itraconazole

REMS

CapsulesTreatment of the following fungal infections in immunocompromised or nonimmunocompromised patients:
- Histoplasmosis,
- Blastomycosis,
- Aspergillosis in patients refractory or intolerant to amphotericin B,
- Onychomycosis of fingernails,
- Onychomycosis of toenails.
Oral solutionOropharyngeal and esophageal candidiasis.

Contraindicated in:

Hypersensitivity;
Cross-sensitivity with other azole antifungals (miconazole, ketoconazole) may occur;
Concurrent use of avanafil, dofetilide, disopyramide, dronedarone, eplerenone, ergot alkaloids, felodipine, finerenone, irinotecan, isavuconazonium, ivabradine, lomitapide, lovastatin, lurasidone, methadone, midazolam (PO), nisoldipine, pimozide, quinidine, ranolazine, simvastatin, ticagrelor, triazolam, or voclosporin;
Concurrent use of colchicine, fesoterodine, or solifenacin in patients with varying degrees of hepatic or renal impairment;
Concurrent use of eliglustat in patients who are poor or intermediate CYP2D6 metabolizers or patients taking moderate or strong CYP2D6 inhibitors;
Concurrent use of venetoclax in patients with chronic lymphocytic leukemia or small lymphocytic leukemia during the initiation and ramp-up phase of venetoclax;
HF or other evidence of left ventricular dysfunction.

Use Cautiously in:

Hepatic impairment (dose ↓ may be required);
Renal impairment;
Achlorhydria or hypochlorhydria (absorption will be ↓);
Immunocompromised patients (may have ↓ bioavailability);
OB: Use for systemic infections during pregnancy only if potential maternal benefit justifies potential fetal risk. Should not be used for treatment of onychomycosis in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Rep: Should not be used for treatment of onychomycosis in women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk of hearing loss in older adults.

CV: edema, HF, hypertension

Derm: photosensitivity, pruritus, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS

EENT: hearing loss, tinnitus

Endo: adrenal insufficiency, pseudoaldosteronism

F and E: hypokalemia

GI: nausea, abdominal pain, anorexia, diarrhea, flatulence, HEPATOTOXICITY, vomiting

GU: ↓libido, albuminuria, erectile dysfunction

MS: RHABDOMYOLYSIS

Neuro: dizziness, drowsiness, fatigue, headache, malaise, neuropathy

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Drug-drug:

↑risk of potentially fatal arrhythmias with quinidine, dofetilide, methadone, disopyramide, dronedarone, or pimozide; concurrent use contraindicated.
↑risk of excessive sedation with midazolam (PO) or triazolam; concurrent use contraindicated.
↑risk of adverse CNS reactions with pimozide; concurrent use contraindicated.
↑risk of myopathy with lomitapide, simvastatin, or lovastatin; concurrent use contraindicated.
↑risk of vasoconstriction with ergot alkaloids (dihydroergotamine, ergotamine, methylergonovine); concurrent use contraindicated.
Significantly ↑ avanafil, nisoldipine, felodipine, isavuconazonium, lurasidone, ranolazine, eplerenone, finerenone, voclosporin, and irinotecan levels and risk of toxicity; concurrent use contraindicated.
Significantly ↑ colchicine, fesoterodine, and solifenacin levels and risk of toxicity in patients with varying degrees of hepatic or renal impairment; concurrent use contraindicated.
Significantly ↑ eliglustat levels and risk of toxicity in patients who are poor or intermediate CYP2D6 metabolizers or those taking moderate or strong CYP2D6 inhibitors; concurrent use contraindicated.
↑risk of bradycardia and heart block with ivabradine; concurrent use contraindicated.
↑risk of tumor lysis syndrome with venetoclax during initiation and ramp-up phase of venetoclax in patients with chronic lymphocytic leukemia or small lymphocytic leukemia; concurrent use during these dosing phases contraindicated.
May ↑ levels and risk of toxicity of alprazolam, aripiprazole, atorvastatin, axitinib, bortezomib, budesonide, buspirone, busulfan, carbamazepine, cariprazine, cilostazol, clarithromycin, cobicistat, cyclosporine, dabrafenib, dasatinib, dexamethasone, diazepam, digoxin, docetaxel, elbasvir/grazoprevir, eletriptan, entrectinib, erlotinib, erythromycin, fentanyl, fluticasone, gefitinib, glecaprevir/pibrentasvir, haloperidol, ibrutinib, imatinib, ivacaftor, ixabepilone, lapatinib, lumacaftor/ivacaftor, methylprednisolone, midazolam, mobocertinib, nilotinib, oral hypoglycemic agents, pemigatinib, ponatinib, quetiapine, ramelteon, rifabutin, risperidone, ritonavir, sirolimus, sunitinib, suvorexant, tacrolimus, talazoparib, tenofovir disoproxil fumarate, trabectedin, tretinoin (oral), vinca alkaloids, and warfarin.
May ↑ levels and the negative inotropic effects of calcium channel blockers.
Absorption of tablets, 200-mg capsules, and oral solution ↓ by antacids, H2 blockers, sucralfate, proton pump inhibitors, or other agents that increase gastric pH (take ≥1 hr before or 2 hr after itraconazole).
Antacids, histamine H2 blockers, sucralfate, proton pump inhibitors, or other agents that gastric pH may ↑ levels of 65-mg capsules; may need to ↓ itraconazole dose.
Phenytoin, phenobarbital, nevirapine, isoniazid, rifampin, rifabutin, efavirenz, and carbamazepine may ↓ levels and effectiveness; ↑ itraconazole dose.
If hypokalemia occurs, the risk of digoxin toxicity is ↑.

