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Overview
Penicillin G benzathine is a antibiotic that is FDA approved for the treatment of Upper Respiratory Tract (pharyngitis): streptococci (group A – without bacteremia), Venereal Infections: Syphilis, Yaws, bejel, and pinta.. Common adverse reactions include hemolytic anemia, leucopenia, thrombocytopenia, neuropathy, and nephropathy.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Intramuscular penicillin G benzathine is indicated in the treatment of infections in both children and adults due to penicillin G-susceptible microorganisms that are susceptible to the low and very prolonged serum levels common to this particular dosage form in the indications listed below. Therapy should be guided by clinical response.
Note: When high sustained serum levels are required, injectable penicillin G either IM or IV should be used.
The following infections will usually respond to adequate dosages of intramuscular penicillin G benzathine:
Upper Respiratory Tract (pharyngitis): streptococci (group A – without bacteremia).
Venereal Infections: Syphilis
Yaws, bejel, and pinta.
Administer by deep IM injection in the upper outer quadrant of the buttock. In infants and small children, the mid-lateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site (see PRECAUTIONS).
Pediatric Dosage Schedule
In children under 12 years of age, dosage should be adjusted in accordance with the age and weight of the child and the severity of the infection. Under 2 years of age, the dose may be divided between the two buttocks if necessary.
Streptococcal Infections (group A) pharyngitis
A single injection of 900,000 units for older children; l,200,000 units for adults.
Venereal Infections
Syphilis
Primary, secondary, and latent: 2.4 million units (1 dose).
Late Syphilis (tertiary and neurosyphilis)
3 million units at 7 day intervals for a total of 6–9 million units.
Congenital Syphilis (asymptomatic with normal cerebrospinal fluid)
Under 2 years of age–50,000 units/kg body weight in a single dose; ages 2–12 years–adjust dosage based on adult dosage schedule.
Yaws, Bejel, and Pinta
1.2 million units (1 injection).
Prophylaxis
For rheumatic fever and glomerulonephritis.
Following an acute attack, penicillin G benzathine (parenteral) may be given in doses of 1,200,000 units once a month or 600,000 units every 2 weeks.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Penicillin G benzathine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Penicillin G benzathine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Penicillin G benzathine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Penicillin G benzathine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Penicillin G benzathine in pediatric patients.
Contraindications
A history of a previous hypersensitivity reaction to any penicillin is a contraindication.
Warnings
Serious and occasionally fatal hypersensitivity (anaphylactoid) 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 any penicillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillin, cephalosporins, and other allergens. If an allergic reaction occurs, the drug should be discontinued and the appropriate therapy instituted. Serious anaphylactoid reactions require immediate emergency treatment with epinephrine. Oxygen, intravenous steroids, and airway management–including intubation, should be administered as indicated.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Penicillin G benzathine in the drug label.
Postmarketing Experience
The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum sickness reactions, laryngeal edema and anaphylaxis. Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leucopenia, thrombocytopenia, neuropathy, and nephropathy are infrequent reactions and usually associated with high doses of parenteral penicillin.
Drug Interactions
There is limited information regarding Penicillin G benzathine Drug Interactions in the drug label.
