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Permapen (Penicillin G Benzathine) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

Medical Conditions in Which Penicillin G Benzathine Therapy is Indicated As Prophylaxis

Rheumatic fever and/or chorea: Prophylaxis with penicillin G benzathine has proven effective in preventing recurrence of these conditions. It has also been used as follow-up prophylactic therapy for rheumatic heart disease and acute glomerulonephritis.

DOSAGE AND ADMINISTRATION

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.

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%.

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

Rx only

23-1173-00-3

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