Tigecycline Accord
Glycylcycline antibiotic for complicated infections — powder for solution for infusion
Quick Facts About Tigecycline Accord
Key Takeaways About Tigecycline Accord
- Reserved antibiotic: Tigecycline is only used when other antibiotics are considered unsuitable due to a slightly increased mortality risk observed in clinical trials
- Broad-spectrum activity: Effective against gram-positive, gram-negative, and anaerobic bacteria, including many multi-drug resistant strains such as MRSA and VRE
- Hospital-only administration: Always given as an intravenous infusion over 30–60 minutes by a healthcare professional in a clinical setting
- Not for children under 8: Contraindicated in children under 8 years due to the risk of permanent tooth discoloration, similar to other tetracycline-class antibiotics
- Monitor for pancreatitis: Severe abdominal pain, nausea, and vomiting during treatment may indicate acute pancreatitis, which requires immediate medical attention
What Is Tigecycline Accord and What Is It Used For?
Tigecycline Accord is a glycylcycline antibiotic that works by inhibiting bacterial protein synthesis. It is used to treat complicated skin and soft tissue infections (cSSTI) and complicated intra-abdominal infections (cIAI) in adults and children over 8 years of age, specifically when other antibiotics are considered unsuitable.
Tigecycline belongs to the glycylcycline class of antibiotics, which are structurally related to tetracyclines but engineered to overcome common resistance mechanisms. By binding to the 30S ribosomal subunit of bacteria, tigecycline blocks the entry of aminoacyl-tRNA molecules into the ribosome's A site, effectively halting protein synthesis and bacterial growth. This mechanism gives tigecycline a remarkably broad spectrum of activity.
The drug demonstrates potent activity against a wide range of pathogens, including gram-positive organisms such as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), and Streptococcus species. It also covers gram-negative bacteria including Escherichia coli, Klebsiella pneumoniae, and Acinetobacter baumannii, as well as anaerobic bacteria such as Bacteroides fragilis. However, it has limited activity against Pseudomonas aeruginosa and Proteus species.
Tigecycline Accord is specifically indicated for two types of complicated infections. Complicated skin and soft tissue infections (cSSTI) include deep soft tissue infections, major abscesses, infected wounds, and infected burns that extend beyond the skin into subcutaneous tissue, fascia, or muscle. Importantly, diabetic foot infections are excluded from this indication because clinical trial data did not support efficacy in this population. Complicated intra-abdominal infections (cIAI) include intra-abdominal abscesses, perforated appendicitis, peritonitis, and other conditions where infection has spread beyond a single organ within the abdomen.
It is critical to understand that tigecycline is not a first-line antibiotic. Regulatory authorities, including the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA), have highlighted an increased mortality risk in clinical trials comparing tigecycline with other antibiotics. Therefore, physicians prescribe this medication only when they determine that alternative treatments are inappropriate due to bacterial resistance patterns, patient allergies, or other clinical considerations.
Tigecycline's ability to overcome efflux pumps and ribosomal protection mechanisms makes it a valuable option against multi-drug resistant organisms. However, it should be used judiciously as part of antibiotic stewardship programs to preserve its efficacy for future patients.
What Should You Know Before Receiving Tigecycline Accord?
Before receiving Tigecycline Accord, inform your doctor about any allergies to tigecycline or tetracycline-class antibiotics, liver problems, bleeding disorders, pregnancy, or breastfeeding. Several important drug interactions and contraindications must be considered before starting treatment.
Contraindications
Tigecycline Accord must not be used if you are allergic (hypersensitive) to tigecycline or to any of the other ingredients in the medicine (maltose monohydrate, hydrochloric acid, and sodium hydroxide). Because tigecycline is structurally related to tetracycline antibiotics, patients who are allergic to tetracyclines such as minocycline or doxycycline may also be allergic to tigecycline. Cross-sensitivity should be carefully evaluated before administering this medication.
Warnings and Precautions
Several important safety considerations must be discussed with your healthcare provider before receiving Tigecycline Accord. Tell your doctor or nurse if any of the following situations apply to you:
- Poor wound healing: Tigecycline has been associated with impaired wound healing. If you have wounds that are not healing normally, your physician may need to consider this when deciding on your antibiotic therapy.
- Diarrhea: If you experience diarrhea before, during, or after treatment, tell your doctor immediately. Do not take anti-diarrheal medicines without consulting your doctor first, as severe diarrhea may be a sign of Clostridioides difficile-associated colitis, a potentially serious complication of antibiotic therapy.
