KIRIN Powder for suspension for injection Ref.[28151] Active ingredients: Spectinomycin

Source: Υπουργείο Υγείας (CY)  Revision Year: 2015  Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Other Antibacterials, Antiinfectives for Systemic Use
ATC code: J01XX04

Spectinomycin is an antibiotic of the aminocyclitol group, produced by a soil fungus, Streptomyces spectabilis.

Spectinomycin inhibits bacterial cell protein synthesis, with the site of action being the 30S ribosomal sub-unit.

In vitro studies show that spectinomycin is effective against most strains of Neisseria gonorrhoeae (MIC: 7.5 to 20 mcg/ml).

Resistance is possible. Treponema pallidum and Chlamydia are not sensitive. The in vitro studies show that there is no cross-resistance to N. gonorrhoeae, between spectinomycin and penicillin.

5.2. Pharmacokinetic properties

Absorption

Following intramuscular administration, a single dose of 2g to 4 g spectinomycin is rapidly and completely absorbed.

Distribution

Injection of 2g or 4 g of spectinomycin produces after one hour, a plasma peak concentration of about 100 mcg/ml or 160 mg/ml. After 8 hours, the plasma concentrations are between 15 and 30 mcg/ml. Spectinomycin is not bound to plasma proteins.

Biotransformation

Studies have shown that the entire administered dose was excreted unchanged in the urine, therefore it is assumed that there is no transformation.

Elimination

The drug is excreted primarily in the urine: 24 to 48 hours after injection, there found 70 to 90% of the administered dose. In humans, the half-life of approximately 2 hours.

Since there is no significant binding to plasma proteins spectinomycin, the antibiotic can theoretically be removed by hemodialysis.

5.3. Preclinical safety data

No information.

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