Tigecycline Intravenous

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 tigecycline, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to tigecycline 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

Use of tigecycline injection in children is not recommended. Safety and efficacy have not been established.

Tigecycline may cause permanent discoloration of the teeth and slow down the growth of bones. tigecycline should not be given to children 8 years of age and younger, unless directed by the child's doctor.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of tigecycline injection in the elderly.

Pregnancy

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

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving tigecycline, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using tigecycline 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.

• Cholera Vaccine, Live

Using tigecycline 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.

• Warfarin

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 tigecycline. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea or
• Liver disease or
• Pancreatitis (inflammation of the pancreas)—Use with caution. May make these conditions worse.

• Liver disease, severe—Use with caution. The effects may be increased because of slower removal from the body.

A nurse or other trained health professional will give you tigecycline. tigecycline is given through a needle placed in one of your veins. tigecycline is given slowly, so the needle will remain in place for about 30 to 60 minutes.

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 or nurse immediately if any of the following side effects occur:

• Cough or hoarseness
• dizziness
• fever or chills
• headache
• lower back or side pain
• pain, warmth, or burning in the fingers, toes, and legs
• painful or difficult urination
• problems with vision or hearing

• Abdominal or stomach pain
• accumulation of pus
• bloating or swelling of the face, arms, hands, lower legs, or feet
• changes in skin color
• confusion
• decreased urine
• diarrhea
• difficult or labored breathing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fat in the stool
• irregular heartbeat
• muscle pain or cramps
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pain
• rapid weight gain
• shortness of breath
• slow or fast heartbeat
• sweating
• swollen, red, tender area of infection
• tightness in the chest
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

• Anxiety
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• chest pain or discomfort
• clay-colored stools
• cold sweats
• dark urine
• depression
• muscle cramps in the hands, arms, feet, legs, or face
• nightmares
• pinpoint red spots on the skin
• rash
• shakiness
• slurred speech
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, ankles, or hands
• swollen glands
• tremor
• unpleasant breath odor
• vomiting of blood
• yellow eyes or skin

• Bloating
• constipation
• difficulty with swallowing
• hives
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

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:

• Red streaks on the skin
• swelling, tenderness, or pain at the injection site

• Belching
• heartburn or indigestion
• lack or loss of strength
• stomach discomfort, upset, or pain
• trouble sleeping

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• change in taste or bad unusual or unpleasant (after) taste
• increased clear or white vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• sleepiness or unusual drowsiness

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.

Nausea, vomiting, headache, dizziness, or pain/swelling at the injection site may occur. If any of these effects last or get worse, 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 right away if you have any serious side effects, including: signs of kidney problems (such as change in the amount of urine), unusual fatigue, severe stomach/abdominal pain, hearing changes (such as ringing in the ears, decreased hearing), irregular heartbeat, easy bleeding/bruising, yellowing of the eyes or skin, dark urine.

Tetracycline drugs such as tigecycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tigecycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: headaches that are severe or don't go away, nausea/vomiting that doesn't stop, vision changes (such as blurred/double vision, decreased vision, sudden blindness).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn't stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 or at www.fda.gov/medwatch.

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

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor directs you to do so. A different medication may be necessary in that case.

If you are using this medication for a longer time, lab and/or medical tests (such as liver function tests, blood counts, cultures) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.

Storage

Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised January 2017. Copyright(c) 2017 First Databank, Inc.