Orphenadrine

Generic Name: Orphenadrine

Brand Names: Norgesic, Norgesic Forte, Orfenace, Orphengesic

Drug Type: Small Molecule

Chemical Formula: C_₁₈H_₂₃NO

CAS Number: 83-98-7

Unique Ingredient Identifier: AL805O9OG9

Overview

A muscarinic antagonist used to treat drug-induced parkinsonism and to relieve pain from muscle spasm.

Indication

用于治疗帕金森病和吩噻嗪类药物引起的锥体外系症状，但对迟发性运动障碍无效。用于治疗急性肌骨骼疼痛

Associated Conditions

Back Pain Lower Back
Fever
Menstrual Distress (Dysmenorrhea)
Mild pain
Muscle Spasms
Mild Musculoskeletal Disorder
Mild to moderate pain
Moderate Musculoskeletal Disorder
Moderate Pain

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Multi-Modal Anesthesia Protocol in Pain Management of Patients Undergoing Posterior Lumbar Spinal Fusion Surgery	2022/06/10	NCT05413902	Phase 4	Completed	University of Puerto Rico
Orphenadrine Versus Baclofen in Treatment of Muscle Cramps in Cirrhotic Patients	2020/08/12	NCT04509336	Not Applicable	Terminated	Mansoura University
Multimodal Narcotic Limited Perioperative Pain Control With Colorectal Surgery	2016/11/08	NCT02958566	Phase 4	UNKNOWN	University of Illinois College of Medicine at Peoria
Orphenadrine and Methocarbamol for LBP	2016/01/27	NCT02665286	Phase 4	Completed	Montefiore Medical Center
Intra-Venous Acetaminophen and Muscle Relaxants After Total Knee	2015/05/20	NCT02449369	Phase 4	Completed	AdventHealth
Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis	2015/04/22	NCT02423395	Phase 3	Recruiting	Sherief Abd-Elsalam
Patient Preferences, Analgesic Delivery Method and Pain Reduction in Spine Patients	2010/12/21	NCT01263652	Not Applicable	Withdrawn	Western Galilee Hospital-Nahariya

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Orphenadrine Citrate	Actavis Pharma, Inc.	0591-3222	INTRAMUSCULAR, INTRAVENOUS	30 mg in 1 mL	11/29/2018
Orphenadrine Citrate	St. Mary's Medical Park Pharmacy	60760-810	ORAL	100 mg in 1 1	11/17/2023
Orphenadrine Citrate	Direct_Rx	61919-177	ORAL	100 mg in 1 1	1/9/2024
Orphenadrine Citrate	Preferred Pharmaceuticals, Inc	68788-9150	ORAL	100 mg in 1 1	11/20/2009
ORPHENADRINE CITRATE	Physicians Total Care, Inc.	54868-4102	ORAL	100 mg in 1 1	5/12/2011
Orphenadrine Citrate	Proficient Rx LP	63187-632	ORAL	100 mg in 1 1	11/1/2019
Orphenadrine Citrate	Aidarex Pharmaceuticals LLC	33261-088	ORAL	100 mg in 1 1	10/4/2012
ORPHENADRINE CITRATE	STAT Rx USA LLC	42549-559	ORAL	100 mg in 1 1	5/1/2012
Orphenadrine Citrate	Akorn	17478-538	INTRAMUSCULAR, INTRAVENOUS	30 mg in 1 mL	1/29/2024
Orphenadrine Citrate, Aspirin and Caffeine	Atland Pharmaceuticals, LLC	71993-307	ORAL	50 mg in 1 1	6/19/2023

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
CAMGESIC TABLET	CHULIA PHARMA SDN BHD	SIN09867P	TABLET	35 mg	7/2/1998
SUNITON TABLETS	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN05937P	TABLET	35 mg	5/21/1991
ANAREX TABLETS	BEACONS PHARMACEUTICALS PTE LTD	SIN05584P	TABLET	35 mg	3/30/1991
ONADRINE TABLET 50 mg	SUNWARD PHARMACEUTICAL PRIVATE LIMITED, SUNWARD PHARMACEUTICAL SDN BHD	SIN07611P	TABLET	50 mg	1/18/1994
ORPHENADOL TABLET	Y S P INDUSTRIES (M) SDN BHD	SIN07951P	TABLET	50 mg	12/9/1994
HORGESIC TABLET 35MG/450MG	Hovid Berhad	SIN16415P	TABLET	35 mg	1/7/2022
NORPHEN TABLET	ATLANTIC LABORATORIES CORPN LTD	SIN12142P	TABLET	35 mg	12/5/2002
ORCIGESIC CAPSULE	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN07108P	CAPSULE	35 mg	7/10/1992
NORGESIC TABLET	Adcock Ingram Limited	SIN05552P	TABLET	35 mg	3/20/1991
ORCIGESIC TABLETS	SUNWARD PHARMACEUTICAL PRIVATE LIMITED	SIN06047P	TABLET, FILM COATED	35 mg	5/24/1991

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
NORGESIC TAB	N/A	iNOVA Pharmaceuticals (Hong Kong) Limited	N/A	N/A	4/20/1983
PARACETAMOL & ORPHENADRINE CITRATE TAB	N/A	synco (h.k.) limited	N/A	N/A	10/6/2016
PAINREST TABLETS	N/A	PT. YUNG SHIN PHARMACEUTICAL INDONESIA	N/A	N/A	12/9/2024
UNI-PAINGETEX TABLET	N/A	synco (h.k.) limited	N/A	N/A	1/16/2014
U-NORCETOL TAB	N/A	synco (h.k.) limited	N/A	N/A	4/13/1987
MYOFLEX TAB	N/A	LEAMYK INVESTMENT LIMITED	N/A	N/A	7/23/2007
MANGA TABLETS	N/A	R. MANSTIEN (AUSTRALIA) LIMITED	N/A	N/A	12/1/2017
DIKUTON TAB	N/A	WILCOME PHARMACEUTICAL COMPANY LIMITED	N/A	N/A	11/12/1982

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NORGESIC paracetamol orphenadrine citrate tablet jar	10574	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	7/4/1991
NORFLEX orphenadrine citrate 100 mg slow release tablet blister pack	370413	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	9/29/2021
NORFLEX orphenadrine citrate 100 mg slow release tablet bottle	10573	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	7/4/1991
Norgesic blister pack	156623	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	1/14/2009

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NORFLEX	valeant canada lp / valeant canada s.e.c.	01966154	Tablet (Extended-Release) - Oral	100 MG	12/31/1993
ORPHENADRINE CITRATE INJECTION, USP	Sterimax Inc	02229731	Liquid - Intravenous , Intramuscular	30 MG / ML	12/2/1996
SANDOZ ORPHENADRINE	Sandoz Canada, Inc.	02243559	Tablet (Extended-Release) - Oral	100 MG	2/27/2001
ORFENACE TABLET 100MG	Sterimax Inc	02047535	Tablet - Oral	100 MG	12/31/1994
NORFLEX	valeant canada lp / valeant canada s.e.c.	01966162	Liquid - Intramuscular , Intravenous	30 MG / ML	12/31/1961
NORGESIC FORTE TAB	3 m pharmaceuticals, a division of 3 m canada company	01966189	Tablet - Oral	50 MG	12/31/1976
DISIPAL TAB 50MG	3 m pharmaceuticals, a division of 3 m canada company	01966146	Tablet - Oral	50 MG	12/31/1957
NORGESIC TAB	3 m pharmaceuticals, a division of 3 m canada company	01966170	Tablet - Oral	25 MG	12/31/1964

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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