Description
Levofloxacin is used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection after inhalational exposure. Levofloxacin 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 available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
- Tablet
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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levofloxacin in children. However, because of this medicine's toxicity, it should be used with caution, after other alternatives have been considered or found ineffective. Levofloxacin may be used in children 6 months of age and older to prevent anthrax infection after possible exposure, and to treat plague infection.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levofloxacin 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.
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.
- 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.
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Aminolevulinic Acid
- Calcium
- Dihydroxyaluminum Aminoacetate
- Dihydroxyaluminum Sodium Carbonate
- Iron
- Lanthanum Carbonate
- Magaldrate
- Magnesium Carbonate
- Magnesium Hydroxide
- Magnesium Oxide
- Magnesium Trisilicate
- 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:
- Aortic aneurysm (bulge in the wall of the largest artery) or
- 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 (eg, 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
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.
This medicine comes with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Levofloxacin oral liquid should be taken 1 hour before or 2 hours after eating. Measure your dose with a marked measuring spoon, oral syringe, or medicine cup.
You may take levofloxacin tablets with meals or on an empty stomach.
This medicine is best taken with a full glass (8 ounces) of water. Several additional glasses of water should be taken every day, unless otherwise directed by your doctor. Drinking extra water will help prevent some unwanted effects of levofloxacin.
This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times, day and night. For example, if you are to take one dose a day, try to take it at the same time each day.
If you need to take this medicine for anthrax infection or plague, your doctor will want you to begin taking it as soon as possible after you are exposed to anthrax or bacteria causing the plague.
If you are taking didanosine buffered tablets for oral suspension or the pediatric powder for oral suspension, sucralfate, or antacids, multivitamins, or other products containing aluminum, magnesium, iron, or zinc, take them at least 2 hours before or 2 hours after using levofloxacin. These medicines may keep levofloxacin from working properly.
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 anthrax infection (post-exposure):
- For oral dosage form (oral solution):
- Adults and children 6 months of age and older weighing more than 50 kilograms (kg)—500 milligrams (mg) once a day.
- Children 6 months of age and older and weighing less than 50 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 mg per kg of body weight per dose, given 2 times a day. However, the dose is usually not more than 250 mg.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
- Adults and children 6 months of age and older weighing 50 kilograms (kg) or more—500 milligrams (mg) once a day for 60 days.
- Children 6 months of age and older weighing 30 kg to less than 50 kg—250 mg taken every 12 hours for 60 days.
- Children younger than 6 months of age or weighing less than 30 kg—Use and dose must be determined by your doctor.
- For oral dosage form (oral solution):
- For infections:
- For oral dosage forms (oral solution or tablets):
- Adults—250 to 750 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage forms (oral solution or tablets):
- For plague infection:
- For oral dosage forms (oral solution):
- Adults and children 6 months of age and older, weighing more than 50 kilograms (kg)—500 milligrams (mg) once a day.
- Children 6 months of age and older, weighing less than 50 kg—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 mg per kg of body weight per dose, given 2 times a day. However, the dose is usually not more than 250 mg.
- Children younger than 6 months of age—Use and dose must be determined by your doctor.
- For oral dosage forms (tablets):
- Adults and children 6 months of age and older, weighing 50 kilograms (kg) or more—500 milligrams (mg) once a day for 10 to 14 days.
- Children 6 months of age and older, weighing 30 kg to less than 50 kg—250 mg taken every 12 hours for 10 to 14 days.
- Children younger than 6 months of age or weighing less than 30 kg—Use and dose must be determined by your doctor.
- For oral dosage forms (oral solution):
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 or your child's progress at regular visits to make sure the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.
If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.
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 taking the medicine or after you finish using it. 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 get sudden pain or swelling in a tendon after exercise (eg, in the 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. Call your doctor right away if you have a rash, itching, hives, hoarseness, lightheadedness or fainting, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you or your child take this medicine.
Serious side effects can occur during treatment with this medicine. Sometimes serious side effects can occur without warning. However, possible warning signs include: black, tarry stools, blistering, peeling, or loosening of the skin, bloody or cloudy urine, chills, decreased urination, diarrhea, fever, joint or muscle pain, red skin lesions, often with a purple center, sores, ulcers, or white spots in the mouth or on the lips, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, or yellow skin or eyes. Check with your doctor immediately if you notice any of these warning signs.
Levofloxacin may lower 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.
Levofloxacin may cause serious liver problems, including hepatitis. Check with your doctor right away if you or your child start having nausea or vomiting, dark urine, light-colored stools, stomach pain, or yellow eyes or skin while using this medicine.
Levofloxacin may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using 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 or your child start having numbness, tingling, or burning pain in the 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 or your child 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.
This medicine may increase your risk for aortic aneurysm (bulge in the wall of the largest artery). Check with your doctor right away if you have sudden chest, stomach, or back pain, trouble breathing, cough, or hoarseness.
If you are a diabetic patient using 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 take 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 using 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 patients 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 using 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
Rare
- Agitation
- 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
- stomach cramps or pain (severe)
- skin rash, itching, or redness
- trembling
- unusual behavior
Incidence not known
- Black, tarry stools
- blurred vision
- burning, numbness, tingling, or painful sensations
- cough
- dark urine
- difficulty with breathing
- difficulty with chewing, talking, or swallowing
- drooping eyelids
- fainting
- fast or irregular heartbeat
- general body swelling
- hives
- hoarseness
- joint or muscle pain
- muscle cramps, spasms, pain, 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
- vision changes
- 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:
Less common
- Change in taste
- constipation
- dizziness
- drowsiness
- headache
- lightheadedness
- nausea
- nervousness
- stomach pain or 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.
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