Penicillin V potassium

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Storage

Oral

15–30°C.1

15–30°C.1 Following reconstitution, refrigerate and discard after 14 days.1 2

• A β-lactam antibacterial classified as a natural penicillin.3 The phenoxymethyl analog of penicillin G.1 3

• Usually bactericidal.1 2

• Gram-positive aerobes: active in vitro and in clinical infections against Staphylococcus (nonpenicillinase-producing strains only),1 2 S. pneumoniae,1 2 S. pyogenes (group A β-hemolytic streptococci),1 2 and other streptococci (groups C, G, H, L, M).1 2

• Also active in vitro against Bacillus anthracis,1 2 Corynebacterium diphtheriae,1 2 and Listeria monocytogenes.1 2

• Other organisms: active in vitro against some Actinomyces bovis,1 2 Clostridium,1 2 and Streptobacillus moniliformis.1 2

• Penicillinase-producing bacteria, including penicillinase-producing S. aureus1 2 8 and S. epidermidis are resistant.1 2 Enterococci are resistant.1 2

1. American Heart Association.1984. Prevention of bacterial endocarditis. Circulation 70(6):1123A –1127A.
   
2. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Disk Susceptibility Test; Approved Standard-Eleventh Edition. CLSI document M02-A11. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
   
3. Clinical and Laboratory Standards Institute. Methods for Dilution Antimicrobial Susceptibility Test for Bacteria That Grow Aerobically; Approved Standard-Ninth Edition. CLSI document M07-A9. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.
   
4. Clinical and Laboratory Standards Institute. Performance Standards for Antimicrobial Susceptibility Testing; Twenty-Second Informational Supplement. CLSI document M100-S22. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.

Distributed by:
West-Ward Pharmaceuticals Corp.
Eatontown, NJ 07724 USA

Manufactured by:
HIKMA Pharmaceuticals
P.O. Box 182400
Amman 11118 - Jordan

Issued October 2016

Excretion is considerably delayed.

Fusospirochetosis (Vincent gingivitis and pharyngitis): Treatment of fusospirochetosis (Vincent gingivitis and pharyngitis), in conjunction with dental care for infections involving gum tissue.

Pneumococcal infections: Treatment of mild to moderately severe pneumococcal respiratory tract infections, including otitis media.

Rheumatic fever and/or chorea prophylaxis: Prophylaxis (chronic, secondary) of rheumatic fever and/or chorea.

Staphylococcal infections (penicillin G-sensitive): Treatment of mild infections of the skin and soft tissues.

Streptococcal infections (without bacteremia): Treatment of mild to moderate streptococcal infections of the upper respiratory tract, scarlet fever, and mild erysipelas.

Actinomycosis

Data from a limited number of clinical studies suggest that penicillin V potassium may be beneficial for the treatment of actinomycosis after initial surgical intervention and IV therapy with penicillin G (if clinically indicated) [Hsieh 1993], [Sudhakar 2004]. Clinical experience also suggests the utility of penicillin V potassium in the treatment of actinomycosis [Smego 1998]. Duration is dependent upon disease location and patient-specific factors. Additional data may be necessary to further define the role of penicillin V potassium in this condition.

Bite wounds (animal)

Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and management of skin and soft tissue infections (SSTI), penicillin V potassium, in combination with dicloxacillin, is an effective and recommended option for treatment of animal bites.

Chronic antimicrobial suppression of prosthetic joint infection

Based on the Infectious Diseases Society of America (IDSA) Diagnosis and Management of Prosthetic Joint Infection: Clinical Practice Guideline, penicillin V potassium given for chronic antimicrobial suppression of prosthetic joint infection is effective and recommended in the management of this condition.

Cutaneous anthrax

Based on the Infectious Diseases Society of America (IDSA) Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections (SSTI), penicillin V potassium given for cutaneous anthrax (community acquired) is effective and recommended in the management of this condition.

Cutaneous erysipeloid

Based on the Infectious Diseases Society of America (IDSA) Practice Guidelines for the Diagnosis and Management of Skin and Soft Tissue Infections (SSTI), penicillin V potassium given for cutaneous erysipeloid is effective and recommended in the management of this condition.

