TRACON 100MG 4TAB

Indications

Approved Uses

Depends on local SFDA-approved labeling for this specific product; generally approved uses for oral itraconazole capsules include onychomycosis and a range of mucocutaneous/systemic mycoses (e.g., oropharyngeal/esophageal candidiasis and certain endemic/systemic fungal infections such as histoplasmosis, blastomycosis, and aspergillosis).

Off-Label Uses

Off-label uses may include coccidioidomycosis, paracoccidioidomycosis, chromoblastomycosis, and selected prophylaxis strategies in high-risk immunocompromised patients (institution/specialist-directed).

Dosage & Administration

Dosing by Condition

Oropharyngeal candidiasis: 200 mg/day (either 200 mg once daily or 100 mg twice daily) for 1-2 weeks; may extend to 2 weeks. Esophageal candidiasis: 200 mg/day for at least 3 weeks and for 2 weeks after symptom resolution (may increase to 400 mg/day if needed). Vulvovaginal candidiasis: 200 mg twice daily for 1 day OR 200 mg once daily for 3 days. Tinea corporis/cruris: 200 mg/day for 1 week OR 100 mg/day for 2 weeks. Tinea pedis/manus: 200 mg twice daily for 1 week OR 100 mg/day for 4 weeks. Tinea versicolor: 200 mg/day for 7 days. Onychomycosis (toenail): 200 mg once daily for 12 weeks OR pulse 200 mg twice daily for 1 week/month for 3 pulses. Onychomycosis (fingernail): pulse 200 mg twice daily for 1 week/month for 2 pulses. Histoplasmosis/blastomycosis: typically 200 mg three times daily for 3 days (loading) then 200 mg once or twice daily for months (severity/site dependent). Aspergillosis: commonly 200 mg twice daily for at least several months (specialist-directed).

Initial Dose

100mg once daily (most indications); 200mg once or twice daily for serious systemic infections

Maintenance Dose

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

Maximum Dose

Maximum usual oral dose: 400 mg/day; in severe/life-threatening systemic infections some regimens use up to 600 mg/day short-term (e.g., loading).

Children's Dosage

Not routinely approved for children; pediatric use only when benefit outweighs risk. If used: 5mg/kg/day has been used in clinical studies. Consult specialist

Dose Adjustment Notes

Hepatic impairment: use with caution and monitor LFTs; avoid/stop if significant hepatotoxicity. Renal impairment: no routine dose adjustment, but use caution (especially severe renal dysfunction) due to variable exposure. Acid suppression/achlorhydria: capsule absorption is reduced-avoid PPIs/H2 blockers if possible or separate/acidify; oral solution (if available) is preferred when absorption is a concern.

How to Take

Swallow itraconazole 100 mg capsules whole with (or immediately after) a full meal; do not crush or chew; take at the same time each day.

Side Effects

Common Side Effects

Nausea, vomiting, diarrhea, abdominal pain/dyspepsia, headache, dizziness, rash/pruritus; possible elevated liver enzymes and edema (less common but clinically important).

Side Effect Frequency

Common (≥1% to <10%): GI upset (nausea, abdominal pain, diarrhea, dyspepsia), headache; liver enzyme elevations are commonly reported; serious but less common/rare: hepatotoxicity, congestive heart failure/worsening HF (boxed warning/contraindication in HF), hypokalemia/edema, severe cutaneous reactions, peripheral neuropathy.

Safety & Warnings

Contraindications

Contraindicated in: hypersensitivity to itraconazole; pregnancy (especially for treatment of onychomycosis or other non-life-threatening infections); coadministration with contraindicated CYP3A4 substrates that can cause serious events (e.g., cisapride, pimozide, quinidine, dofetilide; ergot alkaloids; simvastatin/lovastatin; oral midazolam/triazolam); and use for onychomycosis in patients with ventricular dysfunction/CHF history.

Warnings & Precautions

Key precautions: assess for CHF/ventricular dysfunction; baseline and periodic LFT monitoring; rigorous interaction screening (potent CYP3A4 inhibitor); avoid strong enzyme inducers; manage reduced capsule absorption with acid suppressants; discontinue if hepatotoxicity, neuropathy, or severe rash occurs; note capsule vs solution are not interchangeable mg-for-mg.

