DURACAN 150/MG CAP 1/CAP

Indications

Approved Uses

Treatment of mucosal candidiasis (oropharyngeal and esophageal), vulvovaginal candidiasis, systemic Candida infections including candidemia/disseminated candidiasis, cryptococcal meningitis, and prophylaxis to reduce candidiasis in high-risk immunocompromised patients (e.g., bone marrow transplant).

Dosage & Administration

Dosing by Condition

Vaginal candidiasis (uncomplicated): 150 mg PO once. Oropharyngeal candidiasis: 200 mg PO on day 1 then 100 mg PO daily for at least 14 days. Esophageal candidiasis: 200 mg PO on day 1 then 100 mg PO daily for at least 21 days. Cryptococcal meningitis (consolidation/maintenance regimens vary by guideline): commonly 400 mg PO on day 1 then 200-400 mg PO daily for 10-12 weeks (after appropriate induction therapy). Systemic candidiasis/candidemia: typically higher-dose regimens (e.g., 800 mg loading then 400 mg daily) depending on severity and organism susceptibility; specialist guidance recommended.

Initial Dose

150mg as a single dose (vaginal candidiasis); 200-400mg loading dose for systemic infections

Maintenance Dose

100-400mg once daily, depending on indication. [4, 7]

Maximum Dose

800mg daily for life-threatening infections.

Children's Dosage

3mg/kg once daily (equivalent to adult 100mg dose); 6mg/kg once daily (equivalent to adult 200mg); 12mg/kg once daily (equivalent to adult 400mg). Maximum 12mg/kg/day. Not recommended in neonates in the first 2 weeks of life unless benefit outweighs risk.

Dose Adjustment Notes

Renal: for multiple-dose therapy, reduce maintenance dose by ~50% when CrCl ≤50 mL/min (after giving the usual loading dose if used); hemodialysis: give the full dose after each dialysis session. Hepatic: no formal dose adjustment, but use caution and monitor liver function with prolonged therapy or underlying liver disease.

How to Take

Oral use: swallow the 150 mg soft capsule whole with water; may be taken with or without food. For uncomplicated vaginal candidiasis, the usual regimen is a single 150 mg dose as prescribed.

Side Effects

Common Side Effects

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

Side Effect Frequency

Common (≥1%): headache, nausea, abdominal pain, diarrhea, rash, vomiting, elevated liver enzymes, dizziness; Rare/very rare: severe cutaneous adverse reactions (e.g., Stevens-Johnson syndrome/TEN), anaphylaxis, severe hepatotoxicity, QT prolongation/torsades de pointes, blood dyscrasias (e.g., leukopenia/thrombocytopenia).

Safety & Warnings

Contraindications

Contraindicated: hypersensitivity to fluconazole/other azoles; concomitant use with QT-prolonging CYP3A4 substrates such as cisapride, pimozide, quinidine, and erythromycin; terfenadine is contraindicated when fluconazole is used at multiple doses ≥400 mg/day (not relevant to a single 150 mg dose).

Warnings & Precautions

Use caution/monitor in hepatic disease (stop if liver injury signs), renal impairment (dose adjust for repeated dosing), and patients with QT-risk factors (cardiac disease, electrolyte abnormalities, interacting QT-prolonging drugs); discontinue if severe rash occurs; be alert for rare adrenal insufficiency.

Age Restriction

Adults: appropriate for labeled single-dose 150 mg use; Pediatric use requires physician-directed dosing and is not for self-treatment (the 150 mg single-dose regimen is not generally recommended in children/adolescents).

Drug Interactions

Drug Interactions

Major/avoid: cisapride, pimozide, quinidine, erythromycin (QT/torsades risk); Important interactions requiring monitoring/dose adjustment: warfarin (↑INR/bleeding), phenytoin (↑levels), cyclosporine/tacrolimus (↑levels/nephrotoxicity), sulfonylureas (↑hypoglycemia), certain benzodiazepines (↑sedation), rifampicin (↓fluconazole exposure), and CYP3A4 statins (↑myopathy/rhabdo risk).

Interaction Severity

MAJOR/contraindicated or avoid: cisapride, pimozide, quinidine, erythromycin (and other strong QT-prolonging substrates) due to torsades/QT risk; terfenadine is contraindicated with fluconazole at higher doses (classically ≥400 mg/day). MODERATE/clinically significant: warfarin (↑INR), phenytoin, cyclosporine, tacrolimus, sulfonylureas (hypoglycemia), theophylline, rifabutin; monitor levels/clinical effects and adjust doses. Other notable: rifampin may lower fluconazole exposure; hydrochlorothiazide may increase fluconazole levels.