Drug-Food:

Food↑ absorption.

(Generic available)

Capsules: 65 mg; 100 mg
Oral solutioncherry caramel: 10 mg/mL

65-mg tablets are NOT interchangeable with other products.

Aspergillosis

PO (Adults ): 200 mg once or twice daily for ≥3 mo OR 130 mg once or twice daily for ≥3 mo.

Blastomycosis, Histoplasmosis

PO (Adults ): 200 mg once daily; may be ↑ by 100 mg/day up to 200 mg twice daily; continue therapy for ≥ 3 mo; OR 130 mg once daily; may be ↑ by 65 mg/day up to 130 mg twice daily; continue therapy for ≥3 mo.

Onychomycosis

PO (Adults ): Toenail fungus: 200 mg once daily for 12 consecutive wk. Fingernail fungus: 200 mg twice daily for 1 wk; then 3 wk without therapy; then 200 mg twice daily an additional wk–6 mo.

Candidiasis

PO (Adults ): Oropharyngeal candidiasis: 200 mg (20 mL) daily for 1–2 wk. Oropharyngeal candidiasis unresponsive to fluconazole: 100 mg (10 mL) twice daily for at least 2–4 wk. Esophageal candidiasis: 100 mg (10 mL) once daily for at least 3 wk.

~~Onmel,~~ Sporanox, Tolsura

Inhibits enzymes necessary for integrity of the fungal cell membrane.

Therapeutic effects:

Fungistatic effects against susceptible organisms.

Spectrum:

Active against Histoplasma capsulatum, Histoplasma duboisii, Blastomyces dermatitidis, Aspergillus flavus, Aspergillus fumigatus, Candida albicans, and Tinea unguium.

Therapeutic Classification: antifungals (systemic)

Pharmacologic Classification: azoles

Absorption: Absorption is enhanced by food.

Distribution: Tissue concentrations are higher than plasma concentrations. Does not enter CSF.

Protein Binding: Itraconazole: 99.8%; hydroxyitraconazole: 99.5%.

Metabolism/Excretion: Mostly metabolized by the liver by the CYP3A4 isoenzyme and excreted in feces. Hydroxyitraconazole, the major metabolite, has antifungal activity.

Half-Life: 21 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	rapid	4 hr	12–24 hr

Explain purpose and side effects of itraconazole to patient. Instruct patient to take medication as directed, even if feeling better. Doses should be taken at the same time each day. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
May occasionally cause drowsiness, dizziness, or blurred vision. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Instruct patient to notify health care professional immediately if signs and symptoms of liver dysfunction (unusual fatigue, ↓ appetite, nausea, vomiting, jaundice, dark urine, pale stools), HF (shortness of breath, swelling, weight gain), or peripheral neuropathy (numbness/tingling in hands feet) occur.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Advise patient to use sunscreen and wear protective clothing to prevent photosensitivity reactions.
May cause hearing loss; usually resolves when treatment is stopped but can persist. Advise patient to discontinue therapy and notify health care professional if any hearing loss symptoms occur.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraception during therapy and for 2 mo after last dose and to avoid breastfeeding during therapy. Advise patient to notify health care professional if pregnancy is planned or suspected.

