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US Brand Names

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Description

Levofloxacin is used to treat bacterial infections in many different parts of the body. Levofloxacin is also used to treat anthrax and other problems as determined by your doctor.

Levofloxacin belongs to the class of medicines known as fluoroquinolone 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:

• Tablet
• Solution

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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, children, or teenagers. However, this medicine may be used in children to prevent anthrax after possible exposure.

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 tendon disorders and kidney, liver, or heart problems which may require caution in patients receiving levofloxacin.

Pregnancy

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

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.

• Mesoridazine
• Ranolazine
• Thioridazine

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:

• Brain or spinal cord disease, including hardening of the arteries in the brain, or epilepsy or other seizures—Levofloxacin may increase the chance of convulsions (seizures) occurring.

• Diabetes mellitus (sugar diabetes)—Levofloxacin may cause changes in blood sugar, which could lead to problems in controlling blood sugar.

• Diarrhea or
• Heart rhythm problems (e.g., prolonged QT interval) or
• Hypokalemia (low potassium in the blood), uncorrected—Use with caution. May make these conditions worse. .

• Kidney disease or
• Liver disease—Effects may be increased because of slower removal of levofloxacin from the body.

• Sensitivity of the skin to sunlight—Patients taking levofloxacin may have an increased risk of severe reactions to sunlight.

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Proper Use

Levofloxacin oral solution should be taken 1 hour before eating or 2 hours after eating.

Levofloxacin tablets may be taken 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 you are otherwise directed by your doctor. Drinking extra water will help to prevent some unwanted effects of levofloxacin.

This medicine works best when there is a constant amount in the blood or urine. 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, your doctor will want you to begin taking it as soon as possible after you are exposed to anthrax.

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 forms (oral solution or tablets):
  • For treatment of infection:
    • Adults—250 to 750 milligrams (mg) once a day.
    • Children—Use and dose must be determined by your doctor.

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.

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Precautions

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

This medicine may cause serious allergic reactions including anaphylaxis which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have rash; itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Levofloxacin may cause serious liver problems, including hepatitis. Stop taking this medicine and 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 using this medicine.

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.

For patients with an abnormally slow heartbeat: Levofloxacin may increase your risk of experiencing a fast, slow or irregular heartbeat.

If you are taking aluminum-, calcium-, or magnesium-containing antacids, didanosine, iron supplements, sucralfate, or zinc, do not take them at the same time that you take this medicine. It is best to take these medicines at least 2 hours before or 2 hours after taking levofloxacin. These medicines may keep levofloxacin from working properly.

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 taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat and sunglasses.
• Apply a sun block product that has a skin 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 health care professional.
• 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. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Levofloxacin may cause pain, inflammation, or rupture of a tendon. If you experience these symptoms in your hands, shoulders, or calves, stop taking levofloxacin and check with your doctor right away. Refrain from exercise until your doctor says otherwise.

For diabetic patients 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, stop taking levofloxacin and check with your doctor right away:

• Symptoms of low blood sugar can include: Anxious feeling, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty in concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, unusual tiredness or weakness.

For patients with low potassium levels: Levofloxacin may increase your risk of experiencing a fast, slow or irregular heartbeat.

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.

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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:

• Abdominal or stomach cramps or pain (severe)
• Abdominal tenderness
• Agitation
• Blisters
• Confusion
• Diarrhea (watery and severe) which may also be bloody
• Fever
• Hallucinations (seeing, hearing, or feeling things that are not there)
• Pain, inflammation, or swelling in calves of legs, shoulders, or hands
• Psychosis
• Redness and swelling of skin
• Sensation of skin burning
• Skin rash, itching, or redness
• Trembling

• Abnormal brain wave patterns
• Black, tarry stools
• Bleeding gums
• Blurred vision
• Burning, numbness, tingling, or painful sensations
• Coma
• Confusion
• Cough
• Dark-colored urine
• Difficult breathing
• Difficulty swallowing
• Failure of the heart, lungs, kidneys, and/or liver
• Fast or irregular heartbeat
• General body swelling
• Hives
• Hoarseness
• Increased bleeding time
• Joint or muscle pain
• Muscle cramps or spasms
• Muscle pain or stiffness
• Peeling or loosening of skin
• Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• Severe dizziness
• Sharp drop in blood pressure
• Shortness of breath
• Sore throat
• Swollen glands
• Tightness in chest
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Voice changes
• Weakness in arms, hands, legs, or feet
• Wheezing

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:

• Abdominal or stomach pain or discomfort
• Change in sense of taste
• Constipation
• Diarrhea
• Dizziness
• Drowsiness
• Headache
• Lightheadedness
• Nausea
• Nervousness
• Trouble in sleeping
• Vaginal itching and discharge
• Vomiting

• Feeling faint
• Feeling of warmth or heat
• Flushing or redness of skin, especially on face and neck
• Sweating

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Abdominal or stomach cramps and pain (severe)
• Abdominal tenderness
• Diarrhea (watery and severe) which may also be bloody
• Fever

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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