Eloza SB 65mg Capsule

✔️ Side Effects

Common or reported adverse effects include:

• Nausea
• Abdominal pain
• Dyspepsia
• Constipation
• Headache
• Dizziness
• Elevated liver enzymes
• Menstrual disorders

Less common but potentially serious reactions include:

• Allergic reactions, including pruritus, rash, urticaria, and angioedema
• Hepatitis
• Cholestatic jaundice
• Peripheral neuropathy
• Stevens-Johnson syndrome
• Hypokalaemia
• Oedema
• Hair loss, particularly with prolonged treatment

Patients should seek medical attention if symptoms of severe allergic reaction, liver injury, heart failure, or severe skin reaction

✔️ 100 mg & 200 mg Preparations

Non-Systemic Fungal Infections

✔️ Systemic Fungal Infections

The dose and duration should be determined by the treating physician based on the clinical condition and response to therapy.

✔️ 65 mg & 130 mg Preparations

Non-Systemic Fungal Infections

✔️ Systemic Fungal Infections

The dose and duration of systemic antifungal treatment should be individualized according to the patient's clinical response and the treating physician's assessment.

✔️ Drug Interactions

Itraconazole is a potent inhibitor of CYP3A4 and can cause clinically significant interactions with numerous medicines.

Concomitant use may be contraindicated or require specialist management with medicines such as:

• Terfenadine
• Astemizole
• Cisapride
• Simvastatin and certain other HMG-CoA reductase inhibitors
• Oral midazolam
• Triazolam

Significant interactions may also occur with:

• Rifampicin/rifampin
• Phenytoin
• Phenobarbital
• Digoxin
• Calcium-channel blockers
• Other medicines metabolized through CYP3A4

Patients should inform their doctor about all prescription medicines, over-the-counter medicines, vitamins, and herbal products they are taking before starting itraconazole.

✔️ Safety Information:

• Absorption of some itraconazole formulations may be reduced when gastric acidity is decreased.
• Acid-neutralizing medicines such as aluminium hydroxide may interfere with absorption. When appropriate, antacids should be taken at least 2 hours after itraconazole.
• Some formulations should be taken immediately after a full meal; administration instructions may vary by formulation. Follow the product-specific instructions provided by the doctor or pharmacist.
• Liver injury, including hepatitis and jaundice, has rarely been reported, particularly during prolonged treatment.
• Liver function should be monitored in patients receiving continuous treatment for more than one month or when clinically indicated.
• Itraconazole can cause clinically important drug interactions because it strongly inhibits CYP3A4.
• Patients with heart failure or risk factors for heart failure should be evaluated carefully before treatment because itraconazole has been associated with negative inotropic effects.
• Treatment of systemic fungal infections should be supervised by an experienced physician.

✔️ Eloza SB is contraindicated in patients with:

• Known hypersensitivity to itraconazole or any component of the formulation
• Certain serious drug interactions where concomitant administration is contraindicated
• Pregnancy, except when specifically prescribed for serious or life-threatening fungal infections where the potential benefits outweigh the risks

✔️ 50 mg Capsule – Pediatric Use

Pediatric itraconazole dosing should be prescribed by a specialist and may require therapeutic drug monitoring.

For children >4 weeks to <12 years, a commonly used treatment dose is 1.25–2 mg/kg per dose twice daily, up to a maximum initial dose of 100 mg per dose. For severe infections, the dose may be increased under specialist supervision.

The dose should be rounded appropriately to facilitate administration.

For children ≥12 years, a usual dose may be 50–100 mg once daily, with higher doses considered for severe infections under medical supervision.

For prophylaxis in children ≥2 years, a dose of 2.5 mg/kg once daily, up to a maximum initial dose of 200 mg daily, may be used with therapeutic drug monitoring.

Because pediatric dosing varies according to the infection, formulation, age, weight, and clinical condition, itraconazole should not be administered to children without appropriate medical supervision.

✔️ Pregnancy & Lactation

Itraconazole should generally not be used during pregnancy unless specifically prescribed for a serious fungal infection when the potential benefit justifies the potential risk.

Breastfeeding is generally not recommended during treatment with itraconazole unless specifically advised by a healthcare professional.

✔️ Storage:

• Store below 25°C.
• Keep in a cool and dry place.
• Protect from light.
• Keep out of reach of children.
• Store the medicine according to the specific product label, particularly where the formulation has special storage requirements.