Diflucan Information
Diflucan () 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-α,α-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of CHFNO and molecular weight of 306.3. The structural formula is:
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.
Diflucan () Clinical Pharmacology
The pharmacokinetic properties of fluconazole are similar following administration by the intravenous or oral routes. In normal volunteers, the bioavailability of orally administered fluconazole is over 90% compared with intravenous administration. Bioequivalence was established between the 100 mg tablet and both suspension strengths when administered as a single 200 mg dose.
Peak plasma concentrations (Cmax) in fasted normal volunteers occur between 1 and 2 hours with a terminal plasma elimination half-life of approximately 30 hours (range: 20–50 hours) after oral administration.
In fasted normal volunteers, administration of a single oral 400 mg dose of Diflucan () (fluconazole) leads to a mean Cmax of 6.72 µg/mL (range: 4.12 to 8.08 µg/mL) and after single oral doses of 50–400 mg, fluconazole plasma concentrations and AUC (area under the plasma concentration-time curve) are dose proportional.
The C and AUC data from a food-effect study involving administration of Diflucan () (fluconazole) tablets to healthy volunteers under fasting conditions and with a high-fat meal indicated that exposure to the drug is not affected by food. Therefore, Diflucan () may be taken without regard to meals. (see .)
Administration of a single oral 150 mg tablet of Diflucan () (fluconazole) to ten lactating women resulted in a mean Cmax of 2.61 µg/mL (range: 1.57 to 3.65 µg/mL).
Steady-state concentrations are reached within 5–10 days following oral doses of 50–400 mg given once daily. Administration of a loading dose (on day 1) of twice the usual daily dose results in plasma concentrations close to steady-state by the second day. The apparent volume of distribution of fluconazole approximates that of total body water. Plasma protein binding is low (11–12%). Following either single- or multiple oral doses for up to 14 days, fluconazole penetrates into all body fluids studied (see table below). In normal volunteers, saliva concentrations of fluconazole were equal to or slightly greater than plasma concentrations regardless of dose, route, or duration of dosing. In patients with bronchiectasis, sputum concentrations of fluconazole following a single 150 mg oral dose were equal to plasma concentrations at both 4 and 24 hours post dose. In patients with fungal meningitis, fluconazole concentrations in the CSF are approximately 80% of the corresponding plasma concentrations.
A single oral 150 mg dose of fluconazole administered to 27 patients penetrated into vaginal tissue, resulting in tissue:plasma ratios ranging from 0.94 to 1.14 over the first 48 hours following dosing.
A single oral 150 mg dose of fluconazole administered to 14 patients penetrated into vaginal fluid, resulting in fluid:plasma ratios ranging from 0.36 to 0.71 over the first 72 hours following dosing.
In normal volunteers, fluconazole is cleared primarily by renal excretion, with approximately 80% of the administered dose appearing in the urine as unchanged drug. About 11% of the dose is excreted in the urine as metabolites.
The pharmacokinetics of fluconazole are markedly affected by reduction in renal function. There is an inverse relationship between the elimination half-life and creatinine clearance. The dose of Diflucan () may need to be reduced in patients with impaired renal function. (See .) A 3-hour hemodialysis session decreases plasma concentrations by approximately 50%.
In normal volunteers, Diflucan () administration (doses ranging from 200 mg to 400 mg once daily for up to 14 days) was associated with small and inconsistent effects on testosterone concentrations, endogenous corticosteroid concentrations, and the ACTH-stimulated cortisol response.
In children, the following pharmacokinetic data {Mean (%cv)} have been reported:
Clearance corrected for body weight was not affected by age in these studies. Mean body clearance in adults is reported to be 0.23 (17%) mL/min/kg.
In premature newborns (gestational age 26 to 29 weeks), the mean (%cv) clearance within 36 hours of birth was 0.180 (35%, N=7) mL/min/kg, which increased with time to a mean of 0.218 (31%, N=9) mL/min/kg six days later and 0.333 (56%, N=4) mL/min/kg 12 days later. Similarly, the half-life was 73.6 hours, which decreased with time to a mean of 53.2 hours six days later and 46.6 hours 12 days later.
Fluconazole resistance may arise from a modification in the quality or quantity of the target enzyme (lanosterol 14-α-demethylase), reduced access to the drug target, or some combination of these mechanisms.
