Penicillin V is the phenoxymethyl analog of penicillin G.

Penicillin V potassium is the potassium salt of penicillin V.

Each penicillin V potassium tablet, USP contains 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 tablet, USP, 250 mg contains 0.71 mEq (27.9 mg) of potassium and each penicillin V potassium tablet, USP, 500 mg contains 1.43 mEq (55.8 mg) of 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 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 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 for oral solution, USP, 250 mg (400,000 units) per 5 mL contains 0.71 mEq (27.9 mg) of potassium.

Monopotassium (2S,5R,6R)-3,3-dimethyl-7-oxo-6-(2-phenoxyacetamido)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate.

Last updated on RxList: 12/2/2009

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 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 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.¹

The dosage of penicillin V potassium tablets and 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
Bottle size	Total Amount of Water Required for Reconstitution
100 mL	75 mL
200 mL	150 mL
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
Bottle size	Total Amount of Water Required for Reconstitution
100 mL	75 mL
200 mL	150 mL
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 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) [See USP Controlled Room Temperature]. Keep tightly closed. Dispense in a tight container as defined in the USP, with a child-resistant closure as required.

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) [See USP Controlled Room Temperature]. After reconstitution, solution must be stored in a refrigerator. Discard any unused portion after 14 days.

REFERENCE

1. American Heart Association, 1984. Prevention of bacterial endocarditis. Circulation 70 (6): 1123A-1127A.

Manufactured In Canada By: Novopharm Ltd., Toronto, Canada M1B 2K9. Manufactured For: Teva Pharmaceuticals USA Sellersville, PA 18960. Rev. F 6/2007

Last updated on RxList: 12/2/2009

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.

No information provided.

Last updated on RxList: 12/2/2009

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 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 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.

General

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 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.

Last updated on RxList: 12/2/2009

No information provided

A previous hypersensitivity reaction to any penicillin is a contraindication.

Last updated on RxList: 12/2/2009

Penicillin V exerts a bactericidal action against penicillin-sensitive microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell-wall mucopeptide. It is not active against the penicillinase-producing bacteria, which include many strains of staphylococci. The drug exerts high in vitro activity against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L, and M), and pneumococci. Other organisms sensitive in vitro to penicillin V are Corynebacterium diphtheriae, Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacillus moniliformis, Listeria monocytogenes, Leptospira, and Neisseria gonorrhoeae. Treponema pallidum is extremely sensitive.

The potassium salt of 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 two to five 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 kidneys, 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 kidney function; however, recovery of the drug from the urine indicates that only about 25% of the dose given is absorbed. In neonates, young infants, and individuals with impaired kidney function, excretion is considerably delayed.

Last updated on RxList: 12/2/2009

Patients should be counseled that antibacterial drugs, including penicillin V potassium tablets and penicillin V potassium for oral solution, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When penicillin V potassium tablets or penicillin V potassium for oral solution is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by penicillin V potassium tablets, penicillin V potassium for oral solution, or other antibacterial drugs in the future.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

Last updated on RxList: 12/2/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

PENICILLIN V POTASSIUM - ORAL SOLIDS

(pen-ih-SILL-in VEE poh-TASS-ee-um)

COMMON BRAND NAME(S): Beepen VK, Ledercillin VK, Pen-Vee K, V-Cillin K, Veetids

USES: Penicillin is an antibiotic used to treat and prevent a wide variety of bacterial infections. It works by stopping the growth of bacteria.

This antibiotic treats and prevents only bacterial infections. It will not work for virus infections (such as the common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

HOW TO USE: Take this medication by mouth as directed by your doctor. This medication may be taken with or without food. However, penicillin is best absorbed when taken on an empty stomach (1 hour before or 2 hours after meals).

The dosage is based on your medical condition and response to treatment.

Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Upset stomach, nausea, vomiting, diarrhea, and mouth sores may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Although this effect is uncommon, you may develop a black, "hairy" tongue while taking this medication. This effect is harmless and usually goes away after treatment. Maintain good oral hygiene, and brush your tongue with a soft toothbrush twice a day. Consult your doctor or pharmacist for more information.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual tiredness, joint/muscle pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bruising/bleeding.

This medication may rarely cause a severe intestinal condition (pseudomembranous colitis) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), new fever, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking penicillin, tell your doctor or pharmacist if you are allergic to it; or to other antibiotics including penicillin-type medications (such as amoxicillin, ampicillin) or cephalosporins (such as cephalexin, cefuroxime); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: vaccines that contain live bacteria, methotrexate, tetracyclines, khat, guar gum.

Before taking penicillin, tell your doctor or pharmacist if you are also taking probenecid. Probenecid slows down the removal of penicillin from your body, resulting in higher levels of this antibiotic in your bloodstream. For certain types of difficult-to-treat infections, your doctor may prescribe these 2 medications together in order to achieve this effect. Consult your doctor or pharmacist for more details.

This medication may decrease the effectiveness of combination-type birth control pills. This can result in pregnancy. You may need to use an additional form of reliable birth control while using this medication. Consult your doctor or pharmacist for details.

Penicillin may cause false positive results with certain diabetic urine testing products (cupric sulfate-type). This drug may also affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe vomiting, persistent diarrhea.

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

With prolonged treatment, laboratory and/or medical tests (such as kidney function, complete blood counts) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.