Dosing & Uses
Dosage Forms & Strengths
powder for injection
- 50mg/vial
Complicated Intra-abdominal Infections
Initial: 100 mg IV infusion, THEN
50 mg IV infusion q12hr for 5-14 days
Complicated Skin Infections
Initial: 100 mg IV infusion, THEN
50 mg IV infusion q12hr for 5-14 days
Community-Acquired Pneumonia
Initial: 100 mg IV infusion, THEN
50 mg IV infusion q12hr for 7-14 days
Dosage Modifications
Renal impairment: Dose adjustment not necessary (minimum dialyzed through hemodialysis or peritoneal dialysis)
Hepatic impairment
- Severe (Child-Pugh C): Maintenance 25 mg IV q12hr (following initial 100 mg)
Dosing Considerations
Not indicated for the treatment of diabetic foot infections; a clinical trial failed to demonstrate noninferiority
Not indicated for the treatment of hospital-acquired or ventilator-associated pneumonia; in a comparative clinical trial, greater mortality and decreased efficacy were reported in tigecycline-treated patients
Susceptible organisms
- Complicated skin infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible only), Staphylococcus aureus (MRSA and methicillin-susceptible), Streptococcus pyogenes, Streptococcus anginosus grp, Streptococcus agalactiae, or Bacteroides fragilis
- Complicated intra-abdominal infections caused by E coli, Enterococcus faecalis (vancomycin-susceptible only), S aureus (methicillin-susceptible only), Citrobacter freundii, Enterobacter cloacae, Klebsiella pneumoniae, K oxytoca, B thetaiotaomicron, B uniformis, B vulgatus, Clostridium perfringens, Peptostreptococcus micros
- Community-acquired pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae, Legionella pneumophila
Acute Myeloid Leukemia (Orphan)
Orphan designation for treatment of acute myeloid leukemia
Tigecycline selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis
Orphan sponsor
- Stem Cell Therapeutics Corporation; 96 Skyway Avenue; Toronto, ON M9W 4Y9, Canada
<18 years: Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (4)
- BCG vaccine live
tigecycline decreases effects of BCG vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
- cholera vaccine
tigecycline, cholera vaccine. pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid coadministration of cholera vaccine with systemic antibiotics since these agents may be active against the vaccine strain. Do not administer cholera vaccine to patients who have received oral or parenteral antibiotics within 14 days prior to vaccination.
- microbiota oral
tigecycline decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
- typhoid vaccine live
tigecycline decreases effects of typhoid vaccine live by pharmacodynamic antagonism. Contraindicated. Wait until Abx Tx complete to administer live bacterial vaccine.
Monitor Closely (12)
- bazedoxifene/conjugated estrogens
tigecycline will decrease the level or effect of bazedoxifene/conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- conjugated estrogens
tigecycline will decrease the level or effect of conjugated estrogens by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- dichlorphenamide
dichlorphenamide, tigecycline. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.
- digoxin
tigecycline will increase the level or effect of digoxin by altering intestinal flora. Applies only to oral form of both agents. Use Caution/Monitor.
- estradiol
tigecycline will decrease the level or effect of estradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- estrogens conjugated synthetic
tigecycline will decrease the level or effect of estrogens conjugated synthetic by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- estropipate
tigecycline will decrease the level or effect of estropipate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- ethinylestradiol
tigecycline will decrease the level or effect of ethinylestradiol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
tigecycline will decrease the level or effect of levonorgestrel oral/ethinylestradiol/ferrous bisglycinate by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor. Antibiotics may decrease hormonal contraceptive efficacy.
- mestranol
tigecycline will decrease the level or effect of mestranol by altering intestinal flora. Applies only to oral forms of hormone. Low risk of contraceptive failure. Use Caution/Monitor.
- mipomersen
mipomersen, tigecycline. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Both drugs have potential to increase hepatic enzymes; monitor LFTs.
- sodium picosulfate/magnesium oxide/anhydrous citric acid
tigecycline decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.
sodium picosulfate/magnesium oxide/anhydrous citric acid decreases levels of tigecycline by cation binding in GI tract. Use Caution/Monitor. Take at least 2 hours before and not less than 6 hours after administration of sodium picosulfate, magnesium oxide and anhydrous citric acid to avoid magnesium chelation.
Minor (7)
- balsalazide
tigecycline will decrease the level or effect of balsalazide by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- biotin
tigecycline will decrease the level or effect of biotin by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- digoxin
tigecycline decreases levels of digoxin by unspecified interaction mechanism. Minor/Significance Unknown.
