Penicillin G benzathine

Penicillin G benzathine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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.

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 (FDA): B

• Reproduction studies 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.

Pregnancy Category (AUS):

• 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

Pencillin G benzathine has been reported in milk. Caution should be exercised when penicillin G benzathine is administered to a nursing woman.

Pediatric Use

• Pencillins are excreted largely unchanged by the kidney. Because of incompletely developed renal function in infants, the rate of elimination will be slow. Use caution in administering to newborns and evaluate organ system function frequently.

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

• Penicillin in overdosage has the potential to cause neuromuscular hyperirritability. In case of overdosage discontinue medication, treat symptomatically, and institute supportive measures as required.
• Penicillin G is hemodialyzable.

Pharmacology

There is limited information regarding Penicillin G benzathine Pharmacology in the drug label.

Mechanism of Action

Structure

File:Penicillin G benzathine01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Penicillin G benzathine in the drug label.

Pharmacokinetics

• Intramuscular penicillin G benzathine is absorbed very slowly into the blood stream from the intramuscular site and converted by hydrolysis to penicillin G. This combination of hydrolysis and slow absorption results in blood serum levels much lower than those of other parenteral penicillins.
• Approximately 60% of penicillin G is bound to serum protein. The drug is distributed throughout the body tissues in widely varying amounts. Highest levels are found in the kidneys with lesser amounts in the liver, skin, and intestines. Penicillin G penetrates into all other tissues and the spinal fluid to a lesser degree. With normal kidney function the drug is excreted rapidly by tubular excretion. A small amount is secreted into the bile. In neonates and young infants, and in individuals with impaired kidney function, excretion is considerably delayed.

Nonclinical Toxicology

• Penicillin G exerts a bactericidal action against penicillin-susceptible microorganisms during the stage of active multiplication. It acts through the inhibition of biosynthesis of cell wall mucopeptide. It is not active against the penicillinase-producing bacteria, which includes many strains of staphylococci.
• While in vitro studies have demonstrated the susceptibility of most strains of the following organisms, clinical efficacy for infections other than those included in the INDICATIONS AND USAGE section has not been documented. Penicillin G exerts high in vitro activity against staphylococci (except penicillinase-producing strains), streptococci (groups A, C, G, H, L, and M), and pneumococci. Other organisms sensitive to penicillin G are: Corynebacterium diphtheriae, Bacillus anthracis, Clostridia, Actinomyces bovis, Streptobacillus moniliformis, Listeria monocytogenes, and Leptospira. Treponema pallidum is extremely sensitive to the bactericidal action of penicillin G.
• Penicillin acts synergistically with gentamicin or tobramycin against many strains of enterococci.

Clinical Studies

There is limited information regarding Clinical Studies of Penicillin G benzathine in the drug label.

How Supplied

• Permapen (Penicillin G Benzathine) Injectable Suspension is supplied in an ISOJECT syringe: 1,200,000 units in packages of 10 (NDC 0049-0210-35). ISOJECT is a pre-filled disposable syringe unit with a 20-gauge, 1¼ inch needle. Each 2 mL contains 1,200,000 units penicillin G benzathine; 0.0l2 g sodium citrate; 0.006 g polyvinylpyrrolidone; 0.020 g lecithin, and 0.006 g sodium carboxymethylcellulose. Preservatives: methylparaben 0.09%, propylparaben 0.01%.

Storage

• The product should be stored between 2°–8°C (36°–46°F). Keep from freezing.

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

• PERMAPEN ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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