Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Ketek
  2. Ketek Pak

Descriptions


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.

This product is available in the following dosage forms:

  • Tablet

Before Using

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.

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.

Pregnancy

Information about this telithromycin-oral-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

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.

Drug Interactions

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
  • Amifampridine
  • Bepridil
  • Cisapride
  • Colchicine
  • Dronedarone
  • Ivabradine
  • Lomitapide
  • Lovastatin
  • Lurasidone
  • Maraviroc
  • Mesoridazine
  • Nimodipine
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Saquinavir
  • Silodosin
  • Simvastatin
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Tolvaptan
  • 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.

  • Ado-Trastuzumab Emtansine
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Apomorphine
  • Aprindine
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atorvastatin
  • Avanafil
  • Axitinib
  • Azithromycin
  • Bedaquiline
  • Bosutinib
  • Brentuximab Vedotin
  • Bretylium
  • Cabazitaxel
  • Cabozantinib
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine
  • Cobicistat
  • Crizotinib
  • Cyclobenzaprine
  • Cyclosporine
  • Dabrafenib
  • Dasatinib
  • Desipramine
  • Dibenzepin
  • Dihydroergotamine
  • Disopyramide
  • Docetaxel
  • Dofetilide
  • Dolasetron
  • Domperidone
  • Doxepin
  • Droperidol
  • Encainide
  • Enflurane
  • Enzalutamide
  • Ergoloid Mesylates
  • Ergotamine
  • Erythromycin
  • Eslicarbazepine Acetate
  • Everolimus
  • Fentanyl
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Fluticasone
  • Formoterol
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydrocodone
  • Ibrutinib
  • Ibutilide
  • Ifosfamide
  • Iloperidone
  • Imipramine
  • Isoflurane
  • Isradipine
  • Ivacaftor
  • Ixabepilone
  • Lapatinib
  • Levofloxacin
  • Levomethadyl
  • Levomilnacipran
  • Lidoflazine
  • Lopinavir
  • Lorcainide
  • Lumefantrine
  • Macitentan
  • Mefloquine
  • Methadone
  • Methylergonovine
  • Mifepristone
  • Moxifloxacin
  • Nilotinib
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Ondansetron
  • Oxycodone
  • Paliperidone
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perflutren Lipid Microsphere
  • Pomalidomide
  • Ponatinib
  • Primidone
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Regorafenib
  • Retapamulin
  • Rifampin
  • Risperidone
  • Romidepsin
  • Ruxolitinib
  • Salmeterol
  • Sertindole
  • Sildenafil
  • Simeprevir
  • Sirolimus
  • Sodium Phosphate
  • Sodium Phosphate, Dibasic
  • Sodium Phosphate, Monobasic
  • Sorafenib
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Sunitinib
  • Tacrolimus
  • Tadalafil
  • Tamsulosin
  • Telaprevir
  • Telavancin
  • Temsirolimus
  • Tetrabenazine
  • Ticagrelor
  • Tizanidine
  • Toremifene
  • Trabectedin
  • Trazodone
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vasopressin
  • Vemurafenib
  • Venlafaxine
  • Vilanterol
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Voriconazole
  • Warfarin
  • Zotepine

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.

  • Carbamazepine
  • Digoxin
  • Fosphenytoin
  • Itraconazole
  • Ketoconazole
  • Metoprolol
  • Midazolam
  • Phenobarbital
  • 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

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

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

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

  1. Abdominal or stomach pain
  2. blistering, peeling, or loosening of the skin
  3. blurred vision
  4. chest pain or discomfort
  5. chills
  6. confusion
  7. convulsions
  8. cough
  9. dark urine
  10. decreased urine
  11. difficulty with breathing, chewing, swallowing, or talking
  12. dizziness
  13. double vision
  14. drooping eyelids
  15. dry mouth
  16. fainting
  17. faintness or lightheadedness when getting up suddenly from a lying or sitting position
  18. fast, slow, or irregular heartbeat
  19. fever with or without chills
  20. increased thirst
  21. itching
  22. joint pain
  23. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  24. light-colored stools
  25. loss of appetite
  26. mood changes
  27. muscle pain or cramps
  28. muscle weakness
  29. nausea
  30. nervousness
  31. numbness or tingling in the hands, feet, or lips
  32. red, irritated eyes
  33. shortness of breath
  34. skin rash
  35. sores, ulcers, or white spots in the mouth or on the lips or tongue
  36. stomach cramps, tenderness, or pain
  37. sweating
  38. tightness in the chest
  39. unusual tiredness or weakness
  40. upper right abdominal or stomach pain
  41. vomiting
  42. watery or bloody diarrhea
  43. weakness or heaviness of the legs
  44. wheezing
  45. yellow eyes and skin

Incidence not known

  1. Black, tarry stools
  2. clay-colored stools
  3. continuous vomiting
  4. dark-colored urine
  5. decreased appetite
  6. general feeling of tiredness or weakness
  7. swelling of the feet or lower legs
  8. unpleasant breath odor
  9. 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

  1. Diarrhea

Less common

  1. Abnormal dreams
  2. acid or sour stomach
  3. belching
  4. bloated, full feeling, or pressure in the stomach
  5. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  6. burning feeling in the chest or stomach
  7. change in color, amount, or odor of vaginal discharge
  8. change in sense of smell
  9. change in taste
  10. difficulty focusing the eyes
  11. difficulty having a bowel movement (stool)
  12. disturbed attention span
  13. dry lips
  14. dry skin
  15. excess air or gas in the stomach or intestines
  16. feeling of constant movement of self or surroundings
  17. feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest
  18. frequent urination
  19. headache
  20. heartburn
  21. increased amount of pale, dilute urine
  22. indigestion
  23. itching of the vagina or outside genitals
  24. lack or loss of strength
  25. lightheadedness
  26. loose stools
  27. loss of appetite
  28. loss of sense of taste
  29. pain during sexual intercourse
  30. pain or tenderness around the eyes and cheekbones
  31. passing gas more often than usual
  32. redness of the skin
  33. redness, swelling, or soreness of the tongue
  34. sensation of spinning
  35. shakiness in the legs, arms, hands, or feet
  36. skin rash, encrusted, scaly, and oozing
  37. sleeplessness
  38. sore mouth or tongue
  39. sore throat
  40. stomach upset or pain
  41. stuffy or runny nose
  42. swelling or puffiness of the face
  43. tenderness in the stomach area
  44. thick, white curd-like vaginal discharge, without odor or with mild odor
  45. tooth discoloration
  46. trouble sleeping
  47. weight loss
  48. 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.