Tetracaine

Overview

Tetracaine is an ester local anaesthetic currently available in combination with lidocaine as a cream and patch.

Background

Tetracaine is an ester local anaesthetic currently available in combination with lidocaine as a cream and patch.

Indication

Ophthalmic tetracaine is indicated for the for procedures requiring a rapid and short- acting topical ophthalmic anesthetic. The combination lidocaine and tetracaine patch is indicated for local dermal analgesia for superficial dermatological procedures and superficial venous access. The combination lidocaine and tetracaine cream is intended to provide topical local analgesia for superficial dermatological procedures.

Associated Conditions

Dermabrasion
Haemorrhoids
Insect Bites
Rash caused by poison ivy
Sunburn
Minor burns

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparing Topical Tetracaine Drops to Topical Focal Phenol for Local Anesthesia During Intratympanic Steroid Injection	2021/03/12	NCT04794842	Early Phase 1	Active, not recruiting	Our Lady of the Lake Hospital
Chloroprocaine 3% Gel Eye Drop as Topical Anestheticsin Phacoemulsification.	2020/12/28	NCT04685538	Phase 3	Completed	Sintetica SA
Study to Determine the Effect of a Newly Formulated Tetracaine Product PET500 on Penile Skin Sensation	2020/01/30	NCT04247230	Phase 1	Completed	Futura Medical Developments Ltd.
Short Term Topical Tetracaine is Safe and Highly Efficacious for the Treatment of Pain Caused by Corneal Abrasions	2019/12/05	NCT04187417	Not Applicable	Completed	INTEGRIS Southwest Medical Center
Pupil Centroid Shift Compensation in Photorefractive Keratectomy Candidates	2019/02/18	NCT03844178	Phase 2	UNKNOWN	Shahid Beheshti University of Medical Sciences
Ametop Compared to Ametop With Pain Ease Spray	2018/11/21	NCT03749915	Not Applicable	UNKNOWN	University of British Columbia
Efficacy of Tetracaine/Oxymetazoline Nasal Spray for Endodontic Treatment	2018/04/18	NCT03502135	Phase 4	Withdrawn	University of North Carolina, Chapel Hill
: Pulpal Blood Flow With the Use of Intra-nasal Anesthetic	2017/12/11	NCT03368391	Phase 4	UNKNOWN	Louisiana State University Health Sciences Center in New Orleans
Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification	2017/05/08	NCT03143452	Not Applicable	Completed	Indonesia University
Neurobiological and Cognitive Changes Following Exposure to Either Sevoflurane- or Propofol-based Anesthesia in Children	2017/01/16	NCT03022240	Phase 3	Completed	University of Calgary

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tetracaine Hydrochloride	Oceanside Pharmaceuticals	68682-920	OPHTHALMIC	5 mg in 1 mL	2/28/2022
Tetracaine	Bryant Ranch Prepack	63629-9160	ORAL	10 mg in 1 mL	2/2/2022
Tetracaine Hydrochloride	REMEDYREPACK INC.	70518-4183	OPHTHALMIC	5 mg in 1 mL	5/22/2025
Lidocaine and Tetracaine	Innovida Pharmaceutique Corporation	71800-631	TOPICAL	70 mg in 1 g	10/20/2021
Tetracaine Hydrochloride	NuCare Pharmaceuticals,Inc.	68071-5079	OPHTHALMIC	5 mg in 1 mL	2/19/2021
Tetracaine Hydrochloride	Bausch & Lomb Incorporated	24208-092	OPHTHALMIC	5 mg in 1 mL	5/31/2022
Tetracaine	Akorn	17478-045	SUBARACHNOID	10 mg in 1 mL	4/14/2010
Kovanaze	St. Renatus	69803-100	NASAL	30 mg in 1 mL	11/16/2018
LIDOCAINE 23% / TETRACAINE 7%	Sincerus Florida, LLC	72934-2140	TOPICAL	7 g in 100 g	6/4/2020
Cetacaine Anesthetic	Cetylite Industries, Inc.	10223-0202	TOPICAL	0.004 g in 0.2 g	5/11/2023

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
MINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 1% w/v	LABORATOIRE CHAUVIN SA	SIN04204P	SOLUTION	0.01g/mL	4/12/1990
MINIMS TETRACAINE HYDROCHLORIDE EYE DROPS 0.5% w/v	LABORATOIRE CHAUVIN SA	SIN04188P	SOLUTION	0.005g/mL	4/14/1990
PLIAGLIS CREAM 70mg/g + 70mg/g	Laboratoires Galderma	SIN14793P	CREAM	7.00% w/w	6/2/2015

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Tetracaine Hydrochloride Gel	湖北福人福通药业有限公司	国药准字H20123292	化学药品	凝胶剂	8/2/2022
Tetracaine Hydrochloride Injection	江苏九旭药业有限公司	国药准字H20040583	化学药品	注射剂	12/25/2020
Tetracaine Hydrochloride for Injection	大同五洲通制药有限责任公司	国药准字H20084317	化学药品	注射剂	3/13/2023
Tetracaine Hydrochloride for Injection	海南碧凯药业有限公司	国药准字H20093223	化学药品	注射剂	10/9/2023
Tetracaine Hydrochloride for Injection	河北一品制药股份有限公司	国药准字H20113121	化学药品	注射剂	2/9/2021
Tetracaine Hydrochloride for Injection	江苏九旭药业有限公司	国药准字H20020144	化学药品	注射剂	7/23/2020
Tetracaine Hydrochloride for Injection	江苏九旭药业有限公司	国药准字H20020143	化学药品	注射剂	7/23/2020
Tetracaine Hydrochloride for Injection	成都天台山制药股份有限公司	国药准字H20084307	化学药品	注射剂	3/1/2023
Tetracaine Hydrochloride for Injection	悦康药业集团股份有限公司	国药准字H20093124	化学药品	注射剂(冻干粉针剂)	3/24/2020
Tetracaine Hydrochloride for Injection	江苏九旭药业有限公司	国药准字H20000309	化学药品	注射剂	7/23/2020

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
MINIMS tetracaine (amethocaine) hydrochloride 0.5% 5 mg/mL eye drops tube	32252	Bausch & Lomb Australia Pty Ltd	Medicine	A	10/30/1991
MINIMS tetracaine (amethocaine) hydrochloride 1.0% 10 mg/mL eye drops tube	32254	Bausch & Lomb Australia Pty Ltd	Medicine	A	10/30/1991
LACERAINE GEL TOPICAL WOUND ANAESTHETIC vial	443931	Phebra Pty Ltd	Medicine	A	3/18/2024

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