Telithromycin (patient information)

IMPORTANT WARNING:

Telithromycin may cause worsening of symptoms, including breathing problems, when taken by people with myasthenia gravis (a disease that causes muscle weakness). These breathing problems may be severe or life-threatening and may cause death. Tell your doctor if you have myasthenia gravis. You should not take telithromycin if you have this condition.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with telithromycin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/cder) or the manufacturer's website to obtain the Medication Guide.

Why is this medication prescribed

Telithromycin is used to treat certain types of pneumonia (an infection of the lungs) that is caused by bacteria. Telithromycin is in a class of medications called ketolide antibiotics. It works by killing bacteria. Antibiotics will not kill viruses that can cause colds, flu, or other infections.

How should this medicine be used

Telithromycin comes as a tablet to take by mouth. It is usually taken with or without food once a day for 7-10 days. To help you remember to take telithromycin, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take telithromycin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

You should start to feel better early in your treatment. Call your doctor if your condition does not improve while you are taking telithromycin. Take telithromycin until you finish the prescription, even if you feel better. If you stop taking telithromycin too soon or if you skip doses of telithromycin, your infection may not be cured and the bacteria may become resistant to antibiotics.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow

Before taking telithromycin:

• tell your doctor and pharmacist if you are allergic to telithromycin, azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac, no longer available in the U.S..), erythromycin (E.E.S., E-Mycin, Erythrocin), troleandomycin (TAO, no longer available in the U.S.), or any other medications.
• do not take telithromycin if you are taking cisapride (Propulsid, no longer available in the U.S..) or pimozide (Orap).
• tell your doctor if you have had hepatitis (swelling of the liver) or jaundice (yellowing of the skin or eyes) while taking telithromycin or azithromycin (Zithromax), clarithromycin (Biaxin), dirithromycin (Dynabac, no longer available in the U.S.), erythromycin (E.E.S., E-Mycin, Erythrocin), or troleandomycin (TAO, no longer available in the U.S.). Your doctor will tell you not to take telithromycin.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin); antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral); carbamazepine (Tegretol); cholesterol-lowering medications such as atorvastatin (Lipitor, in Caduet), lovastatin (Altoprev, Mevacor, in Advicor), and simvastatin ( Zocor, in Vytorin); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); ergot-type medications such as bromocriptine (Parlodel), cabergoline (Dostinex), dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Germinal, Hydergine), ergonovine (Ergotrate), ergotamine (Bellergal-S, Cafergot, Ergomar, Wigraine), methylergonovine (Methergine), methysergide (Sansert), and pergolide (Permax); medications for irregular heartbeat, including amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), procainamide (Procanbid), quinidine, or sotalol (Betapace); metoprolol (Lopressor, Toprol XL); midazolam (Versed); phenobarbital (Luminal, Solfoton); phenytoin (Dilantin); repaglinide (Prandin); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane); sirolimus (Rapamune); tacrolimus (Prograf); and triazolam (Halcion). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking theophylline (Theo-24, Theobid, Theo-Dur, others), take it 1 hour before or after telithromycin.
• tell your doctor if you or anyone in your family has or has had a heart problem that may cause fainting and a slow or irregular heartbeat, or heart disease; or if you have low blood levels of potassium or magnesium; or kidney or liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking telithromycin, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking telithromycin.
• you should know that telithromycin may cause dizziness or fainting. If you feel lightheaded and have severe nausea or vomiting, do not drive a car, operate machinery or participate in dangerous activities. If you faint, call your doctor before taking another dose of telithromycin.
• You should know that antibiotics, including telithromycin, may cause an infection in the intestines with symptoms of watery diarrhea, diarrhea that does not go away, or bloody stools; stomach cramps; or fever. Call your doctor if you have these symptoms. These symptoms can occur up to two months after finishing treatment.
• you should know that telithromycin may cause liver damage, which may be severe or life-threatening. This reaction may happen at any time while you are taking telithromycin or right after you finish taking this medication. Stop taking telithromycin and call your doctor right away if you have any of the following symptoms: tiredness, lack of energy, unusual bleeding or bruising, loss of appetite, nausea, itchy skin, dark urine, light-colored stools, yellowing of your skin or eyes, pain or tenderness in the upper right part of your stomach, swelling of the abdomen, or flu-like symptoms.
• you should know that telithromycin may cause vision problems, including blurred vision, difficulty focusing, and seeing double. These problems usually happen after the first or second dose and last for a few hours. To avoid these problems, avoid quick changes in looking from things far away to things close by. Do not drive a car, operate machinery, or participate in dangerous activities until you know how this medication affects you. If you have vision problems while taking telithromycin, call your doctor before taking another dose.

What special dietary instructions should I follow

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Never take more than one dose of telithromycin in 24 hours. Do not take a double dose to make up for a missed one.

Side effects

Mild side effects

Telithromycin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• nausea
• vomiting
• headache
• dizziness

Severe side effects

Some side effects can be serious. If you experience any of these symptoms, or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• fainting
• rapid, irregular, or pounding heartbeat
• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

Telithromycin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know

Keep all appointments with your doctor.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the telithromycin, call your doctor.

Brand names

• Ketek®