Tigecycline Panpharma
Glycylcycline antibiotic for complicated infections — 50 mg powder for solution for infusion
Quick Facts About Tigecycline Panpharma
Key Takeaways About Tigecycline Panpharma
- Reserve antibiotic: Tigecycline is used only when alternative antibiotics are considered unsuitable, because of a slightly increased mortality risk observed in pooled clinical trial data
- Broad-spectrum activity: Covers gram-positive, gram-negative, and anaerobic bacteria, including MRSA, VRE, and many ESBL-producing Enterobacteriaceae, but is not active against Pseudomonas aeruginosa or Proteus species
- Hospital-only administration: Always given as a 30–60 minute intravenous infusion by a healthcare professional, after reconstitution and dilution of the 50 mg powder
- Not for children under 8: Contraindicated in children under 8 years due to the risk of permanent tooth discoloration and effects on developing bones, consistent with the tetracycline drug class
- Pancreatitis warning: Severe abdominal pain, persistent nausea, or elevated amylase during treatment may indicate acute pancreatitis and require the drug to be stopped
What Is Tigecycline Panpharma and What Is It Used For?
Tigecycline Panpharma 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 from 8 years of age, and is reserved for situations where other antibiotics are considered unsuitable.
Tigecycline Panpharma contains the active substance tigecycline, the first member of the glycylcycline class of antibiotics. Glycylcyclines were developed as structural derivatives of the older tetracyclines, specifically engineered to overcome the two most important mechanisms of tetracycline resistance: efflux pumps, which actively pump tetracyclines out of bacterial cells, and ribosomal protection proteins, which block tetracycline binding to the ribosome. By adding a bulky N,N-dimethylglycylamido side chain to the tetracycline scaffold, tigecycline evades both resistance mechanisms while retaining potent activity against sensitive organisms.
Mechanistically, tigecycline binds reversibly to the 30S ribosomal subunit of bacteria, occupying a site that prevents the entry of aminoacyl-tRNA molecules into the A site of the ribosome. Without aminoacyl-tRNA binding, the bacterium cannot add new amino acids to the growing peptide chain, and protein synthesis is arrested. This bacteriostatic effect halts bacterial replication and gives the patient’s immune system the time it needs to clear the infection.
Tigecycline Panpharma has a notably broad antimicrobial spectrum. It is active against many clinically important gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and streptococci. Among gram-negative organisms, it covers Escherichia coli (including extended-spectrum beta-lactamase [ESBL] producers), Klebsiella pneumoniae, Enterobacter species, Citrobacter species, and many strains of Acinetobacter baumannii. It also has significant activity against anaerobes such as Bacteroides fragilis and Clostridium perfringens. Clinically relevant gaps in the spectrum include Pseudomonas aeruginosa, Proteus mirabilis, Providencia species, and Morganella morganii, which are intrinsically less susceptible.
Tigecycline Panpharma is licensed for two specific indications. 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 randomised clinical trial data did not support efficacy in this high-risk population. Complicated intra-abdominal infections (cIAI) include intra-abdominal abscesses, perforated appendicitis, peritonitis, and infections following abdominal surgery, where the infection has spread beyond a single organ within the abdomen.
It is critical to understand that tigecycline is not a first-line antibiotic. The European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and major clinical guidelines all recommend restricting tigecycline to situations in which other antibiotics are not suitable. This restriction reflects meta-analyses of clinical trials showing a small but consistent excess mortality in tigecycline-treated patients compared with comparator antibiotic regimens, even in indications for which the drug is approved.
Tigecycline’s ability to overcome efflux pumps and ribosomal protection makes it a valuable option against multi-drug resistant organisms. However, it should be prescribed judiciously as part of antibiotic stewardship programmes, with the goal of preserving its efficacy against future resistant infections while minimising mortality risk in individual patients.
What Should You Know Before Receiving Tigecycline Panpharma?
Before receiving Tigecycline Panpharma, inform your doctor about any allergies to tigecycline or tetracycline-class antibiotics, liver problems, bleeding disorders, pregnancy, or breastfeeding. The medicine has several important contraindications and cautions that require careful clinical assessment.
Contraindications
Tigecycline Panpharma must not be used if you are allergic (hypersensitive) to tigecycline or to any of the other ingredients in the product. Because tigecycline shares a core tetracycline backbone, there is a theoretical risk of cross-sensitivity with tetracycline-class antibiotics such as doxycycline, minocycline, oxytetracycline, and tetracycline. Patients with a documented history of anaphylaxis, Stevens–Johnson syndrome, or toxic epidermal necrolysis to any tetracycline should not receive tigecycline.
