Miconazole Cream And Fluconazole Capsule - Kit

Pronunciation: mye-KON-a-zole/floo-KON-a-zole

Common Brand Name(s): Monicure Combo

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.

Uses

This product contains 2 medications: one fluconazole capsule and a tube of miconazole cream. Both are used to treat vaginal yeast infections. They work by stopping the growth of vaginal yeast (fungus). Fluconazole is taken by mouth to clear the infection. Miconazole cream is used on the skin around the vaginal area to reduce symptoms such as burning and itching. These medications belong to a class of drugs known as azole antifungals.

This product is available without a prescription. Before using this over-the-counter product to self-treat, talk to your doctor if this is your first vaginal yeast infection, if this is your second infection within 2 months, or if you are considering treatment for a girl under 12 years old.

Vaginal yeast infections do not cause fever, chills, stomach/abdominal pain, or vaginal discharge with a bad odor. If you have these symptoms, do not use this product. Contact your doctor right away because these may be signs of a more serious infection.

Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients. Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.

How To Use

Before using this product, read all directions on the product package and the Patient Information Leaflet. Ask your doctor or pharmacist if you have any questions. If your doctor has prescribed this medication, use it as directed.

Take the fluconazole capsule by mouth usually as a single dose, with or without food at any time of the day, or as directed by your doctor.

Apply a small amount of the miconazole cream to the vaginal area and rub it in gently, usually twice daily to relieve burning/itching, or as directed by your doctor. Wash your hands before and after use. Avoid getting the cream in your eyes. If this occurs, wash your eyes right away with plenty of water.

Your condition should start to improve within 1 day of taking the fluconazole. The effect of the fluconazole continues for several days. Tell your doctor if your condition does not improve after 3 days, if symptoms last more than 7 days, or if you get another yeast infection within 2 months. If you think you may have a serious medical problem, get medical help right away.

Side Effects

Nausea, stomach/abdominal pain, or headache may occur with fluconazole. Diarrhea and dizziness may rarely occur with fluconazole. Miconazole cream may cause mild burning, itching, or redness. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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

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

  • fast/irregular heartbeat
  • severe dizziness
  • fainting

This drug may rarely cause serious liver disease. Get medical help right away if you develop any symptoms of liver disease, including:

  • severe stomach/abdominal pain
  • persistent nausea/vomiting
  • yellowing eyes/skin
  • dark urine
  • unusual tiredness

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 miconazole/fluconazole, tell your doctor or pharmacist if you are allergic to either of these drugs; or to other azole antifungal drugs (such as clotrimazole, itraconazole, ketoconazole); 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.

Fluconazole 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. 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 miconazole passes into breast milk. However, these drugs are unlikely to harm a nursing infant. 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 asunaprevir, cisapride, flibanserin, 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 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

Not applicable.

Missed Dose

Not applicable.

Storage

Store at room temperature away from light and moisture. 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.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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