PCN V K 500 MG Oral Tablet
INDICATIONS AND USAGE Penicillin V Potassium Tablets, USP and Penicillin V Potassium for Oral Solution, USP, are indicated in the treatment of mild to moderately severe infections due to penicillin G- sensitive microorganisms. Therapy should be guided by bacteriological 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. Although no controlled clinical efficacy studies have been conducted, penicillin V 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 who have congenital heart disease or rheumatic or other acquired valvular heart disease when they undergo dental procedures and surgical procedures of the upper respiratory tract. 1 Oral penicillin should not be used in those patients at particularly high risk for endocarditis (e.g. those with prosthetic heart valves or surgically constructed systemic pulmonary shunts). Penicillin V should not be used as adjunctive prophylaxis for genitourinary instrumentation or surgery, lower-intestinal tract surgery, sigmoidoscopy, and childbirth. Since it may happen that alpha haemolytic streptococci relatively resistant to penicillin may be found when patients are receiving continuous oral penicillin for secondary prevention of rheumatic fever, prophylactic agents, other than penicillin may be chosen for these patients and prescribed in addition to their continuous rheumatic fever prophylactic regimen. NOTE: When selecting antibiotics for the prevention of bacterial endocarditis, the physician or dentist should read the full joint statement of the American Heart Association and the American Dental Association. 1 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin V Potassium Tablets, Penicillin V Potassium for Oral Solution and other antibacterial drugs, Penicillin V Potassium Tablets, and 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DAVA Pharmaceuticals, Inc.
S21
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HOW SUPPLIED Penicillin V Potassium Tablets, USP 250 mg (400,000 units) - white, oval, biconvex tablets engraved S20. NDC 67253-200-10 Bottles of 100 NDC 67253-200-11 Bottles of 1,000 Penicillin V Potassium Tablets, USP 500 mg (800,000 units) -white, oval, biconvex tablets engraved S21. NDC 67253-201-10 Bottles of 100 NDC 67253-201-50 Bottles of 500 NDC 67253-201-11 Bottles of 1,000 Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep tightly closed. Protect from moisture. Penicillin V Potassium for Oral Solution, USP, is available as a powder which when reconstituted as directed yields a red color, fruit-flavored solution. NDC 67253-202-10 125 mg/5 mL- 100 mL individual bottles NDC 67253-202-20 125 mg/5 mL- 200 mL individual bottles When reconstituted according to the directions, each 5 mL contains Penicillin V Potassium equivalent to 125 mg (200,000 units) of Penicillin V. NDC 67253-203-10 250 mg/5 mL- 100 ml individual bottles NDC 67253-203-20 250 mg/5 mL- 200 mL individual bottles When reconstituted according to the directions, each 5 mL contains Penicillin V Potassium equivalent to 250 mg (400,000 units) of Penicillin V. Store the dry powder at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. Keep bottle tightly closed. After reconstitution: Store in a refrigerator. Discard unused portion after 14 days.