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 |
|---|---|---|---|---|---|
2024/03/06 | Phase 4 | Recruiting | Research Unit for General Practice in Aalborg | ||
2023/01/23 | Phase 2 | Recruiting | |||
2019/09/10 | Phase 4 | Recruiting | Katarina Hedin | ||
2019/09/10 | Phase 4 | Completed | Uppsala University | ||
2019/02/20 | Phase 1 | Completed | |||
2017/07/05 | Phase 3 | Terminated | Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | ||
2016/10/04 | Phase 4 | UNKNOWN | Royal College of Surgeons, Ireland | ||
2016/03/18 | Phase 4 | Completed | Ass. Prof. Katarina Hedin | ||
2014/07/11 | Phase 1 | Completed | Henrik Enghusen Poulsen | ||
2014/07/09 | Phase 4 | Completed | Margareta Hultin |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Rising Health, LLC | 57237-041 | ORAL | 500 mg in 1 1 | 10/27/2022 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-614 | ORAL | 500 mg in 1 1 | 3/9/2023 | |
| RPK Pharmaceuticals, Inc. | 53002-2130 | ORAL | 250 mg in 5 mL | 1/31/2023 | |
| NorthStar Rx LLC | 16714-235 | ORAL | 500 mg in 1 1 | 10/28/2022 | |
| DirectRX | 61919-649 | ORAL | 500 mg in 1 1 | 6/19/2020 | |
| Liberty Pharmaceuticals, Inc. | 0440-8056 | ORAL | 500 mg in 1 1 | 9/18/2013 | |
| NuCare Pharmaceuticals,Inc. | 68071-3299 | ORAL | 500 mg in 1 1 | 6/30/2023 | |
| Denton Pharma, Inc. dba Northwind Pharmaceuticals | 70934-579 | ORAL | 250 mg in 1 1 | 2/26/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-3562 | ORAL | 250 mg in 1 1 | 1/24/2024 | |
| 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 | SIN01608P | TABLET, FILM COATED | 250 mg | 6/1/1988 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Penicillin V Potassium Buccal Tablets | 国药准字H20080104 | 化学药品 | 片剂 | 5/4/2023 | |
| Phenoxymethylpenicillin Potassium Granules | 国药准字H20030726 | 化学药品 | 颗粒剂 | 4/30/2021 | |
| Phenoxymethylpenicillin Potassium Granules | 国药准字H20090114 | 化学药品 | 颗粒剂 | 5/16/2023 | |
| Phenoxymethylpenicillin Potassium Granules | 国药准字H20040474 | 化学药品 | 颗粒剂 | 8/25/2020 | |
| Phenoxymethylpenicillin Potassium Granules | 国药准字H20051939 | 化学药品 | 颗粒剂 | 4/10/2020 | |
| Phenoxymethylpenicillin Potassium Tablets | 国药准字H20046154 | 化学药品 | 片剂 | 8/10/2020 | |
| Phenoxymethylpenicillin Potassium Tablets | 国药准字H22026062 | 化学药品 | 片剂 | 4/3/2024 | |
| Phenoxymethylpenicillin Potassium Tablets | 国药准字H14023672 | 化学药品 | 片剂 | 4/20/2020 | |
| Phenoxymethylpenicillin Potassium Tablets | 国药准字HJ20140784 | 化学药品 | 片剂 | 3/20/2024 | |
| Phenoxymethylpenicillin Potassium Tablets | 国药准字H20073700 | 化学药品 | 片剂 | 9/8/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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