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telithromycin

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

What is telithromycin?

Telithromycin is an antibiotic. 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 purposes not listed in this medication guide.

What is the most important information I should know about 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).

You should not take telithromycin if you have a muscle disorder called myasthenia gravis, if you are taking cisapride (Propulsid) or pimozide (Orap), or if you have kidney or liver disease AND you are also taking colchicine (Colcrys).

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Do not take this medication if you have ever had an allergic reaction or liver problems caused by telithromycin or similar antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin, EryPed, Pediazole), azithromycin (Zithromax), clarithromycin (Biaxin), troleandomycin (TAO), or dirithromycin (Dynabac).

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Telithromycin will not treat a viral infection such as the common cold or flu.

What should I discuss with my healthcare provider before taking telithromycin?

You should 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);

  • if you have kidney or liver disease AND you are taking colchicine (Colcrys); 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).

To make sure you can safely take telithromycin, tell your doctor if you have any of these other conditions:

  • kidney or liver disease;

  • low levels of potassium or magnesium in your blood;

  • heart disease or a heart rhythm disorder; or

  • a personal or family history of Long QT syndrome.

FDA pregnancy category C. It is not known whether telithromycin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

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 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.

Telithromycin can be taken with or without food.

Do not crush, chew, or break the telithromycin tablet. Swallow it whole.

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

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.

Store this medication at room temperature away from moisture and heat.

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 telithromycin?

This medication may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking telithromycin and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells 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.

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, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using telithromycin and call your doctor at once if you have a serious side effect such as:

  • diarrhea that is watery or bloody;

  • severe dizziness, fainting, fast or pounding heartbeats;

  • confusion, hallucinations; or

  • problems with vision (difficulty focusing, double vision).

Less serious side effects may include:

  • mild diarrhea;

  • mild nausea, vomiting;

  • vaginal itching or discharge; or

  • changes in your sense of taste.

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.

See also: Side effects (in more detail)

Telithromycin Dosing Information

Usual Adult Dose for Pneumonia:

Mild to moderate community-acquired pneumonia: 800 mg orally once a day for 7 to 10 days

Usual Adult Dose for Sinusitis:

800 mg orally once a day for 5 days

Because the risks outweigh the benefits, telithromycin is no longer approved by the FDA for the treatment of acute bacterial sinusitis.

Usual Adult Dose for Bronchitis:

800 mg orally once a day for 5 days

Because the risks outweigh the benefits, telithromycin is no longer approved by the FDA for the treatment of acute bacterial exacerbation of chronic bronchitis.

Usual Adult Dose for Tonsillitis/Pharyngitis:

800 mg orally once a day for 5 days

The use of telithromycin for the treatment of tonsillitis/pharyngitis is not approved by the FDA.

Usual Pediatric Dose for Tonsillitis/Pharyngitis:

13 years or older: 800 mg orally once a day for 5 days

The use of telithromycin for the treatment of tonsillitis/pharyngitis is not approved by the FDA.

What other drugs will affect telithromycin?

There are many other drugs that can cause serious drug interactions if you take them together with telithromycin. Tell your doctor about all other medicines you use, especially:

  • colchicine (Colcrys);

  • cholesterol-lowering medicine such as simvastatin (Zocor, Simcor, Vytorin), lovastatin (Mevacor, Altoprev, Advicor), atorvastatin (Lipitor, Caduet); or

  • heart or blood pressure medicine such as amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide), diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

Many other drugs can interact with telithromycin. Below is just a partial list. Tell your doctor if you are using:

  • a blood thinner such as warfarin (Coumadin, Jantoven);

  • cyclosporine (Sandimmune, Gengraf, Neoral);

  • digoxin (Lanoxin, Lanoxicaps);

  • itraconazole (Sporanox) or ketoconazole (Nizoral);

  • metoprolol (Lopressor, Toprol XL);

  • rifampin (Rifater, Rifadin, Rifamate);

  • tacrolimus (Prograf) or sirolimus (Rapamune);

  • ergot medicine such as ergotamine (Ergomar, Cafergot, Migergot), dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), or methylergonovine (Methergine);

  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);

  • a sedative such as diazepam (Valium), midazolam (Versed), alprazolam (Xanax), chlordiazepoxide (Librium), temazepam (Restoril); or

  • seizure medication such as phenytoin (Dilantin), carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital (Solfoton).

This list is not complete and there are many other drugs that can interact with telithromycin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

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.
  • Disclaimer: 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.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2011-08-30, 12:05:40 PM.

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