Telithromycin (oral route)

Brand Name

US Brand Name

Ketek

Ketek Pak

Description

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

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.

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

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
Asciminib
Asenapine
Astemizole
Atazanavir
Atogepant
Atorvastatin
Avacopan
Avanafil
Avapritinib
Axitinib
Azithromycin
Bedaquiline
Benzhydrocodone
Bictegravir
Bosutinib
Brentuximab Vedotin
Bretylium
Brexpiprazole
Brigatinib
Bromocriptine
Budesonide
Buprenorphine

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.

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

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.

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