U-Azom 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.
U-Azom works by killing bacteria or preventing their growth. However, U-Azom will not work for colds, flu, or other virus infections.
U-Azom 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 U-Azom (U-Azom for injection, USP) and other antibacterial drugs, U-Azom 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.
U-Azom 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*.
U-Azom 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. U-Azom 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 U-Azom 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 U-Azom. 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 U-Azom. These in vitro findings suggest that such beta-lactamase-inducing antibiotics not be used concurrently with U-Azom. Following identification and susceptibility testing of the causative organism(s), appropriate antibiotic therapy should be continued.
How should I use U-Azom?
Use U-Azom Inhalation as directed by your doctor. Check the label on the medicine for exact dosing instructions.
An extra patient leaflet is available with U-Azom Inhalation. Talk to your pharmacist if you have questions about this information.
You should use a bronchodilator (eg, albuterol) before you use U-Azom Inhalation. Contact your doctor for instructions on how and when to use a bronchodilator before using U-Azom Inhalation.
If you are taking several inhaled medicines, talk to your doctor about the best order for taking your medicines.
U-Azom 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 U-Azom Inhalation with.
Do not mix U-Azom Inhalation with other medicines before using it.
Do not use U-Azom 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 U-Azom Inhalation for the full course of treatment. Keep using it even if you feel better in a few days.
U-Azom 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 U-Azom Inhalation.
After you mix U-Azom Inhalation with the diluent, use it immediately. Do not mix more than one dose at a time.
U-Azom 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 U-Azom 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 U-Azom Inhalation.
Uses of U-Azom 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.
This medication is used to treat people with a certain inherited condition (cystic fibrosis) who have a persistent lung infection with a certain bacteria (Pseudomonas aeruginosa). People with cystic fibrosis produce thick, sticky mucus that can plug up the tubes, ducts and passageways in the lungs. This can result in serious breathing problems and infections in the lungs.
U-Azom belongs to a class of drugs known as beta-lactams. U-Azom inhalation solution works by stopping the growth of a certain bacteria (Pseudomonas aeruginosa) that commonly infects the lungs of people with cystic fibrosis. This effect decreases lung infections and damage, decreases the use of other antibiotics, and helps to improve breathing.
This antibiotic treats only bacterial infections. It will not work for viral infections (such as the common cold, flu). Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.
How to use U-Azom inhalation
Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. This medication is used with a special machine called a nebulizer that changes the solution to a fine mist that you inhale. Learn and follow all instructions for the use of this medication and the nebulizer. Children may need help from an adult to use this medication properly. If you have any questions, ask your doctor, pharmacist, or respiratory therapist.
Before treatment with inhaled U-Azom, you should inhale a bronchodilator (such as albuterol, formoterol, salmeterol). Ask your pharmacist or doctor how soon to pre-treat with the specific bronchodilator you are using.
Use this medication with the nebulizer as directed by your doctor, usually three times a day. Each treatment lasts about 2 to 3 minutes. Do not swallow or inject this medication. This medicine is usually used for 28 days in a row, followed by 28 days without this medication, repeating the cycle until your doctor directs you to stop.
Each vial of U-Azom is for one-time use. Inspect each vial before use. Discard the vial if the prepared solution is cloudy or has particles in it, or if it has expired or has been stored at room temperature for longer than 28 days. Use all of the contents of the vial for each dose immediately after mixing the medication. Do not mix U-Azom with any other medicines in the nebulizer.
Do not use other forms of U-Azom in the nebulizer. Other forms of U-Azom may contain arginine which can cause breathing problems if inhaled.
Antibiotics work best when the amount of medicine in your body is kept at a constant level. Therefore, take this drug at evenly spaced intervals.
Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.
Tell your doctor if your condition does not improve or if it worsens.
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]
The recommended dose of U-Azom for both adults and pediatric patients 7 years of age and older is one single-use vial (75 mg of U-Azom) reconstituted with 1 mL of sterile diluent administered 3 times a day for a 28-day course (followed by 28 days off U-Azom therapy). Dosage is not based on weight or adjusted for age. Doses should be taken at least 4 hours apart.
U-Azom is administered by inhalation using an Altera® Nebulizer System. Patients should use a bronchodilator before administration of U-Azom.
Instructions for U-Azom Reconstitution
U-Azom should be administered immediately after reconstitution. Do not reconstitute U-Azom until ready to administer a dose.
Take one amber glass vial containing U-Azom and one diluent ampule from the carton. To open the glass vial, carefully remove the metal ring by pulling the tab and remove the gray rubber stopper. Twist the tip off the diluent ampule and squeeze the liquid into the glass vial. Replace the rubber stopper, then gently swirl the vial until contents have completely dissolved.
