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Tigecycline dosage in neonates

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tigecycline neonates dosage pharmacokinetics

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tigecycline dosage neonates 2024 pharmacokinetics MDR

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https://www.mdpi.com/2079-6382/12/6/1072

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tigecycline neonates

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PMID: 31192975

Here is a comprehensive summary of tigecycline dosing in neonates:

Tigecycline in Neonates

Regulatory Status

Tigecycline is not approved for use in neonates by any major regulatory agency:
  • FDA: Approved only for adults (≥18 years) at 100 mg loading dose + 50 mg q12h IV.
  • EMA: Approved down to ≥8 years at 1.2 mg/kg q12h (max 50 mg) for ages 8-11 years, and 50 mg q12h for ages 12-17 years - without a loading dose. Use below 8 years is off-label.
Neonatal use is strictly off-label salvage therapy when no alternatives exist.

Pharmacokinetic Data in Neonates

There are no formal PK studies in neonates or children under 8 years. This is a major concern because neonates have unique physiological characteristics - altered volume of distribution, immature hepatic metabolism, and different protein binding - all of which affect drug exposure unpredictably. Furthermore, tigecycline's very low blood levels (due to its large Vd of >12 L/kg) make it a particularly poor choice for the most common neonatal infection type: bacteremia.

Reported Off-label Doses in Neonates (Case Reports/Series)

Based on available case series and reports - primarily for XDR/MDR Klebsiella pneumoniae bloodstream infections:
ParameterReported Range
Standard dose1.2 mg/kg q12h IV (extrapolated from pediatric data)
Escalated dose2 mg/kg q12h (used for persistent bacteremia after 96 h)
Loading dose (off-label in children)1.8 - 6.5 mg/kg (no formal data in neonates)
RouteIntravenous (IV) infusion over 30-60 min
The most cited neonatal experience comes from Ipek et al., who used tigecycline in four critically ill preterm neonates with XDR K. pneumoniae bacteremia as salvage combination therapy - all with favorable outcomes (Antibiotics 2023; MDPI review).

Clinical Context and Indications for Neonatal Use

Per the Red Book 2021 (AAP Committee on Infectious Diseases), tigecycline is listed among agents with susceptibility for carbapenemase-producing gram-negative organisms in neonates, but with the note that "experience in neonates is limited." It is used as a last resort when an organism is resistant to all other available agents (e.g., carbapenemase-producing Klebsiella, Acinetobacter baumannii).
It is almost always used in combination, not as monotherapy.

Key Adverse Effects in Neonates to Monitor

  • Thrombocytopenia - noted in all four neonates in the Ipek series, appearing after ~1 week of treatment; resolved after discontinuation
  • Tooth discoloration - permanent yellow staining of teeth has been reported in children <8 years (17% in one series), though data in neonates specifically are lacking
  • Nausea/vomiting, hepatotoxicity - documented in older patients; monitoring LFTs, amylase, lipase, CBC/platelets is recommended
  • Increased all-cause mortality risk - FDA black box warning (based on adult meta-analysis; neonatal data absent)

Practical Guidance

ItemRecommendation
Use only ifNo alternative antibacterial agent available for MDR/XDR infection
ConsultPediatric infectious disease specialist before use
Dose~1.2 mg/kg IV q12h (no loading dose in pediatric extrapolation); may escalate to 2 mg/kg q12h if needed
InfusionOver 30-60 minutes IV
MonitorCBC with platelets, LFTs, coagulation parameters - at baseline and regularly
Avoid if bacteremiaLow serum levels make it a poor primary agent for bloodstream infections

Summary

Tigecycline in neonates is a last-resort, off-label option with no formal PK data for this age group. The most commonly referenced dose extrapolated from pediatric experience is 1.2 mg/kg IV q12h, occasionally escalated to 2 mg/kg q12h. Thrombocytopenia is the most consistently reported adverse effect in neonatal cases. Expert infectious disease consultation is mandatory before use.
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What is the compatible solution with which it should be given

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tigecycline compatible IV solutions reconstitution diluent normal saline dextrose

Here is the complete compatibility information for tigecycline (Tygacil) IV infusion:

Tigecycline - Compatible IV Solutions

Reconstitution (Step 1)

Each 50 mg vial is reconstituted by adding 5.3 mL of any of the following:
  • 0.9% Sodium Chloride (Normal Saline)
  • 5% Dextrose in Water (D5W)
  • Lactated Ringer's Injection
This gives a concentration of 10 mg/mL. The reconstituted solution should be yellow to orange in color - discard if green or black.

Dilution (Step 2)

Withdraw 5 mL (= 50 mg) and add to a 100 mL IV bag of a compatible solution. Maximum final concentration in the bag: 1 mg/mL.

Compatible IV Solutions (for dilution)

SolutionCompatible
0.9% Sodium Chloride (NS)✅ Yes
5% Dextrose in Water (D5W)✅ Yes
Lactated Ringer's Injection✅ Yes
D5W + 0.9% NaCl✅ Yes
D5W + Lactated Ringer's✅ Yes

Y-Site Compatibility

When co-administered via Y-site using NS or D5W, tigecycline is compatible with: amikacin, gentamicin, tobramycin, piperacillin/tazobactam (EDTA formulation), dopamine, dobutamine, norepinephrine, morphine, lidocaine, potassium chloride, propofol, ranitidine, theophylline, haloperidol, metoclopramide.

Y-Site INCOMPATIBILITIES (do NOT co-administer)

  • Amphotericin B - incompatible
  • Diazepam - incompatible

Infusion and Line Flushing

  • Infuse over 30-60 minutes IV
  • If a shared line is used, flush before and after tigecycline with NS, D5W, or Lactated Ringer's

Storage After Reconstitution

ConditionStability
Room temperature (≤25°C)Up to 24 hours total (max 6 h in vial + remainder in bag)
Refrigerated (2-8°C) in NS or D5WUp to 48 hours
In neonates, NS (0.9% NaCl) is generally the preferred diluent as it avoids the glucose load of D5W in critically ill preterm neonates - though either is pharmaceutically compatible.
Sources: Tygacil FDA label, Drugs.com monograph, Pfizer Canada PI
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