AVELOX (moxifloxacin)

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Description
Fluoroquinolones (flu-roe-KWIN-a-lones) are used to treat 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. Fluoroquinolones may also be used for other problems as determined by your doctor.

Fluoroquinolones are available only with your doctor's prescription, in the following dosage forms:

Oral

• Ciprofloxacin
  • Oral suspension (U.S.)
  • Tablets (U.S. and Canada)
• Enoxacin
  • Tablets (U.S.)
• Gatifloxacin
  • Tablets (U.S.)
• Levofloxacin
  • Tablets (U.S. and Canada)
• Lomefloxacin
  • Tablets (U.S.)
• Moxifloxacin
  • Tablets (U.S.)
• Norfloxacin
  • Tablets (U.S. and Canada)
• Ofloxacin
  • Tablets (U.S. and Canada)
• Sparfloxacin
  • Tablets (U.S.)

  Parenteral

• Ciprofloxacin
  • Injection (U.S. and Canada)
• Gatifloxacin
  • Injection (U.S.)
• Levofloxacin
  • Injection (U.S. and Canada)
• Moxifloxacin
  • Injection (U.S.)
• Ofloxacin
  • Injection (U.S.)

Proper Use of This Medicine
Do not take fluoroquinolones if you are pregnant. Do not give fluoroquinolones to infants, children, or teenagers unless otherwise directed by your doctor. These medicines have been shown to cause bone development problems in young animals.

Fluoroquinolones are 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 ciprofloxacin and norfloxacin.

Enoxacin or norfloxacin should be taken on an empty stomach.

Ciprofloxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, ofloxacin, or sparfloxacin may be taken with meals or on an empty stomach. Ciprofloxacin should NOT be taken with dairy products or calcium-fortified juices alone, but may be taken with a meal that contains these products

To help clear up your infection completely, keep taking your medicine 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.

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 two doses a day, the doses should be spaced about 12 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing - The dose of fluoroquinolones 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 fluoroquinolones. Your dose may be different if you have kidney disease. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or amount of oral suspension 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 a fluoroquinolone.

For ciprofloxacin

• For oral dosage form (oral suspension or tablets):
  • Adults: 100 to 750 milligrams (mg) every twelve hours for three to twenty-eight days, depending on the medical problem being treated. Bone and joint infections are usually treated for at least four to six weeks. Gonorrhea is usually treated with a single oral dose of 250 mg. Inhalational anthrax is usually treated for sixty days with 500 mg every twelve hours.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers, except in the case of inhalational anthrax. Inhalational anthrax is usually treated for sixty days with 15 mg per kilogram (kg) (6.8 mg per pound) of body weight every twelve hours.
• For injection dosage form:
  • Adults: 200 to 400 mg every eight to twelve hours.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers, except in the case of inhalational anthrax. Inhalational anthrax is usually treated for sixty days with 10 mg per kg (4.5 mg per pound) of body weight every twelve hours.

  For enoxacin

• For oral dosage form (tablets):
  • Adults: 200 to 400 mg every twelve hours for seven to fourteen days, depending on the medical problem being treated. Gonorrhea is usually treated with a single oral dose of 400 mg.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For gatifloxacin

• For oral dosage form (tablets):
  • Adult: 200 to 400 mg every twenty four hours for seven to fourteen days, depending on the medical problems being treated. Gonorrhea and certain bladder infection are usually treated with a single oral dose of 400 mg.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.
• For injection dosage form:
  • Adults: 200 to 400 mg every twenty four hours for seven to fourteen days, depending on the medical problems being treated. Gonorrhea and certain bladder infection are usually treated with a single oral dose of 400 mg.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For levofloxacin

• For oral dosage form (tablets):
  • Adults: 250 to 750 mg once a day for seven to fourteen days, depending on the medical problem being treated.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.
• For injection dosage form:
  • Adults: 250 to 750 mg, injected slowly into a vein, once a day for seven to fourteen days, depending on the medical problem being treated.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For lomefloxacin

• For oral dosage form (tablets):
  • Adults: 400 mg once a day for three to fourteen days, depending on the medical problem being treated.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For moxifloxacin

