TRACON 100/MG CAP 15/CAP

Indications

Approved Uses

Indications depend on the local SFDA-approved label for this specific product; in general, oral itraconazole capsules are approved/used for: oropharyngeal and esophageal candidiasis; onychomycosis; and certain systemic mycoses such as aspergillosis, blastomycosis, and histoplasmosis (and may include other dermatomycoses depending on the country label).

Off-Label Uses

Common off-label uses include prophylaxis of fungal infections in selected immunocompromised patients (institution/protocol dependent), coccidioidomycosis, paracoccidioidomycosis, chromoblastomycosis, and some cases of cutaneous/lymphocutaneous sporotrichosis when alternatives are unsuitable.

Dosage & Administration

Dosing by Condition

Typical adult dosing (capsules) per established references: Oropharyngeal candidiasis: 200 mg/day (either 200 mg once daily or 100 mg twice daily) for 1-2 weeks (often 15 days). Esophageal candidiasis: 200 mg/day (may increase to 200 mg twice daily) for 2-3 weeks. Onychomycosis: toenails 200 mg once daily for 12 weeks OR pulse 200 mg twice daily for 1 week/month for 3 pulses; fingernails pulse 200 mg twice daily for 1 week/month for 2 pulses. Aspergillosis: 200 mg twice daily (some regimens use loading 200 mg three times daily for 3 days) with duration guided by response. Histoplasmosis/blastomycosis: commonly 200 mg three times daily for 3 days then 200 mg twice daily; duration often months (e.g., histoplasmosis may require prolonged therapy). Tinea corporis/cruris: 100 mg daily for 2 weeks or 200 mg daily for 1 week; Tinea pedis: 100 mg daily for 4 weeks or 200 mg twice daily for 1 week; Tinea versicolor: 200 mg daily for 5-7 days.

Initial Dose

Initial dosing varies by indication: for superficial mycoses 100 mg once or twice daily; for oropharyngeal candidiasis 20 mL oral solution once or twice daily for 1-4 weeks, or 200 mg daily (capsules); for onychomycosis 200 mg once daily for 12 weeks; for blastomycosis and histoplasmosis 200 mg once daily (capsules), maximum 400 mg daily; for invasive aspergillosis 200-400 mg daily (capsules) or 20 mL solution every 12 hours. There is no universal 100 mg once-daily initial dose for most indications.

Maintenance Dose

200-400mg daily, given in one or two divided doses.

Maximum Dose

600mg per day (loading dose for 3 days in aspergillosis/histoplasmosis); 400mg per day for maintenance

Dose Adjustment Notes

Capsules require an acidic gastric environment and are best absorbed with food; avoid/space acid-suppressing therapy (or use an acidic beverage if needed). No routine renal dose adjustment, but use caution in hepatic impairment and consider dose reduction/close monitoring; for prolonged therapy or serious infections, therapeutic drug monitoring (TDM) is recommended. Doses >200 mg/day are commonly given in divided doses to improve exposure/tolerability.

How to Take

Oral itraconazole capsules (TRACON 100 mg): swallow capsules whole immediately after a full meal; do not crush/chew. Avoid acid-suppressing agents (antacids/H2-blockers/PPIs) around the dose-separate antacids by at least 2 hours; if gastric acidity is reduced, consider taking the capsule with an acidic beverage (e.g., non-diet cola) to improve absorption.

Side Effects

Common Side Effects

Common: nausea, abdominal pain/dyspepsia, diarrhea, vomiting, headache, dizziness, rash/pruritus; can also cause elevated liver enzymes. Important clinically relevant adverse effects include peripheral edema and hypokalemia (less common) and constipation/flatulence may occur.

Side Effect Frequency

Common (1-10%): nausea, abdominal pain/dyspepsia, diarrhea, headache, rash; liver enzyme elevations occur and are generally reported as common; serious reactions (e.g., hepatotoxicity, heart failure, SJS/TEN, anaphylaxis) are rare/uncommon.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to itraconazole/azoles; coadministration with contraindicated CYP3A4 substrates (notably QT‑prolonging agents such as cisapride, pimozide, quinidine, dofetilide; ergot alkaloids; oral midazolam/triazolam; lovastatin/simvastatin; and other label-listed contraindicated drugs); and use for onychomycosis in patients with ventricular dysfunction/CHF history; pregnancy is contraindicated for onychomycosis indication.

Warnings & Precautions

Key precautions: assess/monitor for CHF (avoid in ventricular dysfunction for onychomycosis); baseline and periodic LFTs and stop if hepatotoxicity symptoms occur; manage major CYP3A4/P‑gp interactions; counsel on reduced capsule absorption with PPIs/H2 blockers/antacids; discontinue if neuropathy occurs; caution with QT‑risk patients and electrolyte abnormalities; consider hypersensitivity/cross-reactivity with other azoles.

Age Restriction

Pediatrics: safety/efficacy not established; use only if benefit outweighs risk under specialist supervision (no fixed age cutoff). Geriatrics: no specific restriction, but use with caution due to comorbidities and interaction risk.

