Prilocaine

Overview

A local anesthetic that is similar pharmacologically to lidocaine. Currently, it is used most often for infiltration anesthesia in dentistry. (From AMA Drug Evaluations Annual, 1992, p165)

Indication

适用于硬膜外麻醉、阻滞麻醉和浸润麻醉等。

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Effects of EMLA Cream and Cold Application on Pain, Fear and Vital Signs Before Chest Tube Removal in Children	2025/04/06	NCT06913855	Not Applicable	Completed	Istanbul Medeniyet University
Does Botulinum Toxin Type-A Injection an Effective Way of Relieving Pain in Myofascial Pain Syndrome Patients or Not	2025/03/28	NCT06899438	Not Applicable	Completed	Bursa City Hospital
Pharmacological and Nonpharmacological Methods for Children in Venipuncture Pain	2025/03/28	NCT06901271	Not Applicable	Completed	Aynur Aytekin Ozdemir
Spinal Anesthesia by Hyperbaric Prilocaine in Day-Case Perianal Surgery	2024/09/19	NCT06600048	Not Applicable	Completed	Tanta University
Comparison of Infraclavicular Brachial Plexus Block and Local Anesthesia in Arteriovenous Fistula Surgeries and Their Effects on Tissue Oxygen Saturation	2024/05/16	NCT06416111	Not Applicable	Completed	Ankara City Hospital Bilkent
Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section	2024/03/04	NCT06290583	Not Applicable	Completed	South Valley University
Topical Anaesthesia in Cutaneous Head and Neck Surgery	2024/02/23	NCT06274905	Not Applicable	Completed	University Hospital Waterford
Effect of Prilocaine vs Bupivacaine on Hemodynamics in Spinal Anesthesia for Geriatric Patients	2023/12/11	NCT06165679	Phase 3	Completed	Cairo University
Effect of Prilocaine on Motor Block During Caesarean Section	2023/11/18	NCT06133881	Phase 4	Completed	Cairo University
Reducing Port Access Pain and Clinic Wait Time: An Evaluation of EMLA Cream Versus nüm™ Vapocoolant Spray	2023/09/05	NCT06023368	Phase 4	Withdrawn	Marianne Hutti

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Lidocaine and Prilocaine	Actavis Pharma, Inc.	0591-2070	TOPICAL	25 mg in 1 g	7/31/2019
Prilocaine Hydrochloride	Septodont Inc.	0362-9014	SUBCUTANEOUS	40 mg in 1 mL	10/8/2010
Oraqix	Dentsply Pharmaceutical	66312-110	PERIODONTAL	25 mg in 1 g	1/26/2024
DIBUCAINE HCL 0.5% / LIDOCAINE 15% / PHENYLEPHRINE HCL 1% / PRILOCAINE 5%	Sincerus Florida, LLC	72934-5071	TOPICAL	5 g in 100 g	5/10/2019
LIDOCAINE AND PRILOCAINE	Bryant Ranch Prepack	63629-9604	TOPICAL	25 mg in 1 g	11/22/2022
Lidocaine and Prilocaine	NuCare Pharamceuticals,Inc.	68071-1625	TOPICAL	25 mg in 1 g	1/28/2022
LIDOCAINE AND PRILOCAINE	DIRECT RX	61919-443	TOPICAL	25 mg in 1 g	1/20/2020
Citanest Forte	Dentsply Pharmaceutical Inc.	66312-540	SUBMUCOSAL	40 mg in 1 mL	10/17/2017
LIDO BDK	Asclemed USA, Inc.	76420-641	TOPICAL	25 mg in 1 g	11/1/2018
LIDOPRIL	Sterling-knight Pharmaceuticals,LLC	69336-825	TOPICAL	25 mg in 1 g	8/16/2016

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Fortacin	Recordati Ireland Ltd.,Raheens East,Ringaskiddy, Co. Cork,,Ireland	Authorised	11/15/2013

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
RACSER CREAM 5%	Galentic Pharma (India) Pvt. Ltd.	SIN14852P	CREAM	2.5%w/w	9/17/2015
TAKIPRIL SOLUTION FOR INJECTION 20MG/ML	Sintetica SA	SIN16326P	INJECTION, SOLUTION	20.00 mg/ml	9/17/2021
FORTACIN CUTANEOUS SPRAY SOLUTION 7.5MG/dose + 2.5MG/dose	Pharmaserve (North West) Ltd	SIN16538P	SPRAY, METERED	2.5mg/dose	7/5/2022
CITANEST OCTAPRESSIN INJECTION	ASTRA PHARMACEUTICALS PTY LTD	SIN06175P	INJECTION	66 mg/2.2 ml	5/3/1991
EMLA CREAM 5%	Recipharm Karlskoga AB, Aspen Bad Oldesloe GmbH	SIN06443P	CREAM	25 mg/g	7/2/1991

