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

• Spectinomycin is not indicated for the treatment of syphilis infections due to Chlamydia trachomatis or non-gonococcal urethritis. The administration of high doses antibiotics for short periods in treating gonorrhea may mask the symptoms of syphilis incubation or delay their appearance. It is therefore appropriate to perform serological screening for syphilis in patients with gonorrhea for diagnosis. After 3 months, patients treated with spectinomycin must perform a serological test control.
• The safety of using spectinomycin has not been established in children.
• Cases of Clostridium difficile associated diarrhea (CDAD) has been reported with the use of nearly all antibacterial agents, including spectinomycin and severity can range from mild diarrhea to fatal colitis. An antibacterial treatment alters the normal flora of the colon, which results in proliferation. C. difficile infections can be refractory to antimicrobial therapy and may require colectomy. The possibility of CDAD must be considered in all patients who present with diarrhea following the use of antibiotics. A thorough medical history should be performed as CDAD has been reported to occur within two months after the administration of antibacterial agents.

Development of resistance to antibiotics by Neisseria gonorrhoeae has been observed. This appears to only occur rarely with spectinomycin, but the clinical effectiveness should be monitored to detect any evidence for development of antibiotic resistance.
The solvent contains 9 mg benzyl alcohol per ml. Benzyl alcohol may be associated with a “gasping syndrome” (respiratory disorder characterized by open gasping mouth) fatal in premature infants.

Benzyl alcohol must not be given to premature babies or neonates. It may cause toxic reactions and anaphylactic reactions in infants and children up to 3 years old.

Lithium: Spectinomycin decreases lithium clearance thus increasing effect and toxicity of lithium to a clinically significant extent.

Due to the lack of conclusive clinical findings, administration of spectinomycin during pregnancy and lactation is not recommended.

Dizziness and fever have been reported by some patients.

Adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from available data).

Reporting of suspected adverse reactions

Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs Fax: +357 22608649.

None known.