Ketek

DRUG DESCRIPTION

KETEK® tablets contain telithromycin, a semisynthetic antibacterial in the ketolide class for oral administration. Chemically, telithromycin is designated as Erythromycin, 3-de[(2,6-dideoxy-3C-methyl-3-O-methyl-?-L-ribo-hexopyranosyl)oxy]-11,12-dideoxy-6-O-methyl-3-oxo-12,11[oxycarbonyl[[4-[4-(3-pyridinyl)-1H-imidazol-1-yl]butyl]imino]]-.

Telithromycin, a ketolide, differs chemically from the macrolide group of antibacterials by the lack of ?-L-cladinose at position 3 of the erythronolide A ring, resulting in a 3-keto function. It is further characterized by a C11-12 carbamate substituted by an imidazolyl and pyridyl ring through a butyl chain. Its empirical formula is C43H65N5O10 and its molecular weight is 812.03. Telithromycin is a white to off-white crystalline powder. The following represents the chemical structure of telithromycin.

KETEK®
 (telithromycin) Structural Formula Illustration

KETEK (telithromycin) tablets are available as light-orange, oval, film-coated tablets, each containing 400 mg or 300 mg of telithromycin, and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, red ferric oxide, talc, titanium dioxide, and yellow ferric oxide.

What are the possible side effects of telithromycin (Ketek, Ketek Pak)?

Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Stop using telithromycin and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at...

Read All Potential Side Effects and See Pictures of Ketek »

What are the precautions when taking telithromycin (Ketek)?

Before taking telithromycin, tell your doctor or pharmacist if you are allergic to it; or to macrolide antibiotics (e.g., azithromycin, clarithromycin, dirithromycin, erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: myasthenia gravis, previous liver problems (e.g., yellowing eyes/skin, dark urine) while taking telithromycin or a macrolide antibiotic, previous allergic reaction to telithromycin or a macrolide antibiotic.

Before using this medication, tell your doctor or pharmacist...

Read All Potential Precautions of Ketek »


Ketek Consumer (continued)

SIDE EFFECTS: Nausea, vomiting, mild diarrhea, headache, anxiety, or a strange taste in the mouth may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes (e.g., blurred/double vision, difficulty focusing).

Seek immediate medical attention if any of these rare but serious side effects occur: dizziness, fainting, irregular/fast heartbeat, worsening muscle weakness.

Telithromycin may rarely cause very serious liver disease. Seek immediate medical attention if you develop: extreme tiredness, loss of appetite, stomach/abdominal pain, dark urine, yellowing eyes/skin.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to resistant bacteria. This condition may occur weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Tell your doctor immediately if you develop persistent diarrhea, abdominal or stomach pain/cramping, or blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking telithromycin, tell your doctor or pharmacist if you are allergic to it; or to macrolide antibiotics (e.g., azithromycin, clarithromycin, dirithromycin, erythromycin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: myasthenia gravis, previous liver problems (e.g., yellowing eyes/skin, dark urine) while taking telithromycin or a macrolide antibiotic, previous allergic reaction to telithromycin or a macrolide antibiotic.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: severe kidney disease (including dialysis), liver problems (e.g., hepatitis).

Telithromycin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using telithromycin, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using telithromycin safely.

This medication may cause vision problems, dizziness, or fainting. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Ketek Patient Information Including Side Effects

Brand Names: Ketek, Ketek Pak

Generic Name: telithromycin (Pronunciation: tel IT roe MYE sin)

  • What is telithromycin (Ketek)?
  • What are the possible side effects of telithromycin (Ketek)?
  • What is the most important information I should know about telithromycin (Ketek)?
  • What should I discuss with my healthcare provider before taking telithromycin (Ketek)?
  • How should I take telithromycin (Ketek)?
  • What happens if I miss a dose (Ketek)?
  • What happens if I overdose (Ketek)?
  • What should I avoid while taking telithromycin (Ketek)?
  • What other drugs will affect telithromycin (Ketek)?
  • Where can I get more information?

What is telithromycin (Ketek)?

Telithromycin is in a group of drugs called antibiotics. Telithromycin helps the body fight infection that is caused by bacteria.

Telithromycin is used to treat bacterial infections in the lungs and sinuses.

Telithromycin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of telithromycin (Ketek)?

Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Stop using telithromycin and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • irregular heartbeats;
  • feeling light-headed, fainting;
  • problems with vision (difficulty focusing, drooping eyelid);
  • muscle pain or weakness;
  • trouble swallowing; or
  • loss of balance, coordination, or ability to climb stairs or rise from a chair.

Less serious side effects may include:

  • mild nausea, vomiting;
  • vaginal itching or discharge;
  • headache; or
  • dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about telithromycin (Ketek)?

Telithromycin may cause sudden and serious liver damage. In rare cases, liver failure can develop and may cause death. Stop using the medication and call your doctor right away if you have nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Do not take telithromycin if you are taking cisapride (Propulsid) or pimozide (Orap), or if you have a muscle disorder called myasthenia gravis.

Before taking this medicine, tell your doctor if you have ever had an allergic reaction or liver problems caused by telithromycin or similar antibiotics such as erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), azithromycin (Zithromax), clarithromycin (Biaxin), troleandomycin (TAO), or dirithromycin (Dynabac).

Take this medication for as many days as it has been prescribed for you even if you begin to feel better. Your symptoms may start to improve before the infection is completely treated. Telithromycin will not treat a viral infection such as the common cold or flu.

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