Tigecycline

Tigecycline is an intravenous antibiotic designed to treat complex infections which cannot be treated with alternative antibacterial agents.

Overview

Tigecycline is an intravenous antibiotic designed to treat a wide range of bacterial infections. It is suitable for treating infection in many parts of the body, including the skin, stomach, digestive system and lungs. It works by destroying the bacteria responsible for infection and preventing their growth. It cannot treat viral infections, such as cold or flu.

Tigecycline is only designed for the treatment of severe infections which have not been successfully treated with other antibiotics. Death has occurred more often in patients using this antibiotic compared with others, although most deaths associated with the drug appear to have been caused by other medical conditions or complications of the infection. Since it isn’t fully understood whether tigecycline directly causes death, doctors only administer it if other antibiotic treatments have been unsuccessful.

In the US, tigecycline is known by the brand name Tygacil, and it is provided in a powder form which should be reconstituted into a solution and administered intravenously, which means that it is injected into a vein. It is usually only administered by a healthcare professional such as a doctor or nurse.

Condition(s) treated?

  • Bacterial infection
  • Pneumonia

Type of medicine?

  • Antibiotic

Side Effects

There are many side effects associated with tigecycline, most of which are relatively uncommon or very rare. It’s important to familiarize yourself with the potential side effects and report the most serious ones to your healthcare provider.

Serious side effects

The following side effects are more common, and should be reported to a healthcare professional immediately:

  • Cough or hoarseness
  • Headache
  • Problems with vision or hearing
  • Dizziness
  • Fever or chills
  • Pain in lower back or side
  • Pain, warmth or burning sensation in fingers, toes and legs
  • Difficult or painful urination

Less common and rare side effects which should be reported to a doctor or nurse immediately include:

  • Abdominal pain or stomach pain
  • Pain in upper abdomen radiating up the back
  • Muscle pain or cramps
  • Bloating
  • Accumulation of pus in an area
  • Puffiness or swelling of eyes, face, lips or tongue
  • Yellow eyes or skin
  • Changes in skin color
  • Abnormal bleeding or bruising
  • Red, pinpoint spots on skin
  • Sores, white spots or ulcers on mouth or lips
  • Rash or hives
  • Bleeding gums
  • Bloating or swelling of face, arms, hands, legs or feet
  • Numb or tingling sensation in lips, hands or feet
  • Confusion
  • Anxiety
  • Depression
  • Nightmares
  • Abnormal fatigue, tiredness or weakness
  • Shakiness or tremors
  • Slurred speech
  • Dizziness or faintness after getting up from lying or sitting positions
  • Decreased urine output
  • Diarrhea
  • Constipation
  • Fatty stools
  • Black, tarry stools
  • Blood in stools or urine
  • Vomiting blood or substance which looks like coffee grounds
  • Difficulty swallowing
  • Labored or difficult breathing
  • Shortness of breath
  • Tightness in chest
  • Troubled breathing after exertion
  • Irregular, fast or slow heartbeat
  • Rapid weight gain or loss
  • Sweating
  • Swollen glands

Minor side effects

Some side effects associated with tigecycline therapy are minor and don’t usually require medical attention unless they become very persistent and bothersome. You may want to report them to a doctor or nurse if they don’t go away or are causing severe discomfort. These include:

  • Red streaks on skin
  • Swelling, pain or tenderness at injection site
  • Heartburn or indigestion
  • Stomach discomfort
  • Belching
  • Difficult sleeping
  • Unusual drowsiness or sleepiness
  • Loss of strength
  • Changes in taste or unpleasant aftertastes
  • Increase in clear or white vaginal discharge
  • Itchiness in vagina or genitals
  • Discomfort during sexual intercourse

If you notice any other side effects not listed here, discuss them with your doctor or nurse or report them to the FDA.