The empty vial, stopper, and diluent ampule should be disposed of properly upon completion of dosing.
Instructions for U-Azom Administration
U-Azom is administered by inhalation using an Altera Nebulizer System. U-Azom should not be administered with any other nebulizer. U-Azom should not be mixed with any other drugs in the Altera Nebulizer Handset.
U-Azom is not for intravenous or intramuscular administration.
Patients should use a bronchodilator before administration of U-Azom. Short-acting bronchodilators can be taken between 15 minutes and 4 hours prior to each dose of U-Azom. Alternatively, long-acting bronchodilators can be taken between 30 minutes and 12 hours prior to administration of U-Azom. For patients taking multiple inhaled therapies, the recommended order of administration is as follows: bronchodilator, mucolytics, and lastly, U-Azom.
To administer U-Azom, pour the reconstituted solution into the handset of the nebulizer system. Turn the unit on. Place the mouthpiece of the handset in your mouth and breathe normally only through your mouth. Administration typically takes between 2 and 3 minutes. Further patient instructions on how to administer U-Azom are provided in the FDA-approved patient labeling. Instructions on testing nebulizer functionality and cleaning the handset are provided in the Instructions for Use included with the nebulizer system.
Dosage Forms And Strengths
A dose of U-Azom consists of a single-use vial of sterile, lyophilized U-Azom (75 mg) reconstituted with a 1 mL ampule of sterile diluent (0.17% sodium chloride). Reconstituted U-Azom is administered by inhalation.
Storage And Handling
Each kit for a 28-day course of U-Azom contains 84 sterile vials of U-Azom and 88 ampules of sterile diluent packed in 2 cartons, each carton containing a 14-day supply. The four additional diluent ampules are provided in case of spillage.
U-Azom vials and diluent ampules should be stored in the refrigerator at 2 °C to 8 °C (36 °F to 46 °F) until needed. Once removed from the refrigerator, U-Azom and diluent may be stored at room temperature (up to 25 °C/77 °F) for up to 28 days. Do not separate the U-Azom vials from the diluent ampules. U-Azom should be protected from light.
Do not use U-Azom if it has been stored at room temperature for more than 28 days. Do not use U-Azom beyond the expiration date stamped on the vial. Do not use diluent beyond the expiration date embossed on the ampule.
U-Azom should be used immediately upon reconstitution. Do not reconstitute more than one dose at a time.
Do not use diluent or reconstituted U-Azom if it is cloudy or if there are particles in the solution.
Manufactured by: Gilead Sciences, Inc., Foster City, CA 94404. Revised: September 2012
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. U-Azom 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.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of drugs cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of U-Azom was evaluated in 344 patients from two placebo-controlled trials and one open-label follow-on trial. In controlled trials, 146 patients with CF received 75 mg U-Azom 3 times a day for 28 days.
Table 1 displays adverse reactions reported in more than 5% of patients treated with U-Azom 3 times a day in placebo-controlled trials. The listed adverse reactions occurred more frequently in U-Azom-treated patients than in placebo-treated patients.
Table 1 Adverse Reactions Reported in more than 5% of Patients Treated with U-Azom in the Placebo-Controlled Trials
Event (Preferred Term)
75 mg 3 times a day
Adverse reactions that occurred in less than 5% of patients treated with U-Azom were bronchospasm (3%) and rash (2%).
In addition to adverse reactions reported from clinical trials, the following possible adverse reactions have been identified during post-approval use of U-Azom. Because these events have been reported voluntarily from a population of unknown size, estimates of frequency cannot be made.
You should not use this medication if you are allergic to U-Azom.
Before using U-Azom, tell your doctor if you are allergic to any type of antibiotic, especially a cephalosporin (Ceftin, Cefzil, Keflex, Omnicef, and others), a penicillin (Amoxil, Augmentin, Bactocill, Bicillin L-A, Dispermox, Dycill, Dynapen, Moxatag, Principen, PC Pen VK, Pen-V, Pfizerpen, Unasyn, and others), or similar antibiotics such as Invanz, Primaxin, or Merrem.
Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. U-Azom will not treat a viral infection such as the common cold or flu.
U-Azom inhalation should be used only with an Altera brand nebulizer. Do not use any other type of nebulizer or inhaler device with this medication. Do not mix other medicines with U-Azom in the nebulizer.
If you use other inhaled medications, you may need to use them in a certain order while using U-Azom inhalation. Ask your doctor for specific instructions about when to use your other medications in relation to your U-Azom inhalation doses.
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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