Trobicin (Powder) Instructions for Use

Marketing Authorization Holder

Pharmacia, NV/SA (Belgium)

ATC Code

J01XX04 (Spectinomycin)

Active Substance

Spectinomycin (Rec.INN registered by WHO)

Dosage Form

Trobicin

Powder for solution for injection 2 g: fl. with solvent included

Dosage Form, Packaging, and Composition

Solvent water for injections – 3.2 ml.

2 g – vials (1) in a kit with a solvent (amp. – 1 pc.) – plastic contour packaging (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic

Pharmacotherapeutic Group

Tricyclic antibiotic

Pharmacological Action

An antibiotic of a tricyclic structure. It disrupts protein synthesis in the microbial cell by binding to the 30S subunit of bacterial ribosomes.

It is active against gram-negative bacteria, among which Neisseria gonorrhoeae, including penicillinase-producing strains, are the most sensitive. Spectinomycin has a bacteriostatic effect, although it may act bactericidally on sensitive gonococci at concentrations slightly higher than the MIC.

It is not active against Treponema pallidum and Chlamydia spp.

Pharmacokinetics

After intramuscular administration, spectinomycin is rapidly absorbed. Following a single administration of a 2 g dose, C_max (about 100 µg/ml) is reached within 1 hour. Spectinomycin practically does not bind to plasma proteins. It is not metabolized. 70-100% of the dose is excreted in biologically active form in the urine within 24-48 hours. T_1/2 is 1.7-2 hours.

Indications

Urogenital gonorrhea in men and women.

ICD codes

Dosage Regimen

Administer Trobicin by deep intramuscular injection only. The standard adult dose for uncomplicated urogenital gonorrhea is a single 2 g injection.

For patients in geographic areas with known antibiotic resistance or for treatment of gonococcal proctitis, administer a single 4 g dose. Divide the 4 g dose and administer as two 2 g injections at different gluteal sites.

For patients with a history of penicillin allergy or infection with penicillinase-producing *Neisseria gonorrhoeae* (PPNG), the 2 g dose is indicated.

Prepare the solution immediately before use. For the 2 g vial, reconstitute with the entire 3.2 ml ampule of supplied Water for Injections. Shake the vial vigorously immediately after adding the solvent to ensure complete dissolution, resulting in a suspension of approximately 5 ml.

Inject the full volume of the reconstituted suspension deeply into the upper outer quadrant of the gluteus muscle. Aspirate before injection to avoid intravascular administration.

For pediatric patients, the dose is 40 mg/kg as a single injection. This product is contraindicated in children under 3 years of age.

In cases of suspected treatment failure or disseminated infection, obtain cultures to confirm susceptibility and initiate an alternative antibiotic regimen. Spectinomycin is not effective for infections caused by *Treponema pallidum* (syphilis) or *Chlamydia trachomatis*.

Adverse Reactions

After a single administration nausea, headache, dizziness, insomnia, decreased diuresis, fever, chills, skin rashes; rarely – anaphylactoid reactions; pain at the injection site.

With course use in some cases decrease in hemoglobin and hematocrit levels, increase in the level of liver transaminases, alkaline phosphatase, urea in the blood, decrease in creatinine clearance.

Allergic reactions : rarely – itchy erythematous maculopapular rash, urticaria, fever, chills; very rarely – anaphylactic shock.

From the nervous system rarely – dizziness, insomnia.

From the digestive system : nausea.

From the liver : very rarely hepatotoxicity, cholestatic jaundice.

From the urinary system in some cases – decreased diuresis, hematuria.

Local reactions : very rarely – induration and pain at the injection site (in less than 1% of patients).

Other : rarely – decreased creatinine clearance, hematocrit, hemoglobin, increased serum alkaline phosphatase, urea and gamma-glutamyltransferase activity.

Contraindications

Hypersensitivity to spectinomycin; children under 3 years of age.

Use in Pregnancy and Lactation

During pregnancy, it can be used if indicated in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

Contraindicated for use during breastfeeding. If it is necessary to use spectinomycin, breastfeeding should be discontinued.

Use in Renal Impairment

In patients with impaired renal function, the elimination time is significantly increased. Spectinomycin should be used in this category of patients only when other treatment is ineffective.

Pediatric Use

Contraindicated for use in children and adolescents under 3 years of age.

Special Precautions

Spectinomycin is effective in case of resistance to other antibiotics.

In patients with impaired renal function, the elimination time is significantly increased. Spectinomycin should be used in this category of patients only when other treatment is ineffective.

Spectinomycin should not be administered 24 hours before a dialysis session, as its effectiveness may be reduced due to decreased serum concentration. Dialysis leads to a 50% reduction in plasma spectinomycin levels.

Treatment of gonorrhea with antibiotics in high doses may mask the incubation period of syphilis. Therefore, patients receiving therapy for gonorrhea should be observed for 4-6 weeks. If syphilis is suspected, serological testing should be performed for at least 4 months.

Drug Interactions

Spectinomycin reduces the excretion of lithium, which requires a reduction in the dose of lithium preparations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.