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Drugs reference index «Ketek Pak»

Ketek Pak

Generic Name: telithromycin (Oral route)

tel-ith-roe-MYE-sin

Oral routeTablet

Telithromycin is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of telithromycin .

Telithromycin is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of telithromycin .

Commonly used brand name(s):

In the U.S.

  • Ketek
  • Ketek Pak

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antibiotic

Chemical Class: Ketolide

Uses For Ketek Pak

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 Ketek Pak

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

No information is available 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 geriatrics-specific problems that would limit the usefulness of telithromycin in the elderly. However, elderly patients are more likely to have age-related renal and liver function impairment, which may require an adjustment in the dose for patients receiving telithromycin .

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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.

Breast Feeding

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.

Interactions with Medicines

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.

  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine
  • Pimozide
  • Silodosin
  • 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.

  • Acecainide
  • Ajmaline
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Aprindine
  • Arsenic Trioxide
  • Astemizole
  • Atorvastatin
  • Azimilide
  • Bretylium
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Clarithromycin
  • Colchicine
  • Dasatinib
  • Desipramine
  • Dibenzepin
  • Dihydroergotamine
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Doxepin
  • Droperidol
  • Encainide
  • Enflurane
  • Ergoloid Mesylates
  • Ergotamine
  • Erythromycin
  • Everolimus
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Fluticasone
  • Foscarnet
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Isoflurane
  • Isradipine
  • Ixabepilone
  • Lapatinib
  • Levomethadyl
  • Lidoflazine
  • Lorcainide
  • Lovastatin
  • Mefloquine
  • Methadone
  • Methylergonovine
  • Nilotinib
  • Nortriptyline
  • Octreotide
  • Ondansetron
  • Pazopanib
  • Pentamidine
  • Pirmenol
  • Prajmaline
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Ranolazine
  • Rifampin
  • Risperidone
  • Romidepsin
  • Salmeterol
  • Sematilide
  • Sertindole
  • Simvastatin
  • Sotalol
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Sunitinib
  • Tadalafil
  • Tamsulosin
  • Tedisamil
  • Telavancin
  • Temsirolimus
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Vasopressin
  • Venlafaxine
  • Verapamil
  • 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
  • Cyclosporine
  • Digoxin
  • Fosphenytoin
  • Hexobarbital
  • Itraconazole
  • Ketoconazole
  • Metoprolol
  • Midazolam
  • Phenobarbital
  • Phenytoin
  • Repaglinide
  • Sirolimus
  • Tacrolimus
  • Theophylline

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 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) or
  • Hypomagnesemia (low magnesium in the blood) or
  • QTc prolongation (rare heart rhythm problem)—May cause these conditions to become worse .
  • Hepatitis or
  • Jaundice or
  • Myasthenia gravis—Should not use in patients with these conditions .
  • Kidney disease—May cause side effects to become worse .

Proper Use of telithromycin

This section provides information on the proper use of a number of products that contain telithromycin. It may not be specific to Ketek Pak. Please read with care.

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 While Using Ketek Pak

Telithromycin should not be taken with 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 immediately if you experience 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 a lightheaded. If these side effects occur and they bother you, check with your doctor .

This medicine may cause you to have severe diarrhea. Ask your doctor before taking any medicine to stop the diarrhea .

Ketek Pak 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 pain
  • blistering, peeling, or loosening of 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 from a lying or sitting position suddenly
  • fast, slow, or irregular heartbeat
  • fever with or without chills
  • increased thirst
  • itching
  • joint pain
  • large, hive-like swelling on 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 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 chest
  • unusual tiredness or weakness
  • upper right abdominal 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 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 chest or stomach
  • change in 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 span
  • dry lips
  • dry skin
  • excess air or gas in 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 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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  • Telithromycin Professional Patient Advice (Wolters Kluwer)
  • Ketek Prescribing Information (FDA)
  • Ketek Detailed Consumer Information (PDR)
  • Ketek MedFacts Consumer Leaflet (Wolters Kluwer)
  • Ketek Consumer Overview