- pantothenic acid
tigecycline will decrease the level or effect of pantothenic acid by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- pyridoxine
tigecycline will decrease the level or effect of pyridoxine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- pyridoxine (Antidote)
tigecycline will decrease the level or effect of pyridoxine (Antidote) by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
- thiamine
tigecycline will decrease the level or effect of thiamine by altering intestinal flora. Applies only to oral form of both agents. Minor/Significance Unknown.
Adverse Effects
>10%
Nausea (29.5%)
Vomiting (19.7%)
Diarrhea (12.7%)
1-10%
Infection (8.3%)
Fever (7.1%)
Abd pain (6.8%)
Headache (5.9%
HTN (4.9%)
Anemia (4.2%)
Dizziness (3.5%)
Dyspnea (2.9%)
Pruritus (2.6%)
Rash (2.4%)
Hypotension (2.3%)
Insomnia (2.3%)
Postmarketing Reports
Anaphylaxis/anaphylactoid reactions
Acute pancreatitis
Hypofibrinogenemia
Hepatic cholestasis and jaundice
Severe skin reactions, including Stevens-Johnson Syndrome
Symptomatic hypoglycemia in patients with or without diabetes mellitus
Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), eosinophilia, increased international normalized ratio (INR), thrombocytopenia
Warnings
Black Box Warnings
Increased mortality with use of tigecycline for FDA-approved indications, as well as for nonapproved indications, compared with other antibiotics
Analysis from 10 clinical trials for FDA-approved uses (cSSSI, cIAI, CABP), including trials conducted after the drug was approved, showed a higher risk of death among patients receiving tigecycline, compared with other antibacterial drugs: 2.5% (66/2640) vs. 1.8% (48/2628), respectively; the adjusted risk difference for death was 0.6%, with a corresponding 95% confidence interval (0.0%, 1.2%)
Contraindications
Documented hypersensitivity
Cautions
FDA approved to treat complicated skin and skin structure infections (cSSSI), complicated intra-abdominal infections (cIAI), and community-acquired bacterial pneumonia (CABP); it is not approved for treatment of diabetic foot infection or for hospital-acquired or ventilator-associated pneumonia
Increase in all-cause mortality reported in tigecycline treated patients versus comparator-treated patients; generally, deaths were the result of worsening infection, complications of infection or underlying co-morbidities; therapy should be reserved for use in situations when alternative treatments are not suitable
A trial of patients with hospital-acquired, including ventilator-associated, pneumonia failed to demonstrate drug efficacy with lower cure rates in hospital-acquired pneumonia
Anaphylactic reactions reported with nearly all antibacterial agents and may be life-threatening; tigecycline is structurally similar to tetracycline-class antibacterial drugs and should be avoided in patients with known hypersensitivity to tetracycline-class antibacterial drugs
Monotherapy should be avoided in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation
The drug is structurally similar to tetracycline-class antibacterial drugs and may have similar adverse effects, including photosensitivity, pseudotumor cerebri, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia)
Prescribing therapy in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
Increases in total bilirubin concentration, prothrombin time and transaminases reported in patients treated with tigecycline; caution in severe hepatic impairment (reduce dose); patients who develop abnormal liver function tests during therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy; hepatic dysfunction may occur after drug has been discontinued
Hypofibrinogenemia reported; obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment
Avoid use in patients with known hypersensitivity to tetracyclines
May have adverse effects similar to those of tetracyclines (eg, photosensitivity, pseudotumor cerebri, antianabolic action)
Pancreatitis, including fatalities, reported; if pancreatitis suspected, consider stopping treatment; diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis; cases reported in patients without known risk factors for pancreatitis; patients usually improve after therapy discontinuation; consider cessation of treatment in cases suspected of having developed pancreatitis
Increased mortality risk with use of IV tigecycline (see Black Box Warnings)
May cause fetal harm when administered to a pregnant woman
Tooth discoloration
- Use during tooth development may cause permanent discoloration of teeth; adverse reaction is more common during long-term use but has been observed following repeated short-term courses; enamel hypoplasia has also been reported
- Use during second and third trimester of pregnancy, infancy and childhood up to the age of 8 years may cause reversible inhibition of bone growth; tetracyclines form a stable calcium complex in any bone-forming tissue; a decrease in fibula growth rate has been observed in premature infants given oral tetracycline in doses of 25 mg/kg every 6 hours; effect was shown to be reversible when therapy was discontinued; advise patient of potential risk to fetus if drug is used during second or third trimester of pregnancy
Clostridioides difficile
- Clostridioides difficile-associated diarrhea (CDAD) reported with use and may range in severity from mild diarrhea to fatal colitis; treatment with antibacterial agents alters normal flora of colon leading to overgrowth of C. difficile
- C. difficile produces toxins A and B which contribute to development of CDAD; hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy; CDAD must be considered in all patients who present with diarrhea following antibacterial drug use; careful medical history necessary since CDAD reported to occur over two months after administration of antibacterial agents
- If CDAD suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
Pregnancy & Lactation
Pregnancy
May cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during second and third trimesters of pregnancy
There are no available data on risk of major birth defects or miscarriage following use during pregnancy
Advise patients of potential risk to fetus if drug is used during second or third trimester
Animal data
- Administration of intravenous tigecycline in pregnant rats and rabbits during period of organogenesis was associated with reduction in fetal weights and an increased incidence of skeletal anomalies (delays in bone ossification) at exposures of 5 and 1 times the human exposure at recommended clinical dose in rats and rabbits, respectively
Lactation
There are no data on presence of drug in human milk; however, tetracycline-class antibacterial drugs are present in breast milk
Not known whether drug has an effect on breastfed infant or on milk production
Drug has low oral bioavailability; therefore, infant exposure is expected to be low
Drug is present in rat milk with little or no systemic exposure to drug in nursing pups as a result of exposure via maternal milk; when drug is present in animal milk, it is likely that the drug will be present in human milk
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed child from drug or from underlying maternal condition
Because of theoretical risk of dental discoloration and inhibition of bone growth, avoid breastfeeding if receiving therapy for longer than three weeks
A lactating woman may consider interrupting breastfeeding and pumping and discarding breastmilk during administration of therapy and for 9 days (approximately 5 half-lives) after last dose in order to minimize drug exposure to a breastfed infant
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
A glycylcycline antibiotic that is structurally similar to tetracycline antibiotics; inhibits bacterial protein translation by binding to 30S ribosomal subunit, and blocks entry of amino-acyl tRNA molecules in ribosome A site.
Distribution
Protein bound: 71-89%
Vdss: 500-700 L
Metabolism
Not extensive
Elimination
Half-life: (single dose) 27 hr; (multiple dose) 42 hr
Excretion: urine (33%); feces (59%)
Administration
IV Incompatibilities
Y-site: amphotericin B, chlorpromazine, methylprednisolone, voriconazole
IV Compatibilities
Solution: NS, D5W
Y-site: dobutamine, dopamine, LR, KCl, theophylline, ranitidine, lidocaine
IV Preparation
Reconstitute each vial with 5.3 mL NS or D5W to achieve a conc of 10 mg/mL
Gently swirl to dissolve
Immediately withdraw 5 mL and add to a 100-mL infusion bag
IV Administration
Infuse over 30-60 min
Through dedicated line or Y-site
Storage
Store vials at 20-25°C (68-77°F)
May be stored in IV bag at room temp for up to 6 hr or refrigerated at 2-8°C for up to 24 hr
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| tigecycline intravenous - | 50 mg vial |  | |
| Tygacil intravenous - | 50 mg vial |  | |
| Tygacil intravenous - | 50 mg vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
tigecycline intravenous
TIGECYCLINE - INJECTION
(TYE-ge-SYE-kleen)
COMMON BRAND NAME(S): Tygacil
WARNING: This medication may increase the risk of death. It should only be used when other treatments have not worked. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for your infection, with your doctor.
USES: Tigecycline is used to treat certain serious bacterial infections when other antibiotics may not work. It is related to a class of drugs known as tetracycline antibiotics. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using tigecycline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a vein over 30 to 60 minutes by a healthcare professional. It is given as directed by your doctor, usually every 12 hours. The dosage is based on your medical condition and response to treatment.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Swirl the medication gently to mix. Do not shake. The mixed medication should be yellow to orange in color. Before using, check this product visually for particles or green/black discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.For the best effect, use this antibiotic at evenly spaced times. To help you remember, use this medication at the same times every day.Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: 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 this medication has been prescribed because your doctor 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 increased pressure around the brain (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 due to a bacteria called C. difficile. 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.If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms 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.
PRECAUTIONS: See also Side Effects section.Before using tigecycline, tell your doctor or pharmacist if you are allergic to it; or to tetracyclines (such as doxycycline, minocycline, tetracycline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Tigecycline may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using tigecycline before having any immunizations/vaccinations.This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Children younger than 8 years may be more sensitive to the side effects of tigecycline, especially tooth discoloration. Tooth discoloration has also occurred in older children and in young adults. Discuss the risks and benefits of this medication with the doctor.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using tigecycline. Tigecycline may harm an unborn baby. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug are: retinoid medications taken by mouth (such as acitretin, isotretinoin).
OVERDOSE: 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 tells you to.Lab and/or medical tests (such as liver function, fibrinogen levels, blood counts, cultures) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for 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 May 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
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