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
EMLA 5% CREAM (kit)	12046	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/13/1991
3% CITANEST DENTAL WITH OCTAPRESSIN 2.2mL injection cartridge	12080	Dentsply Sirona Pty Ltd	Medicine	A	8/13/1991
Citanest 0.5% 250mg/50mL injection vial	12079	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/13/1991
PRILOTEKAL prilocaine hydrochloride 100 mg/5 mL solution for injection ampoule	376271	B Braun Australia Pty Ltd	Medicine	A	3/8/2023
CITANEST 2% POLYAMP DUOFIT prilocaine hydrochloride 100mg/5mL injection BP ampoule	53722	Aspen Pharmacare Australia Pty Ltd	Medicine	A	5/2/1996
NUMIT 5% CREAM tube	265292	Ego Pharmaceuticals Pty Ltd	Medicine	A	12/3/2015
3% CITANEST DENTAL WITH OCTAPRESSIN 2.2mL injection cartridge	220320	Dentsply Sirona Pty Ltd	Medicine	A	5/26/2014
EMLA 5% CREAM tube	12886	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/13/1991
EMLA DERMAL PATCH carton	60820	Aspen Pharmacare Australia Pty Ltd	Medicine	A	8/26/1997
4% CITANEST DENTAL Prilocaine hydrochloride 88mg/2.2mL injection cartridge	12082	Dentsply Sirona Pty Ltd	Medicine	A	8/13/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ORAQIX	dentsply canada limited	02325993	Gel - Topical	2.5 %	2/11/2010
PRILOCAINE HCL 4% EPINEPH 1:200000INJ	novocol pharmaceutical of canada inc	00393746	Solution - Block/Infiltration	40 MG / ML	12/31/1977
EMLA CREAM	Aspen Pharmacare Canada Inc.	00886858	Cream - Topical	2.5 %	12/31/1991
DENTSPLY 4% PRILOCAINE AND EPINEPHRINE INJECTION 1:200,000	dentsply canada limited	00519227	Solution - Block/Infiltration	40 MG / ML	12/31/1968
DENTSPLY 4% PRILOCAINE HYDROCHLORIDE DENTAL INJECTION	dentsply canada limited	00519235	Solution - Block/Infiltration	40 MG / ML	12/31/1964
EMLA PATCH	Aspen Pharmacare Canada Inc.	02057794	Patch - Topical	2.5 %	12/31/1994
4% CITANEST FORTE DENTAL WITH EPINEPHRINE 1:200,000	dentsply canada limited	02347695	Solution - Block/Infiltration	40 MG / ML	1/18/2011
4% CITANEST PLAIN DENTAL	dentsply canada limited	02435276	Solution - Block/Infiltration	40 MG / ML	12/23/2015

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ANESTOPIC 25 MG/G + 25 MG/G CREMA	Mesoestetic Pharma Group S.L.	78664	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
LIDOCAINA/PRILOCAINA RATIOPHARM 25MG/G + 25MG/G CREMA	Teva Pharma S.L.U.	79196	CREMA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ANESTEAL 25MG/G + 25MG/G CREMA	Pierre Fabre Iberica S.A.	73848	CREMA	Medicamento Sujeto A Prescripción Médica	Not Commercialized
ANESTDERMA 25 MG/G + 25 MG/G CREMA	Galenicum Derma S.L.U.	84812	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
ANAMAP 25 MG/G + 25 MG/G CREMA	Glenmark Arzneimittel Gmbh	83948	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
EMLA 25 mg/g + 25 mg/g CREMA	Aspen Pharma Trading Limited	61096	CREMA	Medicamento Sujeto A Prescripción Médica	Commercialized
ORAQIX GEL PERIODONTAL	Dentsply De Trey Gmbh	66719	GEL PERIODONTAL	Medicamento Sujeto A Prescripción Médica	Commercialized
FORTACIN 150 MG/ML + 50 MG/ML SOLUCION PARA PULVERIZACION CUTANEA	Recordati Ireland Limited	113881002	SOLUCIÓN PARA PULVERIZACIÓN CUTÁNEA	Sin Receta	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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