In the U.S.—

In Canada—

• Antibacterial, systemic

Telithromycin (tel-ith-roe-MYE-sin) 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, in the following dosage forms:

Oral
• Tablets (U.S. and Canada)

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 telithromycin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to telithromycin or to any related medicines, such as macrolide antibiotics (e.g., erythromycin, azithromycin, clarithromycin). Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Telithromycin has not been studied in pregnant women. However, studies in animals have shown that telithromycin causes birth defects and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—Telithromycin passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing the use of telithromycin in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.

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 telithromycin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Amiodarone (e.g., Cordarone) or
• Dofetilide (e.g., Tikosyn) or
• Procainamide (e.g., Procan SR, Promine) or
• Quinidine (e.g., Dura-tabs, Quinidex)—May increase the risk of heart rhythm problems

• Atorvastatin (e.g., Lipitor) or
• Lovastatin (e.g., Mevacor) or
• Simvastatin (e.g., Zocor)—Telithromycin may increase the chance of side effects of these medicines. Your doctor will decide if you need to stop taking these medications while taking telithromycin

• Carbamazepine (e.g., Tegretol) or
• Cyclosporine (e.g., Neoral) or
• Dihydroergotamine (e.g., D.H.E, Migronal) or
• Ergotamine (e.g., Ergomar) or
• Hexobarbital or
• Other benzodiazepines such as Triazolam (e.g., Halcion) or
• Phenytoin (e.g., Dilantin, Phenytek) or
• Sirolimus (e.g., Rapamune) or
• Tacrolimus (e.g., Prograf)—Telithromycin may increase the chance of side effects of these medicines

• Cisapride (e.g., Propulsid)—Cisapride should not be taken with telithromycin

• Digoxin (e.g., Lanoxicaps, Lanoxin, Digitek)—Telithromycin may increase the amount of digoxin in the blood and increase the chance of side effects

• Metoprolol (e.g., Lopressor, Toprol XL)—May increase the chance of side effects especially in patients with heart failure

• Midazolam—May increase the amount of midazolam in the blood and your doctor may need to change your dose

• Pimozide (e.g., Orap)—Use with telithromycin is not recommended; increases the amount of pimozide in your blood and the chance of side effects

• Rifampin (e.g., Rifadin)—Use with telithromycin is not recommended

• Sotalol (e.g., Betapace, Sorine)—May decrease the amount of telithromycin in the blood and increase the risk of heart rhythm problems.

• Theophylline (e.g., Theo-Dur)—Theophylline may worsen side effects such as nausea and vomiting; theophylline and telithromycin should be taken at least 1 hour apart.

• Bradycardia (slow heartbeat) or
• Heart rhythm problems or
• Hypokalemia (not enough potassium in your blood) or
• Hypomagnesemia (not enough magnesium in your blood) or
• QTc prolongation (rare heart rhythm problem)—Telithromycin may cause these condition to become worse

• Hepatitis or
• Jaundice—Telithromycin should be used with caution in patients with these conditions

• Kidney disease—Patients with severe kidney disease may have an increased chance of side effects

• Myasthenia gravis—Telithromycin may make this condition worse

Telithromycin may be taken with or without food.

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.

Dosing—

The dose of telithromycin 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 telithromycin. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For acute bacterial infections in patients with chronic bronchitis or sinusitis:
    • Adults—800 mg once daily for 5 days
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For community-acquired pneumonia
    • Adults—800 mg once daily for 7 to 10 days
    • Children—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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Telithromycin should not be taken with cisapride or pimozide . 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.

This medicine may cause changes in your vision. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are having vision problems. .

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 pain;  blistering, peeling, loosening of skin;  blood bilirubin, elevated;  blurred vision;  chest pain or discomfort ;  chills;  confusion;  convulsions;  cough;  dark urine;  decreased urine;  difficulty in breathing, chewing, swallowing, or talking;  dizziness;  double vision;  drooping eyelids;  dry mouth;  fainting;  faintness, or lightheadedness when getting up from a lying or sitting position suddenly;  fast, slow, or irregular heartbeat;  fever;  increased blood alkaline phosphatase;  increased eosinophil count;  increased thirst;  itching;  joint pain;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs;  light-colored stools;  loss of appetite;  mood changes;  muscle weakness;  muscle pain or cramps ;  nausea;  nervousness;  numbness or tingling in hands, feet, or lips;  red irritated eyes;  shortness of breath;  skin rash;  sores, ulcers, or white spots in mouth or on lips or tongue;  stomach cramps, tenderness, or pain;  sweating;  tightness in chest;  unusual tiredness or weakness;  upper right abdominal pain;  vomiting ;  watery or bloody diarrhea;  weakness or heaviness of legs;  wheezing;  yellow eyes and skin 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• More Common
  • Diarrhea 
  
  

• Less common or rare
  • Acid or sour stomach;  abnormal dream ;  belching;  bloated or full feeling or pressure in the stomach;  burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings;  burning feeling in chest or stomach;  change in the color, amount or odor of vaginal discharge;  change in sense of smell;  change in taste;  difficulty focusing eyes;  difficulty having a bowel movement (stool);  disturbed attention ;  dry lips;  dry skin;  excess air or gas in stomach or intestines;  fear;  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 platelet count;  increased volume of pale, dilute urine;  indigestion;  itching of the vagina or outside genitals;  lab results that show problems with liver;  lack or loss of strength;  lightheadedness;  loose stools;  loss of appetite;  loss of sense of taste;  pain or tenderness around eyes and cheekbones;  pain during sexual intercourse ;  passing gas;  redness of skin;  redness , swelling, or soreness of tongue;  reflux;  sensation of spinning;  shakiness in legs, arms, hands, 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 face;  tenderness in stomach area;  thick, white curd-like vaginal discharge without odor or with mild odor;  tooth discoloration;  trouble sleeping;  unable to sleep;  weight loss;  white patches in mouth and/or on tongue  
  
  

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