Injection site discomfort

As with all other intravenous drugs, tigecycline therapy may cause irritation to the skin at the injection site. Usually this is nothing to worry about and the symptoms go away after the therapy is finished, but if it becomes particularly persistent or uncomfortable you could mention it to your doctor or nurse. People most often report some mild tenderness and swelling at the injection site, but in rare instances patients might experience:

  • Bleeding
  • Blistering
  • Burning
  • Coldness
  • Discolored skin
  • Sensation or pressure
  • Hives
  • Infection
  • Inflammation
  • Itchiness
  • Lumps
  • Numbness
  • Pain
  • Rash
  • Redness
  • Scarring
  • Stinging
  • Tingling
  • Ulceration
  • Warmth

Dosage

For adults, the recommend initial dosage of tigecycline is 100 mg, which is usually followed by 50 mg every 12 hours until the infection is cleared. The intravenous injections should be administered slowly, over the course of 30 to 60 minutes.

Children aged 12 to 17 usually receive 50 mg of tigecycline every 12 hours. For children aged 8 to 11, dosage can vary between 1.2 mg and 50 mg every 12 hours. For children under the age of 8, the safety and efficacy of the drug has not been established.

In patients with hepatic impairment, tigecycline dosage may be reduced. They may be given 100 mg in their initial infusion, but subsequent doses should be 25 mg every 12 hours. If hepatic impairment is severe, they may be more closely monitored while undergoing the treatment.

The number of tigecycline intravenous infusions a patient has depends on the nature and severity of the infection they’re suffering from. For skin infections and intra-abdominal infections, tigecycline is usually administered between 5 and 14 days. For bacterial pneumonia, treatment might last between 7 and 14 days.

Interactions

If tigecycline is to be administered by a Y-site, it should not be given at the same time as the following drugs:

  • Amphotericin B lipid complex (Abelcet)
  • Diazepam (Valium)
  • Esomeparzole (Nexium)
  • Omeprazole (Prilosec)

Warnings

Risk of mortality

Tigecycline features a boxed warning regarding the increased risk of mortality associated with the drug. In clinical trials of the drug, death occurred in 4% of patients taking the drug compared to 3% taking comparative drugs. The deaths may not have been directly caused by tigecycline, since they appeared to be as a result of complications of the infection or underlying health problems. However, tigecycline is still recommended for use only in situations where other treatments are either not suitable for the patient or they have proven to be ineffective.

Allergy and hypersensitivity

If you have had an allergic reaction or hypersensitivity to tigecycline in the past, it should not be administered to you in the future. Let your doctor know of any allergic or hypersensitive reactions you’ve had to any drugs in the past, particularly antibiotics. The drug is very similar to tetracycline-class antibiotics and may not be suitable for patients who have had an adverse reaction to these types of antibiotics before. Examples of tetracyline-class antibiotics include:

  • Doxycyline (Adoxa, Alodox, Articlate, Avidoxy, Doryx, Doxy 100, Momodox, Morgidox, Ocudox, Oraxyl, Oracea, Periostat, Vibramycin, Vibra-Tabs)
  • Democlocycline (Declomycin)
  • Monocycline (Dynacin, Minocin, Minolira, Myrac, Solodyn, Cleeravue-M, Ximino)
  • Oxytetracycline (Terramycin)
  • Tatracycline (Achromycin V, Actisite, Ala-Tet, Brodspec, Panmycin, Sumycin, Tetracap, Tetracon)

Pediatric use

Tigecycline is not recommended for use in children because the safety and efficacy of the drug have not been fully established. Furthermore, studies have found that the drug could cause permanent tooth discoloration and slow down bone growth.

However, it may be used in children over the age of eight as a last-resort treatment for complex infections which have not been successfully treated with alternative therapies. In these instances, dosage is usually started at very low levels to minimize health risks and complications. It should not be given to children under the age of eight.