- Tetracycline-related adverse effects: If you have previously experienced side effects from tetracycline-class antibiotics (such as skin photosensitivity, tooth discoloration, pancreatitis, or changes in coagulation parameters), these may also occur with tigecycline.
- Liver disease: Patients with pre-existing liver problems, particularly those with severe hepatic impairment (Child-Pugh C), may require dose adjustments. Your physician will evaluate your liver function and may reduce the maintenance dose to avoid excessive drug accumulation.
- Biliary obstruction (cholestasis): Tigecycline is primarily eliminated through the bile. Conditions that obstruct bile flow may affect how the drug is cleared from your body.
- Bleeding disorders: If you suffer from any type of coagulation disorder or are being treated with anticoagulant medications, inform your physician, as tigecycline can affect blood clotting parameters.
Seek immediate medical attention if you develop symptoms of a severe allergic reaction (difficulty breathing, swelling of the face or throat, rapid heartbeat, skin rash), or if you experience severe abdominal pain with nausea and vomiting, which may indicate acute pancreatitis. Additionally, your doctor will monitor you closely for superinfection with resistant organisms, including fungi, that may emerge during treatment.
Use in Children
Tigecycline Accord can be used in children aged 8 years and older. It must not be used in children under 8 years of age due to the lack of safety and efficacy data in this age group and the risk of permanent defects to developing teeth, including permanent discoloration. This concern is shared with all tetracycline-class antibiotics, which can bind to calcium in developing dental structures.
Pregnancy and Breastfeeding
Tigecycline Accord may be harmful to an unborn baby. If you are pregnant, think you might be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine. Based on animal studies, tigecycline may cause fetal harm, including decreased fetal weight and effects on bone development.
It is not known whether tigecycline passes into breast milk. Women who are breastfeeding should discuss the risks and benefits with their physician before receiving treatment. In most cases, breastfeeding is temporarily interrupted during tigecycline therapy.
Driving and Operating Machinery
Tigecycline may cause side effects such as dizziness that can impair your ability to drive or operate machinery. If you experience these effects, avoid activities requiring alertness until you know how the medicine affects you. Since tigecycline is administered in a hospital setting, this is usually managed under medical supervision during your hospital stay.
Tigecycline Accord contains less than 1 mmol (23 mg) of sodium per vial, meaning it is essentially sodium-free. This is relevant for patients on sodium-restricted diets.
How Does Tigecycline Accord Interact with Other Drugs?
Tigecycline can interact with anticoagulants (blood thinners), oral contraceptives, and immunosuppressants such as tacrolimus and ciclosporin. Always inform your healthcare provider about all medications you are taking to avoid potentially dangerous interactions.
Drug interactions with tigecycline are clinically significant and require careful monitoring. Although tigecycline is not extensively metabolized by cytochrome P450 enzymes, it can affect the pharmacodynamics and pharmacokinetics of several important drug classes. Inform your physician about all medications, supplements, and herbal products you are taking.
Major Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Warfarin and other anticoagulants | Tigecycline prolongs PT/INR; enhanced anticoagulant effect with increased bleeding risk | Close INR monitoring required; dose adjustments of anticoagulant may be necessary |
| Tacrolimus | Tigecycline may increase tacrolimus blood levels and enhance immunosuppressive effects | Monitor tacrolimus trough levels and renal function closely |
| Ciclosporin (Cyclosporine) | Tigecycline may increase ciclosporin blood levels and enhance immunosuppressive toxicity | Monitor ciclosporin levels; adjust dose as needed |
Other Important Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Oral contraceptives | Tigecycline may reduce the effectiveness of hormonal birth control pills | Use additional non-hormonal contraception during and for 7 days after treatment |
| Coagulation tests | Tigecycline may prolong aPTT and PT, affecting laboratory test results | Inform laboratory of concurrent tigecycline use; interpret results with caution |
Because tigecycline is administered intravenously in a hospital setting, healthcare professionals will typically be aware of all concomitant medications and can manage interactions proactively. However, patients should always disclose their complete medication list, including over-the-counter drugs and supplements, to ensure safe use.
What Is the Correct Dosage of Tigecycline Accord?
The standard adult dose is a 100 mg loading dose followed by 50 mg every 12 hours, given as an intravenous infusion over 30–60 minutes. Treatment typically lasts 5 to 14 days. Dosing for children varies by age and weight.
