Generic name: Urobactam 1g
Dosage form: injection, powder, for solution
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Urobactam may be administered intravenously or by intramuscular injection. Dosage and route of administration should be determined by susceptibility of the causative organisms, severity and site of infection, and the condition of the patient.
|Type of Infection||Dose||Frequency |
|* Maximum recommended dose is 8 g per day.|
Urinary tract infections
500 mg or 1 g
8 or 12
Moderately severe systemic infections
1 g or 2 g
8 or 12
Severe systemic or life-threatening infections
6 or 8
Because of the serious nature of infections due to Pseudomonas aeruginosa, dosage of 2 g every six or eight hours is recommended, at least upon initiation of therapy, in systemic infections caused by this organism.
The intravenous route is recommended for patients requiring single doses greater than 1 g or those with bacterial septicemia, localized parenchymal abscess (eg, intra-abdominal abscess), peritonitis, or other severe systemic or life-threatening infections.
The duration of therapy depends on the severity of infection. Generally, Urobactam should be continued for at least 48 hours after the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. Persistent infections may require treatment for several weeks. Doses smaller than those indicated should not be used.
Prolonged serum levels of Urobactam may occur in patients with transient or persistent renal insufficiency. Therefore, the dosage of Urobactam should be halved in patients with estimated creatinine clearances between 10 and 30 mL/min/1.73 m2 after an initial loading dose of 1 or 2 g.
When only the serum creatinine concentration is available, the following formula (based on sex, weight, and age of the patient) may be used to approximate the creatinine clearance (Clcr). The serum creatinine should represent a steady state of renal function.
weight (kg) × (140−age)
Males: Clcr = ———————————————
72 × serum creatinine (mg/dL)
Females: 0.85 × above value
In patients with severe renal failure (creatinine clearance less than 10 mL/min/1.73 m2), such as those supported by hemodialysis, the usual dose of 500 mg, 1 g, or 2 g should be given initially. The maintenance dose should be one-fourth of the usual initial dose given at the usual fixed interval of 6, 8, or 12 hours. For serious or life-threatening infections, in addition to the maintenance doses, one-eighth of the initial dose should be given after each hemodialysis session.
Renal status is a major determinant of dosage in the elderly; these patients in particular may have diminished renal function. Serum creatinine may not be an accurate determinant of renal status. Therefore, as with all antibiotics eliminated by the kidneys, estimates of creatinine clearance should be obtained and appropriate dosage modifications made if necessary.
Urobactam should be administered intravenously to pediatric patients with normal renal function. There are insufficient data regarding intramuscular administration to pediatric patients or dosing in pediatric patients with renal impairment.
|Type of Infection||Dose||Frequency |
|* Maximum recommended dose is 120 mg/kg/day.|
Mild to moderate infections
Moderate to severe infections
6 or 8
A total of 612 pediatric patients aged 1 month to 12 years were enrolled in uncontrolled clinical trials of Urobactam in the treatment of serious Gram-negative infections, including urinary tract, lower respiratory tract, skin and skin-structure, and intra-abdominal infections.
Upon the addition of the diluent to the container, contents should be shaken immediately and vigorously. Constituted solutions are not for multiple-dose use; should the entire volume in the container not be used for a single dose, the unused solution must be discarded.
Depending upon the concentration of Urobactam and diluent used, constituted Urobactam yields a colorless to light straw yellow solution which may develop a slight pink tint on standing (potency is not affected).
Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.
Intravenous infusion solutions of Urobactam not exceeding 2% w/v prepared with Sodium Chloride Injection, USP 0.9% or Dextrose Injection, USP 5%, to which clindamycin phosphate, gentamicin sulfate, tobramycin sulfate, or cefazolin sodium have been added at concentrations usually used clinically, are stable for up to 48 hours at room temperature or 7 days under refrigeration. Ampicillin sodium admixtures with Urobactam in Sodium Chloride Injection, USP 0.9% are stable for 24 hours at room temperature and 48 hours under refrigeration; stability in Dextrose Injection, USP 5% is 2 hours at room temperature and 8 hours under refrigeration.
Urobactam-cloxacillin sodium and Urobactam-vancomycin hydrochloride admixtures are stable in Dianeal 137 (Peritoneal Dialysis Solution) with 4.25% Dextrose for up to 24 hours at room temperature.
Urobactam is incompatible with nafcillin sodium, cephradine, and metronidazole.
Other admixtures are not recommended since compatibility data are not available.
For Bolus Injection: The contents of an Urobactam 15 mL capacity vial should be constituted with 6 to 10 mL Sterile Water for Injection, USP.
For Infusion: If the contents of a 15 mL capacity vial are to be transferred to an appropriate infusion solution, each gram of Urobactam should be initially constituted with at least 3 mL Sterile Water for Injection, USP. Further dilution may be obtained with one of the following intravenous infusion solutions:
The contents of an Urobactam 15 mL capacity vial should be constituted with at least 3 mL of an appropriate diluent per gram Urobactam. The following diluents may be used:
Urobactam solutions for intravenous infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (59°F-86°F/15°C-30°C) or within 7 days if refrigerated (36°F-46°F/2°C-8°C).
Urobactam solutions at concentrations exceeding 2% w/v, except those prepared with Sterile Water for Injection, USP or Sodium Chloride Injection, USP, should be used promptly after preparation; the 2 excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.
Bolus Injection: A bolus injection may be used to initiate therapy. The dose should be slowly injected directly into a vein, or the tubing of a suitable administration set, over a period of 3 to 5 minutes.
Infusion: With any intermittent infusion of Urobactam and another drug with which it is not pharmaceutically compatible, the common delivery tube should be flushed before and after delivery of Urobactam with any appropriate infusion solution compatible with both drug solutions; the drugs should not be delivered simultaneously. Any Urobactam infusion should be completed within a 20- to 60-minute period. With use of a Y-type administration set, careful attention should be given to the calculated volume of Urobactam solution required so that the entire dose will be infused. A volume control administration set may be used to deliver an initial dilution of Urobactam into a compatible infusion solution during administration; in this case, the final dilution of Urobactam should provide a concentration not exceeding 2% w/v.
The dose should be given by deep injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh). Urobactam is well tolerated and should not be admixed with any local anesthetic agent.
If you use other inhaled medications, you may need to use them in a certain order while using Urobactam inhalation. Ask your doctor for specific instructions about when to use your other medications in relation to your Urobactam inhalation doses.
There may be other drugs that can interact with Urobactam. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cefoxitin, imipenem, live bacterial vaccines. Urobactam may cause false positive results with some diabetic urine testing products (cupric sulfate-type). Consult your doctor or pharmacist for recommendations. Make sure laboratory personnel and your doctors know you use this drug.
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Information checked by Dr. Sachin Kumar, MD Pharmacology