Age Restriction

No specific age restriction in adults; pediatric use is not routinely established-use in children only if benefit outweighs risk under specialist supervision.

Drug Interactions

Drug Interactions

Major interactions: strong CYP3A4/P-gp inhibitor-contraindicated with cisapride/pimozide/quinidine/dofetilide (QT/TdP), ergot alkaloids (ergotism), simvastatin/lovastatin (rhabdomyolysis), oral midazolam/triazolam (profound sedation); clinically significant with warfarin (↑INR), calcineurin/mTOR inhibitors (↑levels), digoxin (↑), calcium-channel blockers (↑edema/CHF risk), and strong enzyme inducers (rifampin/rifabutin/phenytoin/carbamazepine) which markedly ↓itraconazole; acid suppressants can ↓capsule absorption.

Interaction Severity

MAJOR/Contraindicated: strong CYP3A4 substrate interactions causing QT prolongation/arrhythmia (e.g., cisapride, quinidine, dofetilide, pimozide) and severe toxicity with certain statins (simvastatin, lovastatin), ergot alkaloids, and oral midazolam/triazolam. MODERATE/Significant: warfarin (↑INR), calcineurin/mTOR inhibitors (tacrolimus/cyclosporine/sirolimus; ↑levels), digoxin (↑levels), some calcium channel blockers (↑levels/edema; HF risk), and strong enzyme inducers (rifampin, carbamazepine, phenytoin) which markedly reduce itraconazole exposure (avoid). Absorption interactions: PPIs/H2 blockers/antacids reduce capsule absorption (manage timing/acid).

Food Interaction

Take itraconazole capsules with a full meal to increase absorption; avoid taking capsules on an empty stomach.

Special Populations

Pregnancy

Contraindicated

Breastfeeding

Consult Doctor

Children

Not routinely approved for children; pediatric use only when benefit outweighs risk. If used: 5mg/kg/day has been used in clinical studies. Consult specialist

Elderly

Standard adult dosing. Use with caution, considering the greater frequency of decreased hepatic, renal, or cardiac function.

Kidney Impairment

CrCl under 10; reduce dose by 50%. In peritoneal and hemodialysis patients, dosing is 100 mg every 12 to 24 hours, with no supplement.

Liver Impairment

No fixed dose adjustment defined; use with caution, avoid/limit in significant hepatic disease when treating non-life-threatening infections, and monitor LFTs closely.

Storage & Patient Advice

Stopping the Medicine

Do not stop “anytime”; stop only on clinician advice-complete the prescribed course unless adverse effects/contraindications occur.

Patient Counseling

Take capsules with or immediately after a full meal; swallow whole. Avoid acid-suppressing agents/antacids around dosing (separate by at least 2 hours; PPIs/H2 blockers can reduce capsule absorption). Report liver injury symptoms (jaundice, dark urine, severe fatigue) and heart failure symptoms (shortness of breath, ankle swelling, rapid weight gain). Tell your clinician/pharmacist about all medicines (many serious interactions). Complete the prescribed course.

Monitoring Requirements

Baseline and periodic liver function tests (especially if treatment >1 month or hepatic risk); assess for signs/symptoms of heart failure/edema; consider therapeutic drug monitoring (itraconazole trough) for serious/systemic infections, poor response, suspected malabsorption, or major interactions.

Pharmacology

Mechanism of Action

Inhibits fungal lanosterol 14-α-demethylase (CYP51), decreasing ergosterol synthesis and disrupting fungal cell membrane structure and function (primarily fungistatic, sometimes fungicidal depending on organism/concentration).

Onset of Action

Absorption/PK: peak plasma concentrations occur ~2-5 hours after a dose; steady state is typically reached in ~1-2 weeks. Clinical response varies by infection site and may take days to weeks (and nails months).

Duration of Effect

Drug persists in keratinized tissues: measurable levels remain for weeks after stopping (skin ~2-4 weeks; nails can persist for months).

Bioavailability

Itraconazole capsules: oral bioavailability is variable and generally ~55% when taken with food; absorption is significantly reduced in the fasting state and with reduced gastric acidity (e.g., PPIs/H2RAs).

Metabolism

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

Product Information

Available Dosage Forms

Capsule, Oral solution, Tablet.

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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