ZITHROMAX 500 mg tablets are engraved with "Pfizer" on one side and "ZTM500" on the other. The oral bioavailability of itraconazole is maximal when SPORANOX ® (itraconazole) Capsules are taken with a full meal. �^�*��ty�r/��.U�r�N!%NunN?n���V��������z8X�mV�13��0���luK/��� �3��1�|��{Ѝeƒ^� {z��� ��s3�ˉ$x��3�/��r]P�UB2k͢�*EL0���@���2 ]:F������$�+(u�L��|�E�P�� ��Q �A����[��b�*Ẅথ�)�킛��LC��H�ͳ�P��-Y�L�V#�a�9�2�i� 81% of subjects treated with TOLSURA achieved a C trough mean level of >1000 ng/mL compared to 44% taking conventional itraconazole capsules *Although the active substance, pharmaceutical form, and route of administration are the same, due to the increased drug absorption seen with TOLSURA 65 mg capsules, it should not be used interchangeably with other formulations of itraconazole. 0000016362 00000 n 0000029600 00000 n x�b```b``�``�� cc`a��R� 0000008147 00000 n 0000017575 00000 n Steady state trough concentrations >250ng/mL were achieved in 6 out of 11 patients ≥ 16 years of age but in none of the 5 patients <16 years of age. The drug’s labeling is truthful and not misleading. %%EOF Adults—200 milligrams (mg) 2 times a day for 1 week, followed by a no treatment period of 3 weeks, then 200 mg 2 times a day for 1 week. As long as the drug company markets the animal drug, the agency continues to monitor:While itraconazole is considered less toxic than many other drugs in the same class, such as ketoconazole and clotrimazole, there’s still a risk for adverse drug events and drug interactions. Keep the bottle upright and insert the dosing syringe through the opening of the top of the bottle ().Do not invert the bottle ().Fill the syringe by pulling the plunger until it reaches the graduation corresponding to the correct mL dose as indicated at the top of the syringe ring (). 0 As part of the approval process, the drug company must prove to FDA that:FDA’s role does not stop after the agency approves an animal drug. <<22A693E70B625E4580CA7E1C7AB02D1E>]>> It may be represented by the following structural formula and nomenclature:3H-1,2,4-Triazol-3-one,4-[4-[4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-2-4-dihydro-2-(1-methylpropyl)-or(±)-1-sec-Butyl-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-di… 0000014111 00000 n
0000030455 00000 n %PDF-1.5 %���� 0000005778 00000 n itraconazole oral solution 2.5 mg/kg bid for 14 days in a pharmacokinetic study. 1931 0 obj <>stream 1895 37 As part of the approval process, the drug company must prove to FDA that: 1.
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Itraconazole side effects.
Adverse drug events reported for ITRAFUNGOL in cats include decreased appetite, vomiting, diarrhea, increased salivation, and elevated hepatic enzymes.ITRAFUNGOL is a cytochrome p-450 inhibitor and may increase or prolong plasma concentrations of other drugs metabolized by this pathway, such as amitriptyline, amlodipine, benzodiazepines, buspirone, cisapride, corticosteroids, cyclosporine, ivermectin, and macrolide antibiotics.FDA is aware that itraconazole is currently the treatment of choice for many systemic fungal infections in animals and alternative oral treatments are lacking.Itraconazole is highly lipophilic and practically insoluble in water.Because of the documented variations in drug absorption and poor bioavailability of oral formulations of itraconazole compounded from bulk drug substances, FDA recommends that you prescribe FDA-approved ITRAFUNGOL for cats that need to be treated with itraconazole. Itraconazole is an azole antifungal agent.
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0000026437 00000 n Children—Use and dose must be determined by your doctor. An official website of the United States government: 0000016964 00000 n 0000003646 00000 n Sixteen patients completed the study.
The pharmacokinetics of itraconazole were studied in 6 healthy male volunteers who received, in a crossover design, single 100-mg doses of itraconazole as a polyethylene glycol capsule, with or without a full meal. 0000002039 00000 n
0000008716 00000 n 0000006807 00000 n 0000012547 00000 n The labeling for ITRAFUNGOL is written specifically for cats and includes all necessary information, including associated risks, so you can use the drug safely and effectively in cats. xref
0000026671 00000 n FDA’s role does not stop after the agency approves an animal drug. 0000029639 00000 n As long as the drug company markets t…
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0000006577 00000 n 0000010012 00000 n 0000001061 00000 n 0000006071 00000 n 0000026928 00000 n Get emergency medical help if you have signs of an allergic reaction: hives, severe skin rash, tingling in your arms or legs; difficult breathing; swelling of your face, lips, tongue, or throat.. Stop using itraconazole and call your doctor at once if you have signs of congestive heart failure: feeling tired or short of breath, cough with mucus, fast … 0000002584 00000 n
Product Safety Information