Spectinomycin Sterile Powder is indicated for the treatment of:

• Acute gonococcal urethritis and proctitis in males
• Acute gonococcal cervicitis and proctitis in females
• Men and women with recent known exposure to gonorrhea should be managed and treated as confirmed cases of gonorrhea.

Tinobac Sterile Powder contains Spectinomycin Hydrochloride, an aminocyclitol antibiotic produced by the soil microorganism Streptomyces spectabilis. It inhibits bacterial protein synthesis by acting on the 30S ribosomal subunit. In vitro studies have demonstrated activity of Spectinomycin Hydrochloride against most strains of Neisseria gonorrhoeae.

Adults (Men and Women): Inject 5 ml intramuscularly for a 2 gm dose. This is also the recommended dose for patients being treated after failure of previous antibiotic therapy.

Intramuscular injections should be made deep into the upper outer quadrant of the gluteal muscle.

Pediatric Use: Safety and effectiveness in the pediatric population have not been established.

The following adverse reactions were reported during single-dose clinical trials: pain or soreness at the injection site, urticaria, dizziness, nausea, chills, fever, and insomnia.

Pregnancy Category B. There are no well-controlled studies of Spectinomycin in pregnant women, and animal studies do not always predict human response. Therefore, Spectinomycin should be used during pregnancy only if clearly necessary. It is not known whether the drug is excreted in human breast milk. Since many drugs are excreted in milk, caution should be taken when administering Spectinomycin to breastfeeding women.

Usual precautions should be taken in atopic individuals. Prescribing Spectinomycin Sterile Powder without confirmed or strongly suspected bacterial infection or a valid prophylactic indication is unlikely to benefit the patient and increases the risk of antibiotic resistance.

There is no available information on human overdose. Hemodialysis has been reported to assist in removing intravenously administered Spectinomycin from the body.

Macrolides

Store below 30°C, protect from light and moisture. Keep out of reach of children.