Permapen Isoject

STORE BETWEEN 2°–8°C (36°–46°F)

SHAKE WELL BEFORE USING

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.

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.

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.

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

Primary, secondary, and latent: 2.4 million units (1 dose).

3 million units at 7 day intervals for a total of 6–9 million units.

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.

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