Not suitable for pregnant women

Tigecycline is a pregnancy category D drug, which means it should not be administered to pregnant women. The drug could inhibit fetal growth and in worst instances cause fetal loss. Other treatments should be used to treat complex infections in pregnant women. If none have been successful and tigecycline is the only suitable treatment, tigecycline may be administered but mothers should be aware of the risk to the fetus.

It is not known whether tigecycline is excreted in breast milk and, if so, what risks it may pose to nursing infants. For this reason, the potential risk should be considered by women who are breastfeeding and in need of antibiotic treatment; other drugs may be preferable, or they may prefer to avoid breastfeeding while undergoing tigecycline therapy.

Risk of hepatic dysfunction

A few cases of hepatic dysfunction or failure have occurred in patients treated with tigecycline. However, the patients were receiving multiple other drugs at the same time as the antibiotic, which makes it difficult to understand exactly why the hepatic problems occurred. If abnormal liver function is monitored during tigecycline therapy, the patient should be continuously monitored and evaluated regularly to assess whether the risk to the liver outweighs the benefits of the drug. In some instances, hepatic dysfunction may occur after tigecycline therapy has finished.

Risk of pancreatitis

Some cases of acute pancreatitis have occurred as a result of tigecycline therapy. If signs of pancreatitis occur, tigecycline may have to be discontinued. Common symptoms of pancreatitis include:

  • Pain and tenderness in the upper abdomen that radiates into the back
  • Abdominal pain which worsens upon eating
  • Fever
  • Nausea
  • Vomiting
  • Rapid pulse

Risk of clostridium difficile associated diarrhea (CDAD)

Antibiotics can alter the natural balance of bacteria in the gut and lead to an overgrowth of harmful bacteria C. difficile. This can result in diarrhea. In some patients, diarrhea may be mild and won’t require treatment, but in some instances it can be severe. Use of tigecycline may have to be discontinued in severe or ongoing cases of CDAD.

Tigecycline unsuitable as monotherapy in patients with intestinal perforation

Patients with intra-abdominal infections associated with intestinal perforation are at an increased risk of sepsis or septic shock when treated with tigecycline. In these instances, other antibiotic combinations are usually recommended over monotherapy of tigecycline.

Full course of antibiotics must be completed

As with all types of antibiotics, tigecycline may make patients feel better within a couple of days, but the full course must be completed to ensure that the infection is completely cured. Stopping a course of tigecycline therapy early could result in the infection recurring, or even lead the bacteria to develop a resistance to antibiotic treatment. This could make the infection untreatable in the future, either by tigecycline or other antibiotic drugs.

Storage

Since tigecycline is designed for intravenous use, it is usually only administered by healthcare professionals and is therefore stored in hospital or clinical environments. It is supplied in single-dose 5 or 10 mL glass vials, each of which contain 50 mg of powder which is to be reconstituted before administration.

In its powder form, tigecycline should be stored at 20° to 25°C (68° to 77°F). Once the powder has been reconstituted into a solution, it may be stored at room temperature in the vial for up to 6 hours and an intravenous bag for 18 more hours. Reconstituted tigecycline should be discarded if not used within 24 hours.

Summary

Tigecycline is an intravenous antibiotic which can treat complex bacterial infections that cannot be treated with other types of antibacterial agents. It poses an increased risk of mortality and should therefore only be used if other treatments aren’t suitable for a patient or they have not been successful in clearing the infection.

The most common side effect associated with tigecycline is diarrhea, which can be serious in some instances. All antibiotics, including tigecycline, can affect the natural balance of bacteria in the gut and lead to an overgrowth of C. difficile, which can cause diarrhea. In severe cases, patients may suffer from dehydration, electrolyte imbalances and other complications.

Tigecycline should not be used by pregnant women due to the serious risks to the fetus. It’s also unsuitable for children under eight since it can cause tooth discoloration and inhibit bone growth. It may be used with caution in children over the age of eight if alternative antibacterial treatments aren’t available.

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Last Reviewed:
December 23, 2017
Last Updated:
December 22, 2017
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