BUFFERED PENICILLIN G POTASSIUM 5000000 [iU]/1
BUFFERED PENICILLIN G POTASSIUM · INJECTION, POWDER, FOR SOLUTION · HF Acquisition Co LLC, DBA HealthFirst
Buffered Penicillin G Potassium is a penicillin antibiotic given by injection into the muscle to treat bacterial infections. It works by stopping the growth of bacteria that cause various infections in the body.
Key Facts
- Brand Name
- BUFFERED PENICILLIN G POTASSIUM
- Generic Name
- BUFFERED PENICILLIN G POTASSIUM
- NDC Code (Product)
51662-1436- Manufacturer
- HF Acquisition Co LLC, DBA HealthFirst
- Strength
- 5000000 [iU]/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA065079
- Marketing Start
- 01/29/2020
Recall History
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
Full Prescribing Information
Indications & Usage
INDICATIONS & USAGE Therapy Buffered 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 Buffered 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Penicillin G Potassium and other antibacterial drugs, Penicillin G 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 susc…
Dosage & Administration
DOSAGE & ADMINISTRTION Buffered Penicillin G Potassium for Injection, USP may be given intravenously or intramuscularly. The usual dose recommendations are as follows: Pediatric patients This product should not be administered to patients requiring less than one million units per dose. (see PRECAUTIONS – Pediatric Use). Renal Impairment Penicillin G is relatively nontoxic, and dosage adjustments are generally required only in cases of severe renal impairment. The recommended dosage regimens are as follows: Creatinine clearance less than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 8 to 10 hours. Uremic patients with a creatinine clearance greater than 10 mL/min/1.73m2; administer a full loading dose (see recommended dosages in the tables above) followed by one-half of the loading dose every 4 to 5 hours. Additional dosage modifications should be made in patients with hepatic disease and renal impairment. For most acute infections, treatment should be continued for at least 48 to 72 hours after the patient becomes asymptomatic. Antibiotic therapy for Group A β-hemolytic streptococcal inf…
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. Pseudomembranous colitis has been reported with nearly all antibacterial agents, including penicillin G, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to…
Contraindications
CONTRAINDICATIONS A history of hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
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 BUFFERED PENICILLIN G POTASSIUM used for?
Buffered Penicillin G Potassium is a penicillin antibiotic given by injection into the muscle to treat bacterial infections. It works by stopping the growth of bacteria that cause various infections in the body.
Is BUFFERED PENICILLIN G POTASSIUM a controlled substance?
BUFFERED PENICILLIN G POTASSIUM is not classified as a controlled substance by the DEA.
What is the generic name for BUFFERED PENICILLIN G POTASSIUM?
The generic name for BUFFERED PENICILLIN G POTASSIUM is BUFFERED PENICILLIN G POTASSIUM. There are no other listed brand versions of BUFFERED PENICILLIN G POTASSIUM.
What is the NDC code for BUFFERED PENICILLIN G POTASSIUM 5000000 [iU]/1?
The NDC (National Drug Code) for BUFFERED PENICILLIN G POTASSIUM 5000000 [iU]/1 is 51662-1436, listed by HF Acquisition Co LLC, DBA HealthFirst.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)