Point mutations in the gene () encoding for the target enzyme lead to an altered target with decreased affinity for azoles. Overexpression of results in the production of high concentrations of the target enzyme, creating the need for higher intracellular drug concentrations to inhibit all of the enzyme molecules in the cell.
The second major mechanism of drug resistance involves active efflux of fluconazole out of the cell through the activation of two types of multidrug efflux transporters; the major facilitators (encoded by genes) and those of the ATP-binding cassette superfamily (encoded by genes). Upregulation of the gene leads to fluconazole resistance, whereas, upregulation of genes may lead to resistance to multiple azoles.
Resistance in usually includes upregulation of genes resulting in resistance to multiple azoles. For an isolate where the MIC is categorized as Intermediate (16 to 32 µg/mL), the highest fluconazole dose is recommended.
There have been reports of cases of superinfection with species other than which are often inherently not susceptible to Diflucan () (e.g., ). Such cases may require alternative antifungal therapy.
Diflucan () Indications And Usage
Diflucan () (fluconazole) is indicated for the treatment of:
Prophylaxis. Diflucan () is also indicated to decrease the incidence of candidiasis in patients undergoing bone marrow transplantation who receive cytotoxic chemotherapy and/or radiation therapy.
Specimens for fungal culture and other relevant laboratory studies (serology, histopathology) should be obtained prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Diflucan () Clinical Studies
Two adequate and well-controlled studies were conducted in the U.S. using the 150 mg tablet. In both, the results of the fluconazole regimen were comparable to the control regimen (clotrimazole or miconazole intravaginally for 7 days) both clinically and statistically at the one month post-treatment evaluation.
The therapeutic cure rate, defined as a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure), along with a negative KOH examination and negative culture for (microbiologic eradication), was 55% in both the fluconazole group and the vaginal products group.
Approximately three-fourths of the enrolled patients had acute vaginitis (
Substantially more gastrointestinal events were reported in the fluconazole group compared to the vaginal product group. Most of the events were mild to moderate. Because fluconazole was given as a single dose, no discontinuations occurred.
Diflucan () Contraindications
Diflucan () (fluconazole) is contraindicated in patients who have shown hypersensitivity to fluconazole or to any of its excipients. There is no information regarding cross-hypersensitivity between fluconazole and other azole antifungal agents. Caution should be used in prescribing Diflucan () to patients with hypersensitivity to other azoles. Coadministration of terfenadine is contraindicated in patients receiving Diflucan () (fluconazole) at multiple doses of 400 mg or higher based upon results of a multiple dose interaction study. Coadministration of other drugs known to prolong the QT interval and which are metabolized via the enzyme CYP3A4 such as cisapride, astemizole, pimozide, and quinidine are contraindicated in patients receiving fluconazole. (See and .)
Diflucan () Warnings
(2) Anaphylaxis: In rare cases, anaphylaxis has been reported.
(3) Dermatologic: Patients have rarely developed exfoliative skin disorders during treatment with Diflucan () . In patients with serious underlying diseases (predominantly AIDS and malignancy), these have rarely resulted in a fatal outcome. Patients who develop rashes during treatment with Diflucan () should be monitored closely and the drug discontinued if lesions progress.
(4) Use in Pregnancy: There are no adequate and well-controlled studies of Diflucan () in pregnant women. Available human data do not suggest an increased risk of congenital anomalies following a single maternal dose of 150 mg. A few published case reports describe a rare pattern of distinct congenital anomalies in infants exposed to high dose maternal fluconazole (400–800 mg/day) during most or all of the first trimester. These reported anomalies are similar to those seen in animal studies. If this drug is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus (See .)
Diflucan () Precautions
Some azoles, including fluconazole, have been associated with prolongation of the QT interval on the electrocardiogram. During post-marketing surveillance, there have been rare cases of QT prolongation and torsade de pointes in patients taking fluconazole. Most of these reports involved seriously ill patients with multiple confounding risk factors, such as structural heart disease, electrolyte abnormalities, and concomitant medications that may have been contributory.
Fluconazole should be administered with caution to patients with these potentially proarrhythmic conditions.
