Tigecycline Injection

In clinical studies, more patients who were treated with tigecycline injection for serious infections died than patients who were treated with other medications for serious infections. These people died because their infections worsened, because they developed complications of their infections, or because of other medical conditions they had. There is not enough information to tell whether using tigecycline injection increases the risk of death during treatment. Your doctor will only treat you with tigecycline injection if other medication cannot be used to treat your infection.

Talk to your doctor about the risk of using tigecycline injection.

Tigecycline injection used to treat certain serious infections including community acquired pneumonia (a lung infection that developed in a person who was not in the hospital), skin infections, and infections of the abdomen (area between the chest and the waist). Tigecycline injection should not be used to treat pneumonia that developed in people who are on ventilators or who were in a hospital or foot infections in people who have diabetes. Tigecycline injection is in a class of medications called tetracycline antibiotics. It works by killing bacteria that cause infection.

Antibiotics such as tigecycline injection will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Tigecycline injection comes as a powder to be mixed with fluid and injected into a vein. It is usually infused (injected slowly) intravenously (into a vein) over a period of 30 to 60 minutes, once every 12 hours. The length of your treatment depends on the type of infection you have and how your body responds to the medication.

You may receive tigecycline injection in a hospital or you may use the medication at home. If you will be using tigecycline injection at home, your healthcare provider will show you how to infuse the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems infusing tigecycline injection.

You should begin to feel better during the first few days of treatment with tigecycline injection. If your symptoms do not improve or get worse, call your doctor.

Use tigecycline injection until you finish the prescription, even if you feel better. If you stop using tigecycline injection too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

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

Before using tigecycline injection,

• tell your doctor and pharmacist if you are allergic to tigecycline injection; other tetracycline antibiotics such as demeclocycline, doxycycline (Monodox, Oracea, Vibramcyin), minocycline (Dynacin, Minocin, Solodyn), and tetracycline (Achromycin V, in Pylera); any other medications, or any of the ingredients in tigecycline injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving tigecycline injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had liver disease.
• you should know that tigecycline may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, or injections). Talk to your doctor about using another form of birth control.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while using tigecycline injection, call your doctor.
• tell your doctor if you are breast-feeding. Your doctor may tell you not to breast-feed during your treatment with tigecycline and for 9 days after your last dose.
• plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sun lamps) and to wear protective clothing, sunglasses, and sunscreen. Tigecycline injection may make your skin sensitive to sunlight or ultraviolet light.
• you should know that when tigecycline injection is used during the second or third trimester of pregnancy or in babies or children up to age 8, it can cause the teeth to become permanently stained and temporarily affect bone growth. Tigecycline should not be used in children under age 8 unless your doctor decides it is needed.

Unless your doctor tells you otherwise, continue your normal diet.

Tigecycline injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• heartburn
• loss of appetite
• change in the way things taste
• headache
• dizziness
• itching of the vagina
• white or yellow vaginal discharge
• pain, redness, swelling, or bleeding near the place where tigecycline was injected

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical help:

• severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
• blistering or peeling skin
• rash
• hives
• tingling or swelling of the face, neck, throat, tongue, lips, or eyes
• difficulty breathing or swallowing
• itching
• ongoing pain that begins in the stomach area but may spread to the back
• sore throat, fever, chills, and other signs of new or worsening infection

Tigecycline injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• nausea
• vomiting

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to tigecycline injection.

If you still have symptoms of infection after you finish tigecycline injection, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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