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Itraconazole: Dosage and Administration

• Reconstitution and Administration

Itraconazole is administered orally or by IV infusion.

• Oral Administration

Bioavailability of oral itraconazole varies depending on whether the drug is administered as capsules or as an oral solution, and the manufacturer states that these preparations should not be used interchangeably. Itraconazole oral solution (not itraconazole capsules) is indicated for the treatment of oropharyngeal or esophageal candidiasis.

While itraconazole oral solution should be administered without food if possible, itraconazole capsules should be administered with a full meal to ensure maximal absorption of the drug. The possibility that GI absorption of the drug may be decreased in patients with hypochlorhydria, which has been reported in HIV-infected individuals, should be considered.

• IV Infusion

Commercially available itraconazole injection must be diluted prior to IV infusion. The entire contents of an ampul containing itraconazole injection (250 mg) should be added to the 0.9% sodium chloride injection diluent (50 mL) provided by the manufacturer to provide a solution containing 3.33 mg/mL in a resultant volume of 75 mL. Correct preparation and administration of the itraconazole solution are necessary to ensure maximum safety and efficacy. It is critical that the appropriate ratio of itraconazole to diluent be used and that a final concentration of 3.33 mg/mL be maintained to provide a stable admixture and avoid formation of a precipitate. Itraconazole injection and diluted solutions of the drug should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

To provide a 200-mg dose of itraconazole, the diluted solution should be mixed gently and then 15 mL of the solution should be withdrawn and discarded. The remaining 60 mL of diluted solution containing 3.33 mg/mL should be given by IV infusion over 60 minutes. The infusion should be given using a controlled-infusion device, the infusion set provided by the manufacturer, and a dedicated IV line. Itraconazole should not be admixed with other drugs and should not be administered through the same IV line as other drugs. Following completion of the infusion, the manufacturer recommends that the infusion set be flushed via the 2-way stopcock using 15-20 mL of 0.9% sodium chloride injection over 30 seconds to 15 minutes; the entire IV line should then be discarded. Bacteriostatic sodium chloride solution should not be used for the flush solution since the compatibility of itraconazole solution with flush solutions other than 0.9% sodium chloride is not known.

• Dosage

Because of differences in oral bioavailability, itraconazole capsules and oral solution should not be used interchangeably on a mg-for-mg basis. Dosage of itraconazole capsules should be based on the type and severity of infection, identity of the causative organism, and patient’s response to therapy. The drug appears to undergo saturable metabolism in the liver; therefore, increases in dosage can result in more than proportional increases in plasma concentrations.

For the treatment of life-threatening systemic fungal infections, IV itraconazole or oral itraconazole capsules should be initiated using a loading dosage. If IV itraconazole is used initially, the recommended loading dosage in adults is 200 mg IV twice daily for 4 consecutive doses followed by 200 mg once daily thereafter. Although clinical studies evaluating the safety and efficacy of oral itraconazole capsules did not include a loading dosage, based on pharmacokinetic considerations, the manufacturer and some clinicians state that oral itraconazole capsules should be initiated in life-threatening infections in adults using an initial loading dose of 200 mg 3 times daily (600 mg daily) for the first 3-4 days of therapy. Subsequent therapy then can be continued at the usual oral dosage of 200-400 mg daily.

The manufacturer states that itraconazole therapy should be continued for at least 3 months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. Some clinicians state that while the optimal duration of therapy for serious fungal infections has not been established, itraconazole therapy probably should be continued for at least 12 months for disseminated or chronic pulmonary histoplasmosis and for 6-12 months for blastomycosis.An inadequate period of treatment can result in recurrence of active infection.

Aspergillosis

For the treatment of pulmonary or extrapulmonary aspergillosis in patients who do not respond to or cannot tolerate amphotericin B, the recommended adult dosage of itraconazole capsules is 200-400 mg daily. Higher oral dosages (i.e., 600 mg daily) also have been used for such infections, and some clinicians recommend that itraconazole dosages of at least 400 mg daily be used for the treatment of invasive aspergillosis.

When IV itraconazole is used for the treatment of aspergillosis in adults, the manufacturer recommends that therapy be initiated with a dosage of 200 mg IV twice daily for 4 doses, then dosage decreased to 200 mg IV once daily. Safety and efficacy of IV itraconazole administered for longer than 14 days has not been established, and itraconazole therapy should be completed using oral itraconazole capsules.

Blastomycosis or Histoplasmosis

For the treatment of pulmonary or extrapulmonary blastomycosis or for nonmeningeal histoplasmosis, the manufacturer recommends that itraconazole capsules be administered to adults in an initial dosage of 200 mg once daily. If there is no apparent improvement or there is evidence of progression of the fungal infection at this dosage, the manufacturer recommends increasing oral itraconazole dosage in 100-mg increments daily up to a maximum dosage of 400 mg daily. Oral dosages exceeding 200 mg daily should be divided into 2 doses daily. For the treatment of mild to moderate pulmonary blastomycosis or nonmeningeal, disseminated blastomycosis, some clinicians suggest that oral itraconazole be given in a dosage of 200-400 mg daily for at least 6 months (12 months in those with bone disease). For the treatment of histoplasmosis, some clinicians recommend that oral itraconazole be given in a dosage of 200 mg once or twice daily for 12-24 months for the treatment of chronic pulmonary infections or for 6-18 months for the treatment of mild to moderate, nonmeningeal, disseminated infections.

When IV itraconazole is used for the treatment of blastomycosis or histoplasmosis in adults, the manufacturer recommends that therapy be initiated with a dosage of 200 mg IV twice daily for 4 doses, then dosage decreased to 200 mg IV once daily. Safety and efficacy of IV itraconazole administered for longer than 14 days have not been established, and more prolonged itraconazole therapy should be completed using oral itraconazole capsules.

Oropharyngeal and Esophageal Candidiasis

For the treatment of oropharyngeal or esophageal candidiasis, the recommended dosage of itraconazole oral solution should be vigorously swished in the mouth (10 mL at a time) for several seconds and then swallowed.

The recommended dosage of itraconazole oral solution for the treatment of oropharyngeal candidiasis is 200 mg (20 mL) daily for 1-2 weeks. Clinical signs and symptoms generally resolve within several days. When itraconazole oral solution is used for the treatment of oropharyngeal candidiasis in patients who have not responded to or are refractory to oral fluconazole therapy, the recommended itraconazole dosage is 100 mg (10 mL) twice daily. A response to itraconazole in these patients generally is evident within 2-4 weeks; however, relapse may be expected shortly after the drug is discontinued. Data are limited to date regarding the safety of long-term use of itraconazole oral solution (i.e., longer than 6 months).

The recommended dosage of itraconazole oral solution for the treatment of esophageal candidiasis is 100 mg (10 mL) daily; however, depending on the patient’s response to the drug, a dosage up to 200 mg (20 mL) daily may be given. Oral itraconazole therapy should be administered for a minimum of 3 weeks in patients with esophageal candidiasis, and should be continued for 2 weeks after symptoms resolve.

Sporotrichosis

If itraconazole is used for the treatment of sporotrichosis, some clinicians recommend that adults receive an oral dosage of 100-200 mg once daily for 3-6 months for cutaneous or lymphocutaneous infections or an oral dosage of 200 mg twice daily for 12 months for osteoarticular infections.

Onychomycosis

For the treatment of onychomycosis (tinea unguium) of the toenails (with or without fingernail involvement), the recommended oral dosage of itraconazole capsules is 200 mg once daily for 12 consecutive weeks. A pulse-dosing regimen that involves administering itraconazole capsules in a dosage of 400 mg once daily for one week each month for 3 months also has been effective for the treatment of tinea unguium of the toenails.

For the treatment of onychomycosis involving only the fingernails, itraconazole capsules are given in a pulse-dosing regimen that involves administering 200 mg of the drug twice daily during the first week, no itraconazole during weeks 2-4, and 200 mg of itraconazole twice daily during the fifth week.

Empiric Therapy in Febrile Neutropenic Patients

For empiric therapy of presumed fungal infections in febrile neutropenic patients, itraconazole therapy is initiated with a dosage of 200 mg IV twice daily for 4 doses, then dosage is decreased to 200 mg IV once daily for up to 14 days; therapy should then be continued with itraconazole oral solution given in a dosage of 200 mg (20 mL) twice daily until clinically important neutropenia has resolved. Safety and efficacy of itraconazole administered for longer than 28 days for this indication are not known.

