Pronunciation:

spar-FLOX-a-sin

Brand Names:

• Zagam

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antibiotic

Chemical—

Fluoroquinolone

Uses of This Medicine:

Sparfloxacin 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.

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—

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.

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—

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.

• Acecainide
• Acetophenazine
• Amiodarone
• Amitriptyline
• Amoxapine
• Astemizole
• Bepridil
• Bretylium
• Chlorpromazine
• Cisapride
• Desipramine
• Disopyramide
• Dofetilide
• Dothiepin
• Doxepin
• Erythromycin
• Ethopropazine
• Fluphenazine
• Haloperidol
• Ibutilide
• Imipramine
• Lofepramine
• Mesoridazine
• Methotrimeprazine
• Moricizine
• Nortriptyline
• Pentamidine
• Perphenazine
• Pipotiazine
• Pirmenol
• Prajmaline
• Probucol
• Procainamide
• Prochlorperazine
• Promazine
• Promethazine
• Propiomazine
• Protriptyline
• Quinidine
• Recainam
• Sotalol
• Terfenadine
• Thiethylperazine
• Thioridazine
• Trifluoperazine
• Triflupromazine
• Trimipramine
• Ziprasidone

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—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

Proper Use of This Medicine:

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 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 (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 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.

Precautions While Using This Medicine:

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

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

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

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, 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.