What is Ketek used for?      

Ketek is an antibiotic used to treat adults 18 years of age and older with certain respiratory (lung and sinus) infections caused by certain germs called bacteria. Ketek kills many of the types of

bacteria that can infect the lungs and sinuses, and has been found to treat these infections safely and effectively in clinical trials. Not all respiratory infections are caused by bacteria. For example, common colds are caused by viruses. Ketek, like other antibiotics, does not kill viruses.

Who should not take Ketek?:

You must not take Ketek if:

·       you have ever had a severe allergic reaction to Ketek or to any of the group of antibiotics known as “macrolides” such as erythromycin, azithromycin (Zithromax), clarithromycin (Biaxin) or dirithromycin (Dynabac).

·       you are currently taking cisapride (Propulsid) or pimozide (Orap).  

General Precautions with Ketek:

·       Ketek may cause problems with vision, particularly when looking quickly between objects close by and objects far away. These events include blurred vision, difficulty focusing, and objects looking doubled. Some patients have severe problems with vision that may interfere with normal activities.  Most events were mild to moderate; however, severe cases have been reported.  These problems lasted several hours and in some patients come back with the next dose. People taking Ketek should be careful when driving a motor vehicle, operating heavy machinery, or engaging in otherwise hazardous activities.

·       There have been reports of side effects on the liver. Signs of jaundice include yellow color of the skin and/or eyes.

·       There have been reports of worsening of myasthenia gravis symptoms in patients with myasthenia gravis.  If you have myasthania gravis and experience worsening of your symptoms (such as muscle weakness, difficulty breathing) during treatment with Ketek, you should stop taking Ketek and seek immediate medical attention.  

What should I tell my health care provider?

Tell your health care provider:

·       if you have, or if a relative has, a rare heart condition known as congenital prolongation of the QT interval.

·       if you are being treated for heart rhythm disturbances with certain medicines known as

antiarrhythmics (such as quinidine, procainamide, or dofetilide) or if you have low blood potassium (hypokalemia), or low blood magnesium (hypomagnesemia).

·       if you have a disease known as myasthenia gravis.

·       if you are pregnant, planning to become pregnant, or are nursing.

·       if you have ever experienced jaundice (yellow color of the skin and/or eyes) while taking Ketek.

·       if you have any other serious medical conditions, including heart, liver, or kidney disease.

Tell your health care provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.  Especially tell your health care provider if you take:

·       if you are taking cisapride (Propulsid) or pimozide (Orap).

·       simvastatin, lovastatin, or atorvastatin (used for lowering cholesterol). You should stop treatment with these medications while you are taking Ketek.

·       medicines that correct heart rhythm called “antiarrhythmics” (such as quinidine, procainamide, or dofetilide).

·       any of the following medicines: itraconazole, ketoconazole, midazolam, digoxin, ergot alkaloid derivatives, cyclosporine, carbamazepine, hexobarbital, phenytoin, tacrolimus, sirolimus, metoprolol, theophylline or rifampin.

·       medicines called diuretics (also sometimes called water pills) such as furosemide or hydrochlorothiazide.

What are some possible side effects of Ketek? (This list is NOT a complete list of side effects reported with Ketek.  Your health care provider can discuss with you a more complete list of side effects.)

The most common side effects of Ketek include:

•  nausea  

• headache  

• dizziness 

• vomiting 

• diarrhea.  If diarrhea persists call your healthcare provider.

Reports of patients’ experience after Ketek became available:

For more detailed information about Ketek, ask your health care provider or pharmacist.

Posted 6/14/04