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Sporanox Injection

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Sporanox Injection

Sporanox Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sporanox (itraconazole) Injection is an antifungal agent used to treat a variety of fungal infections. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include nausea, vomiting, or diarrhea.

The recommended dose of Sporanox Injection is 200 mg twice daily for four doses, followed by 200 mg once daily for up to 14 days. Sporanox may interact with alfuzosin, benzodiazepines, statin drugs, conivaptan, eletriptan, eplerenone, ergot alkaloids, ivabradine, nisoldipine, ranolazine, vardenafil, calcium channel blockers, antibiotics, anti-seizure medicines, antiarrhythmics, chemotherapy drugs, immunosuppressants, HIV protease inhibitors, anti-diabetic drugs, halofantrine, alfentanil, fentanyl, solifenacin, buspirone, repaglinide, glucocorticosteroids, drugs for erectile dysfunction, trimetrexate, aripiprazole, trazodone, tolterodine, blood thinners, and cilostazol. Tell your doctor all medications and supplements you use. During pregnancy, Sporanox Injection should be used only if prescribed. This drug passes into breast milk. Consult your doctor before breastfeeding.

Our Sporanox (itraconazole) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sporanox Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

SPORANOX® (itraconazole injection) has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of SPORANOX® use should be reassessed. (See WARNINGS: Hepatic Effects and PRECAUTIONS: Hepatotoxicity and INFORMATION FOR PATIENTS.)

Adverse Events Reported in Trials in Patients with SPORANOX® (itraconazole injection) Injection

Adverse events considered at least possibly drug related are shown in Table 2 and are based on the experience of 360 patients treated with SPORANOX® (itraconazole injection) Injection in four pharmacokinetic, one uncontrolled and four active controlled studies where the control was amphotericin B or fluconazole. Nearly all patients were neutropenic or were otherwise immunocompromised and were treated empirically for febrile episodes, for documented systemic fungal infections, or in trials to determine pharmacokinetics. The dose of SPORANOX® (itraconazole injection) Injection was 200 mg twice daily for the first two days followed by a single daily dose of 200 mg for the remainder of the intravenous treatment period. The majority of patients received between 7 and 14 days of SPORANOX® (itraconazole injection) Injection.

Table 2 Summary of Possibly or Definitely Drug-Related Adverse Events Reported by ≥ 2% of Subjects

Adverse Event Total SPORANOX® Injection (N=360) % Comparative Studies
SPORANOX Injection (N=234) % Intravenous Fluconazole (N=32) % Intravenous Amphotericin B (N=202) %
Gastrointestinal system disorders
  Nausea 8 9 0 15
  Diarrhea 6 6 3 9
  Vomiting 4 6 0 10
  Abdominal pain 2 2 0 3
  Constipation 0 1 3 0
Metabolic and nutritional disorders
  Hypokalemia 5 8 0 29
  Alkaline phosphatase increased 1 2 3 2
  Serum creatinine increased 2 2 3 26
  Hypomagnesemia 1 1 0 5
  Blood urea nitrogen increased 0 1 0 7
  Fluid overload 0 0 0 3
  Hypocalcemia 0 0 0 3
Liver and biliary system disorders
  Bilirubinemia 4 6 9 3
  SGPT/ALT Increased 2 3 3 1
  Hepatic function abnormal 1 2 0 2
  Jaundice  1 2 0 0
  SGOT/AST increased 1 2 0 0
Body as a whole - General disorders
  Pain 1 2 0 0
  Rigors 0 0 0 34
  Fever 0 0 0 6
Skin and appendages disorders
  Rash 3 3 3 3
  Sweating increased 1 2 0 0
Respiratory system disorder
  Dyspnea 0 0 0 3
Central and peripheral nervous system disorders
  Dizziness 1 2 0 1
  Headache 2 2 0 3
Urinary system disorders
  Renal function abnormal 1 1 0 11
Application site disorder
  Application site reaction 4 0 0 0
Cardiovascular disorders, general
  Hypotension 0 0 0 3
  Hypertension 0 0 0 2
Heart rate and rhythm disorders
  Tachycardia 0 1 0 3
Vascular (extracardiac) disorders
  Vein disorder 3 0 0 0

The following adverse events occurred in less than 2% of patients in clinical trials of SPORANOX® (itraconazole injection) Injection: LDH increased, edema, albuminuria, hyperglycemia, and hepatitis.

Post-marketing Experience

Adverse drug reactions that have been identified during post-approval use of SPORANOX® (itraconazole injection) (all formulations) are listed in the table below. Because these reactions are reported voluntarily from a population of uncertain size, reliably estimating their frequency or establishing a causal relationship to drug exposure is not always possible.

Postmarketing Reports of Adverse Drug Reactions

Blood and lymphatic system disorders: Leukopenia, neutropenia, thrombocytopenia
Immune system disorders: Anaphylaxis; anaphylactic, anaphylactoid and allergic reactions; serum sickness; angioneurotic edema
Metabolism and nutrition disorders: Hypertriglyceridemia, hypokalemia
Nervous system disorders: Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness
Eye disorders: Visual disturbances, including vision blurred and diplopia
Ear and labyrinth disorders: Transient or permanent hearing loss, tinnitus
Cardiac disorders: Congestive heart failure
Respiratory, thoracic and mediastinal Pulmonary edema disorders:
Gastrointestinal disorders: Abdominal pain, vomiting, dyspepsia, nausea, diarrhea, constipation, dysgeusia
Hepato-biliary disorders: Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, reversible increases in hepatic enzymes
Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, leukocytoclastic vasculitis, erythemamultiforme, alopecia, photosensitivity, rash, urticaria, pruritus
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia
Renal and urinary disorders: Urinary incontinence, pollakiuria
Reproductive system and breast disorders: Menstrual disorders, erectile dysfunction
General disorders and administration site conditions: Peripheral edema

There is limited information on the use of SPORANOX® (itraconazole injection) during pregnancy. Cases of congenital abnormalities including skeletal, genitourinary tract, cardiovascular and ophthalmic malformations as well as chromosomal and multiple malformations have been reported during post-marketing experience. A causal relationship with SPORANOX® has not been established. (See CLINICAL PHARMACOLOGY: Special Populations, CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: DRUG INTERACTIONS for more information.)

Read the entire FDA prescribing information for Sporanox Injection (Itraconazole Injection) »

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