NEODOSE

INDICATIONS

• Treatment of congenital syphilis in infants during the first month of life. Recommended as an alternative to aqueous crystalline penicillin G or procaine penicillin G in infants who have a normal physical examination and a serum quantitative nontreponemal titer the same or less than fourfold the maternal titer and the:
  • mother was not treated, inadequately treated, or has no documentation of having received treatment.
  • mother was treated with erythromycin or another non-penicillin regimen.
  • mother received treatment less than 4 weeks before delivery.
• Also recommended in infants whose mother was adequately treated during pregnancy (and treatment given greater than 4 weeks before delivery) and mother has no evidence of reinfection or relapse. Close serologic testing may be used instead of treatment in infants whose mother’s nontreponemal titers decreased fourfold after appropriate therapy for early syphilis and remained stable or low for late syphilis.
• For infants whose mother’s treatment was adequate before pregnancy and nontreponemal serologic titer remained low and stable before and during pregnancy and at delivery (VDRL less than 1:2; RPR less than 1:4), no treatment is required; however, it may be considered if follow-up is not assured.

ADMINISTRATION

Inspect visually for particulate matter and discoloration prior to administration. For deep IM injection only. Do not inject into or near an artery or nerve. Do NOT inject IV or admix with other IV solutions since this has been associated with cardiorespiratory arrest and death. Do not inject into the anterolateral thigh as quadriceps femoris fibrosis and atrophy have been reported. Administer into the upper, outer quadrant of the buttock (dorsogluteal) or the ventrogluteal site; in neonates, infants, and small children, it may be preferable to administer into the midlateral aspect of the thigh. When doses are repeated, vary the injection site. If any discoloration appears in the cartridge upon insertion of the needle and aspiration, withdraw the needle and discard the glass TUBEX(R) cartridge. To avoid blockage of the needle, administer at a slow steady rate.

ADVERSE EFFECTS

Serious and potentially fatal hypersensitivity reactions have occurred. The Jarisch-Herxheimer reaction (fever, chills, myalgia, headache, tachycardia, hyperventilation, mild hypotension) may occur after initiation of therapy in patients with syphilis. Avoid intravenous or intraarterial administration, or injection into or near a nerve; severe neurovascular damage (transverse myelitis with permanent paralysis, gangrene requiring amputation, and necrosis and sloughing at or around injection site) has occurred, especially in infants. Quadriceps femoris fibrosis and atrophy have occurred following repeated intramuscular administration into the anterolateral thigh.

BLACK BOX WARNING

Inadvertent IV administration of penicillin G benzathine (to be given IM only) has been associated with cardiorespiratory arrest and death.