Tigecycline Accord is always administered by a doctor or nurse in a clinical setting. It is given as an intravenous (IV) infusion directly into the bloodstream over a period of 30 to 60 minutes. The powder must be reconstituted and diluted before administration according to specific pharmaceutical protocols.
Adults
Standard Adult Dosing
Loading dose: 100 mg intravenously on the first administration
Maintenance dose: 50 mg every 12 hours
Infusion duration: 30 to 60 minutes per dose
Treatment duration: 5 to 14 days, determined by the treating physician based on infection severity and clinical response
For patients with severe hepatic impairment (Child-Pugh C), the maintenance dose should be reduced to 25 mg every 12 hours after the initial 100 mg loading dose. No dose adjustment is required for patients with renal impairment or for elderly patients with normal organ function.
Children and Adolescents
| Age Group | Dose | Maximum Per Dose | Frequency |
|---|---|---|---|
| 8 to <12 years | 1.2 mg/kg body weight | 50 mg | Every 12 hours |
| 12 to <18 years | 50 mg | 50 mg | Every 12 hours |
| Under 8 years | Not recommended | N/A | Contraindicated due to risk of tooth damage |
Children aged 8 to under 12 years receive a weight-based dose calculated at 1.2 mg/kg, administered intravenously every 12 hours, with a maximum single dose of 50 mg. There is no loading dose for pediatric patients in this age range. Adolescents aged 12 to under 18 years receive the same 50 mg every 12 hours as adults, also without a specific loading dose as per the standard pediatric protocol.
Missed Dose
Since tigecycline is administered by healthcare professionals in a hospital setting, missed doses are unlikely. However, if you are concerned that a dose may have been missed, speak with your doctor or nurse immediately. They will determine the appropriate course of action and adjust the dosing schedule if necessary.
Overdose
If you are concerned that you may have received too much Tigecycline Accord, tell your doctor or nurse immediately. There is no specific antidote for tigecycline overdose. Treatment would be supportive, focusing on maintaining vital functions and managing symptoms. In the hospital setting, overdose events are carefully monitored and managed by the medical team.
What Are the Side Effects of Tigecycline Accord?
The most common side effects of tigecycline are gastrointestinal: nausea, vomiting, and diarrhea, affecting more than 1 in 10 patients. Other common effects include injection site reactions, dizziness, abdominal pain, and increased liver enzymes. Rare but serious effects include pancreatitis and severe allergic reactions.
Like all medicines, Tigecycline Accord can cause side effects, although not everybody gets them. The side effects are categorized below by how frequently they occur. If you experience any of these side effects, or any other unusual symptoms, tell your healthcare provider immediately.
Pseudomembranous colitis (severe inflammation of the bowel) can occur with most antibiotics, including tigecycline. This presents as severe, persistent, or bloody diarrhea with abdominal pain or fever. This serious condition can develop during or after treatment and requires immediate medical attention.
Very Common
May affect more than 1 in 10 patients
- Nausea
- Vomiting
- Diarrhea
Common
May affect up to 1 in 10 patients
- Abscess (collection of pus), infections
- Decreased blood clotting ability (laboratory values)
- Dizziness, headache
- Vein irritation from injection, including pain, inflammation, swelling, and clotting
- Abdominal pain, indigestion, loss of appetite
- Increased liver enzymes, hyperbilirubinemia (excess bile pigment)
- Itching, skin rash
- Poor or slow wound healing
- Elevated amylase (pancreatic enzyme), elevated blood urea nitrogen (BUN)
- Pneumonia
- Low blood sugar (hypoglycemia)
- Sepsis/septic shock (severe blood infection potentially leading to organ failure)
- Injection site reactions (pain, redness, inflammation)
- Low blood protein levels
Uncommon
May affect up to 1 in 100 patients
- Acute pancreatitis (inflammation of the pancreas, causing severe abdominal pain, nausea, and vomiting)
- Jaundice (yellowing of the skin), liver inflammation (hepatitis)
- Low platelet count (thrombocytopenia), potentially causing increased bleeding and bruising
Rare
May affect up to 1 in 1,000 patients
- Low fibrinogen levels (a protein important for blood clotting)
Not Known
Frequency cannot be estimated from available data
- Anaphylactic/anaphylactoid reactions (ranging from mild to severe allergic reactions, including life-threatening shock with difficulty breathing, drop in blood pressure, and rapid pulse)
- Liver failure
- Stevens-Johnson syndrome (severe skin blistering and peeling)
Contact your doctor or nurse immediately if you experience difficulty breathing, swelling of the face or throat, severe skin rash or blistering, severe abdominal pain with vomiting, or signs of severe diarrhea (bloody or watery stools more than 3 times per day). These may be signs of serious, potentially life-threatening conditions.
