Pfizerpen 5000000 [iU]/1

penicillin G potassium · POWDER, FOR SOLUTION · Roerig

2 Recalls on RecordCurrently in Shortage

Plain English

Pfizerpen is a penicillin antibiotic injection used to treat bacterial infections caused by penicillin-sensitive organisms. It is administered as an intramuscular injection and comes as a powder that must be mixed with liquid before use.

Key Facts

Brand Name: Pfizerpen
Generic Name: penicillin G potassium
NDC Code (Product): 0049-0420
Manufacturer: Roerig
Strength: 5000000 [iU]/1
Dosage Form: POWDER, FOR SOLUTION
Route: INTRAMUSCULAR, INTRAPLEURAL, INTRATHECAL, INTRAVENOUS
Marketing Status
Application #: ANDA060657
Marketing Start: 06/01/2010

Recall History

2 Recalls on Record

Class II05/15/2014

Franck's Lab Inc dba Trinity Care Solutions

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

OngoingVoluntary: Firm initiated

Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assure

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug hypersensitivity310 reports

drug ineffective95 reports

off label use74 reports

rash73 reports

arthralgia72 reports

hypersensitivity71 reports

dyspnoea67 reports

nausea67 reports

headache61 reports

drug intolerance60 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Therapy Penicillin G Potassium for Injection 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 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 gangrene, a…

Dosage & Administration

DOSAGE AND ADMINISTRATION Buffered Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Adult patients 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 4–6 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 4–6 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 1 to 6 million units/day Because of its short half-life, Penicillin G is administered in divided doses, usually every 4–6 hours with the exception of meningococcal meningitis/septicemia, i.e. , every 2 hours. Thoracic and abdominal disease 10 to 20 million …

Warnings

WARNINGS Anaphylaxis 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. Severe cutaneous adverse reactions Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, Penicillin G Potassium for Injection should be discontinued immediately and an alternative treatment sh…

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 or 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 oc…

Frequently Asked Questions

What is Pfizerpen used for?

Is Pfizerpen a controlled substance?

Pfizerpen is not classified as a controlled substance by the DEA.

What is the generic name for Pfizerpen?

The generic name for Pfizerpen is penicillin G potassium. There are 9 other brand versions of penicillin G potassium.

What is the NDC code for Pfizerpen 5000000 [iU]/1?

The NDC (National Drug Code) for Pfizerpen 5000000 [iU]/1 is 0049-0420, listed by Roerig.

Product NDC

0049-0420

Package NDC

0049-0420-10

Other Pfizerpen 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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