Zhuoqing Spectinomycin Hydrochloride for Injection

1. Indications and Usage
Gonorrhea:
Indicated for the treatment of gonorrhea due to Neisseria gonorrhoeae in adults and adolescents.
Specific Indications:
Particularly indicated for patients who cannot tolerate beta-lactam antibiotics (e.g., penicillin, cephalosporins), or for infections caused by beta-lactamase-producing strains.
2. Dosage and Administration
Route of Administration:
Intramuscular Injection (IM) ONLY.
Adult Dosage:
Standard Regimen: 2 g (2 million units) as a single dose.
Proctitis/Vaginitis: 2 g IM as a single dose.
Threatened Abortion (during pregnancy): 4 g IM as a single dose.
Reconstitution:
Reconstitute with Sterile Water for Injection or Bacteriostatic Water for Injection prior to administration.
3. Mechanism of Action
Aminoglycoside Antibiotic:
Spectinomycin is an aminoglycoside antibiotic produced by Streptomyces spectabilis.
Protein Synthesis Inhibition:
It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thereby interfering with the formation of the initiation complex.
4. Safety and Warnings
Contraindications:
Contraindicated in patients with a history of hypersensitivity to spectinomycin or other aminoglycosides. Contraindicated in patients with renal disease.
Renal Impairment:
Dosage adjustment is necessary for patients with renal impairment as the drug is primarily excreted unchanged by the kidneys.
Pregnancy:
Safety for use during pregnancy has not been established. Use only if clearly needed.
5. Adverse Reactions
Most Common:
Pain at the injection site.
Others:
Dizziness, nausea, fever, chills, headache, insomnia, and rash.
Laboratory Abnormalities:
Transient increases in serum creatinine, BUN, alkaline phosphatase, and liver enzymes. Decreases in hemoglobin and hematocrit.
6. Drug Interactions
Other Nephrotoxic/Audiotoxic Drugs:
Concomitant use with other aminoglycosides, amphotericin B, or loop diuretics (e.g., furosemide) may increase the risk of nephrotoxicity or ototoxicity.
7. Pharmaceutical Information
Chemical Composition:
Active Ingredient: Spectinomycin Hydrochloride.
Storage:
Store at controlled room temperature. Protect from light.