Penicillin information, interactions and side effects, Penicillin V is the phenoxymethyl analog of penicillin G.
Penicillin V potassium (penicillin v potassium) is the potassium salt of penicillin V.
Each penicillin V potassium tablet, USP contains penicillin V potassium (penicillin v potassium) equivalent to 250 mg (400,000 units) or 500 mg (800,000 units) penicillin V. The inactive ingredients present are dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose, and sodium citrate.
Each penicillin V potassium (penicillin v potassium) Tablets, USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each penicillin V potassium (penicillin v potassium) tablet, USP, 500 mg contains 1.43 mEq (55.8 mg) of potassium
Penicillin V potassium (penicillin v potassium) for oral solution, USP is an off-white to pinkish colored powder, which when reconstituted as directed, yields a red colored solution with cherry flavor in which each 5 mL contains penicillin V potassium (penicillin v potassium) equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V. The inactive ingredients present are cherry flavor, FD&C Red #40, saccharin sodium, sodium benzoate, and sugar.
Each 5 mL of reconstituted penicillin V potassium (penicillin v potassium) for oral solution, USP, 125 mg (200,000 units) per 5 mL contains 0.36 mEq (13.9 mg) of potassium. Each 5 mL of reconstituted penicillin V potassium (penicillin v potassium ) for oral solution, USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium tablets, penicillin V potassium (penicillin v potassium (penicillin v potassium) ) for oral solution, and other antibacterial drugs, penicillin V potassium tablets and penicillin V potassium (penicillin v potassium (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.
Penicillin V potassium tablets and penicillin V potassium (penicillin v potassium (penicillin v potassium) ) for oral solution 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 hemolytic 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.
DOSAGE AND ADMINISTRATION
The dosage of penicillin V potassium tablets and penicillin V potassium (penicillin v potassium (penicillin v potassium) ) for oral solution should be determined according to the sensitivity of the causative microorganisms 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 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 sensitivity tests should be performed): 250 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 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 to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis.
For prophylaxis against bacterial endocarditis1 in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract: 2 gram of penicillin V (1 gram for children under 60 lbs.) 1 hour before the procedure, and then, 1 gram (500 mg for children under 60 lbs) 6 hours later.
Directions for Mixing Oral Solution
Do not add water until you dispense. When dispensing, slowly add the total amount of water for reconstitution (see table below). After partially filling bottle, replace cap and shake vigorously. Add remaining water and repeat shaking. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.
|125 mg/5 mL
||Total Amount of Water Required for Reconstitution
|The resulting solution (red in color) will contain penicillin V potassium equivalent to penicillin V 125 mg (200,000 units) in each 5 mL (teaspoonful).
|250 mg/5 mL
||Total Amount of Water Required for Reconstitution
|The resulting solution (red in color) will contain penicillin V potassium equivalent to penicillin V 250 mg (400,000 units) in each 5 mL (teaspoonful).
Penicillin V potassium (penicillin v potassium (penicillin v potassium) ) tablets, USP are available as follows:
250 mg (400,000 units): biconvex, oval, mottled, white to off-white, uncoated tablets, embossed with “93” on one side and “1172” on the other side in bottles of 100 and 1000.
500 mg (800,000 units): biconvex, oval, mottled, white to off-white, uncoated, scored tablets, embossed “9” to the left of partial bisect and “3” to the right on one side and “1174” on the other side in bottles of 100 and 1000.
Store at 20° to 25°C (68° to 77°F). Keep tightly closed. Dispense in a tight container as defined in the USP, with a child-resistant closure as required.
Penicillin V potassium (penicillin v potassium (penicillin v potassium) ) for oral solution, USP is available as follows:
125 mg (200,000 Units) per 5 mL: bottles of 100 mL and 200 mL.
250 mg (400,000 Units) per 5 mL: bottles of 100 mL and 200 mL.
Keep tightly closed. Store dry powder at 20° to 25°C (68° to 77°F). After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.
Although the incidence of reactions to oral penicillins has been reported with much less frequency than following parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been reported with oral penicillin. The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue. The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum-sicknesslike reactions, laryngeal edema, and anaphylaxis.
Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leukopenia, thrombocytopenia, neuropathy, and nephropathy are infrequent reactions and usually associated with high doses of parenteral penicillin.
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (anaphylactic) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE LIKELY TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH PENICILLIN V POTASSIUM, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, PENICILLIN V POTASSIUM (penicillin v potassium (penicillin v potassium) ) SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC REACTIONS REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED AS INDICATED.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including penicillin V potassium tablets and penicillin V potassium (penicillin v potassium (penicillin v potassium) ) for oral solution, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.
CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Penicillin should be used with caution in individuals with histories of significant allergies and/or asthma.
Prescribing penicillin V potassium tablets or penicillin V potassium (penicillin v potassium (penicillin v potassium) ) for oral solution in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
The oral route of administration should not be relied upon in patients with severe illness, or with nausea, vomiting, gastric dilatation, cardiospasm, or intestinal hypermotility.
Occasionally patients will not absorb therapeutic amounts of orally administered penicillin.
In streptococcal infections, therapy must be sufficient to eliminate the organism (10 day minimum); otherwise the sequelae of streptococcal disease may occur. Cultures should be taken following completion of treatment to determine whether streptococci have been eradicated.
Prolonged use of antibiotics may promote the overgrowth of nonsusceptible organisms, including fungi. Should superinfection occur, appropriate measures should be taken.
A previous hypersensitivity reaction to any penicillin is a contraindication.