DRUG INFORMATION QUERY ON TIGECYCLINE

Dr. Vijetha, Assistant doctor, Department of General Surgery, SSIMS & RC wants
to know in detail about the drug TIGECYCLINE.
STEP 1: SECURE THE DEMOGRAPHICS OF REQUESTER.
A General Surgeon wants to know about the drug Tigecycline and contacted by
direct access to the Drug information Centre.
STEP 2: OBTAIN THE BACKGROUND INFORMATION
Dr. Vijetha wants to know in detail about the drug Tigecycline.
STEP 3: DETERMINE AND CATEGORISE THE ULTIMATE QUESTION
Dr. Vijetha wants to know about the Brand name, Generic name, MOA,
Pharmacokinetics, Drug price, Available brands, Indication, Dose, Dosage
adjustment, Contraindications, Warnings, ADRs, Drug interactions and FDA
approval date of the drug Tigecycline.
STEP 4: DEVELOP SEARCH STRATEGY AND CONDUCT SEARCH.
For proceeding response to drug information query secondary sources like
Lexicomp and Tata 1mg was used.
STEP 5: PERFORM EVALUATION, ANALYSIS AND SYNTHESIS OF
RESULTS
Generic Name: Tigecycline
Brand Name: Tygacil, Emtig
Available Medicine with cost:
- Tygacil (Pfizer Ltd): 50mg vial of 1 injection Rs- 3142
- Emtig (Emcure Pharmaceuticals Ltd): 50mg vial of 1 injection Rs- 6808
- Tgkem (Alkem Laboratories Ltd): 2 variants (50mg vial of 1 injection ,
50mg vial of 1ml injection) Rs- 1420 and 3737
- Tigebax (Glenmark Pharmaceuticals Ltd): vial of 1 powder for injection
Rs- 5635
Category: Glycylcycline antibiotic, similar to tetracyclines
FDA Approval Date: June 15, 2005.
MOA: The drug binds to the 30s ribosomal subunit of susceptible bacteria,
thereby inhibiting the protein synthesis. Tigecycline has demonstrated activity
against variety of gram positive and gram negative bacterial pathogens including
methicillin resistant staphylococci.
Pharmacokinetics:
 Distribution: protein bound 71-89%
 Metabolism: Hepatic via glucuronidation
 Half life: single dose- 27hrs, multiple dose- 42hrs
 Excretion: Urine (33%), feces (59%).

Use:
FDA labeled Indication:
- Multidrug- resistant, Intra abdominal infection.
- Community acquired Pneumonia.
- Complicated skin/skin structure infection.
Non FDA labelled Indication:
- Acinetobacter baumannii infection.
- Multidrug- resistant Stenotrophomonas maltophilia infection.
Dosing: For Adults
- For Intra abdominal Infection: 100mg once, then 50 mg every 12 hrs for
5 days
- For Community acquired Pneumonia: 100mg as a single dose, then 50
mg every 12 hrs for 5 days
- For Complicated skin/skin structure infection: 100mg as a single dose
initially and 50 mg every 12hrs as maintenance dose for 5 -14 days.
For Pediatrics: For susceptible Infection:
Infants and children <8 yrs
- Loading Dose (optional) -IV 1.5 to 3mg/kg once.
- Maintenance Dose- IV 1to 2 mg/kg/dose every 12 hrs; maximum dose of
50 mg/dose
 Children > /= 8 yrs & adolescents
- 8 to 11 years: IV 1.2 to 2mg/kg/dose every 12 hrs; maximum dose:
50mg/dose
- >/= 12 years: IV 50 mg every 12 hrs.
Dosing Altered Kidney Function: For Adults
A. Dosing in renal Impairment:
- Altered kidney Function: No dosage adjustment necessary.
- Hemodialysis: No dosage adjustment necessary
- CRRT: No dosage adjustment necessary
B. Dosing in Hepatic Impairment:
- Mild to moderate hepatic Impairment (child-pugh class A or B): No
dosage adjustment necessary
- Sever hepatic Impairment (child-pugh class C) : Initial 100 mg single
dose; maintenance 25 mg every 12 hrs
Drug Administration:
- Infuse over 30 to 60 minutes.
- Add 5.3ml MS, D5W or LR to each 50mg vial resulting solution is
10mg/ml. Transfer to 100ml IV bag for infusion (final concentration
should not exceed 1mg/ml.

Pregnancy Considerations:
- Tigecycline crosses the placenta
Breast feeding Considerations:
- It is not known if tigecycline is found in the breast milk
Monitoring Parameters:
- Hepatic function (periodically), coagulation parameters (including Aptt,
ptt, fibrinogen)
Contraindications:
- Hypersensitivity to tigecycline
Warnings/Precautions:
- Hepatotoxicity
- Pancreatitis
- Photosensitivity.
Drug-Drug Interactions:
- Pencillins- Tigecycline: Tetracycline may diminish therapeutic effect of
penicillins.
- Sulfonylureas- Tigecycline: Tetracyclines may enhance hypoglycemic
effect of sulfonylureas.
- Warfarin- Tigecycline: Tigecycline may increase the serum
concentration of warfarin.
Adverse Drug Reactions:
- Diarrhea, Nausea, Vomiting, Pneumonia, Chills, dizziness, Intrahepatic
cholestasis.
STEP 6: FORMULATE AND PROVIDE RESPONSE
Tigecycline is a Glycylcycline antibiotic, similar to tetracyclines used in the
treatment of Multidrug- resistant, Intra abdominal infection, Community acquired
Pneumonia, Complicated skin/skin structure infection. The drug does not require
any dosage adjustments for renal impaired patients but, dosage adjustment is
required in severe hepatic impaired patients. Tigecycline has drug interaction with
penicillins, sulfonylureas and warfarin and it is contraindicated in patients with
tigecycline hypersensitivity.
STEP 7: CONDUCT FOLLOW UP AND DOCUMENTATION
Brand name, Generic name, MOA, Pharmacokinetics, Drug price, Available
brands, Indication, Dose, Dosage adjustment, Contraindications, Warnings, ADRs,
Drug interactions and FDA approval date of the drug Tigecycline was documented
and submitted.