Description
Sulopenem and probenecid combination is used to treat uncomplicated urinary tract infections (uUTI). Sulopenem works by killing the bacteria and preventing their growth. However, this medicine will not work for colds, flu, or other virus infection. Probenecid increases the amount of sulopenem in the blood.
This medicine is available only with your doctor's prescription.
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 sulopenem and probenecid combination 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 sulopenem and probenecid combination 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 in 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 taking 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ketorolac
- Ketorolac Tromethamine
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.
- Amoxicillin
- Avibactam
- Baricitinib
- Belinostat
- Bictegravir
- Cephalexin
- Deferiprone
- Doripenem
- Furosemide
- Glimepiride
- Glipizide
- Indomethacin
- Irinotecan
- Irinotecan Liposome
- Ketoprofen
- Lorazepam
- Methotrexate
- Mycophenolate Mofetil
- Naproxen
- Pegloticase
- Pexidartinib
- Phenobarbital
- Primidone
- Sacituzumab Govitecan-hziy
- Seladelpar
- Sodium Phenylbutyrate
- Sulbactam
- Sulopenem
- Tolbutamide
- Vadadustat
- Zalcitabine
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.
- Aspirin
- Bismuth Subsalicylate
- Cefditoren Pivoxil
- Cefotaxime
- Cefpodoxime Proxetil
- Cefprozil
- Choline Magnesium Trisalicylate
- Ciprofloxacin
- Enprofylline
- Ertapenem
- Gatifloxacin
- Magnesium Salicylate
- Meropenem
- Norfloxacin
- Phenprocoumon
- Piretanide
- Pralatrexate
- Sodium Salicylate
- Sodium Thiosalicylate
- Zidovudine
- Zomepirac
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-lactam antibiotics, history of or
- Blood disorders or
- Uric acid kidney stones—Should not be used in patients with these conditions.
- Allergic reaction to other antibiotics (eg, carbapenems, cephalosporins, or penicillins), history of or
- Gout, history of—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
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
Take this medicine with food.
Drink plenty of fluids while you are using this medicine. Drinking extra water will help prevent the risk of uric acid kidney stones.
Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.
Dosing
The dose of this medicine 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 this medicine. 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.
- For oral dosage form (tablets):
- For uncomplicated urinary tract infections:
- Adults—One tablet 2 times a day for 5 days. Each tablet contains 500 milligrams (mg) sulopenem etzadroxil and 500 mg probenecid.
- Children—Use and dose must be determined by your doctor.
- For uncomplicated urinary tract infections:
Missed Dose
If you miss a dose of this medicine, 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.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Precautions
It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it. Blood and urine tests may be needed to check for unwanted effects.
Do not use this medicine together with ketorolac tromethamine (Toradol®) or ketoprofen (Orudis®).
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking 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.
Before you have any medical tests, tell the provider that you are taking this medicine. The results of some tests may be affected by this medicine.
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 immediately if any of the following side effects occur:
More common
- Diarrhea
Less common
- Change in the color, amount, or odor of vaginal discharge
- itching or pain of the vagina or genitals
- thick, white vaginal discharge with mild or no odor
Rare
- Ankle, knee, or great toe joint pain
- back or leg pain
- black, tarry stools
- bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain or tightness
- chills
- confusion
- cough
- dark urine
- difficulty swallowing
- dizziness or lightheadedness
- fast, pounding, or irregular heartbeat or pulse
- feeling of constant movement of self or surroundings
- feeling of warmth
- fever
- headache
- hives, itching, skin rash
- joint stiffness or swelling
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loss of appetite
- lower back or side pain
- nausea or vomiting
- nervousness
- nosebleeds
- pale skin
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- rapid weight gain
- redness of the face, neck, arms and occasionally, upper chest
- right upper abdominal pain and fullness
- sensation of spinning
- slow or fast heartbeat
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling of the face, feet, or lower legs
- swollen glands
- tingling of the hands or feet
- trouble breathing
- unpleasant breath odor
- unusual bleeding or bruising
- unusual weight gain or loss
- vomiting of blood
- yellow eyes or skin
Incidence not known
- Bloody or cloudy urine
- lower back or side pain
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:
Rare
- Acid or sour stomach
- belching
- bloated
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- change in taste
- constipation
- difficulty in moving
- dry mouth
- excess air or gas in the stomach or intestines
- extreme thirst
- full feeling
- heartburn
- indigestion
- joint pain
- lack or loss strength
- loss of taste
- passing gas
- sleepiness or unusual drowsiness
- stomach discomfort or upset
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.
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