PHENOBARBITONE SODIUM

Gardenal sodium

Reviewed by NICU and Pharmacy
November 2011
Dose and Pharmacology Newborn Drug Protocol Index Newborn Services Home Page

 

Management of  Phenobarbitone Administration

Description

Phenobarbitone is a restricted medication, and must be ordered using the red bag and book system, and stored in the locked restricted drug cupboard.

Solution for Injection:
  • Thick clear solution 200 mg/ml amps
  • Contains 79% propylene glycol.
Oral Preparation:
  • Contact Pharmacy for an oral preparation which is suitable for neonates.
  • Phenobarbitone elixir B.P. contains 38% alcohol – do not use for neonates.

Prescription

Administration

Slow IV Infusion

  1. Dilute to 20 mg in 1 mL:
    1. Using a 10 ml syringe draw up 9ml Water for Injection.
    2. In a 2 ml syringe, using a 23 gauge needle, draw up 200 mg (1 ml) phenobarbitone. Measure exactly as there is often overage in the ampoules.
    3. Add to the Water for Injection to make 20 mg/ml. Mix well.
    4. Draw up dose from this 20mg/ml phenobarbitone.
    5. Discard the remaining contents of the 10 ml syringe containing phenobarbitone 20 mg/ml down the sink.
  2. Filter prior to administration through a Pall 0.2 micron filter.
  3. Administer by slow IV infusion (do NOT exceed 1 mg/kg/minute) using a syringe pump.
  4. Compatible with glucose 5%, glucose 10%, and sodium chloride 0.9%. No data available on IVN.
  5. Do NOT mix with other drugs, IV solutions, blood or blood products.
  6. Flush line before and after administration of phenobarbitone.

Oral

  1. Can be administered with food.

Observation and Documentation

  1. Monitor for barbiturate toxicity signs (laboured breathing, cyanosis, clammy skin, hypotension).
  2. Nurse on cardiorespiratory monitor.
  3. Monitor vital signs and document.
  4. Observe for and document seizure activity.

Storage

IV/IM Preparation

Oral preparation

Selected References

1 Bergman I, Painter MJ, Crumrine PK. Neonatal seizures. Semin Perinatol 1982; 6:54-67.
2 Fischer JH, Lockman LA, Zaske D, Kriel R. Phenobarbitone maintenance dose requirements in treating neonatal seizures. Neurology 1981; 31:1042.
3 Pawlak RP, Herfert LA. Drug administration in the NICU 2nd Ed 1991. Neonatal Network. p310.
4 Gilman JT, Gal P, Duchowny MS et al. Rapid sequential phenobarbital treatment of neonatal seizures. Pediatr 1989; 83: 674-8.
5 Reynolds JEF (Ed) Martindale: The Extra Pharmacopoeia. (31st ed). Royal Pharmaceutical Society; 1996: London
6 Paediatric Pharmacopoeia, Royal Children’s Hospital Melbourne and Leicester Royal Infirmary Children’s Hospital, WB Saunders Co. Ltd; 1998: London.
7 Young TE, Mangum O.B. (editors) NeoFax (11th ed): A Manual of Drugs Used in Neonatal Care. Acorn Publishing; 1998: Raleigh, North Carolina.
8 Stockley I. Drug Interactions 4th ed. The Pharmaceutical Press; 1996: London.
9 Evans D, Levene M. Neonatal Seizures. Arch Dis Child Fetal Neonatal Ed. 1998; 78:F70-F75.
10 Hey, E, editor. Neonatal formulary. 5th ed. Oxford: Blackwell Publishing; 2007