Penicillin G Sodium 5000000 [USP'U]/1
Penicillin G Sodium · INJECTION, POWDER, FOR SOLUTION · Sandoz Inc
Penicillin G Sodium is a injection, powder, for solution containing penicillin g sodium at 5000000 [USP'U]/1, taken intramuscular. Manufactured by Sandoz Inc.
Key Facts
- Brand Name
- Penicillin G Sodium
- Generic Name
- Penicillin G Sodium
- NDC Code (Product)
0781-6153- Manufacturer
- Sandoz Inc
- Strength
- 5000000 [USP'U]/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA065068
- Marketing Start
- 02/26/2001
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Therapy Penicillin G Sodium 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 Sodium 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 Israelil Botulism (adjunctive therapy to antitoxin), gas gangr…
Dosage & Administration
DOSAGE AND ADMINISTRATION Penicillin G Sodium 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 ) and 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 million units/day(*) Clostridial infections Botulism (adjunctive therapy to antitoxin) Gas gangrene (debridement and/or surgery as indicated) Tetanus (adjunctive therapy to human tetanus immune globulin) 20 million units/day(*) Diphtheria (adjunctive therapy to antitoxin and for the prevention of the carrier state) 2 to 3 million units/day in divided doses for 10 to 12 days(*) Erysipelothrix endocarditis 12 to 20 million units/day for 4 to 6 …
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 sodium, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora o…
Contraindications
CONTRAINDICATIONS A history of 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, hyperventiliation, vasodilation with flushing and mild hypotension. The pathogenesis of the Herxheimer reaction may be due to the release from the spirochaete of host 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 occ…
Frequently Asked Questions
What is Penicillin G Sodium used for?
Penicillin G Sodium contains Penicillin G Sodium. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is Penicillin G Sodium a controlled substance?
Penicillin G Sodium is not classified as a controlled substance by the DEA.
What is the generic name for Penicillin G Sodium?
The generic name for Penicillin G Sodium is Penicillin G Sodium. There are no other listed brand versions of Penicillin G Sodium.
What is the NDC code for Penicillin G Sodium 5000000 [USP'U]/1?
The NDC (National Drug Code) for Penicillin G Sodium 5000000 [USP'U]/1 is 0781-6153, listed by Sandoz Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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