Fluconazole 10mg/ml Oral Susp 35ml

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 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 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.

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. Your doctor will need to discuss the potential risks and benefits of taking this medication during pregnancy.
If you have rare hereditary conditions, such as glucose-galactose malabsorption, fructose intolerance, or sucrase-isomaltase deficiency.

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your complete medical history, including any health problems you have

Before starting, stopping, or changing the dose of any medication, including this one, you must consult with 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 driving and other activities that require your full attention.

Do not exceed the prescribed duration of treatment, 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.

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, consult your doctor promptly.

Although rare, severe liver problems, sometimes fatal, have occurred in patients taking this drug, often in those with underlying health issues. Discuss any concerns with your doctor.

A severe and potentially life-threatening reaction, characterized by symptoms such as fever, rash, swollen glands, and organ dysfunction (affecting the liver, kidney, blood, heart, muscles and joints, or lungs), has been reported. If you have any 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 during treatment and for a certain 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, notify your doctor immediately.

If you are breastfeeding, inform your doctor to discuss potential risks to your baby and determine the best course of action.

• Terfenadine (at fluconazole doses ≥ 400 mg/day)
• Cisapride
• Astemizole
• Erythromycin
• Pimozide
• Quinidine

• Amiodarone (risk of QT prolongation, Torsades de Pointes)
• Hydrochlorothiazide (increases fluconazole plasma levels)
• Oral Hypoglycemics (sulfonylureas - increased risk of hypoglycemia)
• Phenytoin (increased phenytoin levels)
• Rifampin (decreases fluconazole levels)
• Warfarin (increased prothrombin time, bleeding risk)
• Benzodiazepines (e.g., midazolam, triazolam - increased levels, prolonged effects)
• Cyclosporine (increased cyclosporine levels)
• Tacrolimus (increased tacrolimus levels)
• Sirolimus (increased sirolimus levels)
• Statins (e.g., atorvastatin, simvastatin - increased risk of myopathy/rhabdomyolysis)
• Theophylline (increased theophylline levels)
• Zidovudine (increased zidovudine levels)
• Alfentanil (increased alfentanil levels)
• Fentanyl (increased fentanyl levels)
• Methadone (increased methadone levels)
• NSAIDs (e.g., celecoxib, ibuprofen, naproxen - increased NSAID levels)
• Vincristine/Vinblastine (increased levels, neurotoxicity)
• Tofacitinib (increased tofacitinib levels)
• Ivacaftor (increased ivacaftor levels)
• Lurasidone (increased lurasidone levels)
• Tolvaptan (increased tolvaptan levels)

• Oral Contraceptives (potential for altered efficacy, though often not clinically significant)
• Amitriptyline/Nortriptyline (increased TCA levels)
• Carbamazepine (increased carbamazepine levels)
• Losartan (inhibits metabolism of active metabolite)
• Rifabutin (increased rifabutin levels, uveitis risk)
• Voriconazole (increased fluconazole/voriconazole levels)
• Verapamil (increased verapamil levels)
• Calcium Channel Blockers (dihydropyridines - increased levels)
• Busulfan (increased busulfan levels)
• Everolimus (increased everolimus levels)
• Oxycodone (increased oxycodone levels)
• Tramadol (increased tramadol levels)
• Aripiprazole (increased aripiprazole levels)
• Quetiapine (increased quetiapine levels)
• Ziprasidone (increased ziprasidone levels)

• Cimetidine (minor decrease in fluconazole absorption)
• Antacids (minor decrease in fluconazole absorption)

• Signs of hepatotoxicity (unusual fatigue, anorexia, nausea, vomiting, jaundice, dark urine, pale stools, pruritus)
• Signs of skin reactions (rash, blistering, peeling skin, Stevens-Johnson syndrome, toxic epidermal necrolysis)
• Signs of adrenal insufficiency (fatigue, weakness, nausea, vomiting, hypotension, dizziness)
• Signs of QT prolongation/arrhythmia (palpitations, dizziness, syncope)
• Signs of hypoglycemia (sweating, tremor, confusion, dizziness, hunger)
• Signs of bleeding (unusual bruising, petechiae, melena, hematemesis, epistaxis)
• Signs of myopathy/rhabdomyolysis (muscle pain, tenderness, weakness, dark urine)

Fluconazole is generally not recommended during pregnancy, especially in the first trimester, due to potential for teratogenicity (Category D). However, for severe or life-threatening fungal infections where other antifungals are not suitable, the benefits may outweigh the risks. Single-dose treatment for vaginal candidiasis is generally considered lower risk than prolonged high-dose therapy.

Fluconazole is excreted into breast milk. The American Academy of Pediatrics considers fluconazole compatible with breastfeeding. However, caution is advised, especially with high doses or prolonged therapy, due to potential for infant exposure. Monitor infant for adverse effects (e.g., diarrhea, rash).

Dosing is weight-based and varies by age and indication. Neonates require extended dosing intervals due to immature renal function. Close monitoring for adverse effects is crucial. Safety and efficacy in children younger than 6 months for certain indications are not fully established.

No specific dose adjustment is needed based on age alone, but dose adjustments may be necessary due to age-related decline in renal function. Use with caution due to potential for polypharmacy and increased risk of drug interactions and adverse effects (e.g., QT prolongation). Monitor renal function and LFTs.

• 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.
• It penetrates well into various body fluids and tissues, including CSF, urine, and vaginal secretions.
• Be vigilant for drug interactions, especially with drugs metabolized by CYP2C9, CYP2C19, and CYP3A4, and those that prolong the QT interval.
• Monitor liver function tests, especially during prolonged therapy, and discontinue if signs of liver injury occur.
• For vaginal candidiasis, a single 150 mg dose is often sufficient, but recurrent infections may require longer or suppressive regimens.
• Oral suspension must be shaken well before use and measured accurately.

• For candidiasis: Nystatin (oral/topical), Clotrimazole (topical/oral troche), Miconazole (topical/oral buccal tablet), Itraconazole, Voriconazole, Posaconazole, Caspofungin, Micafungin, Anidulafungin, Amphotericin B.
• For cryptococcal meningitis: Amphotericin B + Flucytosine (induction), then fluconazole (consolidation/maintenance).

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 information about the medication taken, the amount, and the time it happened.