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TROBICIN Sterile Powder is indicated in the treatment of acute gonorrheal 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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of TROBICIN Sterile Powder and other antibacterial drugs, TROBICIN Sterile Powder should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
DOSAGE AND ADMINISTRATION
Preparation of Drug for Intramuscular Injection
TROBICIN Sterile Powder, 2 grams: reconstitute with 3.2 mL of Sterile Water for Injection, USP .
Shake vials vigorously immediately after adding Sterile Water for Injection, USP and before withdrawing dose. It is recommended that disposable syringes and needles be used. A 20-gaugc 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.
TROBICIN Sterile Powder is available as:
TROBICIN Sterile Powder, 2-gram vial NDC 0069-8558-22. When reconstituted with 3.2 mL of Sterile Water for Injection, USP , 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 Powder - 100 mg. See package insert for in vitro testing procedure.
Distributed by: Pharmacia & Upjohn Co. Division of Pfizer Inc NY, NY, 10017. Revised: August 2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 9/28/2012
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