Concomitant use of fluconazole and erythromycin has the potential to increase the risk of cardiotoxicity (prolonged QT interval, torsade de pointes) and consequently sudden heart death. This combination should be avoided.
Fluconazole should be administered with caution to patients with renal dysfunction.
Fluconazole is a potent CYP2C9 inhibitor and a moderate CYP3A4 inhibitor. Fluconazole treated patients who are concomitantly treated with drugs with a narrow therapeutic window metabolized through CYP2C9 and CYP3A4 should be monitored.
Diflucan () Powder for Oral Suspension contains sucrose and should not be used in patients with hereditary fructose, glucose/galactose malabsorption, and sucrase-isomaltase deficiency.
When driving vehicles or operating machines, it should be taken into account that occasionally dizziness or seizures may occur.
(See and .) Diflucan () is a potent inhibitor of cytochrome P450 (CYP) isoenzyme 2C9 and a moderate inhibitor of CYP3A4. In addition to the observed /documented interactions mentioned below, there is a risk of increased plasma concentration of other compounds metabolized by CYP2C9 and CYP3A4 coadministered with fluconazole. Therefore, caution should be exercised when using these combinations and the patients should be carefully monitored. The enzyme inhibiting effect of fluconazole persists 4–5 days after discontinuation of fluconazole treatment due to the long half-life of fluconazole. Clinically or potentially significant drug interactions between Diflucan () and the following agents/classes have been observed. These are described in greater detail below:
Oral hypoglycemicsCoumarin-type anticoagulantsPhenytoinCyclosporineRifampinTheophyllineTerfenadineCisaprideAstemizoleRifabutinVoriconazoleTacrolimusShort-acting benzodiazepinesTriazolamOral ContraceptivesPimozideHydrochlorothiazideAlfentanilAmitriptyline, nortriptylineAmphotericin BAzithromycinCarbamazepineCalcium Channel BlockersCelecoxibCyclophosphamideFentanylHalofantrineHMG-CoA reductase inhibitorsLosartanMethadoneNon-steroidal anti-inflammatory drugsPrednisoneSaquinavirSirolimusVinca AlkaloidsVitamin AZidovudine
Fluconazole showed no evidence of carcinogenic potential in mice and rats treated orally for 24 months at doses of 2.5, 5, or 10 mg/kg/day (approximately 2–7× the recommended human dose). Male rats treated with 5 and 10 mg/kg/day had an increased incidence of hepatocellular adenomas.
Fluconazole, with or without metabolic activation, was negative in tests for mutagenicity in 4 strains of and in the mouse lymphoma L5178Y system. Cytogenetic studies (murine bone marrow cells, following oral administration of fluconazole) and (human lymphocytes exposed to fluconazole at 1000 µg/mL) showed no evidence of chromosomal mutations.
Fluconazole did not affect the fertility of male or female rats treated orally with daily doses of 5, 10, or 20 mg/kg or with parenteral doses of 5, 25, or 75 mg/kg, although the onset of parturition was slightly delayed at 20 mg/kg PO. In an intravenous perinatal study in rats at 5, 20, and 40 mg/kg, dystocia and prolongation of parturition were observed in a few dams at 20 mg/kg (approximately 5–15× the recommended human dose) and 40 mg/kg, but not at 5 mg/kg. The disturbances in parturition were reflected by a slight increase in the number of still born pups and decrease of neonatal survival at these dose levels. The effects on parturition in rats are consistent with the species specific estrogen-lowering property produced by high doses of fluconazole. Such a hormone change has not been observed in women treated with fluconazole. (See .)
An open-label, randomized, controlled trial has shown Diflucan () to be effective in the treatment of oropharyngeal candidiasis in children 6 months to 13 years of age. (See .)
The use of Diflucan () in children with cryptococcal meningitis, esophagitis, or systemic infections is supported by the efficacy shown for these indications in adults and by the results from several small noncomparative pediatric clinical studies. In addition, pharmacokinetic studies in children (see ) have established a dose proportionality between children and adults. (See .)
