Application Nr Approved Date Route Status External Links
ANDA208591 2017-06-12 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications & Usage Itraconazole Capsules Are Indicated For The Treatment Of The Following Fungal Infections In Immunocompromised And Non-Immunocompromised Patients: 1. Blastomycosis, Pulmonary And Extrapulmonary 2. Histoplasmosis, Including Chronic Cavitary Pulmonary Disease And Disseminated, Non-Meningeal Histoplasmosis, And 3. Aspergillosis, Pulmonary And Extrapulmonary, In Patients Who Are Intolerant Of Or Who Are Refractory To Amphotericin B Therapy. Specimens For Fungal Cultures And Other Relevant Laboratory Studies (wet Mount, Histopathology,serology) Should Be Obtained Before Therapy To Isolate And Identify Causative Organisms. Therapy May Be Instituted Before The Results Of The Cultures And Other Laboratory Studies Are Known; However, Once These Results Become Available, Antiinfective Therapy Should Be Adjusted Accordingly. Itraconazole Capsules Are Also Indicated For The Treatment Of The Following Fungal Infections In Non-Immunocompromised Patients: 1. Onychomycosis Of The Toenail, With Or Without Fingernail Involvement, Due To Dermatophytes (tinea Unguium), And 2. Onychomycosis Of The Fingernail Due To Dermatophytes (tinea Unguium). Prior To Initiating Treatment, Appropriate Nail Specimens For Laboratory Testing (koh Preparation, Fungal Culture, Or Nail Biopsy) Should Be Obtained To Confirm The Diagnosis Of Onychomycosis.(see Clinical Pharmacology: Special Populations, Contraindications, Warnings,and Adverse Reactions: Post-Marketing Experience For More Information.) Description Of Clinical Studies Blastomycosis Analyses Were Conducted On Data From Two Open-Label, Non-Concurrently Controlled Studies (n=73 Combined) In Patients With Normal Or Abnormal Immune Status. The Median Dose Was 200 Mg/day. A Response For Most Signs And Symptoms Was Observed Within The First 2 Weeks, And All Signs And Symptoms Cleared Between 3 And 6 Months. Results Of These Two Studies Demonstrated Substantial Evidence Of The Effectiveness Of Itraconazole For The Treatment Of Blastomycosis Compared With The Natural History Of Untreated Cases. Histoplasmosis Analyses Were Conducted On Data From Two Open-Label, Non-Concurrently Controlled Studies (n=34 Combined) In Patients With Normal Or Abnormal Immune Status (not Including Hiv-Infected Patients). The Median Dose Was 200 Mg/day. A Response For Most Signs And Symptoms Was Observed Within The First 2 Weeks, And All Signs And Symptoms Cleared Between 3 And 12 Months. Results Of These Two Studies Demonstrated Substantial Evidence Of The Effectiveness Of Itraconazole For The Treatment Of Histoplasmosis, Compared With The Natural History Of Untreated Cases. Histoplasmosis In Hiv-Infected Patients Data From A Small Number Of Hiv-Infected Patients Suggested That The Response Rate Of Histoplasmosis In Hiv-Infected Patients Is Similar To That Of Non-Hiv-Infected Patients. The Clinical Course Of Histoplasmosis In Hiv-Infected Patients Is More Severe And Usually Requires Maintenance Therapy To Prevent Relapse. Aspergillosis Analyses Were Conducted On Data From An Open-Label, "single-Patient-Use" Protocol Designed To Make Itraconazole Available In The U.s. For Patients Who Either Failed Or Were Intolerant Of Amphotericin B Therapy (n=190). The Findings Were Corroborated By Two Smaller Open-Label Studies (n=31 Combined) In The Same Patient Population. Most Adult Patients Were Treated With A Daily Dose Of 200 To 400 Mg, With A Median Duration Of 3 Months. Results Of These Studies Demonstrated Substantial Evidence Of Effectiveness Of Itraconazole As A Second-Line Therapy For The Treatment Of Aspergillosis Compared With The Natural History Of The Disease In Patients Who Either Failed Or Were Intolerant Of Amphotericin B Therapy. Onychomycosis Of The Toenail Analyses Were Conducted On Data From Three Double-Blind, Placebo-Controlled Studies (n=214 Total;110 Given Itraconazole Capsules) In Which Patients With Onychomycosis Of The Toenails Received 200 Mg Of Itraconazole Capsules Once Daily For 12 Consecutive Weeks. Results Of These Studies Demonstrated Mycologic Cure, Defined As Simultaneous Occurrence Of Negative Koh Plus Negative Culture, In 54% Of Patients. Thirty-Five Percent (35%) Of Patients Were Considered An Overall Success(mycologic Cure Plus Clear Or Minimal Nail Involvement With Significantly Decreased Signs) And 14% Of Patients Demonstrated Mycologic Cure Plus Clinical Cure (clearance Of All Signs, With Or Without Residual Nail Deformity). The Mean Time To Overall Success Was Approximately 10 Months. Twenty-One Percent (21%) Of The Overall Success Group Had A Relapse (worsening Of The Global Score Or Conversion Of Koh Or Culture From Negative To Positive). Onychomycosis Of The Fingernail Analyses Were Conducted On Data From A Double-Blind, Placebo-Controlled Study (n=73 Total; 37 Given Itraconazole Capsules) In Which Patients With Onychomycosis Of The Fingernails Received A 1-Week Course (course) Of 200 Mg Of Itraconazole Capsules B.i.d., Followed By A 3-Week Period Without Itraconazole, Which Was Followed By A Second 1-Week Course Of 200 Mg Of Itraconazole Capsules B.i.d. Results Demonstrated Mycologic Cure In 61% Of Patients. Fifty-Six Percent (56%) Of Patients Were Considered An Overall Success And 47% Of Patients Demonstrated Mycologic Cure Plus Clinical Cure. The Mean Time To Overall Success Was Approximately 5 Months. None Of The Patients Who Achieved Overall Success Relapsed.

All Formulated Excipients (13 Total)

Name Structure Kind Function Status
1. Hypromelloses HYPROMELLOSES Unresolved
2. Poloxamer 188 POLOXAMER 188 Unresolved
3. Methylene Chloride METHYLENE CHLORIDE Molecular MISC-Miscellaneous , SOLV-Solvent REG-Food additives for which a petition has been filed and a regulation issued.
4. Polyethylene Glycol 20000 POLYETHYLENE GLYCOL 20000 Unresolved
5. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.
6. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
7. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye
8. Fd&c Red No. 40 FD&C RED NO. 40 Molecular
9. Alcohol ALCOHOL Molecular
10. Isopropyl Alcohol ISOPROPYL ALCOHOL Molecular
11. Butyl Alcohol BUTYL ALCOHOL Molecular MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
12. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
13. Ammonia AMMONIA Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Itraconazole ITRACONAZOLE ZINC4097343

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