• For oral dosage form (tablets):
  • Adult: 400 mg once a day for five to fourteen days, depending on the medical problem being treated.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.
• For injection dosage form:
  • Adult: 400 mg injected in a vein once a day for five to fourteen days, depending on the medical problem being treated.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For norfloxacin

• For oral dosage form (tablets):
  • Adults: 400 mg every twelve hours for three to twenty-eight days, depending on the medical problem being treated. Gonorrhea is usually treated with a single oral dose of 800 mg.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For ofloxacin

• For oral dosage form (tablets):
  • Adults: 200 to 400 mg every twelve hours for three to fourteen days, depending on the medical problem being treated. Prostatitis is usually treated for six weeks. Gonorrhea is usually treated with a single oral dose of 400 mg.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.
• For injection dosage form:
  • Adults: 200 to 400 mg, injected slowly into a vein, every twelve hours for three to fourteen days, depending on the medical problem being treated. Prostatitis is usually treated for six weeks. Gonorrhea is usually treated with a single dose of 400 mg.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

  For sparfloxacin

• For oral dosage form (tablets):
  • Adults: 400 mg on the first day, then 200 mg once a day for an additional nine days.
  • Children up to 18 years of age: This medicine is not recommended for use in infants, children, or teenagers.

Missed dose - If you miss a dose of this medicine, take it as soon as possible. This will help to keep a constant amount of medicine in the blood or urine. 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 - To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Ciprofloxacin oral suspension may be refrigerated. However, keep this medicine from freezing.
• 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.

Additional Information
Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, fluoroquinolones are used in certain patients with the following medical conditions:

• Chancroid
• Pulmonary exacerbations (airway infections) in cystic fibrosis

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

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 the fluoroquinolones, the following should be considered:

Allergies - Tell your doctor if you have ever had any unusual or allergic reaction to any of the fluoroquinolones or to any related medicines such as cinoxacin (e.g., Cinobac) or nalidixic acid (e.g., NegGram). Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy - Studies have not been done in humans. However, use is not recommended during pregnancy since fluoroquinolones have been reported to cause bone development problems in young animals.

Breast-feeding - Some of the fluoroquinolones are known to pass into human breast milk. Since fluoroquinolones have been reported to cause bone development problems in young animals, breast-feeding is not recommended during treatment with these medicines.

Children - Use is not recommended for infants or children since fluoroquinolones have been shown to cause bone development problems in young animals. However, your doctor may choose to use one of these medicines if other medicines cannot be used.

Teenagers - Use is not recommended for teenagers younger than 18 years of age since fluoroquinolones have been shown to cause bone development problems in young animals. However, your doctor may choose to use one of these medicines if other medicines cannot be used.

Older adults - These medicines have been tested and, in effective doses, have not been shown to cause different side effects or problems in older people than they do 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 a fluoroquinolone, it is especially important that your health care professional know if you are taking any of the following:

• Aminophylline or
• Oxtriphylline (e.g., Choledyl) or
• Theophylline (e.g., Elixophyllin, Theo-Dur)Ciprofloxacin, enoxacin, and norfloxacin may increase the chance of side effects of aminophylline, oxtriphylline, or theophylline

• Amiodarone (e.g., Cordarone) or
• Astemizole (e.g., Hismanal) or
• Bepridil (e.g., Vascor) 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., Ormazine, Thorazine Spansule, Thor-Prom], fluphenazine [e.g., Permitil, Prolixin], mesoridazine [e.g., Serentil], methotrimeprazine [e.g., Nozinan], pericyazine [e.g., Neuleptil], perphenazine [e.g., Trilafon], prochlorperazine [e.g., Compazine], promazine [e.g., Primazine, Sparine], thioridazine [e.g., Mellaril], trifluoperazine [e.g., Stelazine], triflupromazine [e.g., Vesprin]) or
• Procainamide (e.g., Pronestyl) or
• Quinidine (e.g., Quinidex) or
• Sotalol (e.g., Sotacor) or
• Terfenadine (e.g., Seldane) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil, Endep], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Norpramin], doxepin [e.g., Sinequan], imipramine [e.g., Norfranil, Tipramine, Tofranil], nortriptyline [e.g., Aventyl, Pamelor], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])Use of these medicines with gatifloxacin, levofloxacin, moxifloxacin or sparfloxacin may cause heart problems, such as an irregular heartbeat