In a noncomparative study of children with serious systemic fungal infections, most of which were candidemia, the effectiveness of Diflucan () was similar to that reported for the treatment of candidemia in adults. Of 17 subjects with culture-confirmed candidemia, 11 of 14 (79%) with baseline symptoms (3 were asymptomatic) had a clinical cure; 13/15 (87%) of evaluable patients had a mycologic cure at the end of treatment but two of these patients relapsed at 10 and 18 days, respectively, following cessation of therapy.
The efficacy of Diflucan () for the suppression of cryptococcal meningitis was successful in 4 of 5 children treated in a compassionate-use study of fluconazole for the treatment of life-threatening or serious mycosis. There is no information regarding the efficacy of fluconazole for primary treatment of cryptococcal meningitis in children.
The safety profile of Diflucan () in children has been studied in 577 children ages 1 day to 17 years who received doses ranging from 1 to 15 mg/kg/day for 1 to 1,616 days. (See .)
Efficacy of Diflucan () has not been established in infants less than 6 months of age. (See .) A small number of patients (29) ranging in age from 1 day to 6 months have been treated safely with Diflucan () .
In non-AIDS patients, side effects possibly related to fluconazole treatment were reported in fewer patients aged 65 and older (9%, n =339) than for younger patients (14%, n=2240). However, there was no consistent difference between the older and younger patients with respect to individual side effects. Of the most frequently reported (>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 fluconazole 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 casual relationship to drug exposure.
Controlled clinical trials of fluconazole 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.
Fluconazole 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 .)
Diflucan () Adverse Reactions
Diflucan () is generally well tolerated.
In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain.
Diflucan () Overdosage
There have been reports of overdose with fluconazole accompanied by hallucination and paranoid behavior.
In the event of overdose, symptomatic treatment (with supportive measures and gastric lavage if clinically indicated) should be instituted.
Fluconazole is largely excreted in urine. A three-hour hemodialysis session decreases plasma levels by approximately 50%.
In mice and rats receiving very high doses of fluconazole, clinical effects in both species included decreased motility and respiration, ptosis, lacrimation, salivation, urinary incontinence, loss of righting reflex, and cyanosis; death was sometimes preceded by clonic convulsions.
Diflucan () Dosage And Administration
The following dose equivalency scheme should generally provide equivalent exposure in pediatric and adult patients:
Experience with Diflucan () in neonates is limited to pharmacokinetic studies in premature newborns. (See .) Based on the prolonged half-life seen in premature newborns (gestational age 26 to 29 weeks), these children, in the first two weeks of life, should receive the same dosage (mg/kg) as in older children, but administered every 72 hours. After the first two weeks, these children should be dosed once daily. No information regarding Diflucan () pharmacokinetics in full-term newborns is available.
Fluconazole is cleared primarily by renal excretion as unchanged drug. There is no need to adjust single dose therapy for vaginal candidiasis because of impaired renal function. In patients with impaired renal function who will receive multiple doses of Diflucan () , an initial loading dose of 50 to 400 mg should be given. After the loading dose, the daily dose (according to indication) should be based on the following table:
These are suggested dose adjustments based on pharmacokinetics following administration of multiple doses. Further adjustment may be needed depending upon clinical condition.
When serum creatinine is the only measure of renal function available, the following formula (based on sex, weight, and age of the patient) should be used to estimate the creatinine clearance in adults:
Males: 72 × serum creatinine (mg/100 mL)
Females: 0.85 × above value
Although the pharmacokinetics of fluconazole has not been studied in children with renal insufficiency, dosage reduction in children with renal insufficiency should parallel that recommended for adults. The following formula may be used to estimate creatinine clearance in children:
K × serum creatinine (mg/100 mL)
(Where K=0.55 for children older than 1 year and 0.45 for infants.)
Diflucan () may be administered either orally or by intravenous infusion. Diflucan () can be taken with or without food. Diflucan () injection has been used safely for up to fourteen days of intravenous therapy. The intravenous infusion of Diflucan () should be administered at a maximum rate of approximately 200 mg/hour, given as a continuous infusion.
Diflucan () injections in glass and Viaflex® Plus plastic containers are intended only for intravenous administration using sterile equipment.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not use if the solution is cloudy or precipitated or if the seal is not intact.
