Telithromycin (Oral)

Telithromycin is used to treat a lung infection known as community-acquired pneumonia (CAP). It is part of a group of medicines called antibiotics. Antibiotics are used to treat infections caused by bacteria. They work by killing bacteria or stopping their growth. However, this medicine will not work for colds, flu, or other viral infections.

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

It is very important for your doctor to check your progress at regular visits to ensure 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 get 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 happen, 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 bother you, check with your doctor.

This medicine may cause diarrhea, and in some cases, it can be severe. It may happen 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 your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, the risks of using 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

Inform your clinician if you have ever had any unusual or allergic reaction to this medication 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.

Pediatric

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.

Geriatric

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 chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential risks prior to using this medicine while breastfeeding.

Interactions with Medicines

Although certain medications 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 clinician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are using 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 drugs is not advised. Your doctor may decide not to treat you with this medicine or change some of the other medications 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 medications is typically not advised, but may be required in some cases. If both drugs are prescribed together, your clinician 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
• Etrasimod
• 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
• Vamorolone
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Voriconazole
• Warfarin
• Zanubrutinib
• Zolpidem
• Zotepine
• Zuclopenthixol
• Zuranolone

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

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

Interactions with Food/Tobacco/Alcohol

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 drugs may additionally cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Issues

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

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

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

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

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.

In the U.S.

• Ketek
• Ketek Pak

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Ketolide

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.