• Antacids, aluminum-, calcium-, and/or magnesium-containing, or
• Didanosine (e.g., Videx, ddI) or
• Iron supplements or
• Sucralfate (e.g., Carafate)Antacids, didanosine, iron, or sucralfate may keep any of the fluoroquinolones from working properly. Ciprofloxacin may be taken 2 hours before or 6 hours after these medicines. Moxifloxacin may be taken 4 hours before or 8 hours after these medicines.

• CaffeineCiprofloxacin, enoxacin, and norfloxacin may increase the chance of side effects of caffeine; caffeine should not be taken during treatment with enoxacin

• Phenytoin (e.g., Dilantin)Ciprofloxacin may keep phenytoin from working properly

• Warfarin (e.g., Coumadin)Ciprofloxacin and norfloxacin may increase the effect of warfarin, increasing the chance of bleeding

Other medical problems - The presence of other medical problems may affect the use of fluoroquinolones. 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 seizuresFluoroquinolones may cause nervous system side effects

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

• Heart disease Gatifloxacin, moxifloxacin or sparfloxacin may make this problem worse

• Kidney disease or
• Liver diseasePatients with kidney disease or liver disease may have an increased chance of side effects with any of the fluoroquinolones

• Sensitivity of the skin to sunlight (previous)Patients taking sparfloxacin or any of the other fluoroquinolones may have an increased risk of severe reactions to sunlight

• Tendinitis (previous)Fluoroquinolones may increase the risk of tendon injury

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- or magnesium-containing antacids, or sucralfate, do not take them at the same time that you take this medicine. It is best to take these medicines at least 6 hours before or 2 hours after taking ciprofloxacin; at least 8 hours before or 2 hours after taking enoxacin; at least 4 hours after taking gatifloxacin; at least 4 hours before or 4 hours after taking sparfloxacin; at least 2 hours before or 2 hours after taking levofloxacin, norfloxacin, or ofloxacin; at least 4 hours before or 2 hours after taking lomefloxacin, and at least 8 hours before and 4 hours after taking moxifloxacin. These medicines may keep fluoroquinolones from working properly.

If you are taking metal cations such as iron, and multivitamin preparations with zinc, or didanosine (Videx) chewable/buffered tablets or the pediatric powder for oral solutiontake moxifloxacin at least 4 hours before or 8 hours after and take ciprofloxacin at least 2 hours before or 6 hours after taking these medicines.

If you are taking levofloxacin, you should not take certain medications which correct a fast, slow or irregular heartbeat. Check with your physician to determine whether you are taking one of these medications.

If you are taking enoxacin, you should not take any caffeine-containing products (e.g., coffee, tea, chocolate, certain carbonated beverages). Taking any of these caffeine-containing products while you are taking enoxacin may increase the effects of caffeine.

Some people who take fluoroquinolones, especially sparfloxacin, 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 sunlamp or tanning bed or booth.

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 the fluoroquinolone and check with your doctor.

Fluoroquinolones may also 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 can be dangerous if you are dizzy or are not alert. If these reactions are especially bothersome, check with your doctor.

Fluoroquinolones 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 the fluoroquinolone 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.

For patients with diabetes 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.

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

For sparfloxacin and moxifloxacin (less common)

Fainting, irregular or slow heart rate

Less common

More common for lomefloxacin and sparfloxacin

bloating or swelling of face, arms, hands, lower legs, or feet, blistering of skin, blurred vision, dizziness, headache, nervousness, pounding in the ears, rapid weight gain , sensation of skin burning, slow or fast heartbeat, skin itching, rash, redness, or swelling, tingling of hands or feet, unusual weight gain or loss

