Description
Levofloxacin injection is used to treat bacterial infections in many different parts of the body. It is also used to prevent an anthrax infection after inhalational exposure. This medicine is also used to treat and prevent plague (including pneumonic and septicemic plague).
Levofloxacin belongs to the class of medicines known as quinolone antibiotics. 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.
This product is available in the following dosage forms:
- 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
Use is not recommended for infants or children. However, levofloxacin injection may be used in children 6 months of age and older to treat plague and to prevent an anthrax infection after a possible exposure.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levofloxacin injection in the elderly. However, elderly patients are more likely to have age-related tendon disorders (including tendon rupture) and kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving levofloxacin 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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Acarbose
- Acecainide
- Acenocoumarol
- Adagrasib
- Albiglutide
- Alfuzosin
- Alogliptin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Betamethasone
- Bretylium
- Budesonide
- Buprenorphine
- Bupropion
- Buserelin
- Canagliflozin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Chlorpropamide
- Cholera Vaccine, Live
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Corticotropin
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.
- Aminolevulinic Acid
- Lanthanum Carbonate
- Phenytoin
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:
- Bradycardia (slow heartbeat) or
- Diabetes or
- Diarrhea or
- Heart rhythm problems (eg, prolonged QT interval), or family history of or
- Hypokalemia (low potassium in the blood), uncorrected or
- Liver disease (including hepatitis) or
- Mental illness, history of or
- Myocardial ischemia (reduced blood supply in the heart) or
- Seizures (epilepsy), or history of—Use with caution. May make these conditions worse.
- Brain disease (eg, hardening of the arteries) or
- Kidney disease, severe or
- Organ transplant (eg, heart, kidney, or lung), history of or
- Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse.
- Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
- Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.
Proper Use
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. The medicine must be injected slowly, so the needle will need to stay in place for at least 1 hour.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Your doctor will give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Drink extra fluids so you will pass more urine while you are using this medicine. This will keep your kidneys working well and help prevent kidney problems.
Precautions
It is very important that your doctor check your or your child's progress while 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.
Levofloxacin may rarely cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to the bones). This can occur while you are receiving the medicine or after your last dose. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, or Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or have received an organ (eg, heart, kidney, or lung) transplant. Check with your doctor right away if you have sudden pain or swelling in a tendon after exercise (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you have a rash, itching, hives, hoarseness, lightheadedness or fainting, trouble breathing or swallowing, or any swelling of your hands, face, or mouth after receiving the injection.
Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are receiving this medicine.
Levofloxacin may cause serious liver problems, including hepatitis. Check with your doctor right away if you start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while you are receiving this medicine.
Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, troubled breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.
Levofloxacin 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.
Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.
If you have low blood potassium or an abnormally slow heartbeat, levofloxacin may increase your risk of having a fast, slow, or irregular heartbeat, loss of consciousness, or fainting spells. If these symptoms occur, tell your doctor right away.
Tell your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, severe headache, trouble sleeping, or unusual thoughts or behaviors.
If you are a diabetic patient taking insulin or diabetes medicine by mouth: Levofloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. If you experience symptoms of low blood sugar, check with your doctor right away:
- Symptoms of low blood sugar can include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty with concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.
Some people who receive levofloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn or skin rash, redness, itching, or discoloration. When you begin receiving this medicine:
- Stay out of direct sunlight, especially between the hours of 10 AM and 3 PM, if possible.
- Wear protective clothing, including a hat and sunglasses.
- Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some people may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
- Do not use a sun lamp or tanning bed or booth.
If you have a severe reaction from the sun, check with your doctor.
Levofloxacin may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.
Before you have any medical tests, tell the medical doctor in charge that you are receiving 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 or nurse immediately if any of the following side effects occur:
Less common
- Diarrhea
Rare
- Agitation
- bleeding, discoloration of the skin, infection, inflammation, lumps, pain, redness, soreness, swelling, tenderness, or warmth at the injection site
- blisters
- confusion
- diarrhea (watery and severe) which may also be bloody
- feeling that others can hear your thoughts or control your behavior
- fever
- pain, inflammation, or swelling in the calves of the legs, shoulders, or hands
- redness and swelling of the skin
- seeing, hearing, or feeling things that are not there
- sensation of burning on the skin
- severe mood or mental changes
- skin rash, itching, or redness
- stomach cramps or pain (severe)
- trembling
- unusual behavior
Incidence not known
- Black, tarry stools
- burning, numbness, tingling, or painful sensations
- change in vision
- cough
- dark urine
- difficulty with breathing
- difficulty with chewing, talking, or swallowing
- fast or irregular heartbeat
- feeling faint
- general body swelling
- hives
- hoarseness
- joint or muscle pain
- muscle cramps, spasms, or stiffness
- peeling or loosening of the skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- severe dizziness
- severe tiredness
- tightness in the chest
- unsteadiness or awkwardness
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- weakness in the arms, hands, legs, or feet
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:
More common
- Headache
Less common
- Change in taste
- constipation
- dizziness
- drowsiness
- lightheadedness
- nausea
- nervousness
- stomach discomfort
- trouble sleeping
- vaginal itching and discharge
- vomiting
Incidence not known
- Feeling of warmth or heat
- flushing or redness of the skin, especially on the face and neck
- sweating
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.
CON-XXXXXXXX
