Pronunciation:

troe-va-FLOX-a-sin

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antibiotic

Chemical—

Fluoroquinolone

Uses of This Medicine:

Alatrofloxacin and trovafloxacin are used to treat very serious bacterial infections in many different parts of the body. They work by killing bacteria or preventing their growth. However, these medicines will not work for colds, flu, or other virus infections.

Liver failure has been reported rarely with the use of alatrofloxacin and trovafloxacin. Because of the risk of liver problems, these medicines are used only to treat serious bacterial infections, such as those that are life-threatening or when there is a risk of losing a limb. Because of this, treatment usually is started in the hospital or in another inpatient health care facility.

These medicines were available only with your doctor's prescription.

The marketing and distribution of trovafloxacin (and alatrofloxacin) have been discontinued.

Before Using This Medicine:

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.

Children—

Use is not recommended for infants, children, or teenagers up to 18 years of age since alatrofloxacin and trovafloxacin have been shown to cause bone development problems in young animals.

Older adults—

Alatrofloxacin and trovafloxacin have been tested in and, in effective doses, have not been shown to cause different side effects or problems in older people than they do in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

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.

Other medicines—

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 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.

• Didanosine
• Iron
• Sucralfate

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 problems that may cause seizures—Alatrofloxacin or trovafloxacin may cause nervous system side effects.

• Liver disease—Patients with liver disease may have an increased chance of side effects.

Proper Use of This Medicine:

Do not take alatrofloxacin or trovafloxacin if you are pregnant. Do not give alatrofloxacin or trovafloxacin to infants, children, or teenagers unless otherwise specified by your doctor. These medicines have been shown to cause bone development problems in young animals.

Trovafloxacin tablets may be taken with or without meals.

If you are taking alatrofloxacin injection, use it exactly as directed by your doctor. If you have any questions, ask your health care professional.

To help clear up your infection completely, keep taking alatrofloxacin or trovafloxacin for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Alatrofloxacin and trovafloxacin work 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, that dose should be taken about the same time every day. If this interferes with your sleep or other daily activities, or if you need help in planning the best time to take your medicine, check with your health care professional.

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 (trovafloxacin tablets):
  • For treatment of bacterial infections:
    • Adults—100 or 200 milligrams (mg) once every twenty-four hours for three days to several weeks, depending on the medical problem being treated. Gonorrhea is treated with a single oral dose of 100 mg.
    • Children up to 18 years of age—This medicine is not recommended for infants, children, or teenagers.
  • For prevention of infection in surgical patients:
    • Adults—200 milligrams one-half to four hours before the start of surgery.
    • Children up to 18 years of age—This medicine is not recommended for infants, children, or teenagers.
• For injection dosage form (alatrofloxacin injection):
  • For treatment of bacterial infections:
    • Adults—200 to 300 milligrams (mg) injected slowly into a vein over a period of sixty minutes, once every twenty-four hours for up to fourteen days, depending on the medical problem being treated.
    • Children up to 18 years of age—This medicine is not recommended for infants, children, or teenagers.
  • For prevention of infection in surgical patients:
    • Adults—200 milligrams injected slowly into a vein over a period of sixty minutes, one half to four hours before the start of surgery.
    • Children up to 18 years of age—This medicine is not recommended for infants, children, or teenagers.

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 While Using This Medicine:

Alatrofloxacin and trovafloxacin may cause liver problems, including liver failure, at any time during treatment in a small number of people who are treated with these medicines. Check with your doctor immediately if you notice that your urine has become dark or your skin or eyes are yellow in color or if you experience loss of appetite, nausea or vomiting, severe abdominal pain, or unusual tiredness or weakness. These may be possible signs or symptoms of a liver problem.

If you are taking aluminum- or magnesium-containing antacids, citric acid buffered with sodium citrate (e.g., Bicitra), iron supplements or vitamins, intravenous morphine, or sucralfate, do not take them at the same time that you take trovafloxacin tablets. It is best to take these medicines at least 2 hours before or 2 hours after taking trovafloxacin. These medicines may keep trovafloxacin tablets from working properly.

Some people who take alatrofloxacin or trovafloxacin 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.
• 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 sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Alatrofloxacin or trovafloxacin may cause some people to become dizzy, lightheaded, 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.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

Rare

Abdominal or stomach cramps and pain (severe)

abdominal tenderness

agitation

confusion

dark urine

diarrhea (watery and severe, which may also be bloody)

difficulty in breathing or swallowing

fever

hallucinations (seeing, hearing, or feeling things that are not there)

loss of appetite

nausea or vomiting

pain at place of injection

pain in calves that spreads to heels

rapid heartbeat

shakiness or tremors

shortness of breath

skin rash, itching, or redness

swelling of calves or lower legs

swelling of face, throat, or tongue

unusual tiredness or weakness

yellow eyes or skin

Note: Some of the above side effects may also occur up to several weeks after you stop taking this medicine.

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

Diarrhea (mild)

dizziness or lightheadedness

headache

vaginal pain and discharge

Less common or rare

Increased sensitivity of skin to sunlight

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.