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In the U.S.—

Zagam

• Antibacterial, systemic

Sparfloxacin ( spar-FLOX-a-sin) belongs to the class of medicines known as antibiotics. It is used to treat bronchitis and pneumonia caused by bacterial infections.

Sparfloxacin 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, in the following dosage form:

Oral
• Tablets (U.S.)

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 sparfloxacin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sparfloxacin or to other fluoroquinolone antibiotics (ciprofloxacin, enoxacin, levofloxacin, lomefloxacin, norfloxacin, ofloxacin). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Sparfloxacin has not been studied in pregnant women. However, this medicine has been shown to cause bone development problems in young animals. Discuss with your doctor whether or not this medicine should be taken during pregnancy.

Breast-feeding—Sparfloxacin passes into the breast milk. It has also been shown to cause bone development problems in young animals. Discuss with your doctor whether or not to breast-feed during treatment with sparfloxacin.

Children—Caution is recommended in using sparfloxacin in children up to 18 years of age because similar medicines have been shown to cause bone development problems in young animals. However, your doctor may choose to use this medicine if other medicines cannot be used.

Older adults—This medicine has been studied in elderly patients and has not been found to cause different side effects or other problems than it does in younger adults.

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 sparfloxacin, it is especially important that your health care professional know if you are taking any of the following:

• Amiodarone (e.g., Cordarone) or
• Astemizole (e.g., Hismanal) or
• Cisapride (e.g., Propulsid) or
• Disopyramide (e.g., Norpace) or
• Erythromycin (e.g., E-Mycin) or
• Pentamidine (e.g., Nebupent) or
• Phenothiazines (acetophenazine [e.g., Tindal], chlorpromazine [e.g., Thorazine], fluphenazine [e.g., Prolixin], mesoridazine [e.g., Serentil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Sparine], promethazine [e.g., Phenergan], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin], trimeprazine [e.g., Temaril]) or
• Terfenadine (e.g., Seldane) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Use with sparfloxacin may lead to an increased risk of heart rhythm problems caused by sparfloxacin or these medicines

• Antacids, aluminum-, calcium-, or magnesium-containing or
• Iron supplements or
• Sucralfate (e.g., Carafate) or
• Zinc—Antacids, iron, sucralfate, or zinc may interfere with absorption of sparfloxacin into the body

Other medical problems—The presence of other medical problems may affect the use of sparfloxacin. 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—Sparfloxacin may increase the chance of convulsions (seizures) occurring

• Heart rhythm problems or
• Heart or blood problems that could lead to heart rhythm problems—Sparfloxacin can cause heart rhythm problems

• Kidney disease—Effects of sparfloxacin may be increased because of slower removal from the body

• Sensitivity of the skin to sunlight (previous)—Increased risk of severe reactions to sunlight caused by sparfloxacin

Sparfloxacin may be taken with meals or on an empty stomach, or with milk products or caffeine-containing products.

Drink plenty of fluids while you are being treated with this medicine. Drinking extra water will help to prevent some unwanted effects of sparfloxacin.

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.

Dosing—

The dose of sparfloxacin 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 sparfloxacin. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For treatment of infection:
    • Adults—400 milligrams (mg) on the first day, then 200 mg once a day for an additional nine days.
    • Children younger than 18 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as you remember. However, if you don't remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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

If you are taking aluminum-, calcium-, or magnesium-containing antacids, 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 4 hours after taking sparfloxacin. These medicines may keep sparfloxacin from working properly.

Some people who take sparfloxacin may become more sensitive to sunlight than they are normally. Exposure to sunlight, even for brief periods of time, may cause severe sunburn; skin rash, redness, itching, or discoloration; or vision changes. 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, while you are taking sparfloxacin and for 5 days after you stop taking sparfloxacin.
• 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. However, wearing a sun block product will not prevent a reaction to sunlight while you are taking sparfloxacin. 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. Stay out of direct sunlight and artificial light (e.g., sunlamp, tanning bed or booth) for the next 5 days or until the reaction has stopped.

If you get a skin rash or other signs of an allergic reaction, stop taking sparfloxacin and check with your doctor.

Sparfloxacin 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.

This medicine may rarely cause inflammation or even tearing of a tendon (the cord that attaches muscles to bones). If you get sudden pain in a tendon after exercise (for example, in your ankle, back of the knee or leg, shoulder, elbow, or wrist), stop taking sparfloxacin and check with your doctor. Rest and do not exercise until the doctor has made sure that you have not injured or torn the tendon.

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 immediately if any of the following side effects occur:

• More common
  • Blisters;  itching;  redness of skin;  sensation of skin burning;  skin rash;  swelling of skin 
  
  

• Rare
  • Abdominal or stomach cramps and pain (severe);  abdominal tenderness;  diarrhea (watery and severe), which may also be bloody;  fever;  pain, inflammation, or swelling in calves, shoulders, or hands 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• Less common
  • Irregular heartbeat 
  
  

• Rare
  • Acute psychosis;  agitation;  confusion;  hallucinations (seeing, hearing, or feeling things that are not there);  tremors 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common
  • Changes in sense of taste;  diarrhea ;  dizziness;  drowsiness ;  headache;  lightheadedness ;  nausea;  nervousness;  trouble in sleeping;  vaginal itching and discharge;  vomiting 
  
  

After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor immediately if you notice any of 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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Revised: 08/10/1998