Tigecycline

Tigecycline is a prescription medication used to treat serious skin and stomach infections and certain types of pneumonia (lung infection). Tigecycline belongs to a group of drugs called glycycline antibiotics, which work by binding to bacteria and killing them.

This medication comes in an injectable form to be given directly into the vein (IV) by a healthcare provider.

Common side effects of tigecycline include nausea, vomiting, and stomach pain. Tigecycline can cause dizziness. Do not drive or operate heavy machinery until you know how tigecycline affects you.

Tigecycline is a prescription medication used to treat serious skin and stomach infections and certain types of pneumonia (lung infection).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Tigecycline may be found in some form under the following brand names:

• Tygacil

Serious side effects have been reported. See "Drug Precautions" section.

Common side effects of tigecycline include the following:

• nausea
• vomiting
• stomach pain
• abnormal liver function test results (measured in the blood)

This is not a complete list of tigecycline side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• warfarin (Coumadin)
• birth control pills

This is not a complete list of tigecycline drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with tigecycline including the following:

• increased risk of death. In clinical trials, patients who received tigecycline were at a higher risk of death than patients receiving a comparable medication. 
• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:
  • chest pain
  • swelling of the face, eyes, lips, tongue, arms, or legs
  • difficulty breathing
  • fainting
  • rash
• pancreatitis. Tell your healthcare provider about any signs or symptoms of pancreatitis (irritation of the pancreas):
  • stomach pain
  • back pain
  • nausea or vomiting that gets worse after eating
  • racing heart
  • dizziness
  • fever
  • yellowing of the skin or eyes
• liver problems. Your healthcare provider will be measuring your blood for imbalances in the liver while on this medication.  Report any stomach pain, yellowing of the skin or eyes, or changes in stool color, which may be a sign of liver problems.   
• lower cure rate in certain pneumonias (lung infections). Patients with certain types of pneumonia (lung infections) that happened after using a ventilator are at a higher risk of not being cured when taking tigecycline.
• photosensitivity. Report any eye sensitivity to sunlight or bright lights or if you get a rash after being in the sun, which can be a sign of photosensitivity (more sensitivity to light).
• diarrhea. Diarrhea is a common problem caused by antibiotics, and it usually ends when the antibacterial is stopped. Even after starting treatment with antibiotics, some patients can develop watery and bloody stools (with or without stomach cramps and fever) as late as 2 or more months after having taken their last dose of the antibacterial. If diarrhea is severe or lasts more than 2 or 3 days, contact your doctor, as this may be a sign of an infection of the bowels.
• Clostridium difficile (C. difficile) associated diarrhea. Some antibiotics can kill the “good” bacteria in the colon leading to a growth of C. difficile bacteria. This “bad” bacterium can cause diarrhea and other digestive problems, and these problems may even occur 2 months after the last dose. Extra caution for this side effect is advised in the elderly population. Tell your healthcare provider if you experience any or all of the following symptoms:
  • watery diarrhea (at least three bowel movements per day for two or more days)
  • loss of appetite
  • abdominal pain or tenderness
  • nausea
  • fever

Tigecycline can cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Do not take tigecycline if you:

• are allergic to tigecycline or to any of its ingredients
• are allergic to tetracycline antibiotics such as:
• tetracycline (Tetracin, Acnecycline)
• doxycycline (Doryx, Oracea, Vibramycin)
• minocycline (Solodyn, Minocin)

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of tigecycline, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking tigecycline, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any ingredient in tigecycline
• have or have had liver problems
• have or have had pancreas problems
• have a gastrointestinal injury (stomach and bowel injury)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Tigecycline falls into category D. It has been shown that use of tigecycline in pregnant women caused some babies to be born with bone and tooth problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if tigecycline crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using tigecycline.

Take tigecycline exactly as prescribed.

Tigecycline comes in injectable form to be given directly into the vein (IV) by a healthcare professional. Tigecycline should be infused into the vein (IV) over 30-60 minutes.

Take tigecycline exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The tigecycline dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your liver function

The recommended dose range for tigecycline in adults is 100 mg initially, then 50 mg every 12 hours for 5-14 days.  

Tigecycline has not been studied for use in children.

If tigecycline is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
 

• Store tigecycline at room temperature at 25°C (77°F). Temperature may vary between 15-30°C (59-86°F).
• Keep this and all medicines out of the reach of children.

All-cause mortality was higher in patients treated with tigecycline than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable.