ITNAZ Capsule (Itraconazole Capsules USP) 100mg: Complete Description

Product Name: ITNAZ (Itraconazole Capsules USP) 100mg.

Capsule Strength: 100mg.

Composition: Each capsule contains Itraconazole pellets equivalent to 100mg of Itraconazole.

Description:

ITNAZ capsules contain the active ingredient Itraconazole, an antifungal agent. Itraconazole is a racemic mixture of four diastereomers, each having three chiral centers, with a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. This medication treats various fungal infections.

Pharmacological Properties:

Mechanism of Action: Itraconazole inhibits the synthesis of ergosterol, a crucial component of fungal cell membranes, essential for fungal growth and integrity.

Pharmacokinetics:

After oral administration, Itraconazole is rapidly absorbed, reaching peak plasma concentrations within 2 to 6 hours. Steady-state concentrations are typically achieved within about 15 days of treatment.

Indications and Usage:

ITNAZ capsules are indicated for treating fungal infections in immunocompromised and non immunocompromised patients, including:

Pulmonary and extrapulmonary blastomycosis

Histoplasmosis, including chronic cavitary pulmonary disease and disseminated,  nonmeningeal histoplasmosis

Pulmonary and extrapulmonary aspergillosis in patients intolerant of or refractory to amphotericin B therapy

Onychomycosis of the toenails and fingernails due to dermatophytes

Dosage and Administration:

The dosage of ITNAZ capsules varies depending on the indication. For short-term usage, the recommended dose for most indications is 100mg once daily for a specific duration. Long-term dosage may vary.

Contraindications:

ITNAZ capsules are contraindicated in patients with:

• History of hypersensitivity to Itraconazole or its components
• Evidence of ventricular dysfunction or congestive heart failure

Warnings and Precautions:

• Hepatotoxicity:  Rare cases of serious liver toxicity have occurred.  Monitor liver function.
• Cardiac Dysrhythmias:  Life-threatening cardiac dysrhythmias and sudden death may occur with concomitant use of certain drugs.  Use caution.
• Interaction Potential:  Itraconazole may interact with various medications,  potentially leading to adverse effects or reduced efficacy.
• Use in Specific Populations:  Use cautiously in pregnant and lactating women.  Efficacy and safety in pediatric patients haven’t been established.

Adverse Reactions:

Common adverse effects include:

• Cardiac disorders
• General disorders
• Hepatobiliary disorders
• Gastrointestinal disorders

Less common adverse effects are also possible.

Drug Interactions:

ITNAZ capsules may interact with various medications, including:

• Alpha blockers
• Analgesics
• Anticoagulants
• Anticonvulsants
• Antivirals

This list is not exhaustive. Consult your healthcare professional for potential interactions with your medications.

Overdosage:

In case of accidental overdosage, use supportive measures. Itraconazole is not removed by dialysis.

Instructions for Use:

• Store and transport ITNAZ capsules below 30 °C.
• Protect from light,  heat,  and moisture.
• Keep out of the reach of children.
• Use only as directed by a physician.

Presentation:

ITNAZ 100mg capsules are available in Alu Alu blister packs of 1 x 4’s.

Disclaimer:

This information is for informational purposes only. Always follow the specific instructions and recommendations provided by your healthcare provider and on the medication’s packaging.