Procaine Penicillin G Shortage

Penicillin G procaine is currently available and the U.S. Food and Drug Administration (FDA) moved it to a resolved shortage status on March 11, 2019. Please notify your local health department of any challenges in procuring product. For more information on the availability of Penicillin G procaine see the FDA Drug Shortage WebsiteExternal.

Penicillin G procaine is one of the recommended treatments for congenital syphilis and an alternative treatment for both neurosyphilis (NS) and ocular syphilis (OS).

Pfizer, the sole manufacturer of Penicillin G procaine in the United States, continues to experience a manufacturing delay of this products. Penicillin G procaine is currently unavailable. The next delivery that was expected by April 2017 is now delayed due to prioritization of Bicillin L-A®.  Pfizer will evaluate the next delivery when the supply of Bicillin L-A® is more stable.  Until Penicillin G procaine is available, CDC suggests the following:

  1. Use recommended options to treat congenital syphilis and neurosyphilis/ocular syphilis:
  1. Congenital Syphilis

Proven or highly probable congenital syphilis
Recommended Regimen
Aqueous crystalline penicillin G 100,000–150,000 units/kg/day, administered as 50,000 units/kg/dose IV every 12 hours during the first 7 days of life and every 8 hours thereafter for a total of 10 days

Possible Congenital Syphilis
Recommended Regimens
Aqueous crystalline penicillin G 100,000–150,000 units/kg/day, administered as 50,000 units/kg/dose IV every 12 hours during the first 7 days of life and every 8 hours thereafter for a total of 10 days

or
Benzathine penicillin G 50,000 units/kg/dose IM in a single dose

  1. Neurosyphilis/Ocular Syphilis

Recommended Regimen

Aqueous crystalline penicillin G 18–24 million units per day, administered as 3–4 million units IV every 4 hours or continuous infusion, for 10–14 days

  • As an option for treating persons with neurosyphilis/ocular syphilis outside of the hospital setting, some providers use the recommended regimen of aqueous crystalline penicillin G IV through a pic line.  Limited data suggest that ceftriaxone 2 g daily either IM or IV for 10–14 days may be effective as an alternative treatment. If an alternative to aqueous crystalline penicillin G is used, close follow-up is essential.
  1. Communicate with healthcare providers and pharmacists
    1. Notify health care providers and pharmacists that Penicillin G procaine is currently unavailable so they are aware and can plan.
    2. Inform clinicians with questions about congenital syphilis, neurosyphilis, and ocular syphilis clinical management to contact the on-line National Network of STD Clinical Prevention Training Centers (NNPTC) STD Clinical Consultation Network (https://www.stdccn.orgExternal) or a local ID specialist.

More information on congenital syphilis, neurosyphilis, and ocular syphilis treatment and clinical management can be found in the 2015 STD Treatment Guidelines CDC is not recommending any changes to these treatment recommendations for patients with congenital syphilis, neurosyphilis, and ocular syphilis.

Additional information on the availability of Penicillin G procaine can be found at https://www.cdc.gov/std/treatment/drugnotices/procaine-peng.htm or on the FDA’s Drug Shortage websiteExternal.