How to store Flucazole
- Keep all medicines out of the reach and sight of children.
- Store in a cool, dry place, away from direct heat and light.
Flucazole side effects
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Call your doctor at once if you have:
fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
fever, chills, body aches, flu symptoms;
easy bruising or bleeding, unusual weakness;
skin rash or skin lesions; or
liver problems--loss of appetite, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
changes in your sense of taste.
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.
During concomitant treatment with Flucazole (200 mg daily) and celecoxib (200 mg), the celecoxib Cmax and AUC increased by 68% and 134%, respectively. Half of the celecoxib dose may be necessary when combined with Flucazole.
Single maternal PO dose of 150 mg for vaginal candidiasis
- Results of a Danish study concludes there is a possible increased risk of miscarriage; women who are pregnant or actively trying to get pregnant should ask their physician about alternative treatments
- Spontaneous abortion between 7 and 22 weeks' gestation occurred significantly more often in women exposed to oral Flucazole than unexposed pregnancies (4.43% vs. 4.25%; hazard ratio, 1.48); Flucazole was also compared with intravaginal azole antifungals to account for confounding by candidiasis, again, the oral drug was associated with significantly increased risk for spontaneous abortion - JAMA. 2016;315(1):58-67
- CDC guidelines recommend only using topical antifungal products to treat pregnant women with vulvovaginal yeast infections, including for longer periods than usual if these infections persist or recur
Serious Side Effects of Flucazole
- Changes in heart rhythm or electrical activity in the heart
- Liver failure and inflammation, including an increase in liver enzyme levels and yellowing of the skin, nails, and whites of the eyes (jaundice)
- Swelling of the lips, mouth, and tongue (angioedema)
- A drop in white blood cell count or platelet count
- Difficulty breathing
- High triglycerides, low potassium levels in the blood
- Severe and potentially life-threatening skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis (TENs)
Exfoliative skin disorders during treatment with DIFLUCAN have been reported. Fatal outcomes have been reported in patients with serious underlying diseases. Patients with deep seated fungal infections who develop rashes during treatment with DIFLUCAN should be monitored closely and the drug discontinued if lesions progress. Flucazole should be discontinued in patients treated for superficial fungal infection who develop a rash that may be attributed to Flucazole.
Mechanism of Injury
The cause of clinically apparent hepatotoxicity from Flucazole is unknown; however, it may relate to the ability of Flucazole to alter sterol synthesis. Flucazole is a potent inhibitor of the cytochrome P450 enzyme CYP 3A4, and can lead to significant increases in plasma levels and serious toxicity from medications that are ordinarily metabolized by CYP3A4, particularly the statins and cyclosporine.
Where can I get more information (Diflucan)?
Your pharmacist can provide more information about Flucazole.
Flucazole and Alcohol
You should avoid or limit drinking alcohol while taking Flucazole.
Since both can cause headaches and stomach discomfort, drinking alcohol while taking Flucazole may worsen these side effects.
There have been published reports that an interaction exists when Flucazole is administered concomitantly with tacrolimus, leading to increased serum levels of tacrolimus. (See PRECAUTIONS.)
Pink trapezoidal tablets containing 50, 100, or 200 mg of Flucazole are packaged in bottles or unit dose blisters. The 150 mg Flucazole tablets are pink and oval shaped, packaged in a single dose unit blister.
DIFLUCAN Tablets are supplied as follows:
In non-A >1%) side effects, rash, vomiting, and diarrhea occurred in greater proportions of older patients. Similar proportions of older patients (2.4%) and younger patients (1.5%) discontinued Flucazole therapy because of side effects. In post-marketing experience, spontaneous reports of anemia and acute renal failure were more frequent among patients 65 years of age or older than in those between 12 and 65 years of age. Because of the voluntary nature of the reports and the natural increase in the incidence of anemia and renal failure in the elderly, it is however not possible to establish a causal relationship to drug exposure.
Controlled clinical trials of Flucazole did not include sufficient numbers of patients aged 65 and older to evaluate whether they respond differently from younger patients in each indication. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Flucazole is primarily cleared by renal excretion as unchanged drug. Because elderly patients are more likely to have decreased renal function, care should be taken to adjust dose based on creatinine clearance. It may be useful to monitor renal function. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION.)
(See CONTRAINDICATIONS.) Flucazole is a moderate CYP2C9 and CYP3A4 inhibitor. Flucazole is also a strong inhibitor of CYP2C19. Patients treated with DIFLUCAN, who are also concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4, should be monitored for adverse reactions associated with the concomitantly administered drugs. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9, CYP2C19, and CYP3A4 coadministered with Flucazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of Flucazole persists 4 to 5 days after discontinuation of Flucazole treatment due to the long half-life of Flucazole. Clinically or potentially significant drug interactions between DIFLUCAN and the following agents/classes have been observed and are described in greater detail below:
The AUC and Cmax of glyburide (5 mg single dose) were significantly increased following the administration of Flucazole in 20 normal male volunteers. There was a mean ± SD increase in AUC of 44% ± 29% (range: –13 to 115%) and Cmax increased 19% ± 19% (range: –23 to 62%). Five subjects required oral glucose following the ingestion of glyburide after 7 days of Flucazole administration. (See PRECAUTIONS.)