Flavoxate

Overview

A drug that has been used in various urinary syndromes and as an antispasmodic. Its therapeutic usefulness and its mechanism of action are not clear. It may have local anesthetic activity and direct relaxing effects on smooth muscle as well as some activity as a muscarinic antagonist. [PubChem]

Indication

For symptomatic relief of dysuria, urgency, nocturia, suprapubic pain, frequency and incontinence as may occur in cystitis, prostatitis, urethritis, urethrocystitis/urethrotrigonitis.

Associated Conditions

Cystitis
Dysuria
Kidney Stones
Menstrual Distress (Dysmenorrhea)
Neurogenic Bladder
Nocturia
Pelvic Floor Dysfunctions
Pelvic Pain
Prostatitis
Suprapubic pain
Urethritis
Urethrotrigonitis
Urinary Incontinence (UI)
Urinary Tract Infection
Urinary Urgency
Uterine dyskinesia
Cystalgia
Urethrocystitis

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Relative Bioavailability Study of 100 mg Flavoxate Hydrochloride Tablets Under Fasting Conditions	2009/10/09	NCT00992238	Phase 1	Completed	Padagis LLC
Etoricoxib With Flavoxate for Reducing Morphine Requirement After Transurethral Prostatectomy (TURP)	2007/02/27	NCT00440739	Phase 4	Completed	Mahidol University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Flavoxate Hydrochloride	PuraCap Laboratories LLC dba Blu Pharmaceuticals	24658-720	ORAL	100 mg in 1 1	12/21/2017
FLAVOXATE HYDROCHLORIDE	Carilion Materials Management	68151-3826	ORAL	100 mg in 1 1	7/24/2014
Flavoxate Hydrochloride	Epic Pharma, LLC	42806-058	ORAL	100 mg in 1 1	12/27/2023
FLAVOXATE HYDROCHLORIDE	Padagis US LLC	0574-0115	ORAL	100 mg in 1 1	12/11/2021
Flavoxate Hydrochloride	Physicians Total Care, Inc.	54868-6326	ORAL	100 mg in 1 1	1/25/2012

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
CLEANXATE TAB 200 mg	SAM CHUN DANG PHARM CO LTD	SIN09677P	TABLET, SUGAR COATED	200 mg	3/19/1998
LAVOXEN TABLET 200 mg	DAE HAN NEW PHARM. CO. LTD.	SIN12299P	TABLET, FILM COATED	200 mg	5/22/2003
URIPAX FILM COATED TABLET 200MG	Y.S.P. Industries (M) Sdn. Bhd.	SIN16400P	TABLET, FILM COATED	200mg	12/14/2021
URISPAS 200 TABLET 200 mg	RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPA	SIN12007P	TABLET, FILM COATED	200 mg	7/1/2002

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
FLAVOXATE	pharmel inc	02236956	Tablet - Oral	200 MG	2/16/1998
URISPAS TAB 200MG	cedona pharmaceuticals b.v.	00612332	Tablet - Oral	200 MG	12/31/1986
APO-FLAVOXATE	Apotex Inc	02244842	Tablet - Oral	200 MG	11/20/2001
URISPAS TAB 200MG	paladin pharma inc.	00728179	Tablet - Oral	200 MG	12/31/1987
PMS-FLAVOXATE	Pharmascience Inc	02245480	Tablet - Oral	200 MG	7/24/2002

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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