Urobactam inhalation is an antibiotic that is used to treat lung infections in patients with cystic fibrosis. The medicine is breathed into the lungs through the mouth to treat infections caused by the Pseudomonas aeruginosa bacteria.
Urobactam works by killing bacteria or preventing their growth. However, Urobactam will not work for colds, flu, or other virus infections.
Urobactam is available only with your doctor's prescription.
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Urobactam (Urobactam for injection, USP) and other antibacterial drugs, Urobactam 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.
Urobactam is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:
Urinary Tract Infections (complicated and uncomplicated), including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter cloacae, Klebsiella oxytoca*, Citrobacter species*, and Serratia marcescens*.
Lower Respiratory Tract Infections, including pneumonia and bronchitis caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and Serratia marcescens*.
Septicemia caused by Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis*, Serratia marcescens*, and Enterobacter species.
Skin and Skin-Structure Infections, including those associated with postoperative wounds, ulcers, and burns, caused by Escherichia coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas aeruginosa, Klebsiella pneumoniae, and Citrobacter species*.
Intra-abdominal Infections, including peritonitis caused by Escherichia coli, Klebsiella species including K. pneumoniae, Enterobacter species including E. cloacae*, Pseudomonas aeruginosa, Citrobacter species* including C. freundii*, and Serratia species* including S. marcescens*.
Gynecologic Infections, including endometritis and pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae*, Enterobacter species* including E. cloacae*, and Proteus mirabilis*.
Urobactam is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections, and infections of serous surfaces. Urobactam is effective against most of the commonly encountered Gram-negative aerobic pathogens seen in general surgery.
* Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Concurrent initial therapy with other antimicrobial agents and Urobactam is recommended before the causative organism(s) is known in seriously ill patients who are also at risk of having an infection due to Gram-positive aerobic pathogens. If anaerobic organisms are also suspected as etiologic agents, therapy should be initiated using an anti-anaerobic agent concurrently with Urobactam. Certain antibiotics (eg, cefoxitin, imipenem) may induce high levels of beta-lactamase in vitro in some Gram-negative aerobes such as Enterobacter and Pseudomonas species, resulting in antagonism to many beta-lactam antibiotics including Urobactam. These in vitro findings suggest that such beta-lactamase-inducing antibiotics not be used concurrently with Urobactam. Following identification and susceptibility testing of the causative organism(s), appropriate antibiotic therapy should be continued.
How should I use Urobactam?
Use Urobactam Inhalation as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with Urobactam Inhalation. Talk to your pharmacist if you have questions about this information.
You should use a bronchodilator (eg, albuterol) before you use Urobactam Inhalation. Contact your doctor for instructions on how and when to use a bronchodilator before using Urobactam Inhalation.
If you are taking several inhaled medicines, talk to your doctor about the best order for taking your medicines.
Urobactam Inhalation should be used with a certain nebulizer (Altera Nebulizer System). Do not use other medicines with this nebulizer. Be sure you know which nebulizer to use Urobactam Inhalation with.
Do not mix Urobactam Inhalation with other medicines before using it.
Do not use Urobactam Inhalation if it is cloudy, contains particles, or if it has been stored at room temperature for more than 28 days.
To clear up your infection completely, use Urobactam Inhalation for the full course of treatment. Keep using it even if you feel better in a few days.
Urobactam Inhalation must be mixed with the provided diluent that comes with it before you use it. Follow your doctor's instructions on how to mix Urobactam Inhalation.
After you mix Urobactam Inhalation with the diluent, use it immediately. Do not mix more than one dose at a time.
Urobactam Inhalation is usually used for 28 days on the medicine followed by at least 28 days off the medicine. Follow the dosing schedule given to you by your doctor carefully.
If you miss a dose of Urobactam Inhalation, use it as soon as possible. If it is less than 4 hours until your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
Ask your health care provider any questions you may have about how to use Urobactam Inhalation.
Uses of Urobactam in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Treatment of patients with urinary tract infections, lower respiratory tract infections, septicemia, skin/skin structure infections, intra-abdominal infections, and gynecological infections caused by susceptible gram-negative bacilli
Off Label Uses
Based on the Infectious Diseases Society of America (IDSA) guidelines for the management of bacterial meningitis and health care-associated ventriculitis and meningitis, Urobactam is an effective and recommended alternative therapy for meningitis due to beta-lactamase positive Haemophilus influenzae, Enterobacteriaceae, or Pseudomonas aeruginosa, and for health care-associated meningitis or ventriculitis requiring empiric therapy for gram-negative pathogens in patients with anaphylaxis to beta-lactams, in combination with other appropriate agents.
Osteomyelitis, native vertebral
Based on the Infectious Diseases Society of America (IDSA) guidelines for the diagnosis and treatment of native vertebral osteomyelitis in adults, Urobactam is an effective and recommended alternative treatment option for the treatment of native vertebral osteomyelitis due to Pseudomonas aeruginosa in patients with severe penicillin allergy and quinolone-resistant strains.
Surgical prophylaxis (perioperative)
Based on the American Society of Health-System Pharmacists (ASHP), the Infectious Diseases Society of America (IDSA), the Surgical Infection Society (SIS), and the Society of Healthcare Epidemiology of America (SHEA) guidelines for antimicrobial prophylaxis in surgery, Urobactam is an effective and recommended alternative agent (in combination with other antibiotics) for patients with beta-lactam allergy for a number of surgical procedures (eg, gastroduodenal, biliary tract, appendectomy, hysterectomy, urologic involving implanted prosthesis, liver transplantation, or pancreas and pancreas-kidney transplantation) and may be used first-line in combination with cefazolin for procedures involving implanted prosthetic material (eg, penile prosthesis).
A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms. [PubChem]
Generic name: Urobactam 1g
Dosage form: injection, powder, for solution
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Dosage in Adult Patients
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.
Table 4: Urobactam Dosage Guidelines for Adults*
Type of Infection
* 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.
Renal Impairment in Adult Patients
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.
Dosage in the Elderly
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.
Dosage in Pediatric Patients
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.
Table 5: Urobactam Dosage Guidelines for Pediatric Patients*
Type of Infection
* 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.
Admixtures with Other Antibiotics
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:
Sodium Chloride Injection, USP, 0.9%
Ringer’s Injection, USP
Lactated Ringer’s Injection, USP
Dextrose Injection, USP, 5% or 10%
Dextrose and Sodium Chloride Injection, USP, 5%:0.9%, 5%:0.45%, or 5%:0.2%
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.
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.
Applies to Urobactam: inhalation powder for solution
Other dosage forms:
powder for solution, solution
In addition to its needed effects, some unwanted effects may be caused by Urobactam (the active ingredient contained in Urobactam). In the event that any of these side effects do occur, they may require medical attention.
Major Side Effects
You should check with your doctor immediately if any of these side effects occur when taking Urobactam:
difficulty with breathing or troubled breathing
shortness of breath
tightness in the chest
Minor Side Effects
Some of the side effects that can occur with Urobactam may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:
You should not use this medication if you are allergic to Urobactam or to a penicillin antibiotic such as amoxicillin (Amoxil, Augmentin), ampicillin (Omnipen, Principen), penicillin (Beepen-VK, Ledercillin VK, Pen-V, Pen-Vee K, Pfizerpen, V-Cillin K, Veetids), and others.
Before using Urobactam, tell your doctor if you are allergic to cephalosporins such as Ceftin, Cefzil, Keflex, Omnicef, and others, or if you have liver or kidney disease, or a history of any type of allergy.
Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Urobactam will not treat a viral infection such as the common cold or flu.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking Urobactam and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.
DailyMed. "AZTREONAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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