The FDA and EMA have both issued warnings regarding an increased risk of death observed in tigecycline-treated patients compared to those receiving other antibiotics in clinical trials. This increased mortality was most notable in patients with hospital-acquired pneumonia, ventilator-associated pneumonia, and diabetic foot infections, which are conditions for which tigecycline is not approved. Healthcare providers weigh this risk against the benefits when prescribing tigecycline.
How Should You Store Tigecycline Accord?
Store unopened vials at room temperature with no special storage requirements. Once reconstituted, the solution should be used within 6 hours at room temperature. Once diluted, the solution is stable for 24 hours at room temperature or 48 hours refrigerated at 2–8°C.
Proper storage of Tigecycline Accord is essential to maintain its efficacy and safety. As this is a hospital-administered medication, storage is typically managed by the pharmacy or clinical staff. However, the following guidelines apply:
- Unopened vials: No special storage conditions are required. Store below the expiry date printed on the vial. The expiry date refers to the last day of the indicated month.
- Reconstituted solution: Chemically and physically stable for up to 6 hours at 20–25°C. From a microbiological standpoint, the product should be used immediately after reconstitution.
- Diluted solution (in infusion bag): Chemically and physically stable for up to 24 hours at 20–25°C and up to 48 hours when refrigerated at 2–8°C. Again, immediate use is recommended from a microbiological perspective.
- Visual inspection: The solution should appear yellow to orange after dissolving the powder. If the solution is any other color (particularly green or black), or if particulate matter is visible, it must be discarded.
Keep this medicine out of the sight and reach of children. Do not dispose of medications via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use, as these measures help protect the environment. Tigecycline Accord is a single-use preparation; any unused solution must be discarded.
What Does Tigecycline Accord Contain?
Each vial of Tigecycline Accord contains 50 mg of tigecycline as the active substance. The inactive ingredients (excipients) are maltose monohydrate, hydrochloric acid, and sodium hydroxide. The product is an orange powder or cake that is reconstituted before use.
Tigecycline Accord is supplied as a powder for solution for infusion in a glass vial. Before administration, the powder appears as an orange-colored powder or cake. The excipients serve specific pharmaceutical purposes: maltose monohydrate acts as a bulking agent and lyoprotectant (protecting the drug during freeze-drying), while hydrochloric acid and sodium hydroxide are used to adjust the pH of the solution.
The product is available in packs of 1 vial or 10 vials. Not all pack sizes may be marketed in every country. Each vial contains a 6% overfill to ensure accurate dosing; when properly reconstituted and 5 mL is withdrawn, this yields exactly 50 mg of the active substance.
Reconstitution and Preparation
The powder should be reconstituted with 5.3 mL of one of the following compatible solutions: sodium chloride 0.9% injection, glucose 5% injection, or Ringer's Lactate injection, to achieve a concentration of 10 mg/mL. The vial should be swirled gently until the active substance dissolves. Then 5 mL of the reconstituted solution should be immediately withdrawn and added to a 100 mL infusion bag or other suitable container for intravenous use.
For the initial 100 mg loading dose, two reconstituted vials are required and their contents are added to a single 100 mL infusion bag. Compatible intravenous solutions for dilution and co-administration include sodium chloride 0.9%, glucose 5%, and Ringer's Lactate. When administered via a Y-site, tigecycline diluted in sodium chloride 0.9% is compatible with amikacin, dobutamine, dopamine, gentamicin, haloperidol, lidocaine, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine, theophylline, and tobramycin.
The marketing authorization holder is Accord Healthcare S.L.U., based in Barcelona, Spain. Manufacturing is carried out at facilities in Poland, Spain, and Greece.
Frequently Asked Questions About Tigecycline Accord
Tigecycline Accord is used to treat two types of serious infections: complicated skin and soft tissue infections (such as deep abscesses, infected wounds, and soft tissue infections extending below the skin) and complicated intra-abdominal infections (such as peritonitis, perforated appendicitis, and intra-abdominal abscesses). It is only prescribed when your doctor considers other antibiotics to be unsuitable, typically due to bacterial resistance or patient-specific factors.
