Sporanox Oral Solution

DRUG DESCRIPTION

SPORANOX® is the brand name for itraconazole, a synthetic triazole antifungal agent. Itraconazole is a 1:1:1:1 racemic mixture of four diastereomers (two enantiomeric pairs), each possessing three chiral centers. It may be represented by the following structural formula and nomenclature:

SPORANOX®
  (itraconazole) Oral Solution Structural Formula Illustration

(±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2R*,4S*)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1ylmethyl)- 1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-?2-1,2,4-triazolin-5-one mixture with (±)-1-[(R*)-sec-butyl]-4-[p-[4-[p-[[(2S*,4R*)-2-(2,4-dichlorophenyl)-2-(1H 1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-?2-1,2,4-triazolin-5-one

or

(±)-1-[(RS)-sec-butyl]-4-[p-[4-[p-[[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1ylmethyl)- 1,3-dioxolan-4-yl]methoxy]phenyl]-1-piperazinyl]phenyl]-?2-1,2,4-triazolin-5-one.

Itraconazole has a molecular formula of C35H38Cl2N8O4 and a molecular weight of 705.64. It is a white to slightly yellowish powder. It is insoluble in water, very slightly soluble in alcohols, and freely soluble in dichloromethane. It has a pKa of 3.70 (based on extrapolation of values obtained from methanolic solutions) and a log (n-octanol/water) partition coefficient of 5.66 at pHS.l.

SPORANOX® (itraconazole) Oral Solution contains 10 mg of itraconazole per mL, solubilized by hydroxypropyl-?-cyclodextrin (400 mg/mL) as a molecular inclusion complex. SPORANOX® Oral Solution is clear and yellowish in color with a target pH of 2. Other ingredients are hydrochloric acid, propylene glycol, purified water, sodium hydroxide, sodium saccharin, sorbitol, cherry flavor 1, cherry flavor 2 and caramel flavor.

What are the possible side effects of itraconazole (Sporanox)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • problems with hearing;
  • numbness or tingly feeling;
  • pain or burning when you urinate; or
  • nausea, stomach pain, low fever, loss of appetite,...

Read All Potential Side Effects and See Pictures of Sporanox Oral Solution »


Sporanox Oral Solution Patient Information Including Side Effects

Brand Names: Sporanox

Generic Name: itraconazole (Pronunciation: IT ra KON a zole)

  • What is itraconazole (Sporanox Oral Solution)?
  • What are the possible side effects of itraconazole (Sporanox Oral Solution)?
  • What is the most important information I should know about itraconazole (Sporanox Oral Solution)?
  • What should I discuss with my healthcare provider before taking itraconazole (Sporanox Oral Solution)?
  • How should I take itraconazole (Sporanox Oral Solution)?
  • What happens if I miss a dose (Sporanox Oral Solution)?
  • What happens if I overdose (Sporanox Oral Solution)?
  • What should I avoid while taking itraconazole (Sporanox Oral Solution)?
  • What other drugs will affect itraconazole (Sporanox Oral Solution)?
  • Where can I get more information?

What is itraconazole (Sporanox Oral Solution)?

Itraconazole is an antifungal medication.

Itraconazole is used to treat infections caused by fungus, which can invade any part of the body including the lungs, mouth or throat, toenails, or fingernails.

Itraconazole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of itraconazole (Sporanox Oral Solution)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fever;
  • feeling short of breath, even with mild exertion;
  • swelling, rapid weight gain;
  • problems with hearing;
  • numbness or tingly feeling;
  • pain or burning when you urinate; or
  • nausea, stomach pain, low fever, loss of appetite, weakness, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • diarrhea, constipation, mild stomach pain;
  • mild itching or skin rash;
  • headache, dizziness; or
  • runny nose or other cold symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about itraconazole (Sporanox Oral Solution)?

Do not take this medication if you are allergic to itraconazole or similar medications such as fluconazole (Diflucan) or ketoconazole (Nizoral), if you have ever had congestive heart failure, or if you are pregnant or may become pregnant during treatment.

You should not take itraconazole together with cisapride (Propulsid), dihydroergotamine (D.H.E. 45, Migranal), dofetilide (Tikosyn), ergonovine (Ergotrate), ergotamine (Ergomar), lovastatin (Altocor, Altoprev, Mevacor), methylergonovine (Methergine), midazolam (Versed), nisoldipine (Sular), pimozide (Orap), quinidine (Quinaglute, Quinidex, Quin-Release), simvastatin (Zocor), or triazolam (Halcion).

Other drugs that should not be taken together with itraconazole include astemizole (Hismanal), or levomethadyl Orlaam) (these drugs are no longer available in the U.S.).

There are many other medicines that can interact with itraconazole. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Before taking itraconazole, tell your doctor if you have heart disease, a history of stroke, a heart rhythm disorder, kidney or liver disease, a breathing disorder, cystic fibrosis, or a history of "Long QT syndrome."

Itraconazole capsules should not be used in place of itraconazole oral solution (liquid) if that is what your doctor has prescribed. Make sure you have received the correct type of this medication at the pharmacy and ask the pharmacist if you have any questions.

Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Call your doctor if your symptoms do not improve.

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