Fluconazole 150mg Tablets

Manufacturer DR.REDDY'S Active Ingredient Fluconazole Tablets(floo KOE na zole) Pronunciation floo KOE na zole
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.
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Drug Class
Antifungal
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Pharmacologic Class
Triazole Antifungal
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Pregnancy Category
Category D (for prolonged/high dose use); Category C (for single dose vaginal candidiasis)
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FDA Approved
Jan 1990
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fluconazole is an antifungal medicine used to treat infections caused by fungus, including vaginal yeast infections, oral thrush, and other serious fungal infections in the body. It works by stopping the growth of the fungus.
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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 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.
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Lifestyle & Tips

  • Take the medicine exactly as prescribed, even if you feel better. Do not stop early unless directed by your doctor.
  • For vaginal yeast infections, a single dose is often enough. For other infections, you may need to take it for weeks or months.
  • Avoid alcohol, especially with prolonged use, as both can affect the liver.
  • Maintain good hygiene to prevent recurrence of fungal infections.

Dosing & Administration

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Adult Dosing

Standard Dose: 150 mg oral tablet as a single dose for vaginal candidiasis.
Dose Range: 50 - 800 mg

Condition-Specific Dosing:

vaginalCandidiasis: 150 mg oral tablet as a single dose.
oropharyngealCandidiasis: 200 mg on day 1, then 100 mg once daily for 7-14 days.
esophagealCandidiasis: 200 mg on day 1, then 100 mg once daily for 14-30 days.
systemicCandidiasis: 400 mg on day 1, then 200-400 mg once daily for several weeks.
cryptococcalMeningitis: 400 mg on day 1, then 200-400 mg once daily for 10-12 weeks after CSF culture is negative.
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Pediatric Dosing

Neonatal: Not established for routine use; consult specialist. Dosing typically 3-12 mg/kg/day depending on indication and age (e.g., post-natal age, gestational age).
Infant: 6 mg/kg on day 1, then 3 mg/kg once daily for oropharyngeal candidiasis. Max 600 mg/day.
Child: 6 mg/kg on day 1, then 3 mg/kg once daily for oropharyngeal candidiasis. Max 600 mg/day. For systemic infections, 6-12 mg/kg/day.
Adolescent: Same as adult dosing for specific indications, e.g., 150 mg single dose for vaginal candidiasis.
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 50 mL/min: No adjustment needed.
Moderate: CrCl 21-50 mL/min: Administer 50% of the recommended dose.
Severe: CrCl < 20 mL/min: Administer 25% of the recommended dose.
Dialysis: Administer 100% of the recommended dose after each hemodialysis session. On non-dialysis days, administer 25% of the usual dose.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended.
Severe: Use with caution; monitor liver function. No specific dose adjustment guidelines available.

Pharmacology

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Mechanism of Action

Fluconazole inhibits fungal cytochrome P450-dependent 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 and leakage of cellular contents, ultimately inhibiting fungal growth.
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Pharmacokinetics

Absorption:

Bioavailability: 90%
Tmax: 1-2 hours
FoodEffect: Absorption is not significantly affected by food.

Distribution:

Vd: 0.7 L/kg (similar to total body water)
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 dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Within hours (clinical improvement typically seen within 24-48 hours for acute infections)
PeakEffect: 1-2 hours (plasma concentration)
DurationOfAction: Prolonged due to long half-life, allowing for once-daily or single-dose regimens.

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:

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 can 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 do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical attention:

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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe skin rash, blistering, or peeling (could be a sign of a serious skin reaction)
  • Yellowing of the skin or eyes, dark urine, pale stools, severe nausea/vomiting, unusual tiredness (signs of liver problems)
  • Fast, pounding, or irregular heartbeat, dizziness, fainting (signs of heart rhythm problems)
  • Swelling of the face, lips, tongue, or throat, difficulty breathing (signs of a severe allergic reaction)
  • Unusual bruising or bleeding
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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 you experienced, including the symptoms that occurred.
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 may 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 with this medication. To ensure your safety, it is crucial to:

Inform your doctor and pharmacist about all the medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Share information about your health problems, as they may affect the safety and efficacy of this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
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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 know how this medication affects you, avoid driving and other activities that require you to be alert.

Do not take this medication for longer than prescribed, as this may increase the risk of a second 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.

There is a risk of severe skin problems, including rashes, which can be life-threatening, especially in individuals with other underlying health conditions. If you experience any skin issues, discuss them with your doctor promptly.

Although rare, severe liver problems, which can be fatal, have been reported with this medication, particularly in individuals with pre-existing health conditions. If you have any concerns, consult with 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, kidney, blood, heart, muscles and joints, or lungs. If you have any questions or concerns, discuss them with your doctor.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

If you are of childbearing age, discuss the need for birth control with your doctor to prevent pregnancy while taking this medication and for a period after your last dose.

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately.

If you are breastfeeding, inform your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Hallucinations
  • Paranoid behavior
  • Seizures

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include gastric lavage if recent ingestion.

