Telithromycin, Oral

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KEY POINTS

• This medicine is taken by mouth to treat a lung infection called community acquired pneumonia. Take it exactly as directed.
• If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away.
• This medicine may cause liver damage, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: ketolide antibiotic

Generic and brand names: telithromycin, oral; Ketek

What is this medicine used for?

This medicine is an antibiotic taken by mouth to treat a lung infection called community acquired pneumonia.

This medicine will not cure viral infections such as colds and the flu.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not take this medicine if you:

• Have myasthenia gravis
• Have ever had liver problems, yellowing of your skin or eyes, or an allergic reaction while taking antibiotics
• Take cisapride or pimozide
• Take colchicine and have kidney or liver problems

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• An irregular heart rhythm or other heart disease
• Kidney disease
• Liver problems such as hepatitis
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Myasthenia gravis
• Problems with low potassium or magnesium levels in the blood
• Severe diarrhea
• Stomach problems or colitis

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval, even if you feel better. If you stop taking it too soon, the infection may return.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Taking it with meals may lessen the chance the drug will upset your stomach. Do not break, crush, or chew the tablets. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: irregular heartbeat, nausea, vomiting.

What should I watch out for?

Do not take this medicine for other infections unless your healthcare provider approves.

This medicine may cause liver damage. If while taking this medicine you develop unusual weakness or tiredness, loss of appetite, dark urine, severe stomach pain, severe nausea or vomiting, unexplained itching, or yellowing of your skin or eyes, contact your healthcare provider right away.

This medicine may cause or worsen diarrhea. If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away. Do not take medicine to treat diarrhea without your provider's approval.

This medicine may cause vision problems such as trouble focusing, double vision, or blurred vision. This medicine may also cause you to have severe dizziness or faint. Do not drive or operate machinery unless you are alert and can see clearly. Contact your provider before taking another dose if you have severe dizziness, fainting, or vision problems.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Contact your healthcare provider if your condition does not improve in a few days or if it gets worse.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Severe or constant diarrhea; yellowing of your skin or eyes; dark urine; light-colored bowel movements; severe stomach pain; severe nausea or vomiting; unexplained itching; unusual bruising or bleeding; fast, slow, or irregular heartbeat; chest pain; severe dizziness or fainting; unusual muscle weakness or pain; muscle cramps; unexplained loss of appetite; unusual weakness or tiredness; vision problems; confusion; hallucinations; new or worsening breathing problems.

Other: Mild diarrhea or loose bowel movements, mild dizziness, change in sense of taste, mild nausea or vomiting, headache.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alpha blockers such as alfuzosin (Uroxatral), silodosin (Rapaflo), and tamsulosin (Flomax)
• Anagrelide (Agrylin)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), and midazolam (Versed)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), and quinidine
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine, rifabutin (Mycobutin), rifampin (Rifadin), and rifapentine (Priftin), and telavancin (Vibativ)
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine, desipramine (Norpramin), desvenlafaxine (Pristiq), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), trazodone, venlafaxine (Effexor), and vilazodone (Viibryd)
• Antifungal medicines such as fluconazole (Diflucan), isavuconazonium (Cresemba), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), fluphenazine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimavanserin (Nuplazid), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), and valproic acid (Depacon, Depakene, Depakote)
• Antiviral medicines such as boceprevir (Victrelis), ombitasvir/paritaprevir/ritonavir/dasabuvir (Viekira), ombitasvir/paritaprevir/ritonavir (Technivie), and simeprevir (Olysio)
• Apomorphine (Apokyn)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), nebivolol (Bystolic), pindolol, and sotalol (Betapace, Sorine)
• Bromocriptine (Cycloset, Parlodel)
• Calcium channel blockers such as amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), felodipine, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as arsenic trioxide (Trisenox), axitinib (Inlyta), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), enzalutamide (Xtandi), erlotinib (Tarceva), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), vemurafenib (Zelboraf), vinblastine, vincristine (Marqibo), and vinorelbine
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), fluvastatin (Lescol), lomitapide (Juxtapid), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor), and simvastatin (Zocor)
• Cinacalcet (Sensipar)
• Cisapride
• Colchicine (Colcrys)
• Corticosteroids such as betamethasone, budesonide (Entocort, Rhinocort, Uceris), cortisone, dexamethasone, fludrocortisone, fluticasone (Flonase, Flovent, Veramyst), hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as repaglinide (Prandin) and saxagliptin (Onglyza)
• Digoxin (Lanoxin)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Ergot medicines such as dihydroergotamine (D.H.E. 45, Migranal), ergotamine (Ergomar), and methylergonovine
• Fingolimod (Gilenya)
• Flibanserin (Addyi)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic), and temsirolimus (Torisel)
• Lumacaftor/ivacaftor (Orkambi)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and theophylline
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), prasugrel (Effient), rivaroxaban (Xarelto), ticagrelor (Brilinta), vorapaxar (Zontivity), and warfarin (Coumadin)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer), macitentan (Opsumit), sildenafil (Revatio), and tadalafil (Adcirca)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as almotriptan (Axert) and eletriptan (Relpax)
• Naloxegol (Movantik)
• Natural remedies such as red yeast rice and St. John's wort
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), droperidol (Inapsine), and ondansetron (Zofran)
• Octreotide (Sandostatin)
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), methadone (Dolophine, Methadose), and oxycodone (OxyContin, Roxicodone)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Sleeping pills such as butabarbital (Butisol), eszopiclone (Lunesta), phenobarbital, ramelteon (Rozerem), suvorexant (Belsomra), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as armodafinil (Nuvigil) and modafinil (Provigil)
• Tetrabenazine (Xenazine)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.