Prepare a suspension at time of dispensing as follows: tap bottle until all the powder flows freely. To reconstitute, add 24 mL of distilled water or Purified Water (USP) to fluconazole bottle and shake vigorously to suspend powder. Each bottle will deliver 35 mL of suspension. The concentrations of the reconstituted suspensions are as follows:
Note: Shake oral suspension well before using. Store reconstituted suspension between 86°F (30°C) and 41°F (5°C) and discard unused portion after 2 weeks. Protect from freezing.
Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier. The inner bag maintains the sterility of the product.
CAUTION:
To Open
Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
DO NOT ADD SUPPLEMENTARY MEDICATION.
Preparation for Administration:
Diflucan () How Supplied
Pink trapezoidal tablets containing 50, 100, or 200 mg of fluconazole are packaged in bottles or unit dose blisters. The 150 mg fluconazole tablets are pink and oval shaped, packaged in a single dose unit blister.
Diflucan () Tablets are supplied as follows:
Diflucan () 50 mg Tablets: Engraved with "Diflucan () " and "50" on the front and "ROERIG" on the back.
NDC 0049-3410-30 Bottles of 30
Diflucan () 100 mg Tablets: Engraved with "Diflucan () " and "100" on the front and "ROERIG" on the back.
NDC 0049-3420-30 Bottles of 30 NDC 0049-3420-41 Unit dose package of 100
Diflucan () 150 mg Tablets: Engraved with "Diflucan () " and "150" on the front and "ROERIG" on the back.
NDC 0049-3500-79 Unit dose package of 1
Diflucan () 200 mg Tablets: Engraved with "Diflucan () " and "200" on the front and "ROERIG" on the back.
NDC 0049-3430-30 Bottles of 30 NDC 0049-3430-41 Unit dose package of 100
Diflucan () for Oral Suspension is supplied as an orange-flavored powder to provide 35 mL per bottle as follows:
NDC 0049-3440-19 Fluconazole 350 mg per bottle NDC 0049-3450-19 Fluconazole 1400 mg per bottle
Diflucan () injections for intravenous infusion administration are formulated as sterile iso-osmotic solutions containing 2 mg/mL of fluconazole. They are supplied in glass bottles or in Viaflex Plus plastic containers containing volumes of 100 mL or 200 mL, affording doses of 200 mg and 400 mg of fluconazole, respectively. Diflucan () injections in Viaflex Plus plastic containers are available in both sodium chloride and dextrose diluents.
Diflucan () Injections in Glass Bottles:
NDC 0049-3371-26 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL × 6NDC 0049-3372-26 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL × 6
Diflucan () Injections in Viaflex® Plus Plastic Containers:
NDC 0049-3435-26 Fluconazole in Sodium Chloride Diluent 200 mg/100 mL × 6NDC 0049-3436-26 Fluconazole in Sodium Chloride Diluent 400 mg/200 mL × 6NDC 0049-3437-26 Fluconazole in Dextrose Diluent 200 mg/100 mL × 6 NDC 0049-3438-26 Fluconazole in Dextrose Diluent 400 mg/200 mL × 6
Diflucan ()
Diflucan () Patient Information
This leaflet contains important information about Diflucan () (dye-FLEW-kan). It is not meant to take the place of your doctor's instructions. Read this information carefully before you take Diflucan () . Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about Diflucan () .
Diflucan () is a tablet you swallow to treat vaginal yeast infections caused by a yeast called Diflucan () helps stop too much yeast from growing in the vagina so the yeast infection goes away.
Diflucan () is different from other treatments for vaginal yeast infections because it is a tablet taken by mouth. Diflucan () is also used for other conditions. However, this leaflet is only about using Diflucan () for vaginal yeast infections. For information about using Diflucan () for other reasons, ask your doctor or pharmacist. See the section of this leaflet for information about vaginal yeast infections.
It is normal for a certain amount of yeast to be found in the vagina. Sometimes too much yeast starts to grow in the vagina and this can cause a yeast infection. Vaginal yeast infections are common. About three out of every four adult women will have at least one vaginal yeast infection during their life.
Some medicines and medical conditions can increase your chance of getting a yeast infection. If you are pregnant, have diabetes, use birth control pills, or take antibiotics you may get yeast infections more often than other women. Personal hygiene and certain types of clothing may increase your chances of getting a yeast infection. Ask your doctor for tips on what you can do to help prevent vaginal yeast infections.
