Beepen-VK

Name: Beepen-VK

Beepen-VK Description

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.

Beepen-VK - Clinical Pharmacology

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.

Microbiology

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.

Contraindications

A previous hypersensitivity reaction to any penicillin is a contraindication.

Warnings

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.

Beepen-VK Dosage and Administration

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 Infectionsmild to moderately severeof 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 Infectionsmild to moderately severeof 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 Infectionsmild 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 oropharynxmild 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.

Directions for mixing oral solutions

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.

How is Beepen-VK Supplied

Beepen-VK for Oral Solution

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

Beepen-VK Tablets

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.

Beepen-VK 
penicillin v potassium powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0029-6165
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
penicillin V potassium (penicillin V) penicillin V 125 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
citric acid  
flavorings  
saccharin sodium  
sodium benzoate  
sodium chloride  
sodium citrate  
sucrose  
xanthan  
FD&C Yellow No. 10  
FD&C Red No. 40  
Packaging
# Item Code Package Description
1 NDC:0029-6165-23 100 mL (100 MILLILITER) in 1 BOTTLE
2 NDC:0029-6165-24 200 mL (200 MILLILITER) in 1 BOTTLE
Beepen-VK 
penicillin v potassium powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0029-6170
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
penicillin V potassium (penicillin V) penicillin V 250 mg  in 5 mL
Inactive Ingredients
Ingredient Name Strength
citric acid  
flavorings  
saccharin sodium  
sodium benzoate  
sodium chloride  
sodium citrate  
sucrose  
xanthan  
FD&C Yellow No. 10  
FD&C Red No. 40  
Packaging
# Item Code Package Description
1 NDC:0029-6170-23 100 mL (100 MILLILITER) in 1 BOTTLE
2 NDC:0029-6170-24 200 mL (200 MILLILITER) in 1 BOTTLE
Beepen-VK 
penicillin v potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0029-6150
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
penicillin V potassium (penicillin V) penicillin V 250 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide  
lactose  
magnesium stearate  
microcrystalline cellulose  
stearic acid  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code Beecham;185
Contains     
Coating false Symbol false
Packaging
# Item Code Package Description
1 NDC:0029-6150-33 1000 TABLET (1000 TABLET) in 1 BOTTLE
Beepen-VK 
penicillin v potassium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0029-6160
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
penicillin V potassium (penicillin V) penicillin V 500 mg
Inactive Ingredients
Ingredient Name Strength
colloidal silicon dioxide  
lactose  
magnesium stearate  
microcrystalline cellulose  
stearic acid  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code Beecham;186
Contains     
Coating false Symbol false
Packaging
# Item Code Package Description
1 NDC:0029-6160-32 500 TABLET (500 TABLET) in 1 BOTTLE
Labeler - GlaxoSmithKline
Revised: 08/2007   GlaxoSmithKline

For the Consumer

Applies to penicillin v potassium: capsule, powder for solution, powder for suspension, solution, suspension, syrup, tablet, tablet for suspension, tablet chewable, tablet extended release

Along with its needed effects, penicillin v potassium (the active ingredient contained in Beepen-VK) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Stop taking penicillin v potassium and get emergency help immediately if any of the following effects occur:

Less common
  • Fast or irregular breathing
  • fever
  • joint pain
  • lightheadedness or fainting (sudden)
  • puffiness or swelling around the face
  • red, scaly skin
  • shortness of breath
  • skin rash, hives, itching

Check with your doctor immediately if any of the following side effects occur while taking penicillin v potassium:

Rare
  • Abdominal or stomach cramps and pain (severe)
  • abdominal tenderness
  • convulsions (seizures)
  • decreased amount of urine
  • diarrhea (watery and severe), which may also be bloody
  • mental depression
  • nausea and vomiting
  • pain at place of injection
  • sore throat and fever
  • unusual bleeding or bruising
  • yellow eyes or skin
Rare - For penicillin G procaine only
  • Agitation or combativeness
  • anxiety
  • confusion
  • fear of impending death
  • feeling, hearing, or seeing things that are not real

Some side effects of penicillin v potassium may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Diarrhea (mild)
  • headache
  • sore mouth or tongue
  • vaginal itching and discharge
  • white patches in the mouth and/or on the tongue

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