Fluconazole 200mg Tablets
It is used to treat fungal infections. It is used to prevent fungal infections.This drug is used to treat vaginal yeast infections.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antifungal
Pharmacologic Class
Triazole Antifungal
Pregnancy Category
Category D (for non-vaginal candidiasis, especially chronic or high dose use); Category C (for single dose vaginal candidiasis)
FDA Approved
Jan 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluconazole is an antifungal medication used to treat various fungal infections, including yeast infections of the mouth, throat, esophagus, and vagina, as well as more serious systemic fungal infections. It works by stopping the growth of the fungus.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food. Continue taking it even if you feel well, unless your doctor or healthcare provider advises you to stop.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take the medication exactly as prescribed, even if symptoms improve.
- Complete the full course of treatment to prevent recurrence and resistance.
- Avoid alcohol consumption, especially with prolonged use, due to potential liver effects.
- Report any signs of liver problems (e.g., unusual tiredness, yellowing of skin/eyes, dark urine) or severe skin rash immediately.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. E.g., Vaginal Candidiasis: 150 mg PO once; Oropharyngeal Candidiasis: 200 mg PO on day 1, then 100 mg PO daily for 7-14 days; Esophageal Candidiasis: 200 mg PO on day 1, then 100 mg PO daily for 14-30 days; Cryptococcal Meningitis: 400 mg PO on day 1, then 200-400 mg PO daily for 10-12 weeks after CSF culture is negative.
Dose Range:
50 - 800 mg
Condition-Specific Dosing:
Vaginal Candidiasis:
150 mg PO once
Oropharyngeal Candidiasis:
200 mg PO on day 1, then 100 mg PO daily
Esophageal Candidiasis:
200 mg PO on day 1, then 100 mg PO daily
Systemic Candidiasis:
400 mg PO on day 1, then 200-400 mg PO daily
Cryptococcal Meningitis (initial):
400 mg PO on day 1, then 200-400 mg PO daily
Cryptococcal Meningitis (suppression):
200 mg PO daily
Pediatric Dosing
Neonatal:
Postnatal age < 14 days: 3-6 mg/kg/dose every 72 hours; Postnatal age 14-28 days: 3-6 mg/kg/dose every 48 hours (for systemic infections).
Infant:
âĨ 1 month: 6-12 mg/kg/day (max 600 mg/day) for systemic infections; 3 mg/kg/day for superficial infections.
Child:
3-6 mg/kg/day for superficial infections; 6-12 mg/kg/day for systemic infections (max 600 mg/day).
Adolescent:
Same as adult dosing, generally.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
Reduce dose by 50% after initial loading dose (CrCl 21-50 mL/min)
Severe:
Reduce dose by 75% after initial loading dose (CrCl < 20 mL/min)
Dialysis:
Administer full dose after each dialysis session; on non-dialysis days, administer 50% of the recommended daily dose.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution and monitor liver function closely.
Pharmacology
Mechanism of Action
Fluconazole inhibits fungal cytochrome P450 enzyme 14-alpha-demethylase, which is essential for the conversion of lanosterol to ergosterol. Ergosterol is a vital component of the fungal cell membrane. Inhibition of ergosterol synthesis leads to increased cellular permeability, leakage of cellular contents, and ultimately fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
90%
Tmax:
1-2 hours
FoodEffect:
Absorption is not significantly affected by food.
Distribution:
Vd:
0.7 L/kg
ProteinBinding:
11-12%
CnssPenetration:
Yes (achieves concentrations in CSF approximately 50-90% of plasma concentrations)
Elimination:
HalfLife:
Approximately 30 hours (range 20-50 hours)
Clearance:
Primarily renal
ExcretionRoute:
Renal (urine)
Unchanged:
Approximately 80% of the administered dose is excreted unchanged in the urine.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within 24-48 hours for acute infections.
PeakEffect:
Not directly applicable as an antifungal, but peak plasma concentrations reached within 1-2 hours.
DurationOfAction:
Due to long half-life, allows for once-daily dosing; antifungal effects persist as long as therapeutic concentrations are maintained.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Seizures
A type of severe abnormal heartbeat (prolonged QT interval), which can increase the risk of another type of severe abnormal heartbeat (torsades de pointes). This is more likely to occur in people with other serious health problems or those taking other medications that may also cause abnormal heartbeats. If you experience a fast or abnormal heartbeat, or if you faint, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Stomach pain or diarrhea
Upset stomach or vomiting
* Change in taste
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of a weak adrenal gland, such as:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling very tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Seizures
A type of severe abnormal heartbeat (prolonged QT interval), which can increase the risk of another type of severe abnormal heartbeat (torsades de pointes). This is more likely to occur in people with other serious health problems or those taking other medications that may also cause abnormal heartbeats. If you experience a fast or abnormal heartbeat, or if you faint, contact your doctor immediately.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Dizziness or headache
Stomach pain or diarrhea
Upset stomach or vomiting
* Change in taste
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe skin rash, blistering, or peeling (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Signs of liver damage (e.g., severe nausea, vomiting, abdominal pain, dark urine, yellowing of skin or eyes, unusual tiredness)
- Signs of adrenal insufficiency (e.g., severe fatigue, weakness, dizziness, nausea, vomiting, low blood pressure)
- Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing)
- Irregular heartbeat, palpitations, or fainting (may indicate QT prolongation)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking any of the following medications: Abrocitinib, astemizole, cisapride, erythromycin, lemborexant, olaparib, pimozide, quinidine, terfenadine, or voriconazole.
