Ketek

(Telithromycin)

The active ingredient in Ketek is telithromycin. Ketek (telithromycin) is a ketolide antibiotic that works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit at two sites, which blocks the bacteria’s ability to produce essential proteins needed for growth and survival. This action stops bacterial multiplication and leads to bacterial death, making Ketek effective against certain respiratory tract infections, including strains resistant to some other antibiotics.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Ketek. However, the following is a synopsis of the general guidelines for the use of Ketek:

• Ketek is taken by mouth, usually once daily.
• Tablets should be swallowed whole with or without food.
• Take Ketek at the same time each day for the full prescribed course.
• Do not stop taking the medication early, even if symptoms improve.
• Skipping doses or stopping too soon may reduce effectiveness and increase bacterial resistance.

Some mild or common side effects of Ketek seen in clinical trials as compared to placebo include:

• Nausea.
• Diarrhea.
• Headache.
• Dizziness.
• Blurred vision or difficulty focusing.
• Vomiting.

Some individuals may experience serious side effects while using Ketek. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of liver injury such as dark urine, yellowing of the skin or eyes, severe fatigue, or abdominal pain.
• Severe allergic reactions, including rash, swelling, or difficulty breathing.
• Worsening muscle weakness in people with myasthenia gravis.
• Life-threatening skin reactions.

These are not all of the possible side effects of Ketek. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Ketek, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Liver problems or a history of hepatitis.
• Myasthenia gravis.
• Heart rhythm problems.
• Vision disorders.
• A history of allergic reactions to macrolide antibiotics.
• Ketek has been associated with serious hepatotoxicity and must be used with caution. Regular monitoring and close follow-up are important during treatment.

Boxed Warning

Ketek has a boxed warning due to the risk of serious and sometimes fatal liver injury. Cases of acute liver failure have been reported, including those requiring liver transplant. Ketek is contraindicated in patients with myasthenia gravis because it can cause life-threatening respiratory failure.

Ketek should not be used in patients who:

• Have myasthenia gravis.
• Have a history of liver injury related to telithromycin use.
• Have known hypersensitivity to telithromycin or related antibiotics.
• Your healthcare provider will determine whether Ketek is appropriate for you.

Ketek begins working shortly after treatment starts. Many patients notice improvement in symptoms within a few days, but it is important to complete the full course of therapy to fully clear the infection and prevent resistance.

When Ketek is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Erythromycin or clarithromycin may increase side effects due to similar activity.
• Certain medicines that affect heart rhythm may increase the risk of arrhythmias.
• Drugs metabolized by liver enzymes may have increased blood levels.

Ketek is available as oral tablets. The specific dose and duration depend on the type and severity of the infection being treated.

If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time.

It should be stored at room temperature, away from the reach of children or pets.

Ketek was manufactured by Sanofi-Aventis.

No. There is no generic version of telithromycin currently available.

Do not stop taking Ketek without talking to your healthcare provider. Stopping early may allow the infection to return or worsen. If serious side effects occur, your healthcare provider will advise you on the next steps.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Ketek should be used during pregnancy only if the potential benefit outweighs the risk.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. It is not known whether telithromycin passes into breast milk, and your healthcare provider will help decide the safest option.