Patriot Pharmaceuticals

Patriot Pharmaceuticals Drugs

• Ultiva
  

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  Ultiva

  

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  Itraconazole Capsules should be taken with a full meal to ensure maximal absorption. Itraconazole Capsules must be swallowed whole.

  Itraconazole Capsules are a different preparation than SPORANOX® (itraconazole) Oral Solution and should not be used interchangeably.

  Treatment of Blastomycosis and Histoplasmosis

  The recommended dose is 200 mg once daily (2 capsules). If there is no obvious improvement, or there is evidence of progressive fungal disease, the dose should be increased in 100-mg increments to a maximum of 400 mg daily. Doses above 200 mg/day should be given in two divided doses.

  Treatment of Aspergillosis

  A daily dose of 200 to 400 mg is recommended.

  Treatment in Life-Threatening Situations

  In life-threatening situations, a loading dose should be used.

  Although clinical studies did not provide for a loading dose, it is recommended, based on pharmacokinetic data, that a loading dose of 200 mg (2 capsules) three times daily (600 mg/day) be given for the first 3 days of treatment.

  Treatment should be continued for a minimum of three months and until clinical parameters and laboratory tests indicate that the active fungal infection has subsided. An inadequate period of treatment may lead to recurrence of active infection.

  Itraconazole Capsules and SPORANOX® (itraconazole) Oral Solution should not be used interchangeably. Only the oral solution has been demonstrated effective for oral and/or esophageal candidiasis.

  Treatment of Onychomycosis

  Toenails with or without fingernail involvement: The recommended dose is 200 mg (2 capsules) once daily for 12 consecutive weeks.

  Treatment of Onychomycosis

  Fingernails only: The recommended dosing regimen is 2 treatment pulses, each consisting of 200 mg (2 capsules) b.i.d. (400 mg/day) for 1 week. The pulses are separated by a 3-week period without itraconazole.

  Use in Patients with Renal Impairment

  Limited data are available on the use of oral itraconazole in patients with renal impairment. Caution should be exercised when this drug is administered in this patient population. (See CLINICAL PHARMACOLOGY: Special Populations and PRECAUTIONS.)

  Use in Patients with Hepatic Impairment

  Limited data are available on the use of oral itraconazole in patients with hepatic impairment. Caution should be exercised when this drug is administered in this patient population. (See CLINICAL PHARMACOLOGY: Special Populations, WARNINGS, and PRECAUTIONS.)

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