Clinical beta

FMBM is currently in clinical beta. Content is for professional review/testing and must not replace local protocols, senior clinical judgment, or official prescribing references.

Drug Monograph

Tigecycline

Tigecycline

Glycylcycline (IV)

BroadMDRMortality signalBacteriostatic

Indication

Complicated intra-abd β€’ SSTI β€’ CAP (selected) β€’ MDR pathogens last-line

At a glance

INDICATIONS (CORE USE)

Broad IV for resistant polymicrobial / MDR situations β€” **FDA mortality warning meta-analysis** β€” avoid empiric monotherapy for serious infection when alternatives exist; **nausea** common; **not renally dosed**.

ADULT DOSE (STANDARD)

100 mg IV load then 50 mg IV q12h

MAX DOSE

50 mg q12h after load (adult)

Route

IV

PEDIATRIC DOSE

Pediatric use very restricted β€” specialist

Do not miss

Must-not-miss safety points

Major warning

- **Mortality signal** in some meta-analyses vs comparators β€” reserve for appropriate cases; combination therapy often preferred - **Bacteriostatic** β€” caution monotherapy in bacteremia (especially pneumonia) - Pancreatitis - Tooth/bone deposition pediatric β€” avoid young kids

Indications

USE IF: Complicated SSTI / intra-abd / CAP when resistant organisms or beta-lactam allergy pathways per ID. AVOID IF: Primary bacteremia monotherapy when better bactericidal options; trivial infection.

Primary

  • Complicated intra-abdominal infection (combination often)
  • Complicated skin/soft tissue infection
  • Community-acquired bacterial pneumonia when beta-lactam unsuitable (narrow indication)

Secondary

  • MDR Acinetobacter / carbapenem-resistant regimens as part of combination β€” specialist

Other

  • Last-line salvage with microbiology + ID approval

Dosing

STANDARD (ADULT PO)

100 mg load β†’ 50 mg q12h

ADULT DOSE

100 mg IV Γ—1 then 50 mg IV q12h over 30–60 min

PEDIATRIC DOSE

Not routine β€” specialist protocols.

MAX DOSE

50 mg q12h maintenance

Practical Note

Hepatic Child-Pugh C β†’ dose adjustment per label.

Warnings

Clinical warnings

  • Nausea/vomiting limits therapy
  • Coagulopathy / hypofibrinogenemia case reports

Adverse effects

  • nausea
  • vomiting
  • diarrhea
  • thrombophlebitis

Contraindications

  • Hypersensitivity to tigecycline

Drug interactions

  • Warfarin β€” monitor INR

Special populations

Pediatrics

Pediatric use very restricted β€” specialist

Pregnancy

Animal fetal toxicity β€” avoid unless no alternative

Lactation

unknown.

Renal impairment

No adjustment; not removed by dialysis significantly β€” clinical effect persists. **CrCl scaffold (FMBM β€” titrate to FDA/SFDA label + institutional pharmacy nomogram):** - **CrCl β‰₯50** β†’ no CrCl adjustment for elimination - **CrCl 10–50** β†’ no CrCl adjustment - **CrCl <10** β†’ no CrCl adjustment; Child-Pugh C hepatic β†’ dose reduction per label

Hepatic impairment

Severe hepatic impairment β†’ reduce dose per label.

Elderly

Mortality confounders β€” clinical judgment.

Administration

IV infusion; antiemetic PRN.

Monitoring

  • Monitor: - Nausea / vomiting limiting intake β†’ **antiemetics**; epigastric pain β†’ **lipase** (pancreatitis) - Serious infection without clear ID plan β†’ avoid empiric monotherapy where outcomes debated - Lipase/amylase if epigastric pain
  • Recheck: - Clinical improvement 48–72h β€” if not, not just β€˜add more tigecycline’ - No clinical improvement at 48–72h β†’ reassess diagnosis, resistance, source control, and drug interactions - If targets not met after reassessment of dose, organ function, and interactions β†’ escalate per protocol (DO NOT continue blindly)

Overdose / toxicity

Clinical Picture

**Life-threatening (first):** **shock** / **severe pancreatitis** (rare). **Secondary:** nausea/vomiting.

Immediate Actions

Stop infusion β†’ antiemetics; lipase if abdominal pain

Antidote

No specific antidote; treat complications (e.g. anaphylaxis β†’ epinephrine per ACLS)

Decontamination

N/A

Escalation

Severe pancreatitis, shock β†’ **ICU**

Clinical pearls

Common mistakes, resistance logic, and bedside traps

High-Yield Summary

Broad MDR rescue drug β€” **black box mortality discussion** in literature. **Not for UTI** (urine penetration poor). **Bacteriostatic** β†’ think twice in sick bacteremia.

Clinical pearls

Combine with other active agents in CRE/MDR regimens per ID. Antiemesis planning improves completion. Black box: document informed indication. *Stewardship (all antimicrobials):* Empiric choice β†’ syndrome severity + **local antibiogram**; shortest effective course.

Stewardship & safety

  • Mortality debate
  • No UTI
  • Antiemesis

Pharmacokinetics

Large Vd; hepatic clearance; penetrates tissues well; poor urine levels β€” **not for UTI**.

Mechanism of action

Glycylcycline β€” 30S ribosome inhibition; broader than tetracyclines.

Common brand names

Global data (no country-specific data available)

Saudi Arabia

(placeholder β€” verify local formulary)

Common trade names are curated examples only β€” formulations and availability vary. Verify the exact product name with your local pharmacy and national regulator before prescribing or dispensing.

Country practice notes

  • Empiric choice β†’ tie to syndrome, severity, and local antibiogram β€” not habit.
  • IV β†’ PO step-down when oral bioavailability and susceptibility allow.
  • Do not use antibiotics for uncomplicated viral illness β€” stewardship.

References

Saudi Arabia

  • SFDA (Saudi Food & Drug Authority)
  • Saudi National Formulary / MOH (where available)

International

  • WHO Model List of Essential Medicines (verify current edition)
  • US FDA or EU EMA product information (when national SmPC is unavailable)
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling
  • Sanford Guide
  • IDSA / ESCMID (indication-specific)
  • Local antimicrobial stewardship / hospital formulary
  • FDA / SFDA / regional product labeling

Do not miss

  • Uncomplicated viral URI/bronchitis β†’ antibiotics rarely indicated
  • Narrow or stop when susceptibilities + clinical stability allow
  • Using tigecycline first-line for CAP when ceftriaxone could work β†’ stewardship failure + risk.
  • Mortality debate
  • No UTI
  • Antiemesis