Fluconazole 40mg/ml Oral Susp 35ml
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
FDA Approved
Jan 1990
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fluconazole is an antifungal medicine used to treat infections caused by fungus, such as yeast infections of the mouth, throat, esophagus, or vagina. 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 with or without food, as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store the liquid suspension at room temperature or in the refrigerator. Do not freeze the medication. Discard any unused portion after 2 weeks. Keep all medications in a safe place, 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 disposing of your medication, 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 a missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication with or without food, as directed. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you're feeling well.
Before using the liquid form of this medication, shake the bottle well. Measure the liquid dose carefully using the measuring device that comes with the medication. If a measuring device is not provided, ask your pharmacist for one.
Storing and Disposing of Your Medication
Store the liquid suspension at room temperature or in the refrigerator. Do not freeze the medication. Discard any unused portion after 2 weeks. Keep all medications in a safe place, 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 disposing of your medication, 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 a missed one.
Lifestyle & Tips
- Take the medicine exactly as prescribed by your doctor, even if you start to feel better. Do not skip doses or stop early.
- Shake the oral suspension well before each use.
- Measure the liquid medicine carefully with the provided measuring device, not a household spoon.
- Store the oral suspension at room temperature, away from moisture and heat. Do not freeze.
- Avoid alcohol consumption, as it may increase the risk of liver side effects.
- Maintain good hygiene to prevent recurrence of fungal infections.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication (e.g., 50-400 mg once daily)
Dose Range:
50 - 400 mg
Condition-Specific Dosing:
Vaginal Candidiasis:
150 mg as a single oral dose
Oropharyngeal Candidiasis:
200 mg on day 1, then 100 mg once daily for at least 2 weeks
Esophageal Candidiasis:
200 mg on day 1, then 100 mg once daily for at least 3 weeks
Systemic Candidiasis (Candidemia, Disseminated Candidiasis):
400 mg on day 1, then 200 mg once daily (up to 800 mg/day for severe infections)
Cryptococcal Meningitis (initial):
400 mg on day 1, then 200-400 mg once daily for 10-12 weeks after CSF culture is negative
Cryptococcal Meningitis (suppression):
200 mg once daily
Pediatric Dosing
Neonatal:
Not established for all indications; for candidiasis in neonates (0-4 weeks), 6 mg/kg on day 1, then 3 mg/kg once daily. Dosing interval may be extended based on postmenstrual age.
Infant:
For candidiasis (4 weeks to 11 months): 6 mg/kg on day 1, then 3 mg/kg once daily. Max 600 mg/day.
Child:
For candidiasis (1-12 years): 6 mg/kg on day 1, then 3 mg/kg once daily. Max 600 mg/day. For cryptococcal meningitis: 12 mg/kg on day 1, then 6 mg/kg once daily. Max 600 mg/day.
Adolescent:
Generally follows adult dosing for most indications.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
Reduce dose by 50% (CrCl 21-50 mL/min)
Severe:
Reduce dose by 50% (CrCl < 20 mL/min)
Dialysis:
Administer 100% of the recommended dose after each hemodialysis session. On non-dialysis days, administer a reduced dose based on CrCl.
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, but close monitoring is advised.
Pharmacology
Mechanism of Action
Fluconazole is a triazole antifungal agent. It inhibits fungal cytochrome P450-dependent 14-alpha-demethylation of lanosterol, an essential step in fungal ergosterol biosynthesis. Ergosterol is a vital component of the fungal cell membrane. Inhibition of its synthesis leads to increased cellular permeability, leakage of cellular contents, and ultimately, fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Greater than 90%
Tmax:
0.5-1.5 hours (oral)
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 (approximately 80% of dose)
Unchanged:
Approximately 80% (in urine)
Pharmacodynamics
OnsetOfAction:
Within hours for symptomatic relief, full antifungal effect over days
PeakEffect:
Within 1-2 hours (plasma concentration)
DurationOfAction:
Due to long half-life, allows for once-daily dosing.
Safety & Warnings
Side Effects
Serious 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 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 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 skin (Stevens-Johnson syndrome, toxic epidermal necrolysis)
- Signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, pale stools, severe stomach pain, unusual tiredness
- Signs of adrenal insufficiency: severe tiredness, weakness, nausea, vomiting, dizziness, lightheadedness, low blood pressure
- Signs of allergic reaction: rash, hives, itching, swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing
- 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 you experienced.
