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AVELOX® (moxifloxacin hydrochloride)

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Avelox is a fluoroquinolone antibiotic that may be prescribed as tablets that are swallowed or as a liquid that is given through a vein (intravenously, or I.V.). Avelox has been shown effective for treating adults (18 years of age or older) with certain infections in the respiratory tract, skin or abdomen. Your health care provider can determine whether Avelox is right for you.

What role does Avelox play in managing sinusitis?
What studies have been done to prove that Avelox works?
What are the side effects of Avelox?
Is there anything you should worry about when taking Avelox?
How can I get Avelox?
Patient Prescribing Information

What role does Avelox play in managing sinusitis?
Which bacteria are contributing to a particular case of sinusitis can be difficult for health care professionals to determine. Up to three quarters of acute bacterial sinusitis cases are caused by either Streptococcus pneumoniae or Haemophilus influenzae. Many strains of these bacteria have developed resistance to the older antibiotics.

The remaining sinusitis cases are caused by different bacteria. This is why treatments for sinusitis should include an antibiotic that is highly active against many types of bacteria.



Drug-resistant bacteria are becoming increasingly common. One recent study reported the worldwide prevalence of drug-resistant Streptococcus pneumoniae and Haemophilus influenzae to be 25% and 17%, respectively. Because Avelox works differently from most other antibiotics, it is often effective against pathogens that are resistant to other drugs.

Avelox is highly active against many kinds of bacteria, including those that are most likely to contribute to acute sinusitis: Haemophilus influenzae and Streptococcus pneumoniae, including Streptococcus pneumoniae bacteria that are resistant to common, older antibiotics like amoxicillin and clarithromycin.

To kill bacteria, an antibiotic must reach the place where the bacteria are causing trouble - the infected tissues. Avelox does this. Avelox rapidly penetrates and concentrates in the sinus tissues. This means it works fast to provide high levels of antibacterial activity right where the infection is.

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What studies have been done to prove that AVELOX works?
Research studies with thousands of patients have shown that Avelox is an effective treatment for acute bacterial sinusitis.


Furthermore, Avelox has been shown to provide rapid recovery in acute bacterial sinusitis. In a study of people with acute bacterial sinusitis, one group took Avelox tablets (400 milligrams) once a day for 10 days. The other group took amoxicillin-clavulanate (875 milligrams) twice a day for 10 days. By day 3 on treatment, more patients taking Avelox once a day had symptom relief compared with those patients taking amoxicillin-clavulanate. In another study examining outcomes in patients who had sinusitis that had not been cured by other antibiotics, 96% of patients taking Avelox had clinical recovery by days 3-4 on treatment.

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What are the side effects of Avelox?
Most people who take Avelox do not have major side effects. The most common side effects, which are usually mild, include nausea, vomiting, stomach pain, diarrhea, dizziness, and headache.

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Is there anything you should worry about when you are taking Avelox?

Some rare, serious side effects have been reported in patients taking Avelox. If you experience fast, powerful heartbeats (palpitations), fainting spells, convulsions, or pain in a tendon, contact your health care professional immediately.

Because some patients feel dizzy when they take Avelox, you should not drive a motor vehicle (including a motorcycle) or operate machinery until you are sure that you can take Avelox without having a dizzy spell.

Do not take certain other medications while you are taking Avelox. These include medicines used to treat abnormal heart rhythms (quinidine, procainamide, amiodarone, and sotalol) and medicines that change electrocardiogram (ECG) patterns (cisapride, erythromycin, some antidepressants, and some antipsychotic drugs). Many antacids and multivitamins interfere with how well the body accepts Avelox and may prevent it from working properly. Always take Avelox at least 4 hours before or 8 hours after taking any of these products. Consult your health care professional for more information about this.

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How can I get Avelox?
Avelox is available only by prescription from a health care professional.

Avelox   is generally given once a day for 7-10 days for the treatment of Acute Bacterial Sinusitis.

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Patient Prescribing Information
This section contains important information about Avelox (moxifloxacin hydrochloride), and should be read completely before you begin treatment. This section does not take the place of discussions with your doctor or health care professional about your medical condition or your treatment. This section does not list all benefits and risks of Avelox. The medicine described here can be prescribed only by a licensed health care professional. If you have any questions about Avelox talk with your health care professional. Only your health care professional can determine if Avelox is right for you.

