Overview
Proparacaine is a topical anesthetic drug of the amino ester group. It is found in ophthalmic solutions at a concentration of 0.5% as the hydrochloride salt.
Indication
Used as a local (ophthalmic) anesthetic.
Associated Conditions
- Chronic Lymphocytic Leukemia (CLL) - Refractory
- Follicular Lymphoma ( FL)
- Mantle Cell Lymphoma (MCL)
- Marginal Zone Lymphoma (MZL)
- Multiple Myeloma (MM)
- Myelodysplastic Syndrome
- Primary Amyloidosis
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
Research Report
Proparacaine: A Comprehensive Pharmacological and Clinical Review
I. Introduction to Proparacaine
A. Overview and Significance
Proparacaine is a topical anesthetic agent extensively employed in ophthalmic practice. Its primary utility lies in its capacity to induce rapid-onset, short-duration anesthesia of the corneal surface, thereby facilitating a wide array of diagnostic and minor surgical procedures that would otherwise be uncomfortable or impracticable.[1] The ability of Proparacaine to provide effective local anesthesia is crucial for ensuring patient comfort and cooperation during these interventions. This report aims to provide a comprehensive examination of Proparacaine, referencing its DrugBank ID DB00807 and CAS Number 499-67-2, and its classification as a Small Molecule topical anesthetic.[1] The widespread application of Proparacaine highlights a significant clinical requirement for reliable and fast-acting topical anesthesia in ophthalmology. Its effectiveness is, however, counterbalanced by specific safety considerations, particularly regarding corneal health, which necessitate informed and cautious clinical application.
B. Chemical Nature and Formulation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/01 | Not Applicable | Not yet recruiting | PETHEMA Foundation | ||
2025/06/22 | Phase 2 | Not yet recruiting | |||
2025/06/12 | Phase 2 | Not yet recruiting | |||
2025/05/30 | Phase 2 | Not yet recruiting | |||
2025/05/16 | Phase 2 | Recruiting | |||
2025/05/11 | Phase 3 | Not yet recruiting | |||
2025/04/17 | Phase 3 | Not yet recruiting | European Myeloma Network B.V. | ||
2025/04/17 | Phase 2 | Not yet recruiting | |||
2025/04/09 | Phase 3 | Not yet recruiting | |||
2025/04/04 | Phase 2 | Not yet recruiting | Dickran Kazandjian, MD |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Apotex Corp. | 60505-4534 | ORAL | 10 mg in 1 1 | 4/15/2023 | |
Aurobindo Pharma Limited | 59651-347 | ORAL | 25 mg in 1 1 | 5/17/2023 | |
Zydus Pharmaceuticals USA Inc. | 70710-1034 | ORAL | 20 mg in 1 1 | 2/10/2024 | |
NuCare Pharmaceuticals,Inc. | 68071-5139 | OPHTHALMIC | 5 mg in 1 mL | 2/22/2021 | |
Mylan Pharmaceuticals Inc. | 0378-1937 | ORAL | 10 mg in 1 1 | 5/15/2022 | |
MWI | 13985-611 | OPHTHALMIC | 5 mg in 1 mL | 3/27/2015 | |
Celgene Corporation | 59572-415 | ORAL | 15 mg in 1 1 | 8/31/2021 | |
Exelan Pharmaceuticals, Inc. | 76282-701 | ORAL | 25 mg in 1 1 | 10/13/2022 | |