The medicine is also contraindicated in children younger than 8 years of age because of the risk of permanent dental discolouration, enamel hypoplasia, and potential effects on developing skeletal bone, which are well-documented class effects of tetracyclines. There is no established role for tigecycline in infants or young children.
Warnings and Precautions
Several important safety considerations must be reviewed with your healthcare team before you start Tigecycline Panpharma. Tell your doctor or nurse if any of the following applies to you:
- Poor wound healing: Tigecycline has been associated with impaired wound healing, including a higher rate of wound dehiscence after abdominal surgery in some studies. If you have non-healing wounds or are recovering from a recent operation, this should be factored into the choice of antibiotic.
- Diarrhoea and C. difficile: If you develop diarrhoea during or in the weeks after treatment, tell your doctor immediately. Do not take anti-diarrhoeal medicines on your own, as severe or bloody diarrhoea can indicate Clostridioides difficile-associated colitis, a potentially life-threatening complication of any antibiotic therapy that requires specific treatment and, in some cases, surgery.
- Acute pancreatitis: Cases of acute pancreatitis, including fatal cases, have been reported with tigecycline. The diagnosis should be considered in any patient who develops severe, persistent abdominal pain, nausea, vomiting, or elevated serum amylase/lipase during therapy.
- Liver problems: Increases in liver enzymes are common, and rare cases of jaundice, hepatitis, and liver failure have been reported. Patients with severe hepatic impairment (Child–Pugh C) require a dose reduction, and liver function should be monitored during treatment.
- Biliary obstruction (cholestasis): Tigecycline is eliminated mainly via the bile. Conditions that impair bile flow may increase systemic exposure to the drug and prolong elimination.
- Coagulation disorders: Tigecycline can prolong prothrombin time (PT), activated partial thromboplastin time (aPTT), and the international normalised ratio (INR), and has been associated with decreased fibrinogen levels. If you have a bleeding disorder or are taking anticoagulants, clotting parameters should be monitored.
- Super-infection: Prolonged antibiotic therapy may allow overgrowth of resistant bacteria or fungi (for example Candida). If new signs of infection appear during treatment, additional investigations are needed.
Seek immediate medical attention if you develop symptoms of a severe allergic reaction (difficulty breathing, swelling of the face, lips, tongue, or throat, rapid heartbeat, or widespread rash), severe persistent abdominal pain with nausea and vomiting (possible pancreatitis), yellowing of the eyes or skin (possible liver injury), or severe, watery, or bloody diarrhoea. Regulatory agencies have issued warnings about an increased mortality risk with tigecycline, so close clinical monitoring is essential throughout therapy.
Use in Children
Tigecycline Panpharma may be used in children aged 8 years and older when alternative treatments are considered unsuitable. It must not be used in children under 8 years of age because tigecycline, like other tetracyclines, can bind to calcium in developing teeth and bones. This binding can lead to permanent yellow-grey-brown discolouration of the teeth, enamel hypoplasia, and reversible reductions in bone growth rate. In children aged 8 to under 12 years, there is also a lack of efficacy and safety data specifically for complicated infections, so treatment decisions are made on an individualised basis with input from a paediatric infectious diseases specialist.
Pregnancy and Breastfeeding
Tigecycline Panpharma may be harmful to an unborn baby. If you are pregnant, think you may be pregnant, or are planning a pregnancy, discuss this with your doctor before starting treatment. Animal studies have shown that tigecycline crosses the placenta and has been associated with decreased fetal weight and effects on bone development. Tigecycline is expected to cause fetal harm similar to other tetracyclines, which can affect fetal tooth and bone development when used in the second half of pregnancy.
It is not known whether tigecycline passes into human breast milk in clinically significant amounts, although animal data suggest some excretion. Because of the potential for serious adverse reactions in breast-fed infants, women who are breastfeeding are usually advised to pause breastfeeding during tigecycline therapy and for a short period after the last dose. The decision should be individualised based on the severity of infection and the availability of alternative antibiotics.
Use in Older Adults
No dose adjustment is required in elderly patients on the basis of age alone. However, older adults may be more likely to have reduced liver or kidney function, multiple concomitant medications, and pre-existing conditions that increase the risk of adverse effects. Careful clinical monitoring is therefore warranted, particularly for pancreatitis, liver injury, and coagulation changes.