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 and your doctor will need to discuss whether this medication is suitable for you.
If you have rare hereditary conditions, such as glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase deficiency.
Please note that this list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking (including prescription, over-the-counter, natural products, and vitamins) and any health issues you have. This will help ensure your safety while taking this medication. Always consult with your doctor before starting, stopping, or changing the dose of any medication.
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.
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 and your doctor will need to discuss whether this medication is suitable for you.
If you have rare hereditary conditions, such as glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase deficiency.
Please note that this list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all the medications you are taking (including prescription, over-the-counter, natural products, and vitamins) and any health issues you have. This will help ensure your safety while taking this medication. Always consult with your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require your full attention, such as driving, wait until you understand how this drug affects you.
Adhere to the prescribed duration of treatment. Taking this medication for an extended period may increase the risk of a second infection.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Additionally, consult your doctor before consuming alcohol while taking this medication.
Be aware that severe skin reactions, including potentially life-threatening rashes, have been associated with this drug, 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 medication, often in those with underlying health issues. If you have concerns, talk to 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 questions or concerns, consult 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 while taking this medication and for a certain period after the 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, immediately contact your doctor.
If you are breastfeeding, inform your doctor to discuss potential risks to your baby.
Adhere to the prescribed duration of treatment. Taking this medication for an extended period may increase the risk of a second infection.
Regular blood tests will be necessary, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Additionally, consult your doctor before consuming alcohol while taking this medication.
Be aware that severe skin reactions, including potentially life-threatening rashes, have been associated with this drug, 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 medication, often in those with underlying health issues. If you have concerns, talk to 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 questions or concerns, consult 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 while taking this medication and for a certain period after the 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, immediately contact your doctor.
If you are breastfeeding, inform your doctor to discuss potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Hallucinations
- Paranoid behavior
- Seizures
- Liver dysfunction
What to Do:
Seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and may include gastric lavage and forced diuresis to increase fluconazole elimination.
Drug Interactions
Contraindicated Interactions
- Terfenadine (at fluconazole doses âĨ400 mg/day)
- Cisapride
- Astemizole
- Erythromycin
- Pimozide
- Quinidine
Major Interactions
- Amiodarone
- Benzodiazepines (e.g., midazolam, triazolam)
- Carbamazepine
- Cyclosporine
- Fentanyl
- HMG-CoA reductase inhibitors (statins, e.g., atorvastatin, simvastatin)
- Hydrochlorothiazide
- Ivacaftor
- Losartan
- Methadone
- Non-steroidal anti-inflammatory drugs (NSAIDs, e.g., celecoxib, ibuprofen, naproxen)
- Oral contraceptives
- Oral hypoglycemics (sulfonylureas, e.g., glipizide, glyburide, tolbutamide)
- Phenytoin
- Rifabutin
- Rifampin
- Sirolimus
- Tacrolimus
- Theophylline
- Tofacitinib
- Tolvaptan
- Tretinoin
- Warfarin
- Zidovudine
Moderate Interactions
- Amitriptyline
- Busulfan
- Cimetidine
- Corticosteroids (e.g., prednisone)
- Dapsone
- Digoxin
- Halofantrine
- Lidocaine
- Nortriptyline
- Phenobarbital
- Ritonavir
- Saquinavir
- Vincristine
- Voriconazole
Minor Interactions
- Not specifically categorized as minor for fluconazole, but many drugs may have theoretical interactions due to CYP inhibition, requiring monitoring.
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, especially for prolonged courses or in patients with underlying liver disease.
Renal function (CrCl, BUN, serum creatinine)
Rationale: Fluconazole is primarily renally eliminated; baseline assessment is crucial for dose adjustment.
Timing: Prior to initiation of therapy.
Electrolytes (Potassium, Magnesium)
Rationale: To assess for baseline abnormalities that could predispose to QT prolongation.
Timing: Prior to initiation, especially if patient has risk factors for arrhythmias or is on other QT-prolonging drugs.
Routine Monitoring
Liver function tests (ALT, AST, ALP, bilirubin)
Frequency: Periodically during prolonged therapy (e.g., weekly to monthly), or if symptoms of liver dysfunction occur.
Target: Within normal limits or stable from baseline.
Action Threshold: Significant elevation (e.g., >3-5x ULN) or clinical signs of liver injury warrant discontinuation.
