Penicillin G Potassium 1000000 [iU]/1

Penicillin G Potassium · INJECTION, POWDER, FOR SOLUTION · WG Critical Care, LLC

4 Recalls on RecordCurrently in Shortage

Plain English

Penicillin G Potassium is a prescription antibiotic injection used to treat bacterial infections caused by organisms sensitive to penicillin. It is administered as an intramuscular injection and belongs to the penicillin class of antibiotics.

Key Facts

Brand Name: Penicillin G Potassium
Generic Name: Penicillin G Potassium
NDC Code (Product): 44567-310
Manufacturer: WG Critical Care, LLC
Strength: 1000000 [iU]/1
Dosage Form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAMUSCULAR, INTRAVENOUS
Marketing Status
Application #: ANDA065149
Marketing Start: 05/10/2012

Recall History

4 Recalls on Record

Class I06/27/2025

Sandoz Inc

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit

OngoingVoluntary: Firm initiated

Class II05/21/2012

Franck's Lab Inc., d.b.a. Franck's Compounding Lab

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

TerminatedVoluntary: Firm initiated

Class II02/22/2017

Advanced Pharma Inc.

Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.

TerminatedVoluntary: Firm initiated

Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity669 reports

drug ineffective324 reports

dyspnoea239 reports

rash239 reports

diarrhoea233 reports

nausea211 reports

off label use202 reports

malaise198 reports

abdominal pain upper180 reports

drug intolerance180 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Therapy Penicillin G Potassium for Injection, USP is indicated in the treatment of serious infections caused by susceptible strains of the designated microorganisms in the conditions listed below. Appropriate culture and susceptibility tests should be done before treatment in order to isolate and identify organisms causing infection and to determine their susceptibility to penicillin G. Therapy with Penicillin G Potassium for Injection, USP may be initiated before results of such tests are known when there is reason to believe the infection may involve any of the organisms listed below; however, once these results become available, appropriate therapy should be continued. CLINICAL INDICATION INFECTING ORGANISM Septicemia, empyema, pneumonia, pericarditis, endocarditis, meningitis Streptococcus pyogenes (group A β-hemolytic streptococcus), other β-hemolytic streptococci including groups C, H, G, L and M, Streptococcus pneumoniae and Staphylococcus species (non-penicillinase producing strains) Anthrax Bacillus anthracis Actinomycosis (cervico-facial disease and thoracic and abdominal disease) Actinomyces israelii Botulism (adjunctive therapy to antitoxin), gas g…

Dosage & Administration

DOSAGE AND ADMINISTRATION Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Adult patients (*) Because of its short half-life, Penicillin G is administered in divided doses, usually every 4 to 6 hours with the exception of meningococcal meningitis/septicemia, i.e. , every 2 hours. CLINICAL INDICATION DOSAGE Serious infections due to susceptible strains of streptococci (including S. pneumoniae ) septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 12 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours Serious infections due to susceptible strains of staphylococci septicemia, empyema, pneumonia, pericarditis, endocarditis and meningitis 5 to 24 million units/day depending on the infection and its severity administered in equally divided doses every 4 to 6 hours Anthrax Minimum of 8 million units/day in divided doses every 6 hours. Higher doses may be required depending on susceptibility of organism Actinomycosis Cervicofacial disease Thoracic and abdominal disease 1 to 6 million units/day (*) 10 to 20 milli…

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 G, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, penicillin G 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 G Potassium for Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alte…

Contraindications

CONTRAINDICATIONS A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.

Drug Interactions

Drug Interactions Bacteriostatic antibacterials (i.e., chloramphenicol, erythromycins, sulfonamides or tetracyclines) may antagonize the bactericidal effect of penicillin, and concurrent use of these drugs should be avoided. This has been documented in vitro ; however, the clinical significance of this interaction is not well-documented. Penicillin blood levels may be prolonged by concurrent administration of probenecid which blocks the renal tubular secretion of penicillins. Other drugs may compete with penicillin G for renal tubular secretion and thus prolong the serum half-life of penicillin. These drugs include: aspirin, phenylbutazone, sulfonamides, indomethacin, thiazide diuretics, furosemide and ethacrynic acid.

Adverse Reactions

ADVERSE REACTIONS Body as a whole The Jarisch-Herxheimer reaction is a systemic reaction, that may occur after the initiation of penicillin therapy in patients with syphilis or other spirochetal infections (i.e., Lyme disease and Relapsing fever). The reaction begins one to two hours after initiation of therapy and disappears within 12 to 24 hours. It is characterized by fever, chills, myalgias, headache, exacerbation of cutaneous lesions, tachycardia, hyperventilation, vasodilation with flushing and mild hypotension. The pathogenesis of the Herxheimer reaction may be due to the release from the spirochetes of heat-stable pyrogen. Hypersensitivity reactions The reported incidence of allergic reactions to all penicillins ranges from 0.7 to 10 percent in different studies (see WARNINGS ). Sensitization is usually the result of previous treatment with a penicillin, but some individuals have had immediate reactions when first treated. In such cases, it is postulated that prior exposure to penicillin may have occurred via trace amounts present in milk or vaccines. Two types of allergic reactions to penicillin are noted clinically - immediate and delayed. Immediate reactions usually occu…

Frequently Asked Questions

What is Penicillin G Potassium used for?

Is Penicillin G Potassium a controlled substance?

Penicillin G Potassium is not classified as a controlled substance by the DEA.

What is the generic name for Penicillin G Potassium?

The generic name for Penicillin G Potassium is Penicillin G Potassium. There are 4 other brand versions of Penicillin G Potassium.

What is the NDC code for Penicillin G Potassium 1000000 [iU]/1?

The NDC (National Drug Code) for Penicillin G Potassium 1000000 [iU]/1 is 44567-310, listed by WG Critical Care, LLC.

Product NDC

44567-310

Package NDC

44567-310-10

Other Penicillin G Potassium Dosages

Other Penicillin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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