole cream may cause temporary burning, itching, or redness. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that 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.

Get medical help right away if you have any very serious side effects, including:

• fast/irregular heartbeat
• severe dizziness
• fainting

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• 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 fluconazole or clotrimazole, tell your doctor or pharmacist if you are allergic to either of them; or to other azole antifungal drugs (such as ketoconazole, itraconazole); 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:

• liver disease
• kidney disease

Fluconazole may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using fluconazole, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

• certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
• family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluconazole safely.

This drug may rarely make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

During pregnancy, this medication should be used only when clearly needed. Clotrimazole cream may decrease the effectiveness of latex condoms and diaphragms during treatment and for 3 days after last use. Fluconazole may harm an unborn baby if taken during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor.

Fluconazole passes into breast milk. It is unknown if clotrimazole passes into breast milk. However, it is unlikely to pass into breast milk in large amounts. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• clopidogrel

Many drugs besides fluconazole may affect the heart rhythm (QT prolongation), including pimozide, quinidine, macrolide antibiotics (such as erythromycin), among others.

Fluconazole can slow down the removal of other medications from your body, which can affect how they work. Examples of affected drugs include abrocitinib, asunaprevir, flibanserin, lemborexant, macitentan, mavacamten, among others.

Overdose

The cream may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. 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

If your doctor has directed you to use this medication, use it for your current condition only. Do not use it later for another infection unless your doctor tells you to.

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.

Missed Dose

If you are prescribed more than one dose and you miss it, contact your doctor for instructions.

Storage

Store the capsule at room temperature away from light and moisture. Store the cream at room temperature or in the refrigerator. Do not store in the bathroom. Keep all medications 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.