Can a newborn infant (2–4 kg, ≤28 days old) be given a suppository?

Can Suppositories Be Given to Newborns?

Yes, suppositories can be given to newborn infants (≤28 days old, 2-4 kg), but their use should be selective and evidence-based, with glycerin suppositories being the most commonly studied formulation in this population.

Evidence for Suppository Use in Neonates

Acetaminophen Suppositories

• Acetaminophen suppositories are safe and effective in premature neonates and term infants when dosed appropriately, with extensive pharmacokinetic data supporting their use 1
• For premature neonates at 30 weeks' postconception, rectal acetaminophen maintenance doses of 25 mg/kg/day (capsule suppository) or 30 mg/kg/day (triglyceride suppository) achieve therapeutic concentrations 1
• At term (40 weeks postconception), doses increase to approximately 60 mg/kg/day orally or equivalent rectal dosing adjusted for bioavailability 1
• Bioavailability is formulation-dependent: capsule suppositories have 92% bioavailability at 28 weeks postconception decreasing to 86% at 2 years, while triglyceride-base suppositories decrease from 86% to 50% over the same period 1

Glycerin Suppositories

• Glycerin suppositories are frequently used in very low birth weight (VLBW) infants but lack strong evidence for routine prophylactic use 2, 3
• In a retrospective study of 1,073 VLBW infants, 49.1% received glycerin suppositories, but their use was associated with longer time to reach full enteral feeds and longer hospital stays 2
• A pilot randomized controlled trial found glycerin suppositories feasible to administer but noted rectal bleeding in 10% of participants (5-43 days after treatment), with anal fissures documented in two cases 3
• No cases of rectal perforation occurred, but one infant developed necrotizing enterocolitis 3

Critical Safety Considerations

Contraindications and Precautions

• Thrombocytopenia is a contraindication to suppository use due to bleeding risk 3
• Clinical instability or signs of gastrointestinal pathology should prompt careful evaluation before suppository administration 3
• Life-threatening congenital anomalies affecting the gastrointestinal or anorectal anatomy are contraindications 3

Dosing Principles in Neonates

• Neonates are NOT simply small adults or scaled-down children—they have immature drug elimination pathways that require age-specific dosing 4
• Drug clearance in neonates is substantially reduced compared to older infants, with maturation occurring over the first weeks to months of life 1, 5
• Size, maturation, and organ function are the three principal contributors to pharmacokinetic variability in this population 4

Clinical Algorithm for Suppository Use

When to Consider Suppositories

1. For pain management: Acetaminophen suppositories are appropriate when oral/IV routes are unavailable or contraindicated 1
2. For constipation/meconium evacuation: Glycerin suppositories may be considered, but evidence suggests they may be a marker for gastrointestinal dysmotility rather than an effective treatment 2
3. Avoid routine prophylactic use of glycerin suppositories given the association with delayed feeding tolerance 2

Pre-Administration Checklist

• Verify platelet count is adequate (>50,000/μL is a reasonable threshold based on bleeding risk) 3
• Assess for anorectal anomalies or contraindications 3
• Confirm appropriate weight-based dosing using gestational age and postnatal age 1, 5
• Consider alternative routes (oral, IV) if available and appropriate 1

Common Pitfalls to Avoid

• Do not use adult weight-based dosing (mg/kg) directly scaled down—this results in overdosing in neonates whose elimination pathways are immature 4
• Do not assume all suppository formulations are equivalent—bioavailability varies significantly by formulation type 1
• Avoid prolonged acetaminophen suppository use (>2-3 days) due to hepatotoxicity risk, even at therapeutic doses 1
• Do not use glycerin suppositories routinely for all VLBW infants—reserve for specific clinical indications given the association with delayed feeding outcomes 2

Monitoring Requirements

• For acetaminophen: Monitor for signs of hepatotoxicity if used beyond 2-3 days 1
• For glycerin suppositories: Monitor for rectal bleeding, anal fissures, and feeding tolerance 3
• Adjust dosing based on postconceptional age (gestational age + postnatal age) rather than postnatal age alone 1, 5