Infant Data
Results
INDICATIONS
- Treatment of congenital syphilis in infants during the first month of life: Proven or highly probable
- an abnormal physical examination consistent with congenital syphilis.
- a serum quantitative nontreponemal serologic titer that is fourfold higher than the mother’s titer.
- a positive darkfield test of body fluid(s).
- Possible (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.
ADVERSE EFFECTS
Serious and potentially fatal hypersensitivity reactions have occurred. Avoid intravenous or intra-arterial 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. Prolonged therapy may lead to an increased risk of neutropenia and serum sickness-like reactions.
ADMINISTRATION
For IM injection only. Avoid injection into or near an artery or nerve. Administer by deep IM injection in the midlateral aspect of the thigh. Rotate injection site for repeated administration. Needle may be blocked if injection is not made at a slow, steady rate due to high concentration of suspended material in the product.
MONITORING
Periodic monitoring of CBC and renal function is recommended.