Consumer Drug Information

Ketek Pak

Generic Name: telithromycin (tel IT roe MYE sin)
Brand Names: Ketek, Ketek Pak

What is Ketek Pak (telithromycin)?

Telithromycin is in a group of drugs called antibiotics. Telithromycin helps the body fight infection that is caused by bacteria.

Telithromycin is used to treat bacterial infections in the lungs and sinuses.

Telithromycin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Ketek Pak (telithromycin)?

Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Do not take telithromycin if you are taking cisapride (Propulsid) or pimozide (Orap), or if you have a muscle disorder called myasthenia gravis.

Before taking this medicine, tell your doctor if you have ever had an allergic reaction or liver problems caused by telithromycin or similar antibiotics such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), azithromycin (Zithromax), clarithromycin (Biaxin), troleandomycin (TAO), or dirithromycin (Dynabac).

Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Telithromycin will not treat a viral infection such as the common cold or flu.

What should I discuss with my healthcare provider before taking Ketek Pak (telithromycin)?

Do not take this medication if you are allergic to telithromycin, or if you have:

myasthenia gravis;
if you are also taking cisapride (Propulsid) or pimozide (Orap); or
if you have a history of liver problems caused by telithromycin or similar antibiotics such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), azithromycin (Zithromax), clarithromycin (Biaxin), troleandomycin (TAO), or dirithromycin (Dynabac).

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

kidney disease;
liver disease;
myasthenia gravis (a nerve and muscle disorder);
low levels of potassium or magnesium in your blood;
a heart rhythm disorder; or
a family history of "Long QT syndrome."

FDA pregnancy category C. It is not known whether telithromycin is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether telithromycin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Ketek Pak (telithromycin)?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the medicine with a full glass (8 ounces) of water.

Telithromycin can be taken with or without food.

Telithromycin is usually taken once a day. Follow your doctor's instructions. Try to take telithromycin at about the same time each day. Follow your doctor's instructions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Telithromycin is not expected to cause overdose symptoms.

What should I avoid while taking Ketek Pak (telithromycin)?

Telithromycin can cause blurred vision, double vision, or trouble focusing. Be careful if you drive or do anything that requires you to be awake and alert.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

If you also use theophylline (Elixophyllin, Theo-24, Theochron, Uniphyl, and others), avoid using it within 1 hour before or after you take telithromycin.

Ketek Pak (telithromycin) side effects

Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes). Stop using telithromycin and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

diarrhea that is watery or bloody;
irregular heartbeats;
feeling light-headed, fainting;
problems with vision (difficulty focusing, drooping eyelid);
muscle pain or weakness;
trouble swallowing; or
loss of balance, coordination, or ability to climb stairs or rise from a chair.

Less serious side effects may include:

mild nausea, vomiting;
vaginal itching or discharge;
headache; or
dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Ketek Pak (telithromycin)?

Before taking telithromycin, tell your doctor if you are also using any of the following drugs:

a blood thinner such as warfarin (Coumadin);
cholesterol-lowering medicine such as simvastatin (Zocor), lovastatin (Mevacor), atorvastatin (Lipitor);
ergot medicine such as ergotamine (Ergomar), dihydroergotamine (D.H.E. 45, Migranal Nasal Spray), ergonovine (Ergotrate), or methylergonovine (Methergine);
a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax), chlordiazepoxide (Librium), temazepam (Restoril);
itraconazole (Sporanox) or ketoconazole (Nizoral);
heart rhythm medication such as amiodarone (Cordarone, Pacerone), sotalol (Betapace, Betapace AF, Sorine), quinidine (Cardioquin, Quinaglute), disopyramide (Norpace), procainamide (Pronestyl, Procanbid), dofetilide (Tikosyn);
rifampin (Rifadin, Rimactane);
seizure medication such as phenytoin (Dilantin), carbamazepine (Tegretol), phenobarbital (Luminal);
metoprolol (Lopressor, Toprol XL);
tacrolimus (Prograf) or sirolimus (Rapamune);
cyclosporine (Sandimmune, Neoral); or
digoxin (Lanoxin, Lanoxicaps).

This list is not complete and there may be other drugs that can interact with telithromycin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about telithromycin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.