Driving and Operating Machinery
Tigecycline may cause dizziness, which could impair the ability to drive or operate machinery. Because tigecycline is administered in hospital, this is usually managed as part of routine inpatient care. If you continue to feel dizzy or unwell after discharge, avoid driving or operating machinery until the symptoms resolve.
Tigecycline Panpharma contains less than 1 mmol (23 mg) of sodium per vial, meaning it is essentially sodium-free. This is relevant for patients on a strict sodium-controlled diet, although the sodium load from the accompanying intravenous fluid used for dilution should also be considered.
How Does Tigecycline Panpharma Interact with Other Drugs?
Tigecycline can interact with oral anticoagulants (such as warfarin), hormonal contraceptives, and the immunosuppressants tacrolimus and ciclosporin. It can also affect coagulation laboratory values. Always inform your healthcare team about every medicine and supplement you take.
Tigecycline is not significantly metabolised by cytochrome P450 enzymes and does not inhibit or induce the major CYP isoenzymes in clinically relevant concentrations. As a result, classical pharmacokinetic drug interactions via CYP450 are uncommon. However, several clinically important interactions occur through pharmacodynamic or non-CYP mechanisms, as summarised below.
Major Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Warfarin and other oral anticoagulants | Tigecycline prolongs PT/INR and aPTT; enhanced anticoagulant effect with increased bleeding risk | Monitor INR closely during and after treatment; adjust anticoagulant dose as needed |
| Tacrolimus | Case reports suggest tigecycline may increase tacrolimus blood levels, enhancing immunosuppressive toxicity | Monitor tacrolimus trough levels and renal function; adjust tacrolimus dose if required |
| Ciclosporin (cyclosporine) | May increase ciclosporin exposure, with potential for nephrotoxicity and neurotoxicity | Check ciclosporin trough levels; titrate dose based on therapeutic drug monitoring |
| Live bacterial vaccines (e.g. typhoid, BCG) | Tigecycline may reduce the immune response to live attenuated bacterial vaccines | Avoid administering live bacterial vaccines during therapy and for a suitable interval afterwards |
Other Important Interactions
| Interacting Drug | Effect | Clinical Action |
|---|---|---|
| Combined oral contraceptives | Tigecycline, like other tetracyclines, may theoretically reduce the efficacy of hormonal contraception | Use an additional non-hormonal contraceptive method (e.g. barrier) during and for 7 days after treatment |
| Laboratory coagulation tests | Tigecycline may prolong aPTT and PT, affecting the interpretation of coagulation monitoring | Inform the laboratory of current tigecycline therapy and interpret clotting results in this context |
| Bactericidal antibiotics (e.g. beta-lactams) | Theoretical antagonism because tigecycline is bacteriostatic and may slow bacterial replication needed for bactericidal action | In empirical combinations, consider clinical context; routinely combined without evidence of inferior outcomes |
Because tigecycline is administered intravenously in hospital, the medical team usually has a complete and up-to-date list of your concurrent medicines and can anticipate interactions before they cause harm. Nevertheless, it is important to disclose every medicine you are taking, including over-the-counter drugs, herbal products, and dietary supplements, so that interactions and duplications can be reviewed.
What Is the Correct Dosage of Tigecycline Panpharma?
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. Paediatric doses are lower and weight-based. Dose adjustment is required only for severe liver impairment.
Tigecycline Panpharma is always administered by a trained healthcare professional in a clinical setting. The medicine is supplied as an orange powder in a glass vial, which is reconstituted and then diluted in an infusion bag before being given intravenously over a period of 30 to 60 minutes. The preparation process must be performed under aseptic conditions according to the local pharmacy protocol to ensure sterility and correct dosing.
Adults
Standard Adult Dosing
Loading dose: 100 mg intravenously as a single dose on the first administration
Maintenance dose: 50 mg every 12 hours
Infusion duration: 30 to 60 minutes per dose
Treatment duration: Typically 5 to 14 days, determined by the treating physician on the basis of infection severity, clinical response, and microbiological results
For patients with severe hepatic impairment (Child–Pugh class C), the maintenance dose should be reduced to 25 mg every 12 hours after the standard 100 mg loading dose. No dose adjustment is required for mild to moderate hepatic impairment (Child–Pugh A or B), for renal impairment, or for patients on dialysis, because tigecycline is eliminated primarily via the bile and not the kidneys.
