Description
Meropenem and vaborbactam combination injection is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection).
Meropenem and vaborbactam are antibiotics that belong to the group of medicines known as beta-lactams and beta-lactamase inhibitors. They work by killing the bacteria and preventing their growth. However, these medicines 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.
This product is available in the following dosage forms:
- Powder for Solution
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 meropenem and vaborbactam 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 meropenem and vaborbactam combination injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine and are more likely to have age-related kidney problems, which may require caution in the dose for patients receiving meropenem and vaborbactam combination injection.
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
- Desogestrel
- Dienogest
- Drospirenone
- Estetrol
- Estradiol
- Ethinyl Estradiol
- Ethynodiol
- Etonogestrel
- Gestodene
- Levonorgestrel
- Medroxyprogesterone
- Mestranol
- Nomegestrol
- Norelgestromin
- Norethindrone
- Norgestimate
- Norgestrel
- Segesterone
- Ulipristal
- Valproic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Probenecid
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 cephalosporins, beta-lactams, or penicillins, known or history of—Should not be used in patients with this condition.
- Brain infection (eg, meningitis) caused by bacteria or
- Brain lesions or
- Kidney problems or
- Seizures, history of—Use with caution. May increase the risk for seizures.
- 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. It is given through an IV catheter placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for at least 3 hours.
Precautions
It is very important that your doctor check your progress while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.
Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while receiving the medicine, tell your doctor right away.
This medicine may cause a serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Some patients may develop tremors or seizures while receiving this medicine. If you already have a history of seizures and you are taking medicine for seizures, you should continue unless otherwise directed by your doctor. Tell your doctor if you are taking divalproex sodium (Depakote®) or valproic acid (Depakene®).
This medicine may cause rhabdomyolysis (a serious muscle problem). Check with your doctor right away if you have dark urine, fever, muscle cramps, spasms, pains, or stiffness, or unusual tiredness or weakness.
Meropenem and vaborbactam combination injection 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. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
This medicine may cause confusion, headaches, or numbness. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
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:
Less common
- Bluish color
- changes in skin color
- decreased urine
- diarrhea
- dry mouth
- increased thirst
- irregular heartbeat
- loss of appetite
- mood changes
- muscle pain or cramps
- nausea
- numbness or tingling in the hands, feet, or lips
- seizures
- swelling of the foot or leg
- unusual tiredness or weakness
- vomiting
Rare
- Anxiety
- black, tarry stools
- bloody or cloudy urine
- blurred vision
- body aches or pain
- chest discomfort
- chest pain
- chills
- cold sweats
- confusion
- cool, pale skin
- cough
- depression
- difficulty breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- dryness or soreness of the throat
- fast heartbeat
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- hoarseness
- increased hunger
- increased urination
- itching of the vagina or genitals
- loss of consciousness
- nervousness
- nightmares
- pain in the lower back or side
- pain, redness, or swelling in the arm or leg
- painful or difficult urination
- runny nose
- seeing, hearing, or feeling things that are not there
- shakiness
- slurred speech
- sore mouth, throat, or tongue
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- sweating
- tender, swollen glands in the neck
- thick, white vaginal discharge with mild or no odor
- trouble in swallowing
- unexplained weight loss
- unusual bleeding or bruising
- voice changes
- weakness or heaviness of the legs
Incidence not known
- Dark urine
- muscle pain or stiffness
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
- Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- decreased appetite
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-20406505
