"The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).
The components of this product, trimethoprim/sulfamethoxazole/phenazopyridine hydrochloride, are indicated in the treatment of urinary tract infections as follows:
Trimethoprim/Sulfamethoxazole is indicated for the treatment of urinary tract infections due to susceptible strains of the following organisms: Escherichia coli, Klebsiella species, Enterobacter species, Morganella morganii, Proteus mirabilis and Proteus vulgaris.
Phenazopyridine Hydrochloride is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection. The use of phenazopyridine hydrochloride for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. Because it provides only symptomatic relief, prompt appropriate treatment of the cause of pain must be instituted and phenazopyridine hydrochloride should be discontinued when symptoms are controlled.
Phenazopyridine is compatible with antibacterial therapy and can help to relieve pain and discomfort during the interval before antibacterial therapy controls the infection. Treatment of a urinary tract infection with phenazopyridine hydrochloride should not exceed 2 days. (See DOSAGE AND ADMINISTRATION section.)
DOSAGE AND ADMINISTRATION
Trimethoprim/Sulfamethoxazole: One (1) double strength (160 mg/ 800 mg) tablet every 12 hours for 10 days.
Phenazopyridine Hydrochloride: One (1) 200 mg tablet 3 times a day after meals. The administration of phenazopyridine hydrochloride should not exceed 2 days.
For Patients with Impaired Renal Function: When renal function is impaired, a reduced dosage of trimethoprim/sulfamethoxazole should be employed using the following table:
Creatinine Clearance (mL/min)
Recommended Dosage Regimen
Usual standard regimen
½ the usual regimen
Use not recommended
This product consists of a blister card containing trimethoprim/sulfamethoxazole double strength (160 mg/800 mg) tablets and phenazopyridine hydrochloride 200 mg tablets for oral administration as follows:
Twenty double strength (160 mg/800 mg) trimethoprim/sulfamethoxazole tablets, each a white capsule-shaped scored tablet with beveled edges, plain on one side, scored in half on the other, with "93" embossed on one side of the breakline and "089" embossed on the other side and six 200 mg phenazopyridine hydrochloride tablets, each a round, sugar coated, deep maroon tablet, imprinted "AP2" on one side.
Store at controlled room temperature 15°C-25°C (59°F-77°F) in a dry place and protected from light.
1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically Fifth Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne, PA, January, 2000.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing - Tenth Informational Supplement (Aerobic Dilution). NCCLS Document M100-S10 (M7), NCCLS, Wayne, PA, January, 2000.
3. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests Seventh Edition. Approved Standard NCCLS Document M2-A7, Vol. 20, No. 1, NCCLS, Wayne, PA, January, 2000.
4. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Susceptibility Testing - Tenth Informational Supplement (Disk Diffusion). NCCLS Document M100-S10 (M2), NCCLS, Wayne, PA, January, 2000.
5. Brumfitt W, Pursell R. Trimethoprim-sulfamethoxazole in the treatment of bacteriuria in women. J lnfect Dis. November 1973;128 (suppl):S657-S663.
Phenazopyridine Hydrochloride 200 mg tablets are manufactured by: Able Laboratories, Inc.
6 Hollywood Court,
South Plainfield, NJ 07080
Trimethoprim/sulfamethoxazole double strength tablets are manufactured by: TEVA Pharmaceutical Industries, Ltd. Kfar Sava Plant, 1 Hashikma Street Industrial Zone Kfar Sava, 44102 Israel for Able Laboratories, Inc.
This product is packaged by: Packaging Coordinators, Inc. , 3001 Red Lion Road Philadelphia, PA 19114 for Able Laboratories, Inc.
Last reviewed on RxList: 1/28/2005
This monograph has been modified to include the generic and brand name in many instances.
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