DIFLUCAN 150/MG CAP 1/CAP

Indications

Approved Uses

Fluconazole is approved for: vaginal candidiasis; oropharyngeal candidiasis; esophageal candidiasis; systemic Candida infections (including candidemia, disseminated candidiasis, and Candida pneumonia); Candida urinary tract infections; Candida peritonitis; cryptococcal meningitis; and prophylaxis to reduce the incidence of candidiasis in patients undergoing bone marrow transplantation with cytotoxic chemotherapy and/or radiation.

Off-Label Uses

Common off-label uses include: tinea versicolor; dermatophytosis (tinea corporis/cruris/pedis) when systemic therapy is needed; coccidioidomycosis; histoplasmosis or blastomycosis (selected cases when alternatives unsuitable); and antifungal prophylaxis in certain high-risk populations (e.g., some NICU/preterm protocols or other immunocompromised settings per institutional guideline).

Dosage & Administration

Dosing by Condition

Vaginal candidiasis: 150 mg PO once. Oropharyngeal candidiasis: 200 mg PO on day 1, then 100 mg PO daily for at least 2 weeks. Esophageal candidiasis: 200 mg PO on day 1, then 100 mg PO daily (may increase up to 400 mg/day) for at least 3 weeks and for ≥2 weeks after symptom resolution. Cryptococcal meningitis: 400 mg PO on day 1, then 200-400 mg PO daily for 10-12 weeks (often longer in immunocompromised per guideline/clinical response). Systemic candidiasis/candidemia: 800 mg (12 mg/kg) loading dose then 400 mg (6 mg/kg) daily (step-down to 400 mg daily when appropriate), duration guided by source control and clearance.

Initial Dose

150mg for vaginal candidiasis; 200mg on day 1 for oropharyngeal candidiasis, esophageal candidiasis, cryptococcal meningitis.

Maintenance Dose

100-400mg once daily, depending on the indication.

Maximum Dose

800mg per day (in severe systemic infections)

Children's Dosage

Oropharyngeal candidiasis: 3mg/kg once daily. Esophageal candidiasis: 3mg/kg once daily (max 12mg/kg/day). Systemic candidiasis/cryptococcal meningitis: 6-12mg/kg/day. Not recommended in neonates under 4 weeks except in life-threatening situations

Dose Adjustment Notes

Renal: if CrCl ≤50 mL/min (and not on dialysis), give 50% of the usual maintenance dose; no adjustment is needed for a loading dose. Hemodialysis: give the full dose after each dialysis session (on non-dialysis days, reduce per CrCl). Hepatic: no specific dose adjustment is defined, but use caution and monitor liver tests if clinically indicated.

How to Take

Swallow capsule whole with water; may be taken with or without food

Side Effects

Common Side Effects

Headache, nausea, abdominal pain, diarrhea, vomiting, rash, dizziness, and elevated liver enzymes.

Side Effect Frequency

Common: headache, nausea, abdominal pain, diarrhea, rash, vomiting, and transient LFT elevations. Serious but rare: severe cutaneous adverse reactions (SJS/TEN), hepatotoxicity/hepatic failure, anaphylaxis, QT prolongation/torsades (risk increased with interacting drugs/electrolyte abnormalities), and blood dyscrasias (e.g., leukopenia/thrombocytopenia).

Safety & Warnings

Contraindications

Hypersensitivity to fluconazole or other azole antifungals, co-administration with terfenadine (when fluconazole doses ≥400mg/day), co-administration with cisapride, co-administration with astemizole, co-administration with pimozide, co-administration with quinidine, co-administration with erythromycin

Warnings & Precautions

Use caution and monitor in hepatic dysfunction (stop if liver injury suspected), renal impairment (dose adjust), and patients with QT-risk/proarrhythmic conditions; discontinue if severe rash occurs; review interacting QT-prolonging/CYP-substrate drugs carefully.

Age Restriction

Pediatric use is permitted when clinically indicated; dosing is age/weight-based and in neonates requires extended dosing intervals (e.g., every 72 hours in the first 2 weeks, every 48 hours in weeks 2-4). The 150 mg single-capsule product is generally intended for adults/adolescents who can swallow capsules; infants/young children typically require liquid formulations and specialist dosing.

Drug Interactions

Drug Interactions

Major/contraindicated or avoid: cisapride, pimozide, quinidine, and (with higher fluconazole doses) terfenadine; clinically important interactions also include warfarin, phenytoin, cyclosporine, tacrolimus, sulfonylureas, certain benzodiazepines, some statins, and rifampicin (may reduce fluconazole exposure).