Drug Interactions

Drug Interactions

Major: strong CYP3A4 inducers (rifampin/rifabutin, carbamazepine, phenytoin, phenobarbital) can markedly reduce itraconazole exposure; itraconazole is a strong CYP3A4 inhibitor increasing levels of many drugs-some are contraindicated (e.g., simvastatin/lovastatin, oral midazolam/triazolam, cisapride/pimozide/quinidine/dofetilide, ergot alkaloids). Other clinically important interactions: warfarin (↑INR), digoxin (↑levels via P‑gp), calcineurin inhibitors (cyclosporine/tacrolimus/sirolimus ↑), and acid-suppressing therapy (PPIs/H2 blockers/antacids) can reduce capsule absorption.

Interaction Severity

MAJOR/contraindicated: strong QT-risk substrates and CYP3A4 substrates such as cisapride, pimozide, quinidine, dofetilide; ergot alkaloids; oral midazolam/triazolam; simvastatin/lovastatin (rhabdomyolysis risk). MAJOR (avoid): strong enzyme inducers (rifampin/rifabutin, phenytoin, carbamazepine) markedly reduce itraconazole levels. MODERATE/significant: warfarin (↑INR), digoxin (↑levels), cyclosporine/tacrolimus/sirolimus (↑levels), some calcium channel blockers (↑levels/edema), vinca alkaloids (↑neurotoxicity), and some sulfonylureas (↑hypoglycemia risk). MINOR/PK management: antacids/H2-blockers/PPIs reduce capsule absorption-separate/adjust.

Food Interaction

Capsules: take with/after a full meal to enhance absorption; absorption is reduced with low gastric acidity (PPIs/H2-blockers/antacids) and may be improved with an acidic beverage if needed. Avoid grapefruit juice (can increase itraconazole exposure via CYP3A4 inhibition).

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Consult Doctor

Elderly

Standard adult dosing; use with caution due to increased risk of drug interactions, heart failure, and hepatotoxicity; monitor liver function and cardiac status more closely

Kidney Impairment

No routine dose adjustment; use with caution in severe renal impairment and in dialysis (oral exposure may be reduced/variable).

Liver Impairment

No standardized dose adjustment; use with caution in hepatic impairment, avoid or use only with close monitoring in severe hepatic disease, and monitor LFTs (stop if hepatotoxicity suspected).

Storage & Patient Advice

Stopping the Medicine

Complete the prescribed course; do not stop early without prescriber advice, but it is appropriate to stop once the full course is finished.

Patient Counseling

Take TRACON (itraconazole) capsules by mouth immediately after a full meal; swallow whole. Avoid antacids within 2 hours and discuss PPIs/H2-blockers (may reduce absorption; an acidic beverage may help if needed). Complete the prescribed course. Avoid grapefruit juice. Seek care urgently for liver injury symptoms (dark urine, jaundice, severe fatigue, persistent nausea/abdominal pain) or heart failure symptoms (shortness of breath, swelling, rapid weight gain). Tell clinicians/pharmacists about all medicines (many serious interactions; do not start new OTC/herbals without checking). Use effective contraception during treatment and for a period after stopping if advised by the prescriber (avoid in pregnancy unless clearly needed).

Monitoring Requirements

Baseline and periodic liver function tests (especially if therapy >1 month or in hepatic disease); assess for signs/symptoms of heart failure (itraconazole has a negative inotropic effect and can cause/worsen CHF); consider potassium monitoring if clinically indicated (e.g., prolonged therapy, diuretics, edema). For serious infections, prolonged therapy, suspected malabsorption, or major interactions, consider therapeutic drug monitoring (itraconazole ± hydroxy-itraconazole troughs).

Pharmacology

Mechanism of Action

Inhibits fungal lanosterol 14α-demethylase (CYP51), decreasing ergosterol synthesis and impairing fungal cell membrane structure and function (primarily fungistatic, can be fungicidal against some organisms at higher exposures).

Onset of Action

Pharmacokinetic onset: peak plasma concentrations typically occur ~3-5 hours after a capsule dose (with food). Clinical improvement varies by infection-often days for mucosal candidiasis, weeks for dermatophyte infections, and months for onychomycosis/systemic mycoses.

Duration of Effect

Itraconazole persists in tissues after stopping: skin/mucosal levels can remain for ~2-4 weeks; in nails, drug can persist for months (commonly up to ~6 months) after completing onychomycosis therapy.

Half-Life

Approximately 21 hours after a single dose, increasing to 34-42 hours at steady state.

Bioavailability

Approximately 55% (oral capsules); absorption is increased when taken with food and requires gastric acidity (reduced by PPIs/H2RAs/antacids).

Metabolism

Extensive hepatic metabolism primarily via CYP3A4 to multiple metabolites; hydroxy-itraconazole is the major active metabolite with similar antifungal activity.

Product Information

Available Dosage Forms

Capsule, Oral solution.

Composition per Dose

Each capsule: 100mg itraconazole

Generic Availability

Yes

OTC Alternatives

No OTC alternative for systemic antifungal therapy; topical OTC antifungals (clotrimazole, miconazole) available for superficial skin infections only

Application

Oral

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