ICON (Itraconazole Capsules BP):

Comprehensive Description

Product Specifications: BP

Icon 100 mg Capsules:

ICON CAPSULES Each capsule contains Itraconazole pellets equivalent to 100 mg Itraconazole BP.

Boxed Warning:

CONGESTIVE HEART FAILURE, CARDIAC EFFECTS, AND DRUG INTERACTIONS

• Do not  administer Icon Capsules for onychomycosis in patients with evidence of ventricular dysfunction,  such as congestive heart failure (CHF) or a history of CHF.
• If signs or symptoms of congestive heart failure occur while taking Icon Capsules,  discontinue administration immediately.
• When administered intravenously to dogs and healthy human volunteers,  Itraconazole was associated with negative inotropic effects.

Pharmaceutical Form: Capsule for oral use.

Description:

• ICON contains Itraconazole,  an azole antifungal agent.
• Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64.

Indications:

Icon (Itraconazole) Capsules are indicated for treating the following fungal infections:

• Vulvovaginal candidiasis
• Blastomycosis,  both pulmonary and extrapulmonary
• Dermatophytoses caused by organisms susceptible to Itraconazole (Trichophyton spp, Microsporum spp, Epidermophyton floccosum),  such as tinea pedis,  tinea cruris,  tinea corporis,  and tinea manuum
• Oropharyngeal candidiasis
• Onychomycosis caused by dermatophytes and/or yeasts.  Before starting treatment,  obtain appropriate nail specimens for laboratory testing (KOH preparation,  fungal culture,  or nail biopsy) to confirm the diagnosis of onychomycosis.

Additional Indications (Icon only):

• Pityriasis versicolor
• Blastomycosis (systemic fungal conditions)
• Azole-resistant systemic fungal infections
• Prophylaxis of fungal infections in immunocompromised patients (when standard therapy is considered inappropriate)

Posology and Method of Administration:

Treatment schedules in adults for each indication are as follows:

• Tinea corporis,  tinea cruris,  tinea pedis,  tinea manuum:  200 mg twice daily for 1 day
• Oropharyngeal candidiasis:  200 mg once daily for 7 days
• Onychomycosis (toenails with or without fingernail involvement):  200 mg once daily for 3 months
• Blastomycosis,  pulmonary and extrapulmonary:  200 mg once daily
• Prophylaxis of fungal infections in immunocompromised patients:  200 mg once daily or 200 mg twice daily until immune recovery.

Special Warnings and Precautions for Use:

• Heart Failure: Do not administer   to patients with evidence of ventricular dysfunction or a history of CHF,  except for life-threatening or other serious infections.
• Pregnancy: Only use Icon during pregnancy in life-threatening cases.  Women of childbearing age taking Icon Capsules should use contraceptive precautions.
• Hypersensitivity: Icon are contraindicated for patients with hypersensitivity to Itraconazole.  Use caution when prescribing Icon Capsules to patients with hypersensitivity to other azoles.
• Hepatic Effects: Rare cases of serious hepatotoxicity have been associated with Icon.  If clinical signs or symptoms consistent with liver disease develop,  discontinue treatment.
• Cardiac Dysrhythmias:  Life-threatening cardiac dysrhythmias and/or sudden death have occurred in patients using drugs concomitantly with Icon Capsules and/or other CYP3A4 inhibitors.

Interaction Potential:

Icon have the potential for clinically important drug interactions. Co-administration of specific drugs with Icon Capsules may alter the efficacy of Icon and/or the co-administered drug. Drugs that are contraindicated, not recommended, or recommended for use with caution in combination with Icon Capsules are listed in the product labeling.

For a comprehensive list of drug interactions and detailed information, refer to the product labeling.

Effect of Other Drugs on Icon Capsules:

Drugs that share or modify the CYP3A4 pathway may influence the pharmacokinetics of Icon . Clinical drug interactions include:

CYP2D6 Extensive Metabolizers (EMs) taking a strong or moderate CYP2D6 inhibitor:  Contraindicated during and 2 weeks after Icon Capsules treatment.