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Order No Prescription Sporanox (Itraconazole) 100mg

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Itraconazole is authorised in the world under the following brand names: Hyphanox, Itrizole, Oriconazole, Sporal, Sporanos, Sporanox, Sporonox, Triasporn.

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Itraconazole: Statins

Itraconazole increases the risk of skeletal muscle toxicity of some statins by increasing their serum concentrations, but not all statins are equally affected. Concomitant use of atorvastatin, lovastatin, and simvastatin with itraconazole should be avoided or the doses should be reduced; fluvastatin and pravastatin have much less potential than other statins for clinically significant interactions with itraconazole and other CYP3A4 inhibitors; the effects of cerivastatin are intermediate.

In a randomized, open, three-way, crossover study, 18 healthy subjects took single doses of cerivastatin 0.8 mg, atorvastatin 20 mg, or pravastatin 40 mg without or with itraconazole 200 mg. Concomitant cerivastatin + itraconazole and pravastatin + itraconazole produced small increases in AUC, Cmax, and half-life (up to 51%, 25%, and 23% respectively). However, itraconazole markedly increased atorvastatin AUC (150%), Cmax (38%), and half-life (30%). Thus, itraconazole markedly increases systemic exposure to atorvastatin, but results in only modest increases in the plasma concentrations of cerivastatin and pravastatin.

Atorvastatin

Itraconazole increases serum concentrations of atorvastatin by inhibiting CYP3A4. In a randomized, double-blind, crossover study in 10 healthy volunteers,itraconazole 200 mg increased the AUC and half-life of atorvastatin 40 mg about three-fold, with a change in Cmax. The AUC of atorvastatin lactone was increased about 4-fold, and the Cmax and half-life were increased more than 2-fold. Itraconazole significantly reduced the Cmax and AUC of 2-hydroxyatorvastatin acid and 2-hydroxyatorvastatin lactone and increased the half-life of 2-hydroxyatorvastatin lactone. The concomitant use of itraconazole and other potent inhibitors of CYP3A4 with atorvastatin should therefore be avoided, or the dose of atorvastatin should be reduced accordingly.

Cerivastatin

Cerivastatin uses a secondary CYP2C8-mediated metabolic pathway, which is unaffected by itraconazole. The effects of itraconazole on the pharmacokinetics of cerivastatin and its major metabolites have been investigated in a randomized, double-blind, crossover study. Inhibition of the CYP3A4-mediated M-l pathway led to raised serum concentrations of cerivastatin, cerivastatin lactone, and metabolite M-23, resulting in increased concentrations of active HMG-CoA reductase inhibitors. However, the effect was modest.

Fluvastatin

The effects of itraconazole 100 mg on the pharmacokinetics of fluvastatin 40 mg have been studied in a randomized, placebo-controlled, crossover study in 10 healthy volunteers. Itraconazole had no significant effect on the Cmax or total AUC of fluvastatin, but slightly prolonged its half-life.

Lovastatin

The effects of itraconazole 100 mg on the pharmacokinetics of lovastatin 40 mg have been studied in a randomized, placebo-controlled, crossover study in 10 healthy volunteers. Itraconazole, even in this low dosage, greatly increased plasma concentrations of lovastatin and its active metabolite, lovastatin acid, and increased the Cmax of lovastatin about 15-fold and the total AUC by more than 15-fold; similarly, the Cmax and total AUC of lovastatin acid were increased about 12-fold and 15-fold respectively.

Pravastatin

The effects of itraconazole 200 mg on the pharmacokinetics of pravastatin have been studied in a randomized, double-blind, crossover study in 10 healthy volunteers. Itraconazole slightly increased the AUC and Cmax of pravastatin, but the changes were not statistically significant; the half-life was not altered.

Simvastatin

The effects of itraconazole 200 mg on the pharmacokinetics of simvastatin have been studied in a randomized, double-blind, crossover study in 10 healthy volunteers. Itraconazole increased the Cmax and AUC of simvastatin and simvastatin acid at least 10-fold. The Cmax and AUC of total simvastatin acid (naive simvastatin acid plus that derived by hydrolysis of the lactone) were increased 17-fold and 19-fold respectively, and the half-life was increased by 25%.

In two cases, rhabdomyolysis was caused by itraconazole in heart transplant recipients taking long-term ciclosporin and simvastatin. To avoid severe myo-pathy, ciclosporin concentrations should be monitored frequently and statins should be withdrawn or the dosage should be reduced, as long as azoles need to be prescribed in transplant recipients. Patients need to be educated about signs and symptoms that require immediate physician intervention.

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Synonyms of Itraconazole:

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

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