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 kg | 50 mg | 50 mg | Every 12 hours |
| 12 to <18 years, ≥50 kg | 50 mg (adult dose) | 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 every 12 hours, with a maximum single dose of 50 mg. Adolescents aged 12 to under 18 years receive 50 mg every 12 hours, the same dose as adults. A loading dose is not routinely used in paediatric practice; instead, the maintenance dose is started directly. Paediatric use should be reserved for situations in which alternative antibiotics are clearly unsuitable, and it should be guided by a paediatric infectious diseases specialist.
Missed Dose
Because tigecycline is administered by the hospital team, missed doses are unusual. If a dose is delayed or missed for logistical reasons, the medical staff will determine the appropriate action. In most situations, the missed dose is given as soon as possible and the regular 12-hour schedule is resumed from that point. Two doses should never be administered within a short time period to “catch up”, because this would produce supra-therapeutic peak concentrations.
Overdose
There is no specific antidote for tigecycline overdose. Management is supportive, based on close clinical observation and symptomatic care for whatever adverse effects develop. The most common clinical consequences of overdose would be expected to be intensified gastrointestinal side effects (particularly nausea and vomiting) and increases in liver enzymes. Tigecycline is not removed by haemodialysis. If an overdose is suspected, the medical team will monitor vital signs, liver and pancreatic enzymes, and coagulation parameters.
Reconstitution and Administration Summary
The 50 mg vial is reconstituted with 5.3 mL of a compatible diluent (0.9% sodium chloride, 5% glucose, or Ringer’s Lactate injection) to give a 10 mg/mL solution. Exactly 5 mL of this reconstituted solution, corresponding to 50 mg of tigecycline, is then withdrawn and added to a 100 mL infusion bag, giving a final concentration of approximately 1 mg/mL for infusion. For a 100 mg loading dose, the contents of two reconstituted vials are pooled into a single 100 mL infusion bag. The infusion must be completed within the compatibility time-window specified in the product information.
What Are the Side Effects of Tigecycline Panpharma?
The most common side effects of Tigecycline Panpharma are gastrointestinal: nausea, vomiting, and diarrhoea, each affecting more than 1 in 10 patients. Less frequent effects include injection site reactions, dizziness, abdominal pain, and elevated liver enzymes. Rare but serious reactions include acute pancreatitis, severe allergic reactions, and liver failure.
Like all medicines, Tigecycline Panpharma can cause side effects, although not everyone will experience them. The side effects below are grouped according to standard MedDRA frequency categories used across the European Union. Patients should report any new or worsening symptoms during treatment, as early recognition can prevent serious complications.
Antibiotic-associated colitis (Clostridioides difficile infection) can occur during or after treatment with almost any antibiotic, including tigecycline. It usually presents as severe, persistent, or bloody diarrhoea, often with abdominal pain, fever, and dehydration. In severe cases it can progress to toxic megacolon or bowel perforation and may require specific antimicrobial therapy and, occasionally, surgery.
Very Common
May affect more than 1 in 10 patients
- Nausea
- Vomiting
- Diarrhoea
Common
May affect up to 1 in 10 patients
- Abscess (collection of pus), secondary infections
- Decreased blood clotting ability (prolonged PT/aPTT, decreased fibrinogen)
- Dizziness, headache
- Phlebitis (vein inflammation from infusion), including pain, redness, and swelling
- Abdominal pain, indigestion (dyspepsia), loss of appetite
- Increased liver enzymes (ALT, AST) and raised bilirubin
- Itching (pruritus), skin rash
- Poor or delayed wound healing
- Elevated amylase and blood urea nitrogen (BUN)
- Pneumonia
- Low blood sugar (hypoglycaemia)
- Sepsis or septic shock (underlying infection, severity)
- Injection site reactions (pain, redness, inflammation)
- Low blood protein (hypoproteinaemia)
Uncommon
May affect up to 1 in 100 patients
- Acute pancreatitis (severe abdominal pain with raised amylase/lipase)
- Jaundice (yellowing of the skin or eyes), drug-induced hepatitis
- Low platelet count (thrombocytopenia) with bruising or bleeding tendency
- Elevated INR in patients not taking anticoagulants
Rare
May affect up to 1 in 1,000 patients
- Low fibrinogen levels (hypofibrinogenaemia), important for blood clotting
Not Known
Frequency cannot be estimated from available data
- Anaphylactic or anaphylactoid reactions, including life-threatening shock with difficulty breathing, low blood pressure, and rapid pulse
- Liver failure
- Severe cutaneous reactions, including Stevens–Johnson syndrome and drug reaction with eosinophilia and systemic symptoms (DRESS)
- Tooth discolouration when used in individuals below 8 years of age
Tell your doctor or nurse urgently if you develop difficulty breathing, wheeze, swelling of the face, lips, tongue, or throat, a severe rash or skin blistering, severe abdominal pain with persistent vomiting, yellow discolouration of the skin or eyes, unusual bruising or bleeding, or severe, watery, or bloody diarrhoea. These may be signs of serious, potentially life-threatening reactions that require the drug to be stopped and specific treatment to be started.
