Pronunciation:

tel-ith-roe-MYE-sin

Brand Names:

• Ketek
• Ketek Pak

Dosage Forms:

• Tablet

Warnings:

Fatal and life-threatening respiratory failure has been reported in patients with myasthenia gravis treated with telithromycin .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Ketolide

Uses of This Medicine:

Telithromycin is used to treat a lung infection called community-acquired pneumonia (CAP). It belongs to the family of medicines called antibiotics. Antibiotics are medicines used in the treatment of infections caused by bacteria. They work by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of telithromycin in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of telithromycin in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin
• Alprazolam
• Bepridil
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergoloid Mesylates
• Ergotamine
• Finerenone
• Flibanserin
• Fluconazole
• Gepirone
• Isavuconazonium Sulfate
• Itraconazole
• Ivabradine
• Levoketoconazole
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Mavacamten
• Mesoridazine
• Methylergonovine
• Naloxegol
• Nelfinavir
• Nimodipine
• Pacritinib
• Pimozide
• Piperaquine
• Posaconazole
• Saquinavir
• Silodosin
• Simvastatin
• Sparfloxacin
• Terfenadine
• Thioridazine
• Tolvaptan
• Ubrogepant
• Venetoclax
• Voclosporin
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Acalabrutinib
• Adagrasib
• Ado-Trastuzumab Emtansine
• Alfentanil
• Amiodarone
• Amisulpride
• Amitriptyline
• Amoxapine
• Anagrelide
• Apalutamide
• Apomorphine
• Aprepitant
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Artemether
• Asenapine
• Astemizole
• Atazanavir
• Atogepant
• Atorvastatin
• Avacopan
• Avanafil
• Avapritinib
• Axitinib
• Azithromycin
• Bedaquiline
• Benzhydrocodone
• Bosutinib
• Brentuximab Vedotin
• Bretylium
• Brexpiprazole
• Brigatinib
• Bromocriptine
• Budesonide
• Buprenorphine
• Buserelin
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Carbamazepine
• Cariprazine
• Ceritinib
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Cholera Vaccine, Live
• Cilostazol
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Cobicistat
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Dabrafenib
• Daclatasvir
• Daridorexant
• Dasatinib
• Deflazacort
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Dexamethasone
• Dexmedetomidine
• Dibenzepin
• Dihydrocodeine
• Disopyramide
• Docetaxel
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Duvelisib
• Efavirenz
• Elacestrant
• Elagolix
• Elexacaftor
• Encainide
• Encorafenib
• Enflurane
• Entrectinib
• Enzalutamide
• Erlotinib
• Erythromycin
• Escitalopram
• Eszopiclone
• Everolimus
• Fedratinib
• Fentanyl
• Fesoterodine
• Fexinidazole
• Fingolimod
• Flecainide
• Fluoxetine
• Fluticasone
• Formoterol
• Fosaprepitant
• Foscarnet
• Fosnetupitant
• Fostemsavir
• Gatifloxacin
• Gemifloxacin
• Gilteritinib
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydrocodone
• Hydroxychloroquine
• Hydroxyzine
• Ibrexafungerp
• Ibrutinib
• Ibutilide
• Idelalisib
• Ifosfamide
• Iloperidone
• Imipramine
• Infigratinib
• Inotuzumab Ozogamicin
• Irinotecan
• Irinotecan Liposome
• Isoflurane
• Isradipine
• Istradefylline
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Lapatinib
• Larotrectinib
• Lefamulin
• Lemborexant
• Leniolisib
• Lenvatinib
• Leuprolide
• Levofloxacin
• Levomethadyl
• Levomilnacipran
• Lidoflazine
• Lofexidine
• Lopinavir
• Lorcainide
• Lorlatinib
• Lumacaftor
• Lumateperone
• Lumefantrine
• Lurbinectedin
• Macimorelin
• Macitentan
• Manidipine
• Mefloquine
• Meperidine
• Methadone
• Metronidazole
• Midostaurin
• Mifepristone
• Mirtazapine
• Mirvetuximab Soravtansine-gynx
• Mitapivat
• Mobocertinib
• Moxifloxacin
• Nafarelin
• Neratinib
• Netupitant
• Nifedipine
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Olanzapine
• Olaparib
• Omaveloxolone
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Oxycodone
• Ozanimod
• Palbociclib
• Paliperidone
• Palovarotene
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pemigatinib
• Pentamidine
• Pentazocine
• Pexidartinib
• Phenobarbital
• Pimavanserin
• Pirtobrutinib
• Pitolisant
• Ponatinib
• Ponesimod
• Pralsetinib
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Reboxetine
• Regorafenib
• Relugolix
• Retapamulin
• Ribociclib
• Rifampin
• Rimegepant
• Risperidone
• Romidepsin
• Ruxolitinib
• Salmeterol
• Selpercatinib
• Selumetinib
• Sertindole
• Sertraline
• Sevoflurane
• Sildenafil
• Simeprevir
• Siponimod
• Sirolimus
• Sirolimus Protein-Bound
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Sonidegib
• Sorafenib
• Sotalol
• Sparsentan
• Spiramycin
• Sufentanil
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tazemetostat
• Telaprevir
• Telavancin
• Temsirolimus
• Tetrabenazine
• Tezacaftor
• Thiotepa
• Ticagrelor
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Triclabendazole
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Upadacitinib
• Valbenazine
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Warfarin
• Zanubrutinib
• Zolpidem
• Zotepine
• Zuclopenthixol
• Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amlodipine
• Digoxin
• Fosphenytoin
• Metoprolol
• Midazolam
• Phenytoin
• Repaglinide
• Theophylline
• Verapamil

