Fluconazole 100mg Tablets

Fluconazole is a triazole antifungal agent. Its primary mechanism of action is the inhibition of fungal cytochrome P450-dependent 14-alpha-demethylase. This enzyme is essential for the conversion of lanosterol to ergosterol, 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.

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 immediately or seek emergency 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 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 affect heart rhythm. If you experience a fast or abnormal heartbeat, or if you faint, contact your doctor right away.

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 if they bother you or persist, 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.

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 any 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 between this medication and other substances. Therefore, 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 this will help your doctor and pharmacist assess whether it is safe for you to take this medication.
Never start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Until you are aware of 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 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 organ dysfunction (affecting the liver, kidneys, blood, heart, muscles, joints, or 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 potential, discuss the need for birth control with your doctor to prevent pregnancy during treatment and for a period after the last dose, as this medication may harm the unborn baby.

If you become pregnant or suspect you are pregnant while taking this medication, immediately contact your doctor.

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

• Terfenadine (at fluconazole doses ≥400 mg/day)
• Cisapride
• Pimozide
• Quinidine
• Erythromycin (due to increased risk of cardiotoxicity)

• Amiodarone (increased risk of QT prolongation and Torsades de Pointes)
• Warfarin (increased prothrombin time/INR, bleeding risk)
• Phenytoin (increased phenytoin levels)
• Sulfonylureas (e.g., glipizide, glyburide, tolbutamide - increased hypoglycemia risk)
• Rifampin (decreased fluconazole levels)
• Hydrochlorothiazide (increased fluconazole levels)
• Cyclosporine (increased cyclosporine levels)
• Tacrolimus (increased tacrolimus levels)
• Sirolimus (increased sirolimus levels)
• Theophylline (increased theophylline levels)
• Benzodiazepines (e.g., midazolam, triazolam - increased benzodiazepine levels)
• Statins (e.g., atorvastatin, simvastatin - increased statin levels, rhabdomyolysis risk)
• Oral contraceptives (altered hormone levels, though clinical significance often minimal)
• Voriconazole (mutual inhibition, increased levels of both drugs)
• Fentanyl (increased fentanyl levels, respiratory depression risk)
• Methadone (increased methadone levels, QT prolongation risk)
• Tofacitinib (increased tofacitinib levels)
• Ivacaftor (increased ivacaftor levels)

• NSAIDs (e.g., celecoxib, ibuprofen, naproxen - increased NSAID levels)
• Amitriptyline (increased amitriptyline levels)
• Nortriptyline (increased nortriptyline levels)
• Losartan (decreased losartan active metabolite)
• Carbamazepine (increased carbamazepine levels)
• Vincristine (increased vincristine levels, neurotoxicity risk)
• Vitamin A (increased vitamin A levels, CNS effects)
• Zidovudine (increased zidovudine levels)
• Saquinavir (increased saquinavir levels)
• Alfentanil (increased alfentanil levels)
• Amprenavir (decreased fluconazole levels)
• Indinavir (increased indinavir levels)
• Ritonavir (increased fluconazole levels)
• Everolimus (increased everolimus levels)

• Cimetidine (minor decrease in fluconazole absorption)
• Antacids (no significant interaction)

• Rash (especially severe cutaneous reactions like SJS/TEN)
• Jaundice or yellowing of skin/eyes
• Dark urine
• Pale stools
• Unusual fatigue or weakness
• Nausea, vomiting, or abdominal pain (signs of liver injury)
• Signs of allergic reaction (swelling of face, lips, tongue, throat, difficulty breathing)
• Dizziness, lightheadedness, fainting (signs of QT prolongation/arrhythmia)
• Changes in mental status or seizures (rare CNS effects)
• Muscle pain or weakness (if co-administered with statins)

Fluconazole is generally considered Category D for pregnancy, meaning there is positive evidence of human fetal risk. However, the risk appears to be dose- and duration-dependent. Single 150 mg doses for vaginal candidiasis are generally considered low risk, while high doses (400-800 mg/day) for prolonged periods (e.g., >14 days) have been associated with a pattern of birth defects (e.g., brachycephaly, abnormal facies, cleft palate, femoral bowing, rib-forearm synostosis, congenital heart disease) in a few cases. Use during pregnancy should be avoided unless the potential benefit justifies the potential risk to the fetus.

Fluconazole is excreted into breast milk. The relative infant dose (RID) is estimated to be 10-20%. While generally considered compatible with breastfeeding for single low doses, caution is advised for high-dose or prolonged therapy due to potential for infant exposure and theoretical risks of hepatotoxicity or cardiac effects. Monitor breastfed infants for adverse effects.

Fluconazole is approved for use in pediatric patients for various fungal infections, including oropharyngeal and esophageal candidiasis, systemic candidiasis, and cryptococcal meningitis. Dosing is weight-based and varies by age and indication. Neonates require specific dosing adjustments due to immature renal function. Close monitoring for adverse effects is important.

No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment may be necessary based on renal function, which is often decreased in elderly patients. Monitor for drug interactions and adverse effects more closely due to polypharmacy and comorbidities.

• Fluconazole has excellent oral bioavailability, allowing for a switch from IV to oral therapy once the patient is stable.
• The long half-life of fluconazole allows for once-daily dosing for most indications and single-dose therapy for vaginal candidiasis.
• Be vigilant for drug interactions, especially with drugs metabolized by CYP2C9, CYP2C19, and CYP3A4, and drugs that prolong the QT interval.
• Monitor liver function tests, especially during prolonged therapy, and discontinue if signs of hepatotoxicity occur.
• For patients with renal impairment, dose adjustment is crucial to prevent accumulation and toxicity.
• While generally well-tolerated, advise patients to report any signs of severe skin reactions or allergic reactions immediately.

• Other Azole Antifungals (e.g., Itraconazole, Voriconazole, Posaconazole, Isavuconazole)
• Echinocandins (e.g., Caspofungin, Micafungin, Anidulafungin) - for invasive candidiasis, especially C. glabrata or C. krusei
• Polyenes (e.g., Amphotericin B formulations, Nystatin)
• Flucytosine (often used in combination with amphotericin B for cryptococcal infections)

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.