Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Less common or rare
Black, tarry stools
blood in urine or stools
burning or itching of vagina
difficulty in breathing
discharge from vagina
discomfort, inflammation, or swelling at the injection site
general feeling of illness
light gray-colored stools
loss of appetite
numbness of tongue
pinpoint red spots on skin
skin rash, redness, or itching
unusual bleeding or bruising
unusual tiredness or weakness
yellow skin or eyes
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common or rare
Abdominal or stomach cramps
altered sense of taste
burning or prickling feeling of skin
nausea or vomiting
ringing, buzzing, or noise in ear
small, nonraised, round, purplish or red spots on skin
trouble in sleeping
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Copyright 2016 Truven Health Analytics, Inc. All Rights Reserved.
Side effects of Urobactam in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
Local reactions such as phlebitis/thrombophlebitis following intravenous administration, and discomfort/swelling at the injection site following intramuscular administration occurred at rates of approximately 1.9% and 2.4%, respectively.
Systemic reactions (considered to be related to therapy or of uncertain etiology) occurring at an incidence of 1% to 1.3% include diarrhea, nausea and/or vomiting, and rash. Reactions occurring at an incidence of less than 1% are listed within each body system in order of decreasing severity:
Gastrointestinal —abdominal cramps; rare cases of C. difficile-associated diarrhea, including pseudomembranous colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Other —vaginal candidiasis, vaginitis, breast tenderness
Body as a Whole —weakness, headache, fever, malaise
Pediatric Adverse Reactions
Of the 612 pediatric patients who were treated with Urobactam for injection in clinical trials, less than 1% required discontinuation of therapy due to adverse events. The following systemic adverse events, regardless of drug relationship, occurred in at least 1% of treated patients in domestic clinical trials: rash (4.3%), diarrhea (1.4%), and fever (1%). These adverse events were comparable to those observed in adult clinical trials.
In 343 pediatric patients receiving intravenous therapy, the following local reactions were noted: pain (12%), erythema (2.9%), induration (0.9%), and phlebitis (2.1%). In the US patient population, pain occurred in 1.5% of patients, while each of the remaining 3 local reactions had an incidence of 0.5%.
The following laboratory adverse events, regardless of drug relationship, occurred in at least 1% of treated patients: increased eosinophils (6.3%), increased platelets (3.6%), neutropenia (3.2%), increased AST (3.8%), increased ALT (6.5%), and increased serum creatinine (5.8%).
In US pediatric clinical trials, neutropenia (absolute neutrophil count less than 1,000/mm3) occurred in 11.3% of patients (8/71) younger than 2 years receiving 30 mg/kg every 6 hours. AST and ALT elevations to greater than 3 times the upper limit of normal were noted in 15% to 20% of patients aged 2 years or above receiving 50 mg/kg every 6 hours. The increased frequency of these reported laboratory adverse events may be due to either increased severity of illness treated or higher doses of Urobactam for injection administered.
Adverse Laboratory Changes
Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:
Hepatic —elevations of AST (SGOT), ALT (SGPT), and alkaline phosphatase; signs or symptoms of hepatobiliary dysfunction occurred in less than 1% of recipients.
Hematologic —increases in prothrombin and partial thromboplastin times, positive Coombs’ test.
Renal —increases in serum creatinine.
What is the most important information I should know about Urobactam?
Urobactam Inhalation only works against bacteria; it does not treat viral infections (eg, the common cold).
Do NOT use more than the recommended dose or use more often than prescribed without checking with your doctor.
Be sure to use Urobactam Inhalation for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
Long-term or repeated use of Urobactam Inhalation may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
Decreases in lung function have occurred after patients have taken Urobactam Inhalation for 28 days. Your doctor may monitor your lung function while you use Urobactam Inhalation. Contact your doctor if you experience new or worsening lung or breathing problems.
Lab tests, including lung function, may be performed while you use Urobactam Inhalation. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Urobactam Inhalation should be used with extreme caution in CHILDREN younger than 7 years old; safety and effectiveness in these children have not been confirmed.
Caution is advised when using Urobactam Inhalation in CHILDREN; they may be more sensitive to its effects, especially fever.
PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Urobactam Inhalation while you are pregnant. If you are or will be breast-feeding while you use Urobactam Inhalation, check with your doctor. Discuss any possible risks to your baby.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
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).
European Chemicals Agency - ECHA. "Aztreonam: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
NCIt. "Aztreonam: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Urobactam are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Urobactam. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported side effects
No survey data has been collected yet
There are no reviews yet. Be the first to write one!