Overview
Antiprotozoal agent effective in trypanosomiasis, leishmaniasis, and some fungal infections; used in treatment of pneumocystis pneumonia in HIV-infected patients. It may cause diabetes mellitus, central nervous system damage, and other toxic effects.
Indication
For the treatment of pneumonia due to Pneumocystis carinii.
Associated Conditions
- Pneumocystis Jirovecii Pneumonia
- Trypanosomiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/11/05 | Phase 1 | Completed | Reinhold Munker | ||
2018/01/18 | Phase 1 | Terminated | |||
2017/06/28 | Phase 1 | Withdrawn | |||
2017/03/30 | Phase 2 | Completed | Fundacion Nacional de Dermatologia | ||
2016/02/01 | N/A | Completed | |||
2014/08/06 | Phase 1 | Completed | |||
2011/05/26 | Phase 3 | Completed | Institute of Tropical Medicine, Belgium | ||
2008/12/18 | Phase 1 | Completed | |||
2008/12/17 | Phase 1 | Completed | |||
2008/12/08 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| XGen Pharmaceuticals DJB, Inc. | 39822-3030 | RESPIRATORY (INHALATION) | 300 mg in 6 mL | 3/18/2024 | |
| Seton Pharmaceuticals | 13925-515 | INTRAMUSCULAR, INTRAVENOUS | 300 mg in 300 mg | 3/20/2018 | |
| Fresenius Kabi USA, LLC | 63323-877 | RESPIRATORY (INHALATION) | 300 mg in 6 mL | 1/23/2020 | |
| XGen Pharmaceuticals DJB, Inc. | 39822-3050 | INTRAVENOUS, INTRAMUSCULAR | 300 mg in 3 mL | 1/25/2024 | |
| Fresenius Kabi USA, LLC | 63323-113 | INTRAMUSCULAR, INTRAVENOUS | 300 mg in 3 mL | 9/13/2022 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-748 | INTRAMUSCULAR, INTRAVENOUS | 300 mg in 300 mg | 4/1/2021 | |
| Seton Pharmaceuticals | 13925-522 | RESPIRATORY (INHALATION) | 300 mg in 300 mg | 10/11/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DBL PENTAMIDINE ISETHIONATE FOR INJECTION BP 300 mg/vial | SIN06766P | INJECTION, POWDER, FOR SOLUTION | 300 mg/vial | 1/13/1992 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PENTACARINAT POWDER FOR INJ 300MG | N/A | main life corp ltd | N/A | N/A | 2/19/1999 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DBL PENTAMIDINE ISETHIONATE 300mg powder for injection | 16260 | Medicine | A | 10/8/1991 | |
| Hospira Pentamidine Isetionate for Injection BP 300 mg/vial | 142577 | Medicine | A | 7/26/2007 | |
| Pentamina (Pentamidina) for Injection 300 mg vial | 140692 | Medicine | A | 6/20/2007 | |
| Hospira Pentamidine Isethionate for Injection BP, 300 mg/Vial | 378671 | Medicine | A | 11/23/2021 | |
| PENTAMIDINE-EMC pentamidine isetionate 300 mg powder for injection vial | 338274 | Medicine | A | 9/26/2023 | |
| Hospira Pentamidine Isethionate for Injection BP, 300 mg/Vial | 377599 | Medicine | A | 11/8/2021 |
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