Description
Fosfomycin injection is used to treat complicated urinary tract infections (cUTI), including pyelonephritis (kidney infection). Fosfomycin 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.
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 fosfomycin 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 fosfomycin injection in the elderly. However, elderly patients are more likely to have age-related heart or kidney problems, which may require caution 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.
- Cholera Vaccine, Live
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:
- Electrolyte problems (eg, high or low levels of calcium, magnesium, phosphorus, potassium, or sodium in the blood) or
- Heart problems (eg, cardiac insufficiency) or
- Heart rhythm problems (eg, QT prolongation, arrhythmias, or torsade de pointes), history of or
- Hypertension (high blood pressure) or
- Kidney disease or
- Liver disease or
- Lung or breathing problems (eg, pulmonary edema)—Use with caution. May make these conditions worse.
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 IV will have to stay in place for at least 1 hour.
Precautions
It is very important that your doctor check your progress while you are receiving this medicine 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.
This medicine may cause electrolyte problems, including hypokalemia (low potassium in the blood) and hypocalcemia (low calcium levels in the blood). Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, seizures, stomach cramps, tremor, trouble breathing, or unusual tiredness or weakness. Your doctor will ask you to take a low sodium diet.
Check with your doctor right away if you have chest pain or discomfort, irregular or slow heartbeat, fainting, or trouble breathing. These maybe symptoms of heart rhythm problems, including QT prolongation and torsade de pointes.
This medicine may cause serious allergic reaction, which can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have difficulty in breathing or swallowing, fast heartbeat, skin itching, rash, or redness, or swelling of the face, throat, or tongue.
This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.
This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 or more months 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.
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
- Black, tarry stools
- chills
- cough
- decreased urine
- dry mouth
- fever
- irregular heartbeat
- increased thirst
- loss of appetite
- lower back or side pain
- mood changes
- muscle pain or cramps
- nausea or vomiting
- numbness or tingling in the hands, feet, or lips
- painful or difficult urination
- seizures
- sore throat
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- Bleeding gums
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blood in the urine or stools
- blurred vision
- bone pain
- chest pain or tightness
- confusion
- dilated neck veins
- dizziness
- fainting
- fast, pounding, or irregular heartbeat or pulse
- flushed, dry skin
- fruit-like breath odor
- high blood pressure
- increased hunger
- increased urination
- irritability
- muscle twitching
- numbness and tingling around the mouth, fingertips, or feet
- pale skin
- pinpoint red spots on the skin
- right upper abdominal or stomach pain and fullness
- stomach cramps, pain, or tenderness
- sweating
- swelling of the feet or lower legs
- tingling of the hands or feet
- tremor
- unexplained weight loss
- vomiting
- weight gain
Incidence not known
- Blindness
- blue-yellow color blindness
- blue lips and fingernails
- chest discomfort
- coughing that sometimes produces a pink frothy sputum
- dark urine
- decreased vision
- diarrhea
- difficulty swallowing
- eye pain
- feeling of constant movement of self or surroundings
- headache
- hives, itching, skin rash
- increased sweating
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- light colored stools
- nervousness
- noisy breathing
- pounding in the ears
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- sensation of spinning
- swelling or puffiness of the face
- swollen or painful glands
- yellow eyes and skin
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
- Constipation
- dry, red, hot, or irritated skin
- hearing loss
- lack or loss of strength
Incidence not known
- Acid or sour stomach
- belching
- heartburn
- indigestion
- 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.
DRG-80008541