Prevention of Fungal Infections in HIV-infected Individuals

Primary Prophylaxis

If itraconazole is used for primary prophylaxis against cryptococcosis in HIV-infected adults and adolescents with CD+ T-cell counts less than 50/mm3, the Prevention of Opportunistic Infections Working Group of the US Public Health Service and the Infectious Diseases Society of America (USPHS/IDSA) recommends that oral itraconazole capsules be given in a dosage of 200 mg once daily. If itraconazole is used for primary prophylaxis against cryptococcosis in HIV-infected infants and children with severe immunosuppression, a dosage of 2-5 mg/kg orally every 12-24 hours is recommended by the USPHS/IDSA.

For primary prophylaxis against histoplasmosis in adults and adolescents with human immunodeficiency virus (HIV) infection and CD4+ T-cell counts less than 100/mm3, the USPHS/IDSA recommends that itraconazole capsules be given in a dosage of 200 mg once daily. For primary prophylaxis against histoplasmosis in HIV-infected infants and children with severe immunosuppression, a dosage of 2-5 mg/kg orally every 12-24 hours is recommended by the USPHS/IDSA.

Prevention of Recurrence

When itraconazole is used for long-term suppressive or maintenance therapy (secondary prophylaxis) to prevent recurrence or relapse of coccidioidomycosis or histoplasmosis in HIV-infected individuals whose fungal infection has been adequately treated, the USPHS/IDSA recommends that adults and adolescents receive oral itraconazole capsules in a dosage of 200 mg twice daily and that infants and children receive an oral dosage of dosage of 2-5 mg/kg every 12-48 hours.

When itraconazole is used for long-term suppressive or maintenance therapy (secondary prophylaxis) to prevent recurrence or relapse of cryptococcosis in HIV-infected individuals whose fungal infection has been adequately treated, the USPHS/IDSA recommends that adults and adolescents receive oral itraconazole capsules in a dosage of 200 mg once daily and that infants and children receive an oral dosage of 2-5 mg/kg every 12-24 hours.

When oral itraconazole is used for long-term suppressive or maintenance therapy (secondary prophylaxis) to prevent recurrence or relapse of mucocutaneous candidiasis, the USPHS/IDSA recommends that HIV-infected adults or adolescents with frequent or severe recurrences of oropharyngeal, esophageal, or vaginal candidiasis receive itraconazole oral solution in a dosage of 200 mg once daily and that HIV-infected infants and children with frequent or severe recurrences of esophageal candidiasis receive the oral solution in a dosage of 5 mg/kg once daily.

Suppressive or maintenance therapy to prevent recurrence or relapse of candidiasis, coccidioidomycosis, cryptococcosis, or histoplasmosis in HIV-infected individuals generally is continued for life. However, the USPHS/IDSA states that consideration can be given to discontinuing such therapy for prophylaxis against recurrence or relapse of cryptococcosis in certain individuals if immune recovery has occurred as a result of potent antiretroviral therapy.

• Dosage in Renal and Hepatic Impairment

Adjustment of oral itraconazole dosage in patients with renal impairment does not appear to be necessary. Itraconazole injection should not be administered to patients with renal impairment (i.e., creatinine clearance less than 30 mL/minute) since severe renal impairment reduces clearance of hydroxypropyl-b-cyclodextrin (an excipient contained in itraconazole injection).

While the effect of hepatic impairment on itraconazole pharmacokinetics currently remains to be elucidated, the manufacturer states that plasma concentrations of the drug should be monitored carefully in patients with such impairment.

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Spanish And French Translations Of Common Medication Words:

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Medications Medicamentos Médicaments
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Capsules Cápsulas Gélules
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Synonyms of Itraconazole *:

ITC, ITCZ, ITR, Itraconazol [Spanish], itraconazole, Itraconazolum [Latin], ITZ

* Official titles and synonyms used in the British, European, and US Pharmacopoeias. INNs in the other main official languages (French, Latin, and Spanish) have also been included in the list of synonyms where these differ from the English INN.

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Dosage forms of Itraconazole:

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Therapeutic classes of Itraconazole:

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