TROBICIN Sterile Powder is indicated in the treatment of acute gon-orrheal urethritis and proctitis in the male and acute gonorrheal cervicitis and proctitis in the female when due to susceptible strains of Neisseria gonorrhoeae. Men and women with known recent exposure to gonorrhea should be treated as those known to have gonorrhea.

The in vitro susceptibility of Neisseria gonorrhoeae to spectinomycin hydrochloride can be tested by agar diluted methods. TROBICIN Susceptibility Powder is available for this purpose and its package insert should be consulted for details.

Preparation of Drug for Intramuscular Injection

TROBICIN Sterile Powder, 2 grams: reconstitute with 3.2 mL of the accompanying diluent.* *Bacteriostatic Water for Injection with Benzyl Alcohol 0.945% w/v added as preservative.

Shake vials vigorously immediately after adding diluent and before withdrawing dose. It is recommended that disposable syringes and needles be used to avoid contamination with penicillin residue, especially when treating patients known to be highly sensitive to penicillin. Use of a 20-gauge needle is recommended.

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

Adults (Men and Women)†?Inject 5 mL intramuscularly for a 2-gram dose. This is also the recommended dose for patients being treated after failure of previous antibiotic therapy.

In geographic areas where antibiotic resistance is known to be prevalent, initial treatment with 4 grams (10 mL) intramuscularly is preferred. The 10-mL injection may be divided between two gluteal injection sites.

Store unreconstituted product at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Store prepared suspension at controlled room temperature 20° to 25°C (68° to 77°F) and use within 24 hours.

Contains benzyl alcohol. (See WARNINGS.)

TROBICIN Sterile Powder, 2-gram vial NDC 0009-0566-01with one ampoule of Bacteriostatic Water for Injection with Benzyl Alcohol 0.945% w/v added as preservative. When reconstituted with 3.2 mL of the accompanying diluent, each vial yields a sufficient quantity for withdrawal of 5 mL of a suspension containing 400 mg spectinomycin per mL (as the hydrochloride). Five mL provides 2 grams spectinomycin. For intramuscular use only.

TROBICIN Susceptibility Powder100 mg. See package insert for in vitro testing procedure.

Manufactured for: Pharmacia & Upjohn Company, A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001, USA, Manufactured by: Pharmacia NV/SA, Puurs, Belgium, Revised September 2003

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