Diflucan

DRUG DESCRIPTION

DIFLUCAN® (fluconazole), the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration, as a powder for oral suspension, and as a sterile solution for intravenous use in glass and in Viaflex® Plus plastic containers.

Fluconazole is designated chemically as 2,4-difluoro-?,?1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C13H12F2N6O and molecular weight of 306.3. The structural formula is:

DIFLUCAN® (Fluconazole) Structural Formula Illustration

Fluconazole is a white crystalline solid which is slightly soluble in water and saline.

DIFLUCAN Tablets contain 50, 100, 150, or 200 mg of fluconazole and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate.

DIFLUCAN for Oral Suspension contains 350 mg or 1400 mg of fluconazole and the following inactive ingredients: sucrose, sodium citrate dihydrate, citric acid anhydrous, sodium benzoate, titanium dioxide, colloidal silicon dioxide, xanthan gum, and natural orange flavor. After reconstitution with 24 mL of distilled water or Purified Water (USP), each mL of reconstituted suspension contains 10 mg or 40 mg of fluconazole.

DIFLUCAN Injection is an iso-osmotic, sterile, nonpyrogenic solution of fluconazole in a sodium chloride or dextrose diluent. Each mL contains 2 mg of fluconazole and 9 mg of sodium chloride or 56 mg of dextrose, hydrous. The pH ranges from 4.0 to 8.0 in the sodium chloride diluent and from 3.5 to 6.5 in the dextrose diluent. Injection volumes of 100 mL and 200 mL are packaged in glass and in Viaflex® Plus plastic containers.

The Viaflex® Plus plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146® Plastic) (Viaflex and PL 146 are registered trademarks of Baxter International, Inc.). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the suitability of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

What are the possible side effects of fluconazole (Diflucan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • easy bruising or bleeding, unusual weakness;...

Read All Potential Side Effects and See Pictures of Diflucan »

What are the precautions when taking fluconazole (Diflucan)?

Before taking fluconazole, tell your doctor or pharmacist if you are allergic to it; 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 infrequently result in 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...

Read All Potential Precautions of Diflucan »


Diflucan Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, diarrhea, stomach upset/pain, headache, dizziness, or hair loss may occur. If any of these effects persist or worsen, tell 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.

Get medical help right away if any of these rare but serious side effects occur: fast/irregular heartbeat, severe dizziness, fainting.

This drug may rarely cause serious liver disease. Get medical help right away if you develop any signs 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: 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.

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 taking fluconazole, tell your doctor or pharmacist if you are allergic to it; 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 infrequently result in 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 affect the heart rhythm. 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.

Although uncommon, this drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

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 effects of this drug, especially rash, vomiting, and diarrhea.

During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby if taken in high doses daily during the first 3 months of pregnancy. Discuss the risks and benefits with your doctor.

Fluconazole passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Diflucan Patient Information Including Side Effects

Brand Names: Diflucan

Generic Name: fluconazole (Pronunciation: floo KOE na zole)

  • What is fluconazole (Diflucan)?
  • What are the possible side effects of fluconazole (Diflucan)?
  • What is the most important information I should know about fluconazole (Diflucan)?
  • What should I discuss with my healthcare provider before taking fluconazole (Diflucan)?
  • How should I take fluconazole (Diflucan)?
  • What happens if I miss a dose (Diflucan)?
  • What happens if I overdose (Diflucan)?
  • What should I avoid while taking fluconazole (Diflucan)?
  • What other drugs will affect fluconazole (Diflucan)?
  • Where can I get more information?

What is fluconazole (Diflucan)?

Fluconazole is an antifungal antibiotic.

Fluconazole is used to treat infections caused by fungus, which can invade any part of the body including the mouth, throat, esophagus, lungs, bladder, genital area, and the blood.

Fluconazole is also used to prevent fungal infection in people with weak immune systems caused by cancer treatment, bone marrow transplant, or diseases such as AIDS.

Fluconazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fluconazole (Diflucan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • fever, chills, body aches, flu symptoms;
  • severe blistering, peeling, and red skin rash;
  • easy bruising or bleeding, unusual weakness; or
  • seizure (convulsions).

Less serious side effects may include:

  • mild nausea, vomiting, diarrhea, or upset stomach;
  • headache;
  • dizziness;
  • unusual or unpleasant taste in your mouth; or
  • skin rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fluconazole (Diflucan)?

Do not use this medication if you are allergic to fluconazole, or similar drugs such as clotrimazole (Lotrimin), econazole (Spectazole), ketoconazole (Nizoral), miconazole (Monistat), sertaconazole (Ertaczo), sulconazole (Exelderm), terconazole (Terazol), tioconazole (Vagistat-1), or voriconazole (Vfend).

Do not use fluconazole if you are also taking cisapride (Propulsid) or terfenadine (Seldane).

Before taking fluconazole, tell your doctor if you have liver disease, kidney disease, a heart rhythm disorder, or a history of "Long QT syndrome."

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Fluconazole will not treat a viral infection such as the common cold or flu.

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