If you get a vaginal yeast infection, you may have any of the following symptoms:
Do not take Diflucan () if you take certain medicines. They can cause serious problems. Therefore, tell your doctor about all the medicines you take including:
Since there are many brand names for these medicines, check with your doctor or pharmacist if you have any questions.
To avoid a possible serious reaction, do NOT take Diflucan () if you are taking erythromycin, astemizole, pimozide, quinidine, and cisapride (Propulsid®) since it can cause changes in heartbeat in some people if taken with Diflucan () .
Take Diflucan () by mouth with or without food. You can take Diflucan () at any time of the day.
Diflucan () keeps working for several days to treat the infection. Generally the symptoms start to go away after 24 hours. However, it may take several days for your symptoms to go away completely. If there is no change in your symptoms after a few days, call your doctor.
Some medicines can affect how well Diflucan () works. Check with your doctor before starting any new medicines within seven days of taking Diflucan () .
Like all medicines, Diflucan () may cause some side effects that are usually mild to moderate.
The most common side effects of Diflucan () are:
Allergic reactions to Diflucan () are rare, but they can be very serious if not treated right away by a doctor. If you cannot reach your doctor, go to the nearest hospital emergency room. Signs of an allergic reaction can include shortness of breath; coughing; wheezing; fever; chills; throbbing of the heart or ears; swelling of the eyelids, face, mouth, neck, or any other part of the body; or skin rash, hives, blisters or skin peeling.
Diflucan () has been linked to rare cases of serious liver damage, including deaths, mostly in patients with serious medical problems. Call your doctor if your skin or eyes become yellow, your urine turns a darker color, your stools (bowel movements) are light-colored, or if you vomit or feel like vomiting or if you have severe skin itching.
In patients with serious conditions such as AIDS or cancer, rare cases of severe rashes with skin peeling have been reported. Tell your doctor right away if you get a rash while taking Diflucan () .
Diflucan () may cause other less common side effects besides those listed here. If you develop any side effects that concern you, call your doctor. For a list of all side effects, ask your doctor or pharmacist.
In case of an accidental overdose, call your doctor right away or go to the nearest emergency room.
Keep Diflucan () and all medicines out of the reach of children.
Medicines are sometimes prescribed for conditions that are mentioned in patient information leaflets. Do not use Diflucan () for a condition for which it was not prescribed. Do not give Diflucan () to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about Diflucan () . If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Diflucan () that is written for health professionals.
You can also visit the Diflucan () Internet site at .
LAB-0380-5.0June 2011
Diflucan () Principal Display Panel - Mg Tablet Bottle Label
Diflucan () Principal Display Panel - Mg Tablet Bottle Label
Diflucan () Principal Display Panel - Mg Tablet Blister Pack
12 Cards x 1 Tablet
NDC 0049-3500-79
Diflucan () Principal Display Panel - Mg Tablet Bottle Label
Diflucan () Principal Display Panel - Ml Bottle Label
Diflucan () Principal Display Panel - Ml Bottle Label
NDC 0049-3371-26
Sterile Solution in 0.9% Sodium Chloride Injection
Diflucan () Principal Display Panel - Ml Bottle Label
NDC 0049-3372-26
Sterile Solution in 0.9% Sodium Chloride Injection
Diflucan () Principal Display Panel - Ml Container Label
*EACH 200 mL CONTAINS 400 mg OF FLUCONAZOLE AND 1.8 g OF SODIUM CHLORIDE (USP) IN WATER FOR INJECTION (USP) OSMOLARITY 315 mOsmol/L (CALC)
DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE PACKAGE INSERT
CAUTIONS DO NOT ADD SUPPLEMENTARY MEDICATION MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY
Diflucan () Principal Display Panel - Ml Container Label
*EACH 200 mL CONTAINS 400 mg OF FLUCONAZOLE AND 11.2 g OF DEXTROSE (USP) IN WATER FOR INJECTION (USP) OSMOLARITY 289 mOsmol/L (CALC)
DOSAGE INTRAVENOUSLY AS DIRECTED BY A PHYSICIAN SEE PACKAGE INSERT
CAUTIONS DO NOT ADD SUPPLEMENTARY MEDICATION MUST NOT BE USED IN SERIES CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY
