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Brand Name


Generic Name


Therapeutic Segment

Antibiotic (Tetracycline)

Available as



Tigecycline for injection, USP is a tetracycline class antibacterial for intravenous infusion. The chemical name of tigecycline is (4S, 4aS, 5aR,12aS)-9-[2-(tert-butylamino) acetamido]-4, 7-bis(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-3, 10, 12, 12a-tetrahydroxy-1, 11-dioxo-2-naphthacenecarboxamide. Its empirical formula is C29H39N5O8 and the molecular weight is 585.65.

Each vial contains:
Tigecycline U.S.P. ……. 50mg
(Product Specs.: U.S.P.)


Pharmacodynamic properties:
Pharmacotherapeutic group: Antibacterials for systemic use tetracyclines.
ATC code: J01AA12.

Mechanism of action:
Tigecycline inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. In general, tigecycline is considered bacteriostatic; however, tigecycline has demonstrated bactericidal activity against isolates of S. pneumoniae and L. pneumophila.

Gram-positive bacteria:

  • Enterococcus faecalis
  • Staphylococcus aureus
  • Streptococcus agalactiae
  • Streptococcus anginosus group
  • Streptococcus intermedius
  • Streptococcus constellatus
  • Streptococcus pneumoniae
  • Streptococcus pyogenes
  • Enterococcus avium
  • Enterococcus casseliflavus
  • Enterococcus faecalis
  • Enterococcus faecium
  • Enterococcus gallinarum
  • Listeria monocytogenes
  • Staphylococcus epidermidis
  • Staphylococcus haemolyticus
  • Mycobacterium abscessus
  • Mycobacterium fortuitum

Gram-negative bacteria:

  • Citrobacter freundii
  • Enterobacter cloacae
  • Escherichia coli
  • Haemophilus influenzae
  • Klebsiella oxytoca
  • Klebsiella pneumoniae
  • Legionella pneumophila
  • Acinetobacter baumannii
  • Aeromonas hydrophila
  • Citrobacter koseri
  • Enterobacter aerogenes
  • Haemophilus influenzae
  • Haemophilus parainfluenzae
  • Pasteurella multocida
  • Serratia marcescens
  • Stenotrophomonas maltophilia

Anaerobic bacteria:

  • Bacteroides fragilis
  • Bacteroides thetaiotaomicron
  • Bacteroides uniformis
  • Bacteroides vulgatus
  • Clostridium perfringens
  • Peptostreptococcus micros
  • Bacteroides distasonis
  • Bacteroides ovatus
  • Peptostreptococcus spp.
  • Porphyromonas spp.
  • Prevotella spp.

Pharmacokinetic properties

Tigecycline is administered intravenously and therefore has 100 % bioavailability.

The in vitro plasma protein binding of tigecycline ranges from approximately 71% to 89% at concentrations (0.1 to 1.0 mcg/mL). The steady-state volume of distribution of tigecycline averaged 500 to 700 L (7 to 9 L/kg), indicating tigecycline is extensively distributed beyond the plasma volume and into the tissues.

On average, it is estimated that less than 20 % of tigecycline is metabolised before excretion.

The recovery of total radioactivity in feces and urine following administration of 14C -tigecycline indicates that 59% of the dose is eliminated by biliary/fecal excretion, and 33% is excreted in urine. Approximately 22% of the total dose is excreted as unchanged tigecycline in urine. The total clearance of tigecycline is 24 L/h after intravenous infusion. Renal clearance is approximately 13 % of total clearance.

Specific Populations
Renal impairment
The pharmacokinetic profile of tigecycline was not significantly altered in any of the renally impaired patient nor it was removed by hemodialysis. No dosage adjustment is required.

Hepatic impairment
The single-dose pharmacokinetic disposition of tigecycline was not altered in patients with mild hepatic impairment. However, systemic clearance of tigecycline was reduced by 25% and the half-life of tigecycline was prolonged by 23% in patients with moderate hepatic impairment and Systemic clearance reduced by 55%, and the half-life prolonged by 43% in patients with severe hepatic impairment.

No significant differences in pharmacokinetics were observed, therefore no dosage adjustment is necessary based on age.


  • Complicated Skin and Skin Structure Infections
  • Complicated Intra-abdominal Infections
  • Community-Acquired Bacterial Pneumonia


An initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of tigecycline for injection should be administered over approximately 30 to 60 minutes every 12 hours.

Avoid use of tigecycline in pediatric patients unless no alternative antibacterial drugs are available. Under these circumstances, the following doses are suggested:

  • Pediatric patients aged 8 to 11 years should receive 1.2 mg/kg of tigecycline every 12 hours intravenously to a maximum dose of 50 mg of tigecycline every 12 hours.
  • Pediatric patients aged 12 to 17 years should receive 50 mg of tigecycline every 12 hours.

Patients with Hepatic impairment:
In patients with severe hepatic impairment the initial dose should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Should be treated with caution and monitored for treatment response.

Method of administration:
Tigecycline is administered only by intravenous infusion over 30 to 60 minutes.

Each vial of tigecycline for injection should be reconstituted with 5.3 mL of 0.9% Sodium Chloride Injection, USP, 5% Dextrose Injection, USP, or Lactated Ringer’s Injection, USP to achieve a concentration of 10 mg/mL of tigecycline. Each vial contains a 6% overage. Thus, 5 mL of reconstituted solution is equivalent to 50 mg of the drug. Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL intravenous bag for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded.

Tigecycline for injection is contraindicated for use in patients who have known hypersensitivity to tigecycline. Reactions have included anaphylactic reactions.


Product contains lactose.
Possibility of untoward reaction for patient with celiac disease relating to the use of such excipients.

Anaphylactic Reactions
Anaphylactic reactions have been reported with nearly all antibacterial agents, including tigecycline, and may be life-threatening.

Hepatic Adverse Effects
Increases in total bilirubin concentration, prothrombin time and transaminases have been seen in patients treated with tigecycline. significant hepatic dysfunction and hepatic failure have been reported in patients. Hepatic dysfunction may occur after the drug has been discontinued.

Acute pancreatitis, including fatal cases, has occurred in association with tigecycline treatment. Patients usually improve after tigecycline discontinuation. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis.

Monitoring of Blood Coagulation Parameters
Hypofibrinogenemia has been reported in patients treated with tigecycline for injection. Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecycline for injection.

Clostridioides difficile Associated Diarrhea
Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including tigecycline for injection, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Sepsis/Septic Shock in Patients with Intestinal Perforation
Monotherapy with tigecycline should be avoided in patients with complicated intraabdominal infections (cIAI) secondary to clinically apparent intestinal perforation.


Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin. Concomitant administration of tigecycline (100 mg followed by 50 mg every 12 hours) and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40% and 23%, an increase in Cmax by 38% and 43% and an increase in AUC by 68% and 29%, respectively.

Calcineurin Inhibitors
Concomitant use of tigecycline for injection and calcineurin inhibitors such as tacrolimus or cyclosporine may lead to an increase in serum trough concentrations of the calcineurin inhibitors.

Oral Contraceptives
Concurrent use of antibacterial drugs with oral contraceptives may render oral contraceptives less effective.

Very Common:

nausea, vomiting, diarrhea.

Sepsis/septic shock, pneumonia, abscess, infections, prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT), hypoglycaemia, hypoproteinaemia, dizziness, phlebitis, abdominal pain, dyspepsia, anorexia, elevated aspartate aminotransferase (AST) in serum, and elevated alanine aminotransferase (ALT) in serum, hyperbilirubinaemia, pruritus, rash, impaired healing, injection site reaction, headache.

Thrombocytopenia, increased international normalised ratio (INR), thrombophlebitis, acute pancreatitis, jaundice, liver injury, mostly cholestatic, injection site inflammation, injection site pain, injection site oedema, injection site phlebitis.

Hypofibrinogenaemia Not Known: Anaphylaxis/ anaphylactoid reactions, hepatic failure, severe skin reactions, including Stevens-Johnson Syndrome.


May cause permanent discoloration of deciduous teeth and reversible inhibition of bone growth when administered during the second and third trimesters of pregnancy. Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.

It is not known whether tigecycline has an effect on the breastfed infant or on milk production. Tigecycline has low oral bioavailability; therefore, infant exposure is expected to be low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tigecycline before using it.

No specific information is available on the treatment of overdosage with tigecycline. Intravenous administration of tigecycline for injection at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting. Tigecycline is not removed in significant quantities by hemodialysis.

The following drugs should not be administered simultaneously through the same Y-site as tigecycline for injection: amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole, haloperidol, and omeprazole.

Shelf life:
2 years.

Once reconstituted and diluted in the bag or other suitable infusion container (e.g., glass bottle), tigecycline should be used immediately.

Tigecycline for injection, USP should be stored at 20° to 25°C. The reconstituted solution may be stored at room temperature (not to exceed 25°C) for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag).
Tigecycline for injection mixed with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP may be stored refrigerated at 2° to 8°C for up to 48 hours following immediate transfer of the reconstituted solution into the intravenous bag.


  • Add 5ml soride 0.9% Injection in vial to prepare solution.
  • Protect from heat, sunlight and moisture store below 25°C.
  • Keep out of the reach of children.
  • Precautions: For single use only,
  • discard unused portion.
  • To be sold on prescription of a registered medical practitioner only.
  • “Product Contains Lactose”

Tigecycline for injection, USP is supplied in a single pack of 1 tubular glass vial of 8mL plus 1 ampoule of SORIDE 0.9% Injection U.S.P. as solvent.