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bradycardia (slow heartbeat) or
• Heart rhythm problems or
• Hypokalemia (low potassium in the blood), uncorrected or
• Hypomagnesemia (low magnesium in the blood), uncorrected or
• QTc prolongation (rare heart rhythm problem), or family history of—Use with caution. May make these conditions worse.

• Hepatitis, history of or
• Jaundice, history of or
• Myasthenia gravis (severe muscle weakness)—Should not be used in patients with these conditions.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Telithromycin may be taken with or without food. Swallow the tablet whole. Do not crush, break, or chew it.

To help clear up your infection completely, keep taking telithromycin for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.

Take this medicine at the same time every day. Do not take more than one dose in 24 hours.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For community-acquired pneumonia:
    • Adults—800 milligrams (mg) once a day for 7 to 10 days.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Telithromycin should not be taken with cisapride (Propulsid®), colchicine, or pimozide (Orap®). Doing so may increase the risk of serious side effects.

If your symptoms do not improve within a few days, or if they become worse, check with your doctor.

Stop taking telithromycin and contact your doctor right away if you have symptoms of liver disease. These symptoms include tiredness, body aches, loss of appetite, nausea, yellow skin and eyes, dark urine, light-colored stools, itchy skin, or severe stomach pains. Severe liver problems and liver failure have been reported, and in some cases, liver injury developed quickly and after only a few doses.

This medicine may cause fainting, blurred vision, or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well or if you feel lightheaded. If these side effects occur and they bother you, check with your doctor.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur up to 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Abdominal or stomach pain

blistering, peeling, or loosening of the skin

blurred vision

chest pain or discomfort

chills

confusion

convulsions

cough

dark urine

decreased urine

difficulty with breathing, chewing, swallowing, or talking

dizziness

double vision

drooping eyelids

dry mouth

fainting

faintness or lightheadedness when getting up suddenly from a lying or sitting position

fast, slow, or irregular heartbeat

fever with or without chills

increased thirst

itching

joint pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

light-colored stools

loss of appetite

mood changes

muscle pain or cramps

muscle weakness

nausea

nervousness

numbness or tingling in the hands, feet, or lips

red, irritated eyes

shortness of breath

skin rash

sores, ulcers, or white spots in the mouth or on the lips or tongue

stomach cramps, tenderness, or pain

sweating

tightness in the chest

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

watery or bloody diarrhea

weakness or heaviness of the legs

wheezing

yellow eyes and skin

Incidence not known

Black, tarry stools

clay-colored stools

continuous vomiting

dark-colored urine

decreased appetite

general feeling of tiredness or weakness

swelling of the feet or lower legs

unpleasant breath odor

vomiting of blood

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Diarrhea

Less common

Abnormal dreams

acid or sour stomach

belching

bloated, full feeling, or pressure in the stomach

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning feeling in the chest or stomach

change in color, amount, or odor of vaginal discharge

change in sense of smell

change in taste

difficulty focusing the eyes

difficulty having a bowel movement (stool)

disturbed attention span

dry lips

dry skin

excess air or gas in the stomach or intestines

feeling of constant movement of self or surroundings

feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest

frequent urination

headache

heartburn

increased amount of pale, dilute urine

indigestion

itching of the vagina or outside genitals

lack or loss of strength

lightheadedness

loose stools

loss of appetite

loss of sense of taste

pain during sexual intercourse

pain or tenderness around the eyes and cheekbones

passing gas more often than usual

redness of the skin

redness, swelling, or soreness of the tongue

sensation of spinning

shakiness in the legs, arms, hands, or feet

skin rash, encrusted, scaly, and oozing

sleeplessness

sore mouth or tongue

sore throat

stomach upset or pain

stuffy or runny nose

swelling or puffiness of the face

tenderness in the stomach area

thick, white curd-like vaginal discharge, without odor or with mild odor

tooth discoloration

trouble sleeping

weight loss

white patches in the mouth and on the tongue

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.