Drug Interactions

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Contraindicated Interactions

  • Terfenadine (with multiple doses of fluconazole 400 mg/day or more)
  • Cisapride
  • Pimozide
  • Quinidine
  • Erythromycin (risk of QT prolongation)
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Major Interactions

  • Amiodarone (increased risk of QT prolongation and Torsades de Pointes)
  • Warfarin (increased INR and bleeding risk)
  • Phenytoin (increased phenytoin levels)
  • Cyclosporine (increased cyclosporine levels)
  • Tacrolimus (increased tacrolimus levels)
  • Rifampin (decreased fluconazole levels)
  • Oral Hypoglycemics (sulfonylureas like glipizide, glyburide; increased risk of hypoglycemia)
  • Statins (e.g., atorvastatin, simvastatin; increased risk of myopathy/rhabdomyolysis)
  • Benzodiazepines (e.g., midazolam, triazolam; increased benzodiazepine levels)
  • Theophylline (increased theophylline levels)
  • Voriconazole (increased fluconazole and voriconazole levels)
  • Hydrochlorothiazide (increased fluconazole levels)
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Moderate Interactions

  • Oral Contraceptives (potential for altered efficacy, though clinical significance often minor)
  • NSAIDs (e.g., celecoxib, ibuprofen; increased NSAID levels)
  • Amitriptyline (increased amitriptyline levels)
  • Carbamazepine (increased carbamazepine levels)
  • Losartan (decreased losartan active metabolite)
  • Methadone (increased methadone levels)
  • Vincristine/Vinblastine (increased vinca alkaloid levels)
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Minor Interactions

  • Cimetidine (minor decrease in fluconazole absorption)

Monitoring

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Baseline Monitoring

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Rationale: Fluconazole can cause hepatotoxicity, especially with prolonged or high-dose therapy.

Timing: Before initiating therapy, especially for patients with pre-existing liver disease or those on prolonged therapy.

Renal Function (CrCl, SCr)

Rationale: Fluconazole is primarily renally eliminated, and dose adjustments are required in renal impairment.

Timing: Before initiating therapy.

Electrolytes (Potassium, Magnesium)

Rationale: To assess baseline risk for QT prolongation, especially if co-administered with other QT-prolonging drugs or in patients with cardiac risk factors.

Timing: Before initiating therapy if indicated.

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Routine Monitoring

Liver Function Tests (ALT, AST, ALP, Bilirubin)

Frequency: Periodically (e.g., weekly to monthly) for patients on prolonged or high-dose therapy. Not typically needed for single-dose 150mg.

Target: Within normal limits

Action Threshold: Discontinue if clinical signs/symptoms of liver disease develop or if LFTs significantly elevate (e.g., >3-5x ULN).

Renal Function (SCr, CrCl)

Frequency: Periodically for patients on prolonged therapy or with changing renal status.

Target: Stable

Action Threshold: Adjust dose if CrCl declines.

INR (for patients on Warfarin)

Frequency: Frequently (e.g., daily to every few days) after initiation or dose change of fluconazole, then as needed.

Target: Therapeutic range for indication

Action Threshold: Adjust warfarin dose to maintain target INR.

Blood Glucose (for patients on sulfonylureas)

Frequency: More frequently after initiation of fluconazole.

Target: Individualized

Action Threshold: Adjust sulfonylurea dose to prevent hypoglycemia.

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Symptom Monitoring

  • Signs of liver injury (e.g., fatigue, anorexia, nausea, vomiting, jaundice, dark urine, pale stools)
  • Signs of severe skin reactions (e.g., rash, blistering, peeling skin, mucosal lesions)
  • Signs of cardiac arrhythmias (e.g., palpitations, dizziness, syncope)
  • Signs of allergic reaction (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
  • Signs of adrenal insufficiency (e.g., fatigue, weakness, nausea, vomiting, low blood pressure)

Special Patient Groups

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Pregnancy

Single oral dose of 150 mg fluconazole for vaginal candidiasis is generally considered low risk and may be used if benefits outweigh risks. However, high-dose or prolonged use of fluconazole during the first trimester has been associated with an increased risk of birth defects (e.g., craniofacial, skeletal, cardiac abnormalities). Avoid prolonged or high-dose use during pregnancy.

Trimester-Specific Risks:

First Trimester: Increased risk of birth defects (e.g., craniofacial, skeletal, cardiac) with prolonged/high-dose exposure. Single 150mg dose appears to have lower risk.
Second Trimester: Generally considered lower risk than first trimester, but still use with caution and only if clearly needed.
Third Trimester: Generally considered lower risk than first trimester, but still use with caution and only if clearly needed.
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Lactation

Fluconazole is excreted into breast milk. The amount transferred to the infant is low, and single-dose fluconazole is generally considered compatible with breastfeeding. For prolonged or high-dose therapy, monitor infant for potential adverse effects (e.g., rash, diarrhea).

Infant Risk: Low risk for single dose. Potential for mild gastrointestinal upset or rash in infant with prolonged maternal use. L2 (Safer).
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Pediatric Use

Dosing is weight-based. Safety and efficacy established for children 6 months and older for certain indications. Neonatal use requires careful consideration and specialist consultation due to immature renal function and potential for prolonged half-life.

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Geriatric Use

No specific dose adjustment needed based on age alone, but consider age-related decline in renal function. Monitor for adverse effects and drug interactions, as elderly patients may be on multiple medications.

Clinical Information

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Clinical Pearls

  • Fluconazole 150 mg is a common single-dose treatment for uncomplicated vaginal candidiasis.
  • It has excellent oral bioavailability, allowing for oral administration to achieve similar concentrations as IV.
  • Due to its long half-life, once-daily dosing is common, and for some indications, weekly dosing is effective.
  • Significant CYP450 inhibitor (especially 2C9, 2C19, 3A4), leading to numerous drug interactions. Always check for potential interactions.
  • Monitor liver function, especially with prolonged therapy, and counsel patients on signs of hepatotoxicity.
  • Caution with patients at risk for QT prolongation or on other QT-prolonging medications.
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Alternative Therapies

  • Clotrimazole (topical/oral)
  • Miconazole (topical/oral)
  • Nystatin (topical/oral)
  • Itraconazole (oral)
  • Voriconazole (oral/IV)
  • Caspofungin (IV)
  • Amphotericin B (IV)
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Cost & Coverage

Average Cost: Varies widely, typically $5 - $50 per 150 mg tablet
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.