Telithromycin (Oral route)
- Ketek Pak
Fatal and life-threatening respiratory failure has been reported in patients with myasthenia gravis treated with telithromycin .
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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of telithromycin in the elderly.
|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.|
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.
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.
- Isavuconazonium Sulfate
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
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Brentuximab Vedotin
- Chloral Hydrate
- Cholera Vaccine, Live
- Doxorubicin Hydrochloride Liposome
- Ergoloid Mesylates
- Inotuzumab Ozogamicin
- Irinotecan Liposome
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Vincristine Sulfate Liposome
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.
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.
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.
- For community-acquired pneumonia:
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.
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:
- Abdominal or stomach pain
- blistering, peeling, or loosening of the skin
- blurred vision
- chest pain or discomfort
- dark urine
- decreased urine
- difficulty with breathing, chewing, swallowing, or talking
- double vision
- drooping eyelids
- dry mouth
- 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
- 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
- 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
- tightness in the chest
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- watery or bloody diarrhea
- weakness or heaviness of the legs
- 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
- More common
- Less common
- Abnormal dreams
- acid or sour stomach
- 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
- increased amount of pale, dilute urine
- itching of the vagina or outside genitals
- lack or loss of strength
- 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
- 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
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:
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:
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.
Last Updated: 9/4/2017