What is Avelox?
Avelox is an antibiotic used to treat lung, sinus, or skin infections caused by certain germs called bacteria. Avelox kills many of the types of bacteria that can infect the lungs and sinuses and has been shown in a large number of clinical trials to be safe and effective for the treatment of bacterial infections.

Sometimes viruses rather than bacteria may infect the lungs and sinuses (for example the common cold). Avelox, like all other antibiotics, does not kill viruses.

You should contact your doctor if you think your condition is not improving while taking Avelox.

How and when should I take Avelox?
Avelox should be taken once a day for 5-21 days depending on your prescription. It should be swallowed and may be taken with or without food. Try to take the tablet at the same time each day.

You may begin to feel better quickly; however, in order to make sure that all bacteria are killed, you should complete the full course of medication. Do not take more than the prescribed dose of Avelox even if you missed a dose by mistake. You should not take a double dose.

Who should not take Avelox?
You should not take Avelox if you have ever had a severe allergic reaction to any of the group of antibiotics known as "quinolones" such as ciprofloxacin or levofloxacin. If you develop hives, difficulty breathing, or other symptoms of a severe allergic reaction, seek emergency treatment right away. If you develop a skin rash, you should stop taking Avelox and call your health care professional.

You should avoid Avelox if you have a rare condition known as congenital prolongation of the QT interval. If you or any of your family members have this condition you should inform your health care professional. You should avoid Avelox if you are being treated for heart rhythm disturbances with certain medicines such as quinidine, procainamide, amiodarone or sotalol. Inform your health care professional if you are taking a heart rhythm drug.

You should also avoid Avelox if the amount of potassium in your blood is low. Low potassium can sometimes be caused by medicines called diuretics such as furosemide and hydrochlorothiazide. If you are taking a diuretic medicine you should speak with your health care professional.

If you are pregnant or planning to become pregnant while taking Avelox, talk to your doctor before taking this medication. Avelox is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Avelox is not recommended for children.

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What are the possible side effects of Avelox?
Avelox is generally well tolerated. The most common side effects caused by Avelox, which are usually mild, include dizziness, nausea, and diarrhea. If diarrhea persists call your health care provider. You should be careful about driving or operating machinery until you are sure Avelox is not causing dizziness. If you notice any side effects not mentioned in this section or you have any concerns about the side effects you are experiencing, please inform your health care professional.

In some people, Avelox, as with some other antibiotics, may produce a small effect on the heart that is seen on an electrocardiogram test. Although this has not caused any serious problems in more than 8,600 patients who have already taken the medication in clinical studies, in theory it could result in extremely rare cases of abnormal heartbeat which may be dangerous. Contact your health care professional if you develop heart palpitations (fast beating), or have fainting spells.

Convulsions have been reported in patients receiving quinolone antibiotics. Be sure to let your physician know if you have a history of convulsions. Quinolones, including Avelox, have been rarely associated with other central nervous system events including confusion, tremors, hallucinations, and depression.

Quinolones, including Avelox, have been rarely associated with inflammation of tendons. If you experience pain, swelling or rupture of a tendon, you should stop taking Avelox and call your health care professional.

What about other medicines I am taking?
Tell your doctor about all other prescription and non-prescription medicines or supplements you are taking. You should avoid taking Avelox with certain medicines used to treat an abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol.

Some medicines also produce an effect on the electrocardiogram test, including cisapride, erythromycin, some antidepressants and some antipsychotic drugs. These may increase the risk of heart beat problems when taken with Avelox.

Many antacids and multivitamins may interfere with the absorption of Avelox and may prevent it from working properly. You should take Avelox either 4 hours before or 8 hours after taking these products.

Remember
Take your dose of Avelox once a day.

Complete the course of medication even if you are feeling better.

Keep this medication out of the reach of children.

This information does not take the place of discussions with your doctor or health care professional about your medical condition or your treatment.

For more complete information about Avelox request full prescribing information from your health care professional or pharmacist.

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