Interaction Severity

MAJOR/contraindicated or avoid: coadministration with strong QT-prolonging CYP3A4 substrates such as cisapride, pimozide, quinidine, and (where applicable) erythromycin due to torsades risk; high-dose fluconazole with terfenadine is contraindicated (and terfenadine/astemizole are largely obsolete). MAJOR/clinically significant: warfarin (↑INR/bleeding), phenytoin (↑levels/toxicity), cyclosporine/tacrolimus (↑levels/nephrotoxicity), sulfonylureas (↑hypoglycemia), certain statins (↑myopathy/rhabdomyolysis), benzodiazepines (↑sedation), theophylline (↑levels), rifabutin (↑toxicity).

Food Interaction

No restriction.

Special Populations

Children

Oropharyngeal candidiasis: 3mg/kg once daily. Esophageal candidiasis: 3mg/kg once daily (max 12mg/kg/day). Systemic candidiasis/cryptococcal meningitis: 6-12mg/kg/day. Not recommended in neonates under 4 weeks except in life-threatening situations

Kidney Impairment

If CrCl >50 mL/min: no adjustment; if CrCl ≤50 mL/min (not on dialysis): give the usual loading dose then reduce maintenance dose by ~50%; hemodialysis: give 100% of the dose after each dialysis session.

Storage & Patient Advice

Missed Dose

If on a multi-day regimen: take the missed dose as soon as remembered unless it is close to the next dose; do not double up. If the regimen is a single 150 mg dose (vaginal candidiasis), take it when remembered the same day; if substantially delayed or symptoms persist, seek clinician advice rather than self-repeating doses.

Stopping the Medicine

Complete the prescribed regimen; do not stop early unless advised by the prescriber (it is appropriate to stop once the prescribed course is finished).

Overdose

Overdose may cause hallucinations/paranoid behavior and GI symptoms; management is supportive, consider gastric decontamination if early, and hemodialysis can enhance elimination-seek urgent medical care.

Patient Counseling

For this 150 mg single-capsule product (commonly for vaginal candidiasis): take 1 capsule by mouth once, with or without food; expect improvement over 1-3 days and seek care if not improving or if recurrent. Avoid doubling doses. Review all medicines for interactions (notably warfarin, diabetes medicines, phenytoin, tacrolimus/cyclosporine, some statins, and QT-prolonging drugs). Seek urgent care for severe rash/blistering, jaundice/dark urine, severe abdominal pain, or palpitations/syncope. Pregnancy: avoid self-treatment in pregnancy-use only if prescribed after clinician assessment.

Monitoring Requirements

Baseline/periodic LFTs if prolonged therapy, pre-existing liver disease, or symptoms of hepatotoxicity; renal function (SCr/CrCl) to guide dosing; INR/PT if on warfarin; glucose if on sulfonylureas/insulin secretagogues; drug levels/clinical toxicity for narrow-therapeutic-index substrates (e.g., phenytoin, tacrolimus/cyclosporine) and ECG/QT risk assessment when combined with QT-prolonging agents.

Pharmacology

Mechanism of Action

Inhibits fungal lanosterol 14-α-demethylase (a CYP450 enzyme), blocking conversion of lanosterol to ergosterol and impairing fungal cell membrane synthesis and function (primarily fungistatic against Candida).

Onset of Action

Absorption is rapid with peak plasma concentrations in ~1-2 hours; symptomatic improvement (e.g., vulvovaginal candidiasis) often begins within ~24 hours but may take 48-72 hours.

Duration of Effect

After a single 150 mg dose, clinically meaningful antifungal exposure persists for several days; fluconazole’s terminal half-life is ~30 hours, so drug levels decline over ~5-6 days (≈5 half-lives).

Half-Life

Approximately 30 hours (range: 20-50 hours).

Bioavailability

>90% oral bioavailability.

Metabolism

Minimal metabolism (about 10-12%); fluconazole is also a clinically relevant inhibitor of CYP2C9, CYP2C19, and CYP3A4.

Excretion

Primarily renal; ~80% excreted unchanged in urine.

Protein Binding

11-12%.

Product Information

Available Dosage Forms

Tablet, Capsule, Oral suspension, Injection for intravenous infusion.

Composition per Dose

Each capsule: 150mg fluconazole

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Application

Oral

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