GI-Nausea, vomiting, elevated liver enzymes, GI disorders, diarrhea, abdominal pain, anorexia Body as whole- edema,fatigue, fever, malaise, myalgia.

Cardiovascular- hypertension, orthostatic hypotension, vasculitis.

Dermatologic- rasg, pruritus

CNS- headache, dizziness/Verigo, libido decreased, somnolence

Miscellaneous- hepatic functionabnormal, hypokalemia, albuminuria, impotence

Frequently reported adverse events- allergic reactions, rash, pruritus, urticaria, angioedema, and in rare cases

Stevens-Johnson syndrome

Coadmin of terfenadine, astemazole, cisapride, triazolam, or oral midazolam. Hypersen to the drug. Do not administer for treatment of onchomycosis to pregnant women or to women comtemplating pregnancy.

Special precautions:

Monitor hepatic enzme tests in patients with pre-existing hepatic disorders. Decreased gastric acidity.

Monitoring- monitor hepatic values in patients with pre-existing hepatic function abnormalites. Momitor hepatic enzyme test values periodically in all patients receiving continuous treatment for > 1 month or at any time patient develops signs or symptoms suggestive of liver dysfunction.

Decreased gastric acidity- under fasted conditions itraconazole absorption was decreased in presence of decreased gastric acidity. The absorption of itraconazole may be decreased with the concomittant administration of antacids or gastric secretion suppressors.

Warnings

Cultures- obtain specimen for fungal cultures and other relevent laboratory studies (wet mount, histopathology, serolgy) prior to therapy to isolate and identify causative organisms. Therapy may be instituted before the results of culture and other laboratory studies are known, However, once these results become available, adjust anti-infective therapy accordingly.

Hepatitis- if signs and symptoms consistent with liver disease that may be attributable to intraconazole discontinue the drug.

HIV- infected patients- because hypochlorhydria has occured in HIV-infected individuals, the absorption of itraconazole in these pastients may be decreased.

Pregnancy- use in pregnancy for systemic fungal infections only if the benefit outweighs the potential risks.

Lactation- itraconazole is excreted in breast milk, therefore do not administer to a nursing woman.

Children- safety and efficacy have not been established

Approved by FDA on Sept 11,1992

Approved by (DCI) Drug Controller  GENERAL -  India  For Marketing                                                                                   (Ref- IDMA Publication)

Indications- Fungal infections Antifungal- Blastomycosis, Histoplasmosis, Aspergillosis, Onychomycosis Approved by FDA on Sept 11,1992

Dosage: recommended daily dose - 200mg once daily. May be increased in 100mg increments to a maximum of 400mg daily.

Overdosage-

1. Itraconazole is not removed by dialysis.

2. In the event of accidental overdosage, employ supportive neasures, including sodium bicarbonate

Missed dose

1. If you miss a dose of this medicine, take it as soon as possible.

2. However, if it is almost time for next dose, skip the missed dose and go back to your regular dosing schedule.

3. Do not double doses.

Refer Ketoconazole

1. Take itraconazole on a full meal.

2. Report any signs and symptoms that may suggest liver dysfunction eg. unusual fatigue, anorexia, nausea, vomiting, jaundice, dark urine or pale stool.

Pharmacology:

Itraconazole is a potent inhibitor of most human fungal pathogens. It inhibits the synthesis of ergosterol which is the primary celluar sterol in fungi. Inhibition of ergosterol synthesis results in abnormalites of membrane permeability, membrane- bound enzyme activity and coordination of chitin synthesis.

Pharmacokinetics:

Oral bioavailability of itraconazole is 55% because of first pass metabolism. Peak plasma levels after a 100mg dose taken with food have been reported to be 130 to 250mcg/L. Itraconazole is extensively metabolised in the liver. Excretion is through bile and urine, and elimination half-life of intraconazole is 20h.

Absorption of itraconazole was increased when coadministred with a cola beverage with AUC and Cmax increasing 75% and 95% repy.

Pregnancy: Use in pregnancy for systemic fungal infections only if the benefit the hazards.

Lactation: Do not administer to a nursing woman.

Children- Safety and efficacy have not been established