beepen-vk (penicillin V potassium) powder, for solution
beepen-vk (penicillin V potassium) tablet
[GlaxoSmithKline]
Beepen-VK (penicillin V potassium) is the potassium salt of penicillin V. Chemically it is 4-Thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic acid, 3,3-dimethyl-7-oxo-6-[(phenoxy-acetyl)aminol-, monopotassium salt, [2S-(2α,5α,6β)]-, and can be represented structurally as:
The oral solutions contain in each 5 mL (teaspoonful) 125 mg or 250 mg of penicillin V activity, respectively. The tablets contain penicillin V potassium equivalent to 250 mg or 500 mg (400,000 or 800,000 units) penicillin V, respectively. The oral solution, 125 mg/5 mL, contains 0.33 mEq of sodium, and the oral solution, 250 mg/5 mL, contains 0.63 mEq of sodium.
Inactive ingredients: Oral solutions: Citric acid, flavorings, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sucrose and xanthan. 125 mg contains FD&C Yellow No. 10 and FD&C Red No. 40. 250 mg contains FD&C Blue No. 1 and FD&C Red No. 3. Tablets: Colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose and stearic acid.
Penicillin V has the distinct advantage over penicillin G in resistance to inactivation by gastric acid. It may be given with meals; however, blood levels are slightly higher when the drug is given on an empty stomach. Average blood levels are 2 to 5 times higher than the levels following the same dose of oral penicillin G and also show much less individual variation. Once absorbed, penicillin V is about 80% bound to serum protein. Tissue levels are highest in the kidney, with lesser amounts in the liver, skin and intestines. Small amounts are found in all other body tissues and the cerebrospinal fluid. The drug is excreted as rapidly as it is absorbed in individuals with normal renal function; however, recovery of the drug from the urine indicates that only about 24% of the dose is absorbed. In neonates, young infants and individuals with impaired renal function, excretion is considerably delayed.
Penicillin V exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. Penicillin V is not active against the penicillinase-producing bacteria, which include many strains of staphylococci. While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been documented. This drug exerts in vitro activity against staphylococci (except penicillinase-producing strains), streptococci (Groups A, C, G, H, L and M) and pneumococci. Other organisms susceptible in vitro to penicillin V are Corynebacterium diphtheriae, Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacilus moniloformis, Listeria monocytogenes, Leptospira and Neisseria gonorrhoeae. Treponema pallidum is extremely susceptible.
Beepen-VK is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below:
Streptococcal infections—mild to moderately severe—of the upper respiratory tract and including scarlet fever and erysipelas.
Pneumococcal infections—mild to moderately severe—of the respiratory tract, including otitis media.
Staphylococcal infections—mild infections of skin and soft tissue (culture and sensitivity tests should be performed).
Fusospirochetosis (Vincent’s infection) of the oropharynx—mild to moderately severe infections.
For prevention of recurrence following rheumatic fever and/or chorea.
Note: Severe pneumonia, empyema, bacteremia, pericarditis, meningitis and arthritis should not be treated with oral penicillins during the acute stage.
Indicated surgical procedures should be performed.
The following infections will usually respond to adequate doses 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 tissue.
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.
A previous hypersensitivity reaction to any penicillin is a contraindication.
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC) REACTIONS HAVE BEEN REPORTED IN PATIENTS ON PENICILLIN THERAPY. THESE REACTIONS ARE MORE APT TO OCCUR IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY AND/OR A HISTORY OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN WELL-DOCUMENTED REPORTS OF INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY REACTIONS WHO EXPERIENCED SEVERE HYPERSENSITIVITY REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH BEEPEN-VK, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY REACTIONS TO PENICILLINS, CEPHALOSPORINS AND OTHER ALLERGENS. IF AN ALLERGIC REACTION OCCURS, BEEPEN-VK SHOULD BE DISCONTINUED AND THE 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.
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including Beepen-VK, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.
Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis.”
After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile.
Penicillins should be used with caution in individuals with a history of significant allergies and/or asthma.
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.
Occasional patients will not absorb therapeutic amounts of orally administered penicillin.
In streptococcal infections, therapy must be sufficient to eliminate the organisms (10 days 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.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe.
In streptococcal infections, cultures should be taken following completion of treatment to determine whether streptococci have been eradicated.
Probenecid decreases the renal tubular secretion of penicillin V. Concurrent use with penicillin V may result in increased and prolonged blood levels.
No long-term studies have been conducted with these drugs.
Reproduction studies performed in the mouse, rat and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin V. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well-controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, penicillin should be used during pregnancy only if clearly needed.
Oral ampicillin class antibiotics are generally poorly absorbed during labor. Studies in guinea pigs have shown that intravenous administration of ampicillin decreased the uterine tone, frequency of contractions, height of contractions and duration of contractions. However, it is not known whether the use of penicillin V in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.
Penicillins have been shown to be excreted in milk. Caution should be exercised when penicillin V is administered to a nursing woman.
Because of incompletely developed renal function in newborns, penicillin elimination may be delayed. Guidelines for the administration of this drug to children are presented under DOSAGE AND ADMINISTRATION.
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-sickness reactions, laryngeal edema and anaphylaxis. Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leucopenia, thrombocytopenia, neuropathy and nephropathy are infrequent reactions usually associated with high doses of parenteral penicillin.
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures as required.
The dosage of Beepen-VK (penicillin V potassium) should be determined according to the susceptibility of the causative organism 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 (400,000 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 mg (400,000 units) every 6 to 8 hours.
Fusospirochetosis (Vincent’s infection) of the oropharynx—mild to moderately severe infections: 250 mg (400,000 units) every 6 to 8 hours.
For prevention of recurrence following rheumatic fever and/or chorea: 125 mg (200,000 units) twice daily on a continuing basis.
Prepare solution at time of dispensing as follows: Tap bottle until all powder flows freely. Add approximately ½ of the total amount of water for reconstitution (as directed on the labeling of the package being dispensed) and shake well to wet powder. Add the remainder of the water and again shake well. Each 5 mL of solution will then contain penicillin V potassium equivalent to 125 mg (200,000 units) or 250 mg (400,000 units) penicillin V, respectively.
The reconstituted solutions are stable for 14 days under refrigeration.
Each 5 mL (teaspoonful) of reconstituted raspberry-berry-cream-flavored solution contains penicillin V potassium equivalent to 125 mg penicillin V. Each 5 mL (teaspoonful) of reconstituted grape-flavored solution containspenicillin V potassium equivalent to 250 mg penicillin V.
125 mg/5 mL
NDC 0029-6165-23 100 mL bottles
NDC 0029-6165-24 200 mL bottles
250 mg/5 mL
NDC 0029-6170-23 100 mL bottles
NDC 0029-6170-24 200 mL bottles
Each tablet contains penicillin V potassium equivalent to 250 or 500 mg penicillin V.
250 mg
NDC 0029-6150-33 bottles of 1000
500 mg
NDC 0029-6160-32 bottles of 500
STORE AT CONTROLLED ROOM TEMPERATURE (15° to 30°C; 59° to 86°F).
DATE OF ISSUANCE MAY 1994
©SmithKline Beecham, 1994
SmithKline Beecham Pharmaceuticals
Philadelphia, PA 19101
BE:L2 Printed in U.S.A.
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