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Patient Information Sheet
Telithromycin (marketed as Ketek)
This is a summary of the most important information about Ketek. For details, talk to your healthcare professional.
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).
- are currently taking cisapride (Propulsid) or pimozide (Orap).
- have ever experienced side effects on the liver while taking Ketek or other antibiotics called macrolides (erythromycin, clarithromycin or azithromycin).
Special Warnings with Ketek:
There have been reports of side effects on the liver, including
severe liver disease. In some cases, liver damage worsened rapidly
and happened after just a few doses of Ketek. If you develop signs
or symptoms of hepatitis (liver disease), such as tiredness, body
aches, loss of appetite, nausea, jaundice (yellow color of the skin
and/or eyes), dark urine, light-colored stools, itchy skin, or belly
pains, stop your medication and immediately contact your healthcare
provider.
If you have myasthenia gravis, you should talk to your healthcare
provider about other treatments before taking Ketek. There have been reports of
worsening of myasthenia gravis symptoms in patients with myasthenia
gravis taking Ketek. If you have myasthenia 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.
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.
What should I tell my healthcare provider?
Tell your healthcare provider if you:
- have, or if a relative has, a rare heart condition known as congenital prolongation of the QT interval.
- 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)
- have a disease known as myasthenia gravis.
- are pregnant, planning to become pregnant, or are nursing.
- have ever experienced jaundice (yellow color of the skin and/or eyes) while taking Ketek.
- have any other serious medical conditions, including heart, liver, or kidney disease.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription
medicines, vitamins, and herbal supplements. Especially tell your
healthcare provider if you take:
- 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,
rifampin, or warfarin and other oral anticoagulants (sometimes
called blood thinners).
- 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 healthcare 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.
For more detailed information about Ketek,
ask your healthcare provider or pharmacist.
Link
to Ketek's Approved Labeling [PDF]
PDF requires the free
Adobe Acrobat Reader
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Ketek
Date created: July 21, 2006 |
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