Phenoxymethylpenicillin

Overview

Phenoxymethylpenicillin is a narrow spectrum antibiotic also commonly referred to as Penicillin V or Penicillin VK. It is a phenoxymethyl analog of Penicillin G, or benzylpenicillin. An orally active naturally penicillin, phenoxymethylpenicillin is used to treat mild to moderate infections in the respiratory tract, skin, and soft tissues caused by penicillin G-sensitive microorganisms. Phenoxymethylpenicillin has also be used in some cases as prophylaxis against susceptible organisms. While there have been no controlled clinical efficacy studies that were conducted, phenoxymethylpenicillin has been suggested by the American Heart Association and the American Dental Association for use as an oral regimen for prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract, except for those who are at an elevated risk for endocarditis.

Indication

Indicated for the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms, with the use of bacteriological studies (including sensitivity tests) and clinical response. Phenoxymethylpenicillin may be used for the treatment of: Off-label Indicated for use as prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract.

Associated Conditions

Actinomycosis
Animal bite
Anthrax
Bacterial Endocarditis
Bacterial Infections
Community Acquired Pneumonia (CAP)
Erythema Chronicum Migrans
Gingivitis, Necrotizing Ulcerative
Lower Respiratory Tract Infection (LRTI)
Scarlet Fever
Skin and Subcutaneous Tissue Bacterial Infections
Streptococcal Pharyngitis
Tonsillitis streptococcal
Mild Otitis media
Mild bacterial upper respiratory tract infections
Moderate Otitis media
Moderate bacterial upper respiratory tract infections
Prophylaxis of Rheumatic fever

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Optimal Antibiotic Treatment Duration for Community-acquired Pneumonia in Adults Diagnosed in General Practice in Denmark (CAP-D)	2024/03/06	NCT06295120	Phase 4	Recruiting	Research Unit for General Practice in Aalborg
GOALIE: Intramuscular vs. Enteral Penicillin Prophylaxis to Prevent Progression of Latent RHD Trial	2023/01/23	NCT05693545	Phase 2	Recruiting	Children's Hospital Medical Center, Cincinnati
Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota	2019/09/10	NCT04084106	Phase 4	Completed	Uppsala University
Sore Throat in Primary Care - a Comparison of Phenoxymethylpenicillin and No Antibiotic Treatment	2019/09/10	NCT04083417	Phase 4	Recruiting	Katarina Hedin
Minimally Invasive Sensing of Beta-lactam Antibiotics	2019/02/20	NCT03847610	Phase 1	Completed	Imperial College London
Efficacy of High Doses Penicillin V Versus High Doses Amoxicillin in the Treatment of Non-severe Pneumonia.	2017/07/05	NCT03208361	Phase 3	Terminated	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Penicillin for the Emergency Department Outpatient Treatment of CELLulitis	2016/10/04	NCT02922686	Phase 4	UNKNOWN	Royal College of Surgeons, Ireland
Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci	2016/03/18	NCT02712307	Phase 4	Completed	Ass. Prof. Katarina Hedin
Pentriox - Induction of Oxidative Stress	2014/07/11	NCT02188472	Phase 1	Completed	Henrik Enghusen Poulsen
Surgical Treatment of Peri-implantitis With and Without Systemically Adjunctive Antibiotics	2014/07/09	NCT02185209	Phase 4	Completed	Margareta Hultin