GAS chronic carrier

Based on the Infectious Diseases Society of America (IDSA) Clinical Practice Guideline for the Diagnosis and Management of Group A Streptococcal Pharyngitis, penicillin V potassium given to chronic carriers of group A streptococcal is effective and recommended in the management of this condition.

Pneumococcal prophylaxis in asplenia/sickle cell

Based on the American Academy of Pediatrics (AAP) Health Supervision for Children With Sickle Cell Disease guidelines and the National Heart Lung and Blood Institute (NHLBI), Evidence-Based Management of Sickle Cell Disease guidelines, penicillin V potassium given for pneumococcal prophylaxis in patients with asplenia/sickle cell is effective and recommended in the management of this condition.

Pneumonia, community-acquired (children)

Following clinical guideline recommendations on the management of CAP reduces the incidence of morbidity and mortality related to pneumonia. Penicillin V is one of the preferred oral options for pathogen-directed therapy aimed at CAP caused by GAS in children older than 3 months of age.

General dosing, susceptible infections:

Infants and Children <12 years: Mild to moderate infection: Oral: 25 to 75 mg/kg/day in divided doses every 6 to 8 hours (maximum daily dose: 2,000 mg/day) (Red Book [AAP 2015])

Children ≥12 years and Adolescents: Oral:

Manufacturer’s labeling (fixed dosing): 125 to 500 mg every 6 to 8 hours

Alternate dosing (weight-based): Mild to moderate infection: 25 to 75 mg/kg/day in divided doses every 6 to 8 hours (maximum daily dose: 2,000 mg/day [Red Book (AAP 2015)])

Indication-specific dosing:

Anthrax (cutaneous), community-acquired (off-label use): Infants, Children, and Adolescents: Oral: 25 to 50 mg/kg/day in divided doses 2 or 4 times daily; maximum single dose: 500 mg (Stevens 2005)

Fusospirochetosis (Vincent infection), mild to moderately severe infections: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Tonsillopharyngitis; Group A streptococcal infection, treatment and primary prevention of rheumatic fever:

Acute treatment (Gerber 2009; Shulman 2012; WHO 2004):

Children ≤27 kg: Oral: 250 mg 2 to 3 times daily for 10 days

Children >27 kg and Adolescents: Oral: 500 mg 2 to 3 times daily for 10 days; in adolescents, 250 mg 4 times daily has also been suggested

Chronic carrier treatment (Group A streptococci) (off-label use): Children and Adolescents: 50 mg/kg/day in 4 divided doses for 10 days in combination with oral rifampin; maximum daily dose: 2,000 mg/day (Shulman 2012)

Recurrent rheumatic fever, prophylaxis (off-label): Children and Adolescents: 250 mg twice daily (Gerber 2009)

Pneumococcal infection prophylaxis for anatomic or functional asplenia (eg, sickle cell disease [SCD]) (off-label use) (AAP 2002; Kavanagh 2011; NHLBI 2014):

Infants (as soon as SCD diagnosed or asplenic) and Children <3 years: Oral: 125 mg twice daily

Children ≥3 years: Oral: 250 mg twice daily; the decision to discontinue penicillin prophylaxis after 5 years of age in children who have not experienced invasive pneumococcal infection and have received recommended pneumococcal immunizations is patient and clinician dependent

Pneumonia, community-acquired; Group A Streptococcus, mild infection or step-down therapy (off-label use): Infants ≥3 months, Children, and Adolescents: Oral: 50 to 75 mg/kg/day in 3 to 4 divided doses (Bradley 2011); maximum daily dose: 2,000 mg/day

There are no dosage adjustments provided in manufacturer’s labeling. Use with caution; excretion is prolonged in patients with renal impairment.

Powder for oral solution: Store dry powder at 20°C to 25°C (68°F to 77°F). Reconstituted oral solution should be stored in refrigerator. Discard unused solution after 14 days (consult manufacturer labeling for specific recommendations).

Tablet: Store at 20°C to 25°C (68°F to 77°F).

Penicillin crosses the placenta. Maternal use of penicillins has generally not resulted in an increased risk of adverse fetal effects. Due to pregnancy-induced physiologic changes, some pharmacokinetic parameters of penicillin V may be altered in the second and third trimester (Heikkilä 1993). If treatment for the management of Bacillus anthracis is needed in pregnant women, other agents are preferred (Meaney-Delman 2014)