Adverse Reaction:
In and multiple dose studies in healthy volunteers a reduction in urine output was noted. however, renal toxicity has not been demonstrated. Single dose- sore injection site, urticaria, dizziness, nausea, chills, fever, insomnia Multiple doses- decrease in hemoglobin, hemotocrit and creatinine clearance, elevation of alkaline phosphsatase BUN, and ALT
Contra-Indications:
Hypersensitivity to spectinomycin
Special precautions-
Monitoring- Monitor clinical effectiveness to detect resistence by N gonorrhoea The dilulent provoded with this product contains benzyl alcohol which has been associated with a fatal gasping syndrome in infants.
Hypersentivity- a few cases of anaphylaxis or anaphylactoid reactions have been reported. Have epinephrine immediately available.
Patient Information:
Ref - USP PDI Vol II 17th Edition (1997)
SPECTINOMYCIN -SYSTEMIC
1.Allergies-
Tell your doctor if you have ever had any unusual or allergic reaction to
Spectinomycin. Also tell your healthcare care professional if you are
allergic to any other substances such as foods. preservatives or dyes.
2.Pregnancy-
Studies have not been done in humans. However, spectinomycin has
been recommended for the treatment of gonorrhea and related infection
in pregnant patients who are allergic to penicillins, cephalosporin or
probenecid. In addition studies in animals have not shown that spectomycin
causes birth defects or other problems.
3. Breast-feeding-
It is not known whether spectinomycin passes into breast milk. However,
spectinomycin has not been reported to cause problems in nursing babies.
4.Children-
This medicine has been used in a limited number of children. In effective
doses the medicine has not been shown to cause different side effects or
problems than it does in adults. However, use in infants is not recommended
5.Older adults-
Although there is no specific information comparing use of spectinomycin
in the elderly with use in other age groups, this medicine is not to cause
different side effects or problems in older people.
6. Other medicines-
Tell your doctor if you are using any other prescription or
non-prescription (Over-the counter) OTC medicine.
Pharmacology/ Pharmacokinetics:
Pharmacology-
Spectinomycin structurallt different from related aminoglycosides inhibits protein synthesis in bacteria cell. Site of action is 30S ribosomal unit.
Pharmacokinetics-
Rapidly absorbed after Im injection . a 2g injection produces average peakserum concentrations of 100mcg/ml at 1 hour a 4g injection, 160mcg/ml at 2 hours. Eight hours after a 2g or 4g injection, plasma concentrations are 15 and 31mcg/ml respy. The majority is excteted in urine inbiologicaly active form
Microbiology-
Active in vitro against most strains of Neiseria gonorrhoeae ,studies show no cross-resistence between spectinomycin and penicillin.
Manufacturer Details