Spectinomycin warnings and precautions

# Warnings
Spectinomycin hydrochloride is not effective in the treatment of syphilis. Antibiotics used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. Since the treatment of syphilis demands prolonged therapy with any effective antibiotic, patients being treated for gonorrhea should be closely observed clinically. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with spectinomycin hydrochloride should have a follow-up serologic test for syphilis after three months.
Contains benzyl alcohol. Benzyl alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants and an increased incidence of neurologic and other complications.

# Precautions
The usual precautions should be observed with atopic individuals.
The clinical effectiveness of TROBICIN Sterile Powder should be monitored to detect evidence of development of resistance by Neisseria gonorrhoeae.
Prescribing TROBICIN Sterile Powder in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

## Information for Patients
Patients should be counseled that antibacterial drugs including TROBICIN Sterile Powder should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When TROBICIN Sterile Powder is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by TROBICIN Sterile Powder or other antibacterial drugs in the future.

## Carcinogenesis, Mutagenesis, Impairment of Fertility
Genotoxicity of spectinomycin hydrochloride was evaluated in six assay test systems including two Ames tests, two micronucleus tests in mice, unscheduled DNA synthesis in rat primary hepatocytes, and a chromosomal aberration test in Chinese hamster ovary cells. Spectinomycin was not shown to be mutagenic or genotoxic in these tests.
No adverse effects on fertility or general reproductive performance were observed when spectinomycin was administered subcutaneously to rats at dose levels up to 300 mg/kg (equivalent to the recommended maximum human dose based on mg/m2). A three-generation reproduction study in rats administered spectinomycin hydrochloride orally at dose levels up to 400 mg/kg (equivalent to the recommended maximum human dose based on mg/m2) produced no evidence of drug-induced toxicity during growth, gestation, or lactation periods of any parental generation. Pregnancy rates of the 400 mg/kg/day groups were consistently lower than those of the control groups. A histopathological examination of the testes and ovaries of the third generation animals was normal.

## Pregnancy Category: B

### Teratogenic Effects
Spectinomycin was not teratogenic or embryocidal when orally or subcutaneously administered to rats at doses of 300 mg/kg/day (equivalent to the recommended maximum human dose based on mg/m2). No teratogenic effects were observed when spectinomycin was administered intraperitoneally to mice or rats at dose levels of 400 or 1600 mg/kg/day, respectively. Spectinomycin was administered intramuscularly or subcutaneously to pregnant rabbits at dose levels up to 300 mg/kg/day (equivalent to the recommended maximum human dose based on mg/m2). Embryonic and fetal development were unaffected by treatment. Since there are no controlled studies of spectinomycin in pregnant women, and because animal reproduction studies are not always predictive of human responses, spectinomycin should be used during pregnancy only if clearly needed.

### Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when spectinomycin is administered to a nursing woman.

### Pediatric Use
Safety and effectiveness in the pediatric population have not been established.