Penicillin G benzathine
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Ammu Susheela, M.D. [2]
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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.
Use in Specific Populations
Pregnancy
- Pregnancy Category
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Penicillin G benzathine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Penicillin G benzathine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Penicillin G benzathine with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Penicillin G benzathine with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Penicillin G benzathine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Penicillin G benzathine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Penicillin G benzathine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Penicillin G benzathine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Penicillin G benzathine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Penicillin G benzathine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Penicillin G benzathine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Penicillin G benzathine in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Penicillin G benzathine in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Penicillin G benzathine in the drug label.
Pharmacology
There is limited information regarding Penicillin G benzathine Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Penicillin G benzathine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Penicillin G benzathine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Penicillin G benzathine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Penicillin G benzathine in the drug label.
How Supplied
Storage
There is limited information regarding Penicillin G benzathine Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Patient Counseling Information of Penicillin G benzathine in the drug label.
Precautions with Alcohol
- Alcohol-Penicillin G benzathine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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