Penicillin V (Penicillin V Potassium) - Indications and Dosage

INDICATIONS AND USAGE

Penicillin V potassium is indicated in the treatment of mild to moderately severe infections due to penicillin G-sensitive microorganisms. Therapy should be guided by bacteriologic studies (including sensitivity tests) and by clinical response.

NOTE: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis, and arthritis should not be treated with penicillin V during the acute stage.

Indicated surgical procedures should be performed.

The following infections will usually respond to adequate dosage of penicillin V.

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

NOTE: Streptococci in groups A, C, G, H, L, and M are very sensitive to penicillin. Other groups, including group D (enterococcus), are resistant.

Pneumococcal infections. Mild to moderately severe infections of the respiratory tract.

Staphylococcal infections –penicillin G-sensitive. Mild infections of the skin and soft tissues.

NOTE: Reports indicate an increasing number of strains of staphylococci resistant to penicillin G, emphasizing the need for culture and sensitivity studies in treating suspected staphylococcal infections.

Fusospirochetosis (Vincent’s gingivitis and pharyngitis)–Mild to moderately severe infections of the oropharynx usually respond to therapy with oral penicillin.

NOTE: Necessary dental care should be accomplished in infections involving the gum tissue.

Medical conditions in which oral penicillin therapy is indicated as prophylaxis:

For the prevention of recurrence following rheumatic fever and/or chorea: Prophylaxis with oral penicillin on a continuing basis has proven effective in preventing recurrence of these conditions.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium for Oral Solution should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

The dosage of Penicillin V Potassium for Oral Solution should be determined according to the sensitivity of the causative microorganism and the severity of infection, and adjusted to the clinical response of the patient.

The usual dosage recommendations for adults and children 12 years and over are as follows:

Streptococcal Infections—mild to moderately severe—of the upper respiratory tract and including scarlet fever and erysipelas: 125 to 250 mg (200,000 to 400,000 units) every 6 to 8 hours for 10 days.

Pneumococcal Infections—mild to moderately severe—of the respiratory tract, including otitis media: 250 mg to 500 mg (400,000 to 800,000 units) every 6 hours until the patient has been afebrile for at least 2 days.

Staphylococcal Infections—mild infections of skin and soft tissue (culture and susceptibility tests should be performed): 250 mg to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.

Fusospirochetosis (Vincent’s infection) of the oropharynx—mild to moderately severe infections: 250 mg to 500 mg (400,000 to 800,000 units) every 6 to 8 hours.

For the prevention of recurrence following rheumatic fever and/or chorea: 125 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.

HOW SUPPLIED

Penicillin V Potassium for Oral Solution, USP

Each 5 mL of reconstituted solution contains penicillin V potassium equivalent to 125 or 250 mg penicillin V.

NDC 0781-6120-46	125 mg/5 mL bottle of 100 mL
NDC 0781-6120-48	125 mg/5 mL bottle of 200 mL
NDC 0781-6121-46	250 mg/5 mL bottle of 100 mL
NDC 0781-6121-48	250 mg/5 mL bottle of 200 mL

Directions for Dispensing Oral Solutions

Prepare this formulation at the time of dispensing. For ease in preparation, add water to the bottle in two portions and shake well after each addition. Add the total amount of water as directed on the labeling of the package being dispensed. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.

Keep tightly closed.

Manufactured by:
Bristol-Myers Squibb Company
Princeton, NJ 08543
for Sandoz Inc.,
Broomfield, CO 80020
PRODUCT OF ITALY

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