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Penicillin V Potassium	Rising Health, LLC	57237-041	ORAL	500 mg in 1 1	10/27/2022
Penicillin V Potassium	PD-Rx Pharmaceuticals, Inc.	43063-614	ORAL	500 mg in 1 1	3/9/2023
Penicillin V Potassium	RPK Pharmaceuticals, Inc.	53002-2130	ORAL	250 mg in 5 mL	1/31/2023
Penicillin V Potassium	NorthStar Rx LLC	16714-235	ORAL	500 mg in 1 1	10/28/2022
PENICILLIN V POTASSIUM	DirectRX	61919-649	ORAL	500 mg in 1 1	6/19/2020
Penicillin V Potassium	Liberty Pharmaceuticals, Inc.	0440-8056	ORAL	500 mg in 1 1	9/18/2013
Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	68071-3299	ORAL	500 mg in 1 1	6/30/2023
Penicillin V Potassium	Denton Pharma, Inc. dba Northwind Pharmaceuticals	70934-579	ORAL	250 mg in 1 1	2/26/2020
Penicillin V Potassium	NuCare Pharmaceuticals,Inc.	68071-3562	ORAL	250 mg in 1 1	1/24/2024
Penicillin V Potassium	Rebel Distributors Corp	21695-559	ORAL	250 mg in 5 mL	10/2/2007

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
PENOPEN 250 TABLET 250 mg	REMEDICA LTD	SIN01608P	TABLET, FILM COATED	250 mg	6/1/1988

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
PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 125mg/5ml powder for oral liquid bottle	159753	AFT Pharmaceuticals Pty Ltd	Medicine	A	12/21/2010
CILICAINE VK 250mg capsule blister pack	339013	Viatris Pty Ltd	Medicine	A	9/23/2020
CILICAINE VK 500mg capsule blister pack	339012	Viatris Pty Ltd	Medicine	A	9/23/2020
CILICAINE V phenoxymethylpenicillin (as benzathine) 150mg/5mL oral liquid, suspension bottle	151598	Viatris Pty Ltd	Medicine	A	6/9/2010
LPV phenoxymethylpenicillin 250mg (as potassium) capsule blister pack	66510	iNova Pharmaceuticals (Australia) Pty Ltd	Medicine	A	10/16/1998
PHENOXYMETHYLPENICILLIN-AFT phenoxymethylpenicillin (as potassium salt) 250mg/5ml powder for oral liquid bottle	159754	AFT Pharmaceuticals Pty Ltd	Medicine	A	12/21/2010
PHENOCAINE VK phenoxymethylpenicillin (as potassium) 500 mg capsule blister pack	339010	Viatris Pty Ltd	Medicine	A	9/23/2020
PHENOCAINE VK phenoxymethylpenicillin (as potassium) 250 mg capsule blister pack	339011	Viatris Pty Ltd	Medicine	A	9/23/2020
ASPECILLIN VK phenoxymethylpenicillin 250mg (as potassium) tablet bottle	200136	Viatris Pty Ltd	Medicine	A	11/20/2012
ASPECILLIN VK phenoxymethylpenicillin 500mg (as potassium) tablet bottle	200137	Viatris Pty Ltd	Medicine	A	11/20/2012

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NADOPEN V 200	lioh inc.	00018635	Powder For Solution - Oral	40000 UNIT / ML	12/31/1969
PENICILLINE V 300 TAB	PRO DOC LIMITEE	00468029	Tablet - Oral	500000 UNIT	12/31/1979
PEN-VEE-ORAL TABLETS 300MG	wyeth-ayerst canada inc.	02043289	Tablet - Oral	300 MG / TAB	12/31/1994
LEDERCILLIN VK TAB 400000UNIT	lederle cyanamid canada inc.	00014982	Tablet - Oral	250 MG / TAB	12/31/1969
PEN-VK	aa pharma inc	00642215	Tablet - Oral	300 MG	12/31/1985
PEN-VEE ORAL TABLETS 300 MG	lioh inc.	02229619	Tablet - Oral	300 MG	11/20/1996
NOVO-PEN VK SYR 500000/5ML	novopharm limited	00391603	Powder For Solution - Oral	300 MG / 5 ML	12/31/1977
PEN VK-300 SUS 500000UNIT/5ML	PRO DOC LIMITEE	00704415	Suspension - Oral	500000 UNIT / 5 ML	12/31/1987
LEDERCILLIN VK TAB 800000UNIT	lederle cyanamid canada inc.	00127760	Tablet - Oral	500 MG / TAB	12/31/1969
NADOPEN V TAB 500000IU	lioh inc.	00018740	Tablet - Oral	500000 UNIT	12/31/1960

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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