Camber Pharmaceuticals, Inc. | 31722-257 | ORAL | 2.5 mg in 1 1 | 7/13/2023 | |
Cipla USA Inc. | 69097-384 | ORAL | 20 mg in 1 1 | 2/2/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 6/14/2007 | ||
Authorised | 6/14/2007 | ||
Authorised | 12/18/2020 | ||
Authorised | 9/20/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
LENANGIO 10 CAPSULES 10 MG | SIN16308P | CAPSULE | 10 mg | 8/24/2021 | |
LENALIDOMIDE-TEVA CAPSULE 25MG | SIN16478P | CAPSULE | 25 mg | 4/14/2022 | |
LINADEX 5 CAPSULES 5 MG | SIN16764P | CAPSULE | 5.000 mg | 4/18/2023 | |
LINADEX 10 CAPSULES 10 MG | SIN16763P | CAPSULE | 10.000 mg | 4/18/2023 | |
Revlimid Capsules 25 mg | SIN13665P | CAPSULE | 25.0 mg | 6/23/2009 | |
Revlimid Capsules 5mg | SIN13662P | CAPSULE | 5.0 mg | 6/23/2009 | |
Revlimid Capsules 10mg | SIN13663P | CAPSULE | 10.0 mg | 6/23/2009 | |
LINADEX 15 CAPSULES 15 MG | SIN16762P | CAPSULE | 15.000 mg | 4/18/2023 | |
LENLI CAPSULES 25MG | SIN16190P | CAPSULE | 25.0 mg | 5/11/2021 | |
MYOLID CAPSULES 15 MG | SIN16953P | CAPSULE | 15mg | 2/19/2024 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Proparacaine Hydrochloride Eye Drops | 国药准字H20253428 | 化学药品 | 眼用制剂 | 2/20/2025 | |
Proparacaine Hydrochloride Eye Drops | alcon nv | 国药准字HJ20160133 | 化学药品 | 眼用制剂 | 2/9/2021 |
Proparacaine Hydrochloride Eye Drops | 国药准字H20143168 | 化学药品 | 眼用制剂 | 10/14/2021 | |
Proparacaine Hydrochloride Eye Drops | 国药准字H20103352 | 化学药品 | 眼用制剂 | 6/22/2020 | |
Proparacaine Hydrochloride Eye Drops | 国药准字H20084062 | 化学药品 | 眼用制剂 | 5/5/2023 | |
Lenalidomide Capsules | 国药准字HJ20200047 | 化学药品 | 胶囊剂 | 12/7/2023 | |
Lenalidomide Capsules | 国药准字HJ20210078 | 化学药品 | 胶囊剂 | 12/8/2021 | |
Lenalidomide Capsules | 国药准字HJ20210077 | 化学药品 | 胶囊剂 | 12/8/2021 | |
Lenalidomide Capsules | 国药准字H20233668 | 化学药品 | 胶囊剂 | 7/18/2023 | |
Lenalidomide Capsules | 国药准字H20170010 | 化学药品 | 胶囊剂 | 11/22/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
LENALEX lenalidomide 2.5 mg capsules blister pack | 338528 | Medicine | A | 7/23/2021 | |
LENALIDOMIDE-RZ lenalidomide 7.5 mg capsule blister pack | 294138 | Medicine | A | 7/10/2021 | |
LENALIDOMIDE DR.REDDY'S lenalidomide 15 mg capsule blister pack | 294075 | Medicine | A | 7/10/2021 | |
LENALIDOMIDE VIATRIS lenalidomide 7.5 mg capsule blister pack | 377101 | Medicine | A | 8/18/2022 | |
Lenalidomide RAN lenalidomide 7.5 mg capsule blister pack | 386050 | Medicine | A | 1/10/2023 | |
Lenalidomide RBX lenalidomide 10 mg capsule blister pack | 386042 | Medicine | A | 1/10/2023 | |
Lenalidomide SUN lenalidomide 25 mg capsule blister pack | 386052 | Medicine | A | 1/10/2023 | |
Lenalidomide RAN lenalidomide 10 mg capsule blister pack | 386044 | Medicine | A | 1/10/2023 | |
LENALIMID lenalidomide 5 mg capsule blister pack | 307066 | Medicine | A | 10/8/2019 | |
LENALIDE lenalidomide 2.5 mg capsules blister pack | 338520 | Medicine | A | 7/23/2021 |
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