NDC Code

10147- Patriot Pharmaceuticals
- 10147-1700- itraconazole
  - 10147-1700-3- 30 CAPSULE in 1 BOTTLE (10147-1700-3)

12578- Janssen Pharmaceutica NV
- 12578-299-
  - 12578-299-00- 25 kg in 1 DRUM (12578-299-00)

13668- Torrent Pharmaceuticals Limited
- 13668-463- Itraconazole
  - 13668-463-05- 500 CAPSULE in 1 BOTTLE (13668-463-05)

13668- Torrent Pharmaceuticals Limited
- 13668-463- Itraconazole
  - 13668-463-30- 30 CAPSULE in 1 BOTTLE (13668-463-30)

13668- Torrent Pharmaceuticals Limited
- 13668-463- Itraconazole
  - 13668-463-37- 28 CAPSULE in 1 CARTON (13668-463-37)

13668- Torrent Pharmaceuticals Limited
- 13668-463- Itraconazole
  - 13668-463-90- 90 CAPSULE in 1 BOTTLE (13668-463-90)

16571- Rising Pharma Holdings, Inc.
- 16571-245- Itraconazole
  - 16571-245-03- 30 CAPSULE in 1 BOTTLE (16571-245-03)

16714- NorthStar RxLLC
- 16714-743- Itraconazole
  - 16714-743-01- 7 BLISTER PACK in 1 CARTON (16714-743-01) / 4 CAPSULE, COATED PELLETS in 1 BLISTER PACK

16714- NorthStar RxLLC
- 16714-743- Itraconazole
  - 16714-743-02- 30 CAPSULE, COATED PELLETS in 1 BOTTLE (16714-743-02)

17511- COHANCE LIFESCIENCES LIMITED
- 17511-114-
  - 17511-114-06- 1 kg in 1 DRUM (17511-114-06)

22568- W. R. Grace & Co.-Conn.
- 22568-1108-
  - 22568-1108-1- 20 kg in 1 DRUM (22568-1108-1)

31722- Camber Pharmaceuticals, Inc.
- 31722-006- Itraconazole
  31722-006-31- 1 BOTTLE, GLASS in 1 CARTON (31722-006-31) / 150 mL in 1 BOTTLE, GLASS

38779- Medisca Inc.
- 38779-2759-
  - 38779-2759-1- 10 g in 1 JAR (38779-2759-1)

38779- Medisca Inc.
- 38779-2759-
  38779-2759-3- 5 g in 1 BOTTLE, GLASS (38779-2759-3)

38779- Medisca Inc.
- 38779-2759-
  38779-2759-4- 25 g in 1 JAR (38779-2759-4)

38779- Medisca Inc.
- 38779-2759-
  38779-2759-5- 100 g in 1 JAR (38779-2759-5)

38779- Medisca Inc.
- 38779-2759-
  38779-2759-9- 1000 g in 1 JAR (38779-2759-9)

46708- Alembic Pharmaceuticals Limited
- 46708-204- ITRACONAZOLE
  46708-204-04- 28 CAPSULE in 1 CARTON (46708-204-04)

46708- Alembic Pharmaceuticals Limited
- 46708-204- ITRACONAZOLE
  - 46708-204-10- 100 CAPSULE in 1 CARTON (46708-204-10)

46708- Alembic Pharmaceuticals Limited
- 46708-204- ITRACONAZOLE
  - 46708-204-30- 30 CAPSULE in 1 BOTTLE (46708-204-30)

46708- Alembic Pharmaceuticals Limited
- 46708-204- ITRACONAZOLE
  - 46708-204-71- 500 CAPSULE in 1 BOTTLE (46708-204-71)

46708- Alembic Pharmaceuticals Limited
- 46708-204- ITRACONAZOLE
  - 46708-204-90- 90 CAPSULE in 1 BOTTLE (46708-204-90)

50268- AvPAK
- 50268-450- Itraconazole
  - 50268-450-12- 20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-450-12) / 1 CAPSULE in 1 BLISTER PACK (50268-450-11)

50458- Janssen Pharmaceuticals, Inc.
- 50458-290- SPORANOX
  - 50458-290-01- 3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACK

50458- Janssen Pharmaceuticals, Inc.
- 50458-290- SPORANOX
  - 50458-290-04- 30 CAPSULE in 1 BOTTLE (50458-290-04)

51862- Mayne Pharma Commercial LLC
- 51862-462- Tolsura
  - 51862-462-60- 60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)

53069- Quimica Sintetica S.A.
- 53069-0450-
  - 53069-0450-5- 25 kg in 1 DRUM (53069-0450-5)

58032- Neuland Laboratories Limited
- 58032-0110-
  58032-0110-0- 1 kg in 1 DRUM (58032-0110-0)

59349- Derivados Quimicos SAU
- 59349-0012-
  59349-0012-0- 1 BAG in 1 DRUM (59349-0012-0) / 1 BAG in 1 BAG / 25 kg in 1 BAG

60592- Kalchem International inc
- 60592-318-
  60592-318-10- 1000 g in 1 BOTTLE (60592-318-10)

60687- American Health Packaging
- 60687-299- Itraconazole
  60687-299-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-299-25) / 1 CAPSULE in 1 BLISTER PACK (60687-299-95)

62332- Alembic Pharmaceuticals Inc.
- 62332-204- ITRACONAZOLE
  - 62332-204-04- 28 CAPSULE in 1 CARTON (62332-204-04)

