DOSAGE AND ADMINISTRATION
Do not inject into or near an artery or nerve. Injection into or near a nerve may result in permanent neurologic damage (see WARNINGS).
Penicillin G procaine (aqueous) is for intramuscular injection only.
Administer by DEEP INTRAMUSCULAR INJECTION in the upper, outer quadrant of the buttock. In neonates, infants and small children, the midlateral aspect of the thigh may be preferable. When doses are repeated, vary the injection site.
The TUBEX® cartridge for this product incorporates several features that are designed to facilitate the visualization of blood on aspiration if a blood vessel is inadvertently entered.
The design of this cartridge is such that blood which enters its needle will be quickly visualized as a red or dark-colored “spot.” This “spot” will appear on the barrel of the glass cartridge immediately proximal to the blue hub. The TUBEX is designed with two orientation marks, in order to determine where this “spot” can be seen. First insert and secure the cartridge in the TUBEX injector in the usual fashion. Locate the yellow rectangle at the base of the blue hub. This yellow rectangle is aligned with the blood visualization“spot.” An imaginary straight line, drawn from this yellow rectangle to the shoulder of the glass cartridge, will point to the area on the cartridge where the “spot” can be visualized. When the needle cover is removed, a second yellow rectangle will be visible. The second yellow rectangle is also aligned with the blood visualization “spot” to assist the operator in locating this “spot.” If the 2 mL metal or plastic syringe is used, the glass cartridge should be rotated by turning the plunger of the syringe clockwise until the yellow rectangle is visualized. If the 1 mL metal syringe is used, it will not be possible to continue to rotate the glass cartridge clockwise once it is properly engaged and fully threaded; it can, however, then be rotated counterclockwise as far as necessary to properly orient the yellow rectangles and locate the observation area. (In this same area in some cartridges, a dark spot may sometimes be visualized prior to injection. This is the proximal end of the needle and does not represent a foreign body in, or other abnormality of, the suspension.)
Thus, before the needle is inserted into the selected muscle, it is important for the operator to orient the yellow rectangles so that any blood which may enter after needle insertion and during aspiration can be visualized in the area on the cartridge where it will appear and not be obscured by any obstructions.
After selection of the proper site and insertion of the needle into the selected muscle, aspirate by pulling back on the plunger. While maintaining negative pressure for 2 to 3 seconds, carefully observe the barrel of the cartridge in the area previously identified (see above) for the appearance of a red or dark-colored “spot.”
Blood or “typical blood color” may not be seen if a blood vessel has been entered-only a mixture of blood and Penicillin G Procaine Injectable Suspension. The appearance of any discoloration is reason to withdraw the needle and discard the glass TUBEX cartridge. If it is elected to inject at another site, a new cartridge should be used. If no blood or discoloration appears, inject the contents of the cartridge slowly. Discontinue delivery of the dose if the subject complains of severe immediate pain at the injection site or if, especially in neonates, infants and young children, symptoms or signs occur suggesting onset of severe pain.
Some TUBEX cartridges may contain a small air bubble which should be disregarded, since it does not affect administration of the product. DO NOT clear any air bubbles from the cartridge or needle as this may interfere with the visualization of any blood or discoloration during aspiration.
Because of the high concentration of suspended material in this product, the needle may be blocked if the injection is not made at a slow, steady rate.
Pneumonia (pneumococcal), moderately severe (uncomplicated): 600,000 to 1,000,000 units daily.
Streptococcal infections (Group A), moderately severe to severe tonsillitis, erysipelas, scarlet fever, upper respiratory tract, skin and soft tissue: 600,000 to 1,000,000 units daily for 10-day minimum.
Staphylococcal infections, moderately severe to severe: 600,000 to 1,000,000 units daily.
In pneumonia, streptococcal (Group A) and staphylococcal infections in pediatric patients under 60 pounds: 300,000 units daily.
Bacterial endocarditis (Group A streptococci) only in extremely sensitive infections: 600,000 to 1,000,000 units daily.
Penicillin G procaine is not recommended for prophylaxis against bacterial endocarditis. For prophylaxis against bacterial endocarditis in patients with congenital heart disease or rheumatic or other acquired valvular heart disease when undergoing dental procedures or surgical procedures of the upper respiratory tract, use penicillin V. For patients unable to take oral medications, aqueous penicillin G is recommended.
Primary, secondary, and latent with a negative spinal fluid in adults and pediatric patients over 12 years of age: 600,000 units daily for 8 days-total 4,800,000 units.
Late (tertiary, neurosyphilis, and latent syphilis with positive spinal-fluid examination or no spinal-fluid examination): 600,000 units daily for 10 to 15 days-total 6 to 9 million units.
Congenital syphilis under 70-lb. body weight: 50,000 units/kg/day for 10 days.
Yaws, Bejel, and Pinta: Treatment as for syphilis in corresponding stage of disease.
Diphtheria-adjunctive therapy with antitoxin: 300,000 to 600,000 units daily.
Diphtheria carrier state: 300,000 units daily for 10 days.
Anthrax-cutaneous: 600,000 to 1,000,000 units/day.
Anthrax-inhalational (post-exposure): 1,200,000 units every 12 hours in adults, 25,000 units per kilogram of body weight (maximum 1,200,000 unit) every 12 hours in children. The available safety data for penicillin G procaine at this dose would best support a duration of therapy of 2 weeks or less. Treatment for inhalational anthrax (post-exposure) must be continued for a total of 60 days. Physicians must consider the risks and benefits of continuing administration of penicillin G procaine for more than 2 weeks or switching to an effective alternative treatment.
Vincent's infection (fusospirochetosis): 600,000 to 1,000,000 units/day.
Erysipeloid: 600,000 to 1,000,000 units/day.
Streptobacillus moniliformis and Spirillum minus (rat-bite fever): 600,000 to 1,000,000 units/day.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.