Renal function (CrCl, BUN, serum creatinine)
Frequency: Periodically during prolonged therapy, especially in patients with pre-existing renal impairment or those on nephrotoxic drugs.
Target: Stable or within acceptable limits.
Action Threshold: Significant decline in renal function warrants dose adjustment or discontinuation.
Electrolytes (Potassium, Magnesium)
Frequency: Periodically, especially in patients at risk for arrhythmias or on concomitant QT-prolonging drugs.
Target: Within normal limits.
Action Threshold: Hypokalemia or hypomagnesemia should be corrected.
INR (for patients on warfarin)
Frequency: Frequently (e.g., daily to every few days) upon initiation and dose changes of fluconazole, then regularly.
Target: Therapeutic range for indication.
Action Threshold: INR outside target range requires warfarin dose adjustment.
Blood glucose (for patients on sulfonylureas)
Frequency: Frequently upon initiation and dose changes of fluconazole.
Target: Target glucose levels.
Action Threshold: Hypoglycemia requires sulfonylurea dose adjustment.
Symptom Monitoring
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Dizziness
- Rash
- Itching
- Yellowing of skin or eyes (jaundice)
- Dark urine
- Unusual fatigue
- Light-colored stools
- Signs of allergic reaction (swelling of face, lips, tongue, throat, difficulty breathing)
- Signs of severe skin reactions (blistering, peeling skin)
- Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, low blood pressure)
Special Patient Groups
Pregnancy
Fluconazole is generally not recommended during pregnancy, especially for non-life-threatening indications like vaginal candidiasis, due to potential risks of birth defects. It is classified as Pregnancy Category D. Use only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
High doses (400-800 mg/day) for prolonged periods during the first trimester have been associated with a pattern of birth defects (e.g., brachycephaly, abnormal facies, cleft palate, femoral bowing, syndactyly, congenital heart defects). Single low doses (e.g., 150 mg for vaginal candidiasis) have not been consistently linked to these defects, but caution is still advised.
Second Trimester:
Limited data, but generally considered safer than first trimester, though still used with caution.
Third Trimester:
Limited data, but generally considered safer than first trimester, though still used with caution.
Lactation
Fluconazole is excreted into breast milk. The American Academy of Pediatrics considers it compatible with breastfeeding. However, caution is advised, especially with high doses or prolonged use. Monitor the infant for potential adverse effects.
Infant Risk:
L3 (Moderately Safe) - Monitor for gastrointestinal upset (diarrhea, vomiting), rash, or signs of liver dysfunction in the infant.
Pediatric Use
Dosing must be carefully calculated based on weight and age. Neonates require extended dosing intervals due to immature renal function. Safety and efficacy in children younger than 6 months for certain indications are not fully established. Close monitoring for adverse effects is crucial.
Geriatric Use
No dosage adjustment is typically needed based solely on age, but dose adjustments are necessary for age-related decline in renal function. Elderly patients may be more susceptible to QT prolongation and liver toxicity; monitor closely.
Clinical Information
Clinical Pearls
- Fluconazole oral suspension should be shaken well before each use.
- The oral suspension is stable for 14 days after reconstitution when stored at room temperature.
- Fluconazole has excellent penetration into various body fluids and tissues, including CSF, making it effective for CNS fungal infections.
- Due to its long half-life, once-daily dosing is common, and a single dose is effective for vaginal candidiasis.
- Significant drug interactions are common due to its potent inhibition of CYP2C9, CYP2C19, and CYP3A4. Always review concomitant medications.
- Monitor liver function tests, especially during prolonged therapy, as hepatotoxicity can occur, though it is rare.
- Patients should be advised to report any signs of liver injury, severe skin reactions, or unusual fatigue immediately.
Alternative Therapies
- Other azole antifungals (e.g., Itraconazole, Voriconazole, Posaconazole)
- Echinocandins (e.g., Caspofungin, Micafungin, Anidulafungin) for invasive candidiasis
- Polyenes (e.g., Amphotericin B) for severe or resistant fungal infections
- Nystatin (topical or oral suspension for superficial candidiasis)
Cost & Coverage
Average Cost:
$20 - $100 per 35ml of 40mg/ml oral suspension
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 for more information. If you have any questions or concerns about this 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 overdose, including the medication taken, the amount, and the time it occurred.