Food Interaction

No restriction.

Special Populations

Pregnancy

Category D (high doses); single 150 mg dose generally avoided but low risk

Breastfeeding

Caution

Children

3mg/kg once daily (equivalent to adult 100mg dose); 6mg/kg once daily (equivalent to adult 200mg); 12mg/kg once daily (equivalent to adult 400mg). Maximum 12mg/kg/day. Not recommended in neonates in the first 2 weeks of life unless benefit outweighs risk.

Elderly

Standard adult dosing; adjust for renal function as creatinine clearance may be reduced in elderly patients

Kidney Impairment

CrCl >50 mL/min: no adjustment; CrCl ≤50 mL/min (not on dialysis): give 50% of the usual maintenance dose (after any loading dose); Hemodialysis: give the full dose after each dialysis session.

Liver Impairment

No routine dose adjustment defined; use with caution and monitor liver function/clinical signs, discontinuing if hepatotoxicity is suspected.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if near next dose. Do not double the dose. [4, 8]

Stopping the Medicine

Take exactly as prescribed; for single-dose therapy (150 mg) no 'course' exists, but for multi-dose/systemic infections do not stop early without prescriber advice to reduce relapse/failure.

Overdose

Possible symptoms include hallucinations/paranoid behavior and GI upset; manage with supportive care (consider gastric decontamination if appropriate) and hemodialysis can enhance elimination (about 50% reduction after ~3 hours).

Patient Counseling

Take exactly as prescribed (for uncomplicated vaginal thrush, usually one 150 mg capsule once); may take with or without food. Expect improvement within 1 day but symptoms may take a few days to fully resolve; seek care if symptoms persist/return. Report rash, blistering, or signs of liver injury (jaundice, dark urine, severe fatigue, persistent nausea). Avoid new medications without checking due to interactions (notably warfarin and QT-risk drugs). Use caution with driving if dizziness occurs. Inform clinician if pregnant/trying to conceive or breastfeeding.

Monitoring Requirements

Monitor liver function tests if prolonged therapy, high doses, or pre-existing liver disease; monitor renal function to guide dosing in impairment; consider ECG/QT risk assessment in patients with risk factors or on QT-prolonging drugs; if co-administered with warfarin, monitor INR closely; monitor drug levels/clinical toxicity for interacting narrow-therapeutic-index agents (e.g., tacrolimus/cyclosporine/phenytoin).

Pharmacology

Mechanism of Action

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

Onset of Action

Peak plasma concentrations occur about 1-2 hours after oral dosing; symptom improvement in vulvovaginal candidiasis often begins within ~24 hours, though full resolution may take several days.

Duration of Effect

Elimination half-life is ~30 hours; after a single 150 mg dose, clinically meaningful antifungal exposure persists for several days (often ~3 days), supporting single-dose therapy for uncomplicated vulvovaginal candidiasis.

Half-Life

Approximately 30 hours (range: 20-50 hours). [1, 5]

Bioavailability

Oral bioavailability >90%.

Metabolism

Minimal hepatic metabolism (a small fraction of dose); fluconazole is also a clinically relevant inhibitor of CYP2C9 and CYP2C19 and a moderate inhibitor of CYP3A4.

Excretion

Primarily renal; ~80% excreted unchanged in urine.

Protein Binding

11-12%

Product Information

Available Dosage Forms

Tablet, Powder for oral suspension, Intravenous injection.

Composition per Dose

Each capsule: 150mg fluconazole

Generic Availability

Yes

OTC Alternatives

There is no OTC oral fluconazole alternative; for uncomplicated vulvovaginal candidiasis, OTC intravaginal/topical azoles (e.g., clotrimazole or miconazole) are common alternatives where locally available OTC.

Application

Oral

Legal Disclaimer - Al Mujtama Pharmacy

The product information provided is derived from verified pharmaceutical references and is intended for general health education only. It is not a substitute for professional medical advice, diagnosis, or treatment.

Al Mujtama Pharmacy assumes no legal or medical liability for:

• Any therapeutic decision made based on the information displayed without consulting a licensed physician or pharmacist
• Any discrepancy between the information provided and the product's package insert or SFDA guidelines
• Any misuse of medication resulting from personal interpretation of the content displayed

Important notice: Drug formulations and instructions may vary between production batches. Always rely on the leaflet included inside the product packaging you have, and consult your pharmacist or physician before starting, adjusting, or discontinuing any medication.

By using this content, you acknowledge that you have read this disclaimer and agree that Al Mujtama Pharmacy bears no liability arising from reliance on this information as a substitute for direct medical consultation.

Your health is a trust - always consult your doctor first.