Rare

Abdominal or stomach cramps and pain (severe), abdominal pain, abdominal tenderness, agitation, area rash, black, tarry stools, bleeding, blisters on mucous membranes, with fever, blistering, itching, loosening, peeling, or redness of skin, bloody or cloudy urine, coldness, burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings, chills, chest pain, clay-colored stools, confusion, cough, dark or amber urine, diarrhea (watery and severe, which may also be bloody), difficulty breathing, difficulty swallowing, discoloration of skin, dizziness, dry mouth, excessive muscle tone, fainting, faintness, dizziness, or lightheadedness when getting up from a lying or sitting position suddenly, fast, pounding, or irregular heartbeat or pulse, fatigue, flushed, dry skin, feeling of pressure, feeling of unreality, feeling of warmth or heat, fever, flushing or redness of skin especially on face and neck, fruit-like breath odor, hallucinations (seeing, hearing, or feeling things that are not there), hives or welts, incoordination, increased hunger, increased thirst, increased urination, inflammation, infection, irregular or fast heart rate , itching, joint pain, lack or loss of strength, large amount of fat in the blood, loss of appetite, loss of memory, lower back, side, or stomach pain, lumps, muscle stiffness, muscle tension or tightness, nausea, noisy breathing, numbness, pain, pain at site of injectionfor ciprofloxacin or ofloxacin injection, pain in calves, radiating to heels, pain, warmth, or burning in fingers, toes and legs, painful or difficult urination, pale stools, palpitations, peeling of the skin, problems with memory, problems with speech or speaking, problems with vision or hearing , rash, rash with flat lesions or small raised lesions on the skin, redness , redness of skin, redness, swelling, or soreness of tongue, scarring, seizures, sense of detachment from self or body, shakiness or tremors, shortness of breath skin rash, sore throat, sores, ulcers, or white spots on lips or in mouth, soreness, stomach pain, stinging, sweating, swelling, swelling of face or neck, swelling of calves, feet, or lower legs, swelling or inflammation of the mouth, swelling or puffiness of face, tenderness, tightness in chest, tingling, troubled breathing, ulceration, unpleasant breath odor, unusual tiredness or weakness , vomiting, vomiting of blood, warmth, wheezing , yellow eyes or skin

Incidence not determined

Observed during clinical practice with levofloxacin; estimates of frequency cannot be determined

abnormal brain wave patterns, black, tarry stools , bleeding gums, blurred vision, coma, confusion , difficult breathing, failure of the heart, lungs, kidneys and/or liver, fatigue, general body swelling, hives, increased bleeding time, irregular reading on a electrocardiogram (heart test), joint or muscle pain, sharp drop in blood pressure , sore throat, swollen glands , unusual bleeding or bruising

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:

More common

Abdominal or stomach pain or discomfort (mild), diarrhea (mild), drowsiness, lightheadedness, nervousness, trouble in sleeping, vaginal pain and discharge

Less frequent or rare

Abnormal dream, acid or sour stomach , back pain, bad, unusual or unpleasant (after) taste, belching, bloated full feeling, burning, crawling, itching, numbness, prickling, "pins and needles" , or tingling feelings, burning feeling in chest or stomach, change in sense of taste, change in sense of smell , change in taste, change in vision, constipation, continuing ringing or buzzing or other unexplained noise in ears, crying, depersonalization, depression, difficulty in moving, difficulty in sleeping, difficulty in speaking, difficulty in urination, dysphoria, euphoria, excess air or gas in stomach or intestines, fear, feeling of constant movement of self or surroundings, general feeling of discomfort or illness, hearing loss, heartburn, impaired vision, increased sensitivity of skin to sunlight, indigestion, mental depression, muscle pain, pain, swelling, or redness in joints, paranoia, passing gas, pelvic pain, pinpoint red or purple spots on skin, puffiness or swelling of the eyelids or around the eyes, face, lips or tongue , quick to react or overreact emotionally, rapidly changing moods, sensation of spinning, shortness of breath, sleeplessness, sleepiness or unusual drowsiness, sore mouth or tongue, or white patches in mouth and/or on tongue , spots on skin resembling a blister or pimple, stomach discomfort, upset or pain, tenderness in stomach area, thinking, abnormal, tongue discoloration, unable to sleep , vaginal yeast infection, vision problems, weight loss

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

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