If you are pregnant or think you might be pregnant. You will need to discuss the potential risks and benefits of this medication with your doctor to determine if it is suitable for you.
Please note that this is not an exhaustive list of all possible interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about your health problems, as they may interact with this medication.
Always check with your doctor before starting, stopping, or changing the dose of any medication to guarantee safe use and minimize potential interactions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction and its symptoms.
If you are currently taking any of the following medications: Abrocitinib, astemizole, cisapride, erythromycin, lemborexant, olaparib, pimozide, quinidine, terfenadine, or voriconazole.
If you are pregnant or think you might be pregnant. You will need to discuss the potential risks and benefits of this medication with your doctor to determine if it is suitable for you.
Please note that this is not an exhaustive list of all possible interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about your health problems, as they may interact with this medication.
Always check with your doctor before starting, stopping, or changing the dose of any medication to guarantee safe use and minimize potential interactions.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention.
Do not exceed the prescribed duration of treatment, as this may increase the risk of a secondary infection.
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor.
Before consuming alcohol, consult with your doctor to understand any potential risks or interactions.
Be aware that severe skin reactions, including potentially life-threatening rashes, have been associated with this medication, particularly in individuals with pre-existing health conditions. If you experience any unusual skin symptoms, promptly discuss them with your doctor.
Although rare, severe liver problems, sometimes fatal, have occurred in patients taking this drug, often in those with other underlying health issues. If you have any concerns, consult your doctor.
In some cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms such as fever, rash, swollen glands, and problems affecting various organs, including the liver, kidneys, blood, heart, muscles, joints, and lungs. If you have any questions or concerns, discuss them with your doctor.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
For women of childbearing age, discuss the potential need for birth control with your doctor to prevent pregnancy during treatment and for a period after the last dose.
This medication may cause harm to an unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant while taking this drug, immediately contact your doctor.
If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention.
Do not exceed the prescribed duration of treatment, as this may increase the risk of a secondary infection.
Regular blood tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor.
Before consuming alcohol, consult with your doctor to understand any potential risks or interactions.
Be aware that severe skin reactions, including potentially life-threatening rashes, have been associated with this medication, particularly in individuals with pre-existing health conditions. If you experience any unusual skin symptoms, promptly discuss them with your doctor.
Although rare, severe liver problems, sometimes fatal, have occurred in patients taking this drug, often in those with other underlying health issues. If you have any concerns, consult your doctor.
In some cases, a severe and potentially life-threatening reaction may occur, characterized by symptoms such as fever, rash, swollen glands, and problems affecting various organs, including the liver, kidneys, blood, heart, muscles, joints, and lungs. If you have any questions or concerns, discuss them with your doctor.
If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.
For women of childbearing age, discuss the potential need for birth control with your doctor to prevent pregnancy during treatment and for a period after the last dose.
This medication may cause harm to an unborn baby if taken during pregnancy. If you become pregnant or suspect you may be pregnant while taking this drug, immediately contact your doctor.
If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Hallucinations
- Paranoid behavior
- Seizures
- Hypokalemia
- QT prolongation
What to Do:
In case of overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Symptomatic and supportive measures should be instituted as necessary. Hemodialysis may be used to remove fluconazole from the body.
Drug Interactions
Contraindicated Interactions
- Terfenadine (at fluconazole doses âĨ 400 mg/day)
- Cisapride
- Pimozide
- Quinidine
- Erythromycin
- Amiodarone (due to risk of QT prolongation and Torsades de Pointes)
Major Interactions
- Warfarin (increased INR/bleeding risk)
- Phenytoin (increased phenytoin levels)
- Sulfonylureas (e.g., glipizide, glyburide; increased hypoglycemic effect)
- Cyclosporine (increased cyclosporine levels)
- Tacrolimus (increased tacrolimus levels)
- Rifampin (decreased fluconazole levels)
- Hydrochlorothiazide (increased fluconazole levels)
- Oral Contraceptives (variable effect, potential for decreased efficacy)
- Statins (e.g., atorvastatin, simvastatin; increased risk of myopathy/rhabdomyolysis)
- Benzodiazepines (e.g., midazolam, triazolam; increased sedation)
- Theophylline (increased theophylline levels)
- Voriconazole (increased fluconazole and voriconazole levels)
- Fentanyl (increased fentanyl exposure)
- Ivacaftor (increased ivacaftor exposure)
- Tofacitinib (increased tofacitinib exposure)
Moderate Interactions
- Amitriptyline (increased amitriptyline levels)
- Nortriptyline (increased nortriptyline levels)
- Celecoxib (increased celecoxib levels)
- Losartan (decreased losartan active metabolite)
- Methadone (increased methadone levels)
- NSAIDs (e.g., ibuprofen, naproxen; increased NSAID levels)
- Vincristine/Vinblastine (increased vinca alkaloid levels, neurotoxicity)
- Vitamin A (potential for CNS side effects)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Liver Function Tests (ALT, AST, ALP, Bilirubin)
Rationale: To establish baseline and identify pre-existing hepatic impairment, as fluconazole can cause hepatotoxicity.
