Penicillin V Potassium


Aurobindo Pharma Limited
Human Prescription Drug
NDC 65862-176
Penicillin V Potassium is a drug for further processing labeled by 'Aurobindo Pharma Limited'. National Drug Code (NDC) number for Penicillin V Potassium is 65862-176. This drug is available in dosage form of Tablet, Film Coated. The names of the active, medicinal ingredients in Penicillin V Potassium drug includes Penicillin V Potassium - 500 mg/1 . The currest status of Penicillin V Potassium drug is Active.

Drug Information:

Drug NDC: 65862-176
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Penicillin V Potassium
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Penicillin V Potassium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Aurobindo Pharma Limited
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Film Coated
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:PENICILLIN V POTASSIUM - 500 mg/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:ORAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 29 Apr, 2008
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA065435
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Aurobindo Pharma Limited
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:834061
834102
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0365862175014
UPC stands for Universal Product Code.
UNII:146T0TU1JB
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class:Penicillin-class Antibacterial [EPC]
Penicillins [CS]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
65862-176-01100 TABLET, FILM COATED in 1 BOTTLE (65862-176-01)29 Apr, 2008N/ANo
65862-176-05500 TABLET, FILM COATED in 1 BOTTLE (65862-176-05)29 Apr, 2008N/ANo
65862-176-991000 TABLET, FILM COATED in 1 BOTTLE (65862-176-99)29 Apr, 2008N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Penicillin v potassium penicillin v potassium penicillin v potassium penicillin v povidone k90 microcrystalline cellulose talc silicon dioxide magnesium stearate hypromellose 2910 (6 mpa.s) polyethylene glycol 400 titanium dioxide white to off-white biconvex e;84 penicillin v potassium penicillin v potassium penicillin v potassium penicillin v povidone k90 microcrystalline cellulose talc silicon dioxide magnesium stearate hypromellose 2910 (6 mpa.s) polyethylene glycol 400 titanium dioxide white to off-white e;8;5

Indications and Usage:

Indications and usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin v potassium and other antibacterial drugs, penicillin v potassium 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 are indicated in the treatment of mild to moderately severe infections due to penicillin g-sensitive microorganisms. therapy should be guided by bacteriologic 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 pro
cedures 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 .

Warnings:

Warnings 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 tablets, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. if an allergic reaction occurs, penicillin v potassium tablets 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 associate
d diarrhea (cdad) has been reported with use of nearly all antibacterial agents, including penicillin v potassium tablets, 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 Precautions:

General prescribing penicillin v potassium 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.

Dosage and Administration:

Dosage and administration the dosage of penicillin v 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 sensitive 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 mg to 250 mg (200,000 to 400,000 units) twice daily on a continuing basis. for prophylaxis against bacterial endocarditis 1 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.

Contraindications:

Contraindications a previous hypersensitivity reaction to any penicillin is a contraindication.

Adverse Reactions:

Adverse reactions 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 like 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.

Description:

Description penicillin v is the phenoxymethyl analog of penicillin g. penicillin v potassium is the potassium salt of penicillin v. penicillin v potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units). the 250 mg tablet is equivalent to 250 mg (400,000 units) penicillin v and the 500 mg tablet is equivalent to 500 mg (800,000 units) penicillin v. in addition, each tablet contains the following inactive ingredients: povidone, microcrystalline cellulose, talc, colloidal silicon dioxide, magnesium stearate, hypromellose, polyethylene glycol, and titanium dioxide. chemical structure

Clinical Pharmacology:

Clinical pharmacology 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 empt
y 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. microbiology susceptibility testing for specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by fda for this drug, please see: https://www.fda.gov/stic.

How Supplied:

How supplied penicillin v potassium tablets usp, 250 mg (400,000 units) are white to off-white, round shaped, biconvex, film-coated tablets debossed with ‘e’ and ‘84’ on one side and break line on the other side. bottles of 100 ndc 65862-175-01 bottles of 1,000 ndc 65862-175-99 penicillin v potassium tablets usp, 500 mg (800,000 units) are white to off-white, capsule shaped, film-coated tablets, debossed with ‘e’ and a breakline on one side and ‘8’ and ‘5’ separated with a breakline on the other side. bottles of 100 ndc 65862-176-01 bottles of 500 ndc 65862-176-05 bottles of 1,000 ndc 65862-176-99 store at 20° to 25°c (68° to 77°f); excursions permitted to 15° to 30°c (59° to 86°f) [see usp controlled room temperature]. dispense in a tight container, as defined in the usp. keep tightly closed. keep out of reach of children.

Information for Patients:

Information for patients patients should be counseled that antibacterial drugs including penicillin v potassium should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when penicillin v potassium 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 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 a
s 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.

Package Label Principal Display Panel:

Package label-principal display panel - 250 mg (100 tablet bottle) ndc 65862-175-01 rx only penicillin v potassium tablets, usp 250 mg (400,000 units) aurobindo 100 tablets package label-principal display panel - 250 mg (100 tablet bottle)

Package label-principal display panel - 500 mg (100 tablet bottle) ndc 65862-176-01 rx only penicillin v potassium tablets, usp 500 mg (800,000 units) aurobindo 100 tablets package label-principal display panel - 500 mg (100 tablet bottle)


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