Source: Υπουργείο Υγείας (CY) Revision Year: 2015 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Spectinomycin is indicated in the treatment of gonorrheal urethritis and acute proctitis in men and gonorrheal cervicitis and acute proctitis in women when they are caused by susceptible strains of N. gonorrhoeae and when beta-lactams are not indicated.
Sexual partners of patients with gonorrhea should also be treated.
The recommended dose is 2 grams spectinomycin, both for men and women. The dose is also recommended for failure of a previous antibiotic treatment. For difficult cases or in case of common antibiotic resistance, a dose of 4g is recommended.
In children, spectinomycin is effective at a dose of 40 mg/kg (see section 4.4).
Intramuscular administration.
The drug should be injected deep into the upper outer quadrant of the gluteal muscle. If a dose of 4g is necessary, the dose may be divided between two injection sites.
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
There is no information on a possible overdose in humans.
Hemodialysis removes the intravenously administered spectinomycin.
5 years.
Reconstituted solution: From microbiological point of view, the product should be used immediately. If not used immediately, in use storage times and conditions prior to use are the responsibility of the user.
Store below 25°C in the original package.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Clear type II glass vials, sealed with stopper and aluminium overcap. Each vial contains the equivalent of 2g spectinomycin as spectinomycin dihydrochloride pentahydrate.
Packs of 1, 10 or 100 vials are available.
Not all pack sizes may be marketed.
Kirin should be reconstituted with suitable aseptic precautions. Using a sterile needle and syringe, add 3.2ml of diluent (sterile water for injection or sterile bacteriostatic water for injection), and vigorously shake. Before administration of the dose the vial should be shaken.
When reconstituted as directed, each vial gives 5ml of a suspension containing 400mg/ml spectinomycin. The reconstituted suspension should immediately be withdrawn and administered by deep intramuscular injection into the upper outer quadrant of the gluteal muscle. If required, the dose may be divided between two injection sites. Any unused suspension should be discarded.
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