pharmacopeia

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Transpeptidase Inhibitors.

Transpeptidase

Indications

Sourced from openFDA
  • Therapy Penicillin G Potassium 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.

Contraindications

Sourced from openFDA
  • A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.contraindicated

Dosage & administration

Sourced from openFDA

Penicillin G Potassium Injection, USP should be administered by intravenous infusion. The usual dose recommendations are as follows: Adult patients (*) Because of its short half-life, Penicillin G is administered in divided doses, usually every 4-6 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 4-6 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.

Warnings & precautions

Sourced from openFDA

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 Injection, USP, 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.

Adverse reactions

Sourced from openFDA

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 occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioneurotic edema, laryngospasm, bronchospasm, hypotension, vascular collapse and death (see WARNINGS ). Such immediate anaphylactic reactions are very rare and usually occur after parenteral therapy, but a few cases of anaphylaxis have been reported following oral therapy.

Use in specific populations

Sourced from openFDA

Pregnancy Reproduction studies performed in the mouse, rat and rabbit have revealed no evidence of impaired fertility or harm to the fetus due to penicillin G. Human experience with the penicillins during pregnancy has not shown any positive evidence of adverse effects on the fetus. There are, however, no adequate and well controlled studies in pregnant women showing conclusively that harmful effects of these drugs on the fetus can be excluded. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

Dose related toxicity may arise with the use of massive doses of intravenous penicillins (40 to 100 million units per day), particularly in patients with severe renal impairment (see PRECAUTIONS ). The manifestations may include agitation, confusion, asterixis, hallucinations, stupor, coma, multifocal myoclonus, seizures and encephalopathy. Hyperkalemia is also possible (see ADVERSE REACTIONS -Metabolic). In case of overdosage, discontinue penicillin, treat symptomatically and institute supportive measures as required. If necessary, hemodialysis may be used to reduce blood levels of Penicillin G, although the degree of effectiveness of this procedure is questionable.

Approval history

Sourced from openFDA
  • Jun 27, 1952NDANDA050141King Pharms Llc
  • May 18, 1953NDANDA050138King Pharms Llc
  • Aug 30, 1968ANDAANDA060657Pfizer
  • Jun 25, 1990NDANDA050638Baxter Hlthcare
  • Feb 26, 2001ANDAANDA065068Sandoz
  • Aug 30, 2002ANDAANDA065079Sandoz
  • Jul 23, 2009ANDAANDA065149Hq Speclt Pharma
  • Aug 18, 2009ANDAANDA065448Istituto Bio Ita Spa

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,779 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Hypersensitivity1,25026%
  2. 2Recalled Product Administered57212%
  3. 3Hypersensitivity4469.3%
  4. 4Drug Ineffective4118.6%
  5. 5Rash3447.2%
  6. 6Dyspnoea3096.5%
  7. 7Off Label Use2725.7%
  8. 8Diarrhoea2705.6%
  9. 9Nausea2495.2%
  10. 10Malaise2274.7%
  11. 11Drug Intolerance2074.3%
  12. 12Abdominal Pain Upper1984.1%
  13. 13Headache1974.1%
  14. 14Pain1974.1%
  15. 15Anxiety1883.9%

Literature

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Recent PubMed references pinned to Penicillin G as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 895 ClinicalTrials.gov registrations naming Penicillin G as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Penicillin G work?
Mechanism-of-action class: Transpeptidase Inhibitors.
What is Penicillin G used for?
According to FDA labeling, Penicillin G carries indications including: Therapy Penicillin G Potassium 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Penicillin G?
Penicillin G is classified as Antibiotics, Beta-lactamase sensitive penicillins, Penicillin-class Antibacterial, Transpeptidase Inhibitors, Decreased Cell Wall Synthesis & Repair.
What are the brand names for Penicillin G?
Penicillin G is marketed under brand names including Albadry, Bactracillin G, Bicillin, Bicillin L-A, Extencilline, Lentocilin, Norocillin, Pfizerpen.
What are the contraindications for Penicillin G?
Penicillin G labeling lists contraindications including: A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.. Always consult the full prescribing information and a clinician.
Note. Data for penicillin-g is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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