Pronunciation:

tye-ge-SYE-kleen

Brand Names:

• Tygacil

Dosage Forms:

• Powder for Solution

Warnings:

An increase in all-cause mortality was observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI, 0.1 to 1.2) has not been established. Tigecycline should be reserved for use in situations when alternative treatments are not suitable .

Classifications:

Therapeutic—

Antibiotic

Chemical—

Glycylcycline

Uses of This Medicine:

Tigecycline injection is used to treat bacterial infections in many different parts of the body (eg, infections on the skin, stomach, or lungs). It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections. This is a tetracycline antibiotic.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

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. This medicine should not be given to children 8 years of age and younger, unless directed by the child's doctor.

Older adults—

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

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.

Other 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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Acitretin

Using this medicine 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.

• Amoxicillin
• Ampicillin
• Bacampicillin
• Bexarotene
• Cholera Vaccine, Live
• Cloxacillin
• Desogestrel
• Dicloxacillin
• Dienogest
• Drospirenone
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etretinate
• Gestodene
• Isotretinoin
• Levoketoconazole
• Levonorgestrel
• Magnesium Sulfate
• Mestranol
• Methicillin
• Methotrexate
• Nafcillin
• Nomegestrol
• Norethindrone
• Norgestimate
• Norgestrel
• Oxacillin
• Palovarotene
• Penicillin G
• Penicillin G Benzathine
• Penicillin G Procaine
• Penicillin V
• Piperacillin
• Pivampicillin
• Sultamicillin
• Temocillin
• Tretinoin

Using this medicine 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.

• Cyclosporine
• Pimecrolimus
• Tacrolimus
• Warfarin

Other interactions—

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 this medicine. 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.

Proper Use of This Medicine:

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

Precautions While Using This Medicine:

It is important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects. If your symptoms do not improve or if they become worse, call your doctor right away.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Birth control pills may not work while you are using tigecycline. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include condoms, a diaphragm, or a contraceptive foam or jelly.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you receive this medicine.

Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Tigecycline may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop taking this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Tigecycline may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. Use a sunscreen when you are outdoors. Wear protective clothing (including a hat) and sunglasses. Avoid sunlamps and tanning beds or booths.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

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:

More common

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

Less common

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

Rare

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

Incidence not known

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:

More common

Red streaks on the skin

swelling, tenderness, or pain at the injection site

Less common

Belching

heartburn or indigestion

lack or loss of strength

stomach discomfort, upset, or pain

trouble sleeping

Rare

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.