Both the FDA and EMA have issued warnings about a higher risk of death observed in tigecycline-treated patients compared with patients receiving other antibiotics in pooled clinical trial analyses. The excess mortality signal was most pronounced in patients with hospital-acquired pneumonia (particularly ventilator-associated pneumonia) and diabetic foot infections, which are not approved indications, but a smaller signal was also observed in approved indications. The clinical team weighs this risk against the benefits of treatment in every individual patient and considers alternative antibiotics when appropriate.
Reporting Side Effects
If you experience any side effects, tell your doctor, pharmacist, or nurse. This includes any possible side effects not listed above. You can also report side effects directly to your national pharmacovigilance system (for example, the EMA’s EudraVigilance database, the FDA’s MedWatch programme, or the UK’s Yellow Card Scheme). Reporting side effects helps regulators gather more information on the safety of this medicine in everyday clinical use.
How Should Tigecycline Panpharma Be Stored?
Unopened vials of Tigecycline Panpharma are stored at room temperature. After reconstitution, the solution should be used immediately, and after dilution it is chemically and physically stable for up to 24 hours at 20–25°C or 48 hours refrigerated at 2–8°C. Never use the medicine after the expiry date or if the reconstituted solution is discoloured.
Because Tigecycline Panpharma is a hospital-administered medicine, storage is usually managed by the hospital pharmacy or ward staff rather than by the patient. However, the product information specifies the following conditions:
- Unopened vials: No special storage conditions are required in the package as supplied. Do not use the vial after the expiry date printed on the carton; the expiry refers to the last day of the stated month.
- Reconstituted solution in the vial: Chemical and physical stability has been demonstrated for up to 6 hours at 20–25°C. From a microbiological standpoint, the reconstituted solution should be used immediately unless reconstitution was performed under controlled and validated aseptic conditions.
- Diluted solution in the infusion bag: Chemical and physical stability is demonstrated for up to 24 hours at 20–25°C and up to 48 hours when refrigerated at 2–8°C, provided that the reconstituted solution is transferred to the infusion bag within 6 hours of reconstitution. If storage is required, refrigeration is preferred.
- Visual inspection: After reconstitution, the solution should be yellow to orange and essentially free from visible particles. If the solution is a different colour (for example green or black) or contains particulate matter, the vial must be discarded and not used.
Keep this medicine out of the sight and reach of children. Do not throw away any medicines via wastewater or household waste. Unused vials and partly used preparations must be disposed of in accordance with local hospital waste policies, which typically include returning them to the pharmacy for safe destruction. These measures help to protect the environment and prevent the spread of antibiotic-resistant bacteria in the community.
What Does Tigecycline Panpharma Contain?
Each vial of Tigecycline Panpharma contains 50 mg of the active substance tigecycline. The inactive ingredients (excipients) include lactose monohydrate (or equivalent carbohydrate carrier), with hydrochloric acid and sodium hydroxide used for pH adjustment. The product is an orange powder that is reconstituted and diluted before use.
Tigecycline Panpharma is supplied as a sterile powder for solution for infusion in a single-use glass vial. Before reconstitution, the product appears as an orange-coloured powder or lyophilised cake. Each vial contains an overfill to ensure that the full nominal dose of 50 mg of tigecycline is delivered after reconstitution and withdrawal according to the pharmacy protocol.
The active substance, tigecycline, belongs to the glycylcycline class and has the chemical formula C29H39N5O8 with a molecular weight of approximately 585.65 g/mol. It is a yellow to orange solid that is slightly soluble in water. The excipients, which do not have any direct therapeutic effect, are included for specific pharmaceutical reasons: the carbohydrate carrier (typically lactose monohydrate or a comparable sugar) acts as a bulking agent and lyoprotectant during freeze-drying, while hydrochloric acid and sodium hydroxide are used to adjust the pH of the reconstituted solution to a value compatible with intravenous administration.
