Description
Aztreonam and avibactam combination injection is used together with other medicines (eg, metronidazole) to treat complicated infections in the abdomen. This medicine is an antibiotic. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
This medicine is to be given only by or under the direct supervision of your doctor.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of aztreonam and avibactam combination injection in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of aztreonam and avibactam combination injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Bupropion
- Cholera Vaccine, Live
- Gemfibrozil
- Hydroxychloroquine
- Nitisinone
- Probenecid
- Teriflunomide
- Vadadustat
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Allergy to beta-lactams, history of—May increase risk of an allergic reaction to occur again.
- Diarrhea, severe, history of or
- Liver disease—Use with caution. May make these conditions worse.
- Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper Use
A nurse or other trained health professional will give you this medicine in a hospital. It is given through an IV catheter that is placed into one of your veins. This medicine must be given slowly, so the IV will have to stay in place for at least 3 hours.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine to see if it is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including rash, flushing, and bronchospasm. Check with your doctor right away if you have chest tightness, cough, difficulty breathing, feeling of warmth or redness of the face, neck, arms and occasionally, upper chest, or a skin rash.
Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness. These may be symptoms of serious skin reaction, including toxic epidermal necrolysis.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop receiving this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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 or nurse immediately if any of the following side effects occur:
More common
- Dark urine
- decreased urine
- diarrhea
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- pale skin
- seizures
- stomach pain, severe
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Less common
- Agitation
- back pain
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- blurred vision
- chest pain or tightness
- chills
- confusion
- cough
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- drowsiness
- eye pain
- feeling of warmth
- fever
- hallucinations
- hives, itching, skin rash
- holding false beliefs that cannot be changed by fact
- irritability
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
- pain during sexual intercourse
- painful or difficult urination
- pinpoint red spots on the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- redness of the face, neck, arms and occasionally, upper chest
- seizures
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stiff neck
- sweating
- thick, white curd-like vaginal discharge without odor or with mild odor
- unusual excitement, nervousness, or restlessness
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:
Incidence not known
- Bad breath
- breast tenderness
- breath odor
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- constipation
- lack or loss of strength
- loss of sense of taste
- muscle aches
- sneezing
- stuffy or runny nose
- trouble 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.
DRG-80003726
