Detailed Product Description

INDICATIONS

V is indicated in the treatment of mild to moderately severe infections due to microorganisms whose susceptibility to penicillin G is within the of levels common to this particular dosage form. should be guided by bacteriologic studies (including susceptibility tests) and by clinical response.

NOTE: Severe , , , , , and should not be treated with penicillin V during the .

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 tract, , and mild erysipelas.

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

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

Staphylococcal Infections Susceptible to Penicillin G: Mild infections of the and soft tissues.

NOTE: Reports an increasing number of strains of staphylococci resistant to penicillin G, which emphasizes the need for and susceptibility studies in treating suspected staphylococcal infections.

Fusospirochetosis (Vincent's and ): Mild to moderately severe infections of the usually respond to therapy with oral penicillin.

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

Medical Conditions in Which Oral Penicillin Therapy Is Indicated as : To prevent following and/or . Prophylaxis with oral penicillin on a continuing basis has proved effective in preventing recurrence of these conditions.

Although no controlled clinical efficacy studies have been conducted, penicillin V has been suggested by the American Association and the for use as an oral for prophylaxis against endocarditis in patients with or rheumatic or other valvular when they undergo dental procedures and surgical procedures of the respiratory tract.¹

Since a-hemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic , agents other than penicillin may be chosen for these patients and prescribed in addition to their continuous prophylactic regimen for rheumatic fever.

Oral penicillin should not be used as adjunctive prophylaxis for instrumentation or , lower intestinal tract surgery, , and childbirth.

NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full statement of the American Heart Association and the American Dental Association.¹

DOSAGE AND ADMINISTRATION

The dosage of penicillin V potassium should be determined according to the susceptibility of the causative microorganism and the severity of and should be 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 infections of the upper respiratory tract, including scarlet fever and mild erysipelas: 200,000 to 500,000 units every 6 to 8 hours for 10 days.

Pneumococcal Infections: Mild to moderately severe infections of the respiratory tract, including : 400,000 to 500,000 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): 400,000 to 500,000 units every 6 to 8 hours.

Fusospirochetosis (Vincent's Infection) of the Oropharynx: Mild to moderately severe infections: 400,000 to 500,000 units every 6 to 8 hours.

Prophylaxis in the Following Conditions: To prevent recurrence following rheumatic fever and/or chorea: 200,000 to 250,000 units twice daily on a continuing basis.

For prophylaxis against bacterial endocarditis¹in patients with heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract, 1 of 2 regimens may be selected:

(1) For the oral regimen, the usual adult dosage is 2 g of penicillin V (1 g for children less than 30 kg) 1 hour before the procedure and then 1 g (500 mg for children less than 30 kg) 6 hours later.

(2) For patients unable to take oral antibiotics, 2,000,000 units of aqueous penicillin G (50,000 units/kg for children) IV or IM may be substituted 30 to 60 minutes before the procedure and 1,000,000 units (25,000 units/kg for children) 6 hours later.

For patients with valves and for those at highest risk for endocarditis, ampicillin, 1 to 2 g (50 mg/kg for children), plus gentamicin, 1.5 mg/kg (2 mg/kg for children), IM or IV, may be given one- half hour prior to the procedure, followed by 1 g of oral penicillin V 6 hours later. Alternatively, the regimen should be repeated once every 8 hours later.

Children's dosages should not exceed the maximum adult doses.

NOTE: Therapy for children under 12 years of age is calculated on the basis of body weight. For infants and small children, the suggested daily dose is 25,000 to 90,000 units (15 to 50 mg)/kg in 3 to 6 divided doses.

After being mixed, the solution should be stored in a refrigerator. It may be kept for 14 days without significant loss of potency. Shake well before using. Keep tightly closed.

Tablets should be stored at controlled room temperature, 59