62332- Alembic Pharmaceuticals Inc.
- 62332-204- ITRACONAZOLE
  - 62332-204-10- 100 CAPSULE in 1 CARTON (62332-204-10)

62332- Alembic Pharmaceuticals Inc.
- 62332-204- ITRACONAZOLE
  - 62332-204-30- 30 CAPSULE in 1 BOTTLE (62332-204-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-204- ITRACONAZOLE
  - 62332-204-71- 500 CAPSULE in 1 BOTTLE (62332-204-71)

62332- Alembic Pharmaceuticals Inc.
- 62332-204- ITRACONAZOLE
  - 62332-204-90- 90 CAPSULE in 1 BOTTLE (62332-204-90)

62991- LETCO MEDICAL, LLC
- 62991-3078-
  - 62991-3078-1- 5 g in 1 JAR (62991-3078-1)

62991- LETCO MEDICAL, LLC
- 62991-3078-
  62991-3078-2- 25 g in 1 JAR (62991-3078-2)

62991- LETCO MEDICAL, LLC
- 62991-3078-
  62991-3078-3- 100 g in 1 JAR (62991-3078-3)

62991- LETCO MEDICAL, LLC
- 62991-3078-
  62991-3078-4- 1000 g in 1 JAR (62991-3078-4)

65015- MYLAN LABORATORIES LIMITED
- 65015-624-
  65015-624-61- 100 kg in 1 DRUM (65015-624-61)

65162- Amneal Pharmaceuticals LLC
- 65162-087- Itraconazole
  65162-087-34- 10 CUP, UNIT-DOSE in 1 TRAY (65162-087-34) / 10 mL in 1 CUP, UNIT-DOSE (65162-087-13)

65162- Amneal Pharmaceuticals LLC
- 65162-087- Itraconazole
  - 65162-087-74- 150 mL in 1 BOTTLE, GLASS (65162-087-74)

65162- Amneal Pharmaceuticals LLC
- 65162-630- Itraconazole
  - 65162-630-03- 30 CAPSULE in 1 BOTTLE (65162-630-03)

66039- Glenmark Life Sciences Limited
- 66039-815-
  - 66039-815-02- 50 kg in 1 DRUM (66039-815-02)

66577- Vasudha Pharma Chem Limited
- 66577-044-
  66577-044-01- 25 kg in 1 DRUM (66577-044-01)

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-1- 1 BAG in 1 BAG (67835-5043-1) / .005 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-2- 1 BAG in 1 BAG (67835-5043-2) / .05 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-3- 1 BAG in 1 BAG (67835-5043-3) / .1 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-4- 1 BAG in 1 DRUM (67835-5043-4) / 1 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-5- 1 BAG in 1 DRUM (67835-5043-5) / 5 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-6- 1 BAG in 1 DRUM (67835-5043-6) / 10 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-7- 1 BAG in 1 DRUM (67835-5043-7) / 15 kg in 1 BAG

67835- SMS Pharmaceuticals Limited
- 67835-5043-
  67835-5043-8- 1 BAG in 1 DRUM (67835-5043-8) / 20 kg in 1 BAG

67877- Ascend Laboratories, LLC
- 67877-454- Itraconazole
  67877-454-05- 500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-05)

67877- Ascend Laboratories, LLC
- 67877-454- Itraconazole
  - 67877-454-30- 30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-30)

67877- Ascend Laboratories, LLC
- 67877-454- Itraconazole
  - 67877-454-84- 3 BLISTER PACK in 1 CARTON (67877-454-84) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK (67877-454-33)

67877- Ascend Laboratories, LLC
- 67877-454- Itraconazole
  - 67877-454-90- 90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-454-90)

69339- Natco Pharma USA LLC
- 69339-159- Itraconazole Oral
  - 69339-159-17- 40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)

71052- DARMERICA, LLC
- 71052-301-
  - 71052-301-10- 100 g in 1 CONTAINER (71052-301-10)

71052- DARMERICA, LLC
- 71052-301-
  71052-301-50- 500 g in 1 CONTAINER (71052-301-50)

71747- Smilax Laboratories Limited
- 71747-002-
  71747-002-15- 15 kg in 1 DRUM (71747-002-15)

71747- Smilax Laboratories Limited
- 71747-002-
  71747-002-25- 25 kg in 1 DRUM (71747-002-25)

72761- AURORE PHARMACEUTICALS PRIVATE LIMITED
- 72761-019-
  72761-019-06- 50 kg in 1 DRUM (72761-019-06)

84206- Tianish Laboratories Private Limited
- 84206-0053-
  84206-0053-1- 100 kg in 1 DRUM (84206-0053-1)

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Availability ⬆ ⬇

Route/Dosage ⬆ ⬇

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Classifications ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Pronunciation ⬆ ⬇

Code ⬆