Tigecycline Accord is always administered in a hospital by a doctor or nurse. It is given as an intravenous infusion (a drip into a vein) over 30 to 60 minutes. Adults typically receive a 100 mg loading dose on the first administration, followed by 50 mg every 12 hours. Treatment usually lasts between 5 and 14 days, depending on the severity of the infection and your clinical response.
Clinical trials showed a slightly higher mortality rate in patients treated with tigecycline compared to those treated with other antibiotics. Both the FDA and EMA have issued safety warnings about this finding. As a result, tigecycline is reserved for situations where other antibiotics are considered unsuitable. This may include cases involving multi-drug resistant bacteria, patient allergies to alternative antibiotics, or complex polymicrobial infections that benefit from tigecycline's broad spectrum of activity.
Tigecycline can be used in children aged 8 years and older. Children aged 8 to under 12 years receive a weight-based dose of 1.2 mg/kg every 12 hours (maximum 50 mg per dose). Adolescents aged 12 to 17 years receive 50 mg every 12 hours. The medicine must not be used in children under 8 years because it can cause permanent tooth discoloration and damage to developing teeth, similar to other tetracycline-class antibiotics.
Yes, tigecycline can prolong coagulation tests (PT and INR) and may enhance the effects of anticoagulant medications such as warfarin. If you are taking any blood-thinning medication, your doctor will monitor your coagulation parameters closely throughout your treatment and may need to adjust the dose of your anticoagulant. Always inform your healthcare team about all medications you are taking.
Since tigecycline is administered in a hospital, your medical team is immediately available. Alert your doctor or nurse right away if you experience severe abdominal pain (possible pancreatitis), difficulty breathing or swelling (allergic reaction), severe or bloody diarrhea (possible C. difficile infection), yellowing of the skin or eyes (liver problems), or any other concerning symptoms. Do not wait for these symptoms to improve on their own.
References
- European Medicines Agency (EMA). Tygacil (tigecycline) — Summary of Product Characteristics. Last updated 2024. Available from EMA product database.
- U.S. Food and Drug Administration (FDA). Tygacil (tigecycline) — Prescribing Information. Revised 2023. FDA label database.
- Wyeth Pharmaceuticals / Pfizer. Tygacil EPAR — European Public Assessment Report. European Medicines Agency, 2006 (updated 2024).
- Babinchak T, Ellis-Grosse E, Dartois N, Rose GM, Loh E. The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data. Clin Infect Dis. 2005;41(Suppl 5):S354–S367.
- Breedt J, Teras J, Gardovskis J, et al. Safety and efficacy of tigecycline in treatment of skin and skin structure infections: results of a double-blind phase 3 comparison study with vancomycin-aztreonam. Antimicrob Agents Chemother. 2005;49(11):4658–4666.
- Cai Y, Wang R, Liang B, Bai N, Liu Y. Systematic review and meta-analysis of the effectiveness and safety of tigecycline for treatment of infectious disease. Antimicrob Agents Chemother. 2011;55(3):1162–1172.
- Prasad P, Sun J, Danner RL, Natanson C. Excess deaths associated with tigecycline after approval based on noninferiority trials. Clin Infect Dis. 2012;54(12):1699–1709.
- World Health Organization (WHO). Model List of Essential Medicines, 23rd list. Geneva: WHO; 2023.
- British National Formulary (BNF). Tigecycline monograph. National Institute for Health and Care Excellence (NICE). Accessed 2025.
- Infectious Diseases Society of America (IDSA). Practice guidelines for the diagnosis and management of skin and soft tissue infections. Clin Infect Dis. 2014;59(2):e10–e52.
Editorial Team
This article was written and medically reviewed by the iMedic Medical Editorial Team, which includes board-certified specialists in infectious disease, clinical pharmacology, and antimicrobial therapy. Our editorial process follows international guidelines from the WHO, EMA, and FDA, with all medical claims supported by Level 1A evidence from systematic reviews and randomized controlled trials.
Authored by specialists in infectious disease and clinical pharmacology with expertise in antimicrobial therapy and drug safety
Reviewed by the iMedic Medical Review Board following GRADE framework and international clinical guidelines
All content on iMedic is evidence-based, peer-reviewed, and independent of commercial funding. We follow the GRADE framework for evaluating evidence quality and adhere to international medical guidelines. Read our full editorial standards.