The bactericidal action of Urobactam results from the inhibition of bacterial cell wall synthesis due to a high affinity of Urobactam for penicillin binding protein 3 (PBP3). By binding to PBP3, Urobactam inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. It is possible that Urobactam interferes with an autolysin inhibitor.
Use Urobactam only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.
Keep using Urobactam for the full treatment time, even if you or your child feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Urobactam should be used with the Altera® Nebulizer System. The inhaled liquid and nebulizer will come with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor may give you or your child additional medicines to use before the Urobactam inhalation liquid, such as bronchodilators or mucolytics. Bronchodilators help open the lungs so you can breathe easier. Mucolytics help clear the mucus from your lungs. Carefully follow your doctor's instructions about how to use your medicines. Urobactam inhalation will work better if you use all of your medicines in the right order.
To use the inhalation solution:
The dose of Urobactam will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of Urobactam. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of Urobactam, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you or your child miss a dose, you may still take all three daily doses of Urobactam as long as the doses are at least 4 hours apart.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is best to store the unopened vials and saline ampules in the original carton in the refrigerator. You may also store the unopened vials at room temperature, away from heat and direct light, for up to 28 days. Do not store the liquid mixture after the powder is dissolved.
Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Urobactam is injected into a muscle or a vein. Urobactam is usually given in a clinic or hospital setting. The medicine may need to be given for several hours or several weeks, depending on how severe your infection is.
You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.
Urobactam is usually given as long as needed until your infection has cleared or you have been symptom-free for at least 48 hours.
Use Urobactam for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Urobactam will not treat a viral infection such as the common cold or flu.
Do not give this medication to another person, even if they have the same symptoms you have.
Urobactam is supplied as a frozen solution in a plastic container. If you use this medicine at home, store the frozen medicine in a freezer. If possible, keep the freezer set at 4 degrees below 0 Fahrenheit or colder.
Thaw the medicine either in a refrigerator or at room temperature. Do not heat the medicine to thaw it more quickly. Urobactam that is thawed in the refrigerator should be used within 2 weeks.
If you have thawed the medicine at room temperature, you must use it within 48 hours.
Once Urobactam has been thawed, it should be clear and appear colorless or slightly yellow. Do not use the medicine if it has changed color or has particles in it, or if the medicine container leaks. Call your doctor or pharmacist for a new prescription.
Single 30-minute intravenous infusions of 500 mg, 1 g, and 2 g doses of Urobactam in healthy subjects produced Urobactam peak serum levels of 54 mcg/mL, 90 mcg/mL, and 204 mcg/mL, respectively, immediately after administration; at 8 hours, serum levels were 1 mcg/mL, 3 mcg/mL, and 6 mcg/mL, respectively (Figure 1). Single 3-minute intravenous injections of the same doses resulted in serum levels of 58 mcg/mL, 125 mcg/mL, and 242 mcg/mL at 5 minutes following completion of injection.
Serum concentrations of Urobactam in healthy subjects following completion of single intramuscular injections of 500 mg and 1 g doses are depicted in Figure 1; maximum serum concentrations occur at about 1 hour. After identical single intravenous or intramuscular doses of Urobactam, the serum concentrations of Urobactam are comparable at 1 hour (1.5 hours from start of intravenous infusion) with similar slopes of serum concentrations thereafter.
The serum levels of Urobactam following single 500 mg or 1 g (intramuscular or intravenous) or 2 g (intravenous) doses of Urobactam exceed the MIC90 for Neisseria sp., Haemophilus influenzae, and most genera of the Enterobacteriaceae for 8 hours (for Enterobacter sp., the 8-hour serum levels exceed the MIC for 80% of strains). For Pseudomonas aeruginosa, a single 2 g intravenous dose produces serum levels that exceed the MIC90 for approximately 4 to 6 hours. All of the above doses of Urobactam result in average urine levels of Urobactam that exceed the MIC90 for the same pathogens for up to 12 hours.
When Urobactam pharmacokinetics were assessed for adult and pediatric patients, they were found to be comparable (down to 9 months old). The serum half-life of Urobactam averaged 1.7 hours (1.5-2.0) in subjects with normal renal function, independent of the dose and route of administration. In healthy subjects, based on a 70 kg person, the serum clearance was 91 mL/min and renal clearance was 56 mL/min; the apparent mean volume of distribution at steady-state averaged 12.6 liters, approximately equivalent to extracellular fluid volume.
In elderly patients, the mean serum half-life of Urobactam increased and the renal clearance decreased, consistent with the age-related decrease in creatinine clearance. Standard Urobactam powder should provide the following range of MIC values noted in Table 3. For the diffusion technique using the 30 mcg disk, the criteria in Table 3 should be achieved.
Table 3: Acceptable Quality Control Ranges for Urobactam
|QC Strain||Minimum Inhibitory Concentrations (mcg/mL)||Disk Diffusion Zone Diameters (mm)|
|Escherichia coli ATCC 25922||0.06-0.25||28-36|
|Haemophilus influenzae ATCC 49247||0.12-5||30-38|
|Pseudomonas aeruginosa ATCC 27853||8-Feb||23-29|
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
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Information checked by Dr. Sachin Kumar, MD Pharmacology