The product is presented in packs containing 1 vial or 10 vials. Not all pack sizes may be marketed in every country. The marketing authorisation holder is Panpharma S.A., a French pharmaceutical company specialising in sterile injectable medicines for hospital use. Manufacturing sites are located in Europe and are audited regularly by national and European medicines regulators to ensure compliance with good manufacturing practice (GMP).
What Tigecycline Panpharma Looks Like
Tigecycline Panpharma is supplied as a sterile, orange, freeze-dried (lyophilised) powder or cake in a clear glass vial sealed with a rubber stopper and an aluminium cap. After reconstitution with a compatible diluent, the solution should be yellow to orange and free from visible particles. Any discolouration beyond the normal yellow-to-orange range, or any sign of particulate matter, requires the vial to be discarded.
IV Compatibility
When diluted in 0.9% sodium chloride, Tigecycline Panpharma has been shown to be compatible for Y-site co-administration with many commonly used intravenous medicines in the intensive care setting, including amikacin, dobutamine, dopamine, gentamicin, haloperidol, lidocaine, metoclopramide, morphine, noradrenaline (norepinephrine), piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine, theophylline, and tobramycin. Compatibility must always be verified locally using up-to-date pharmacy references before any medicines are co-infused.
Frequently Asked Questions About Tigecycline Panpharma
Tigecycline Panpharma 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 prescribed only when the treating physician considers other antibiotics to be unsuitable, typically because of multi-drug resistance or patient-specific factors.
Tigecycline Panpharma is always administered in hospital by a doctor or nurse. It is given as an intravenous infusion (a drip into a vein) over 30 to 60 minutes after reconstitution and dilution in a compatible intravenous fluid. 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 the clinical response.
Tigecycline Panpharma contains the same active substance — tigecycline — as the originator brand Tygacil and other generic brands such as Tigecycline Accord, Tigecycline EQL Pharma, and Tigecycline Viatris. All approved tigecycline products must demonstrate therapeutic equivalence to the reference product, meaning they are expected to have the same efficacy and safety profile at the same doses. The main differences between brands relate to the manufacturer, pack sizes, and excipients, rather than to the active ingredient itself.
Pooled analyses of clinical trials have shown a small but statistically significant increase in mortality in patients treated with tigecycline compared with those treated with other antibiotics. Both the FDA and EMA have issued safety warnings. As a result, tigecycline is reserved for situations where other antibiotics are unsuitable, for example when the infecting bacteria are resistant to first-line agents, when the patient is allergic to alternative antibiotics, or when broad anaerobic and gram-positive coverage is needed and no better option exists.
Tigecycline Panpharma may be used in children aged 8 years and older when alternative treatments are considered unsuitable. 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 tetracyclines can cause permanent tooth discolouration and affect bone growth in this age group.
Yes. Tigecycline can prolong coagulation tests, including the prothrombin time (PT), activated partial thromboplastin time (aPTT), and the international normalised ratio (INR). It can also enhance the anticoagulant effect of medicines such as warfarin and increase the risk of bleeding. If you are taking any blood-thinning medication, your doctor will monitor your coagulation parameters closely throughout treatment and may need to adjust the anticoagulant dose. Always inform your healthcare team about every medicine you take.
Because Tigecycline Panpharma is administered in hospital, your medical team is immediately available. Alert your doctor or nurse straight away if you experience severe abdominal pain (possible pancreatitis), difficulty breathing, swelling of the face or throat (possible allergic reaction), severe or bloody diarrhoea (possible C. difficile infection), yellow discolouration of the skin or eyes (possible liver injury), unusual bruising or bleeding, or any other concerning symptom. Do not wait for these symptoms to improve on their own, as some reactions can progress rapidly.
References
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- U.S. Food and Drug Administration (FDA). Tygacil (tigecycline) — Prescribing Information. Revised 2024. FDA label database.
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- 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.
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- 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). AWaRe Classification of Antibiotics for Evaluation and Monitoring of Use, 2023 revision. Geneva: WHO; 2023.
- 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 2026.
- 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.
- Solomkin JS, Mazuski JE, Bradley JS, et al. Diagnosis and management of complicated intra-abdominal infection in adults and children: guidelines by the Surgical Infection Society and the Infectious Diseases Society of America. Clin Infect Dis. 2010;50(2):133–164.
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 stewardship. 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 randomised controlled trials where available.
Authored by specialists in infectious disease and clinical pharmacology with expertise in antimicrobial therapy, drug safety, and antimicrobial stewardship in hospital settings.
Reviewed by the iMedic Medical Review Board following the GRADE framework and current EMA, FDA, IDSA, and WHO 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.