Timing: Prior to initiation of therapy.
Renal Function (SCr, BUN, CrCl)
Rationale: To determine appropriate dosing adjustments, as fluconazole is primarily renally eliminated.
Timing: Prior to initiation of therapy.
Electrolytes (Potassium, Magnesium)
Rationale: To assess baseline for risk of QT prolongation, especially in patients with pre-existing cardiac conditions or on other QT-prolonging drugs.
Timing: Prior to initiation of therapy, if clinically indicated.
Routine Monitoring
Liver Function Tests (ALT, AST, ALP, Bilirubin)
Frequency: Periodically, especially during prolonged therapy or in patients with underlying liver disease.
Target: Within normal limits or stable from baseline.
Action Threshold: Discontinue if signs/symptoms of liver disease develop or if significant and persistent elevation of LFTs occurs.
Renal Function (SCr, BUN)
Frequency: Periodically, especially during prolonged therapy or in patients with changing renal status.
Target: Stable or within acceptable limits.
Action Threshold: Adjust dose if renal function declines significantly.
INR (for patients on warfarin)
Frequency: Frequently, especially at initiation and dose changes of fluconazole.
Target: Therapeutic range for indication.
Action Threshold: Adjust warfarin dose to maintain target INR.
Blood Glucose (for patients on sulfonylureas)
Frequency: Frequently, especially at initiation and dose changes of fluconazole.
Target: Target glycemic control.
Action Threshold: Adjust sulfonylurea dose to prevent hypoglycemia.
Symptom Monitoring
- Signs and symptoms of hepatotoxicity (e.g., fatigue, anorexia, nausea, vomiting, jaundice, dark urine, pale stools)
- Signs and symptoms of severe skin reactions (e.g., rash, blistering, desquamation)
- Signs and symptoms of adrenal insufficiency (e.g., fatigue, weakness, dizziness, nausea, vomiting, hypotension)
- Signs and symptoms of QT prolongation/arrhythmia (e.g., palpitations, dizziness, syncope)
- Signs and symptoms of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Fluconazole is generally not recommended during pregnancy, especially for non-vaginal candidiasis or prolonged/high-dose use, due to potential for teratogenic effects (Category D). For single-dose vaginal candidiasis, it is Category C, but topical antifungals are generally preferred.
Trimester-Specific Risks:
First Trimester:
Increased risk of birth defects (e.g., craniofacial, skeletal, cardiac abnormalities) with chronic, high-dose fluconazole use (e.g., 400-800 mg/day) during the first trimester. Single low dose (150 mg) for vaginal candidiasis appears to have lower risk, but still generally avoided if alternatives exist.
Second Trimester:
Limited data, but generally avoided due to potential risks.
Third Trimester:
Limited data, generally avoided.
Lactation
Fluconazole is excreted into breast milk. While generally considered compatible with breastfeeding for single-dose or short-term low-dose use, caution is advised, especially for premature infants or those with underlying conditions. Monitor infant for adverse effects (e.g., diarrhea, rash).
Infant Risk:
Low risk for single-dose or short-term low-dose use. Higher risk with prolonged or high-dose maternal therapy.
Pediatric Use
Dosing is weight-based. Neonates require extended dosing intervals due to immature renal function. Safety and efficacy for prevention of fungal infections in very low birth weight infants are established. Close monitoring for adverse effects is crucial.
Geriatric Use
No specific dose adjustment is needed based on age alone, but dose adjustments may be necessary based on renal function, which commonly declines with age. Monitor for drug interactions and adverse effects due to polypharmacy and comorbidities.
Clinical Information
Clinical Pearls
- Fluconazole has excellent oral bioavailability, allowing for a switch from IV to oral administration without dose adjustment.
- Its long half-life supports once-daily dosing for most indications.
- Highly effective for Candida albicans infections, but resistance can develop, especially in non-albicans Candida species (e.g., C. glabrata, C. krusei).
- Caution is advised when co-administering with other drugs metabolized by CYP2C9, CYP2C19, or CYP3A4, or drugs that prolong the QT interval.
- Patients should be advised to report any signs of liver injury or severe skin reactions immediately.
Alternative Therapies
- Itraconazole (for aspergillosis, histoplasmosis, blastomycosis)
- Voriconazole (for invasive aspergillosis, candidemia, scedosporiosis, fusariosis)
- Posaconazole (for prophylaxis of invasive fungal infections, oropharyngeal candidiasis)
- Echinocandins (e.g., caspofungin, micafungin, anidulafungin; for invasive candidiasis, esophageal candidiasis)
- Amphotericin B (for severe, life-threatening fungal infections)
- Nystatin (for superficial candidiasis, e.g., oral thrush)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (200mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.