[05 November 2012]
Products Affected - Description
Chloral hydrate oral solution, Pharmaceutical Associates, Inc.
500 mg/5 mL, 5 mL unit-dose (NDC 00121-0532-05) - discontinued
500 mg/5 mL, 473 mL bottle (NDC 00121-0532-16) - discontinued
Somnote oral capsules, Breckenridge
500 mg capsules, 50 count unit dose (NDC 51991-0080-51)
500 mg capsules, 50 count (NDC 51991-0080-52)
Reason for the Shortage
- Pharmaceutical Associates, Inc. discontinued several oral solution products, including chloral hydrate, in April, 2012 for business reasons.1
- Chloral hydrate is an unapproved drug. Breckenridge discontinued Somnote 500 mg oral soft gel capsules in October 2012.2
- Rectal chloral hydrate was discontinued by G&W Labs in August, 2008.3
There are no presentations of chloral hydrate available.
Estimated Resupply Dates
- Pharmaceutical Associates, Inc. discontinued chloral hydrate oral solution in March, 2012.1
- Breckenridge discontinued Somnote 500 mg oral soft gel capsules in October 2012.2
Implications for Patient Care
Chloral hydrate is labeled as a hypnotic agent for insomnia and as a sedative hypnotic agent prior to surgery and before electroencephalogram (EEG) in adults and pediatric patients. Chloral hydrate is also labeled for the management of the symptoms of alcohol, narcotic, and barbiturate withdrawal.4 Off-label uses of chloral hydrate includes use as agent for conscious sedation in pediatric patients undergoing dental procedures and radiographic procedures (eg, CT, MRI). Chloral hydrate has no intrinsic analgesic activity.5,6,7
- Ensure appropriate monitoring and airway management when choosing an alternate agent for procedural sedation.
- Many alternatives to chloral hydrate are given by multiple different routes (ie, intravenous, rectal, oral), Patient harm can occur if these agents are used erroneously. Use extra caution when checking dose and route of administration.
- ISMP lists chloral hydrate and pentobarbital as agents with heightened risk of causing significant patient harm when used in error.
Alternative Agents & Management
- Chloral hydrate’s niche was for use in pediatric patients who were undergoing non-painful procedures and required a sedative-hypnotic agent. The medication could be given orally or rectally and did not interfere with the interpretation of EEG readings like benzodiazepines and barbiturates.7
- No single agent can be substituted for chloral hydrate. The choice of alternative agent must be patient specific and based on the clinical situation, age of the patient, procedure type and duration, venous access, renal and hepatic function, and other comorbid conditions. Table 1 compares selected agents used for sedation prior to nonpainful procedures. Table 2 provides some alternatives to chloral hydrate for specific clinical situations.
- Pharmaceutical Associates, Inc. (personal communications). April 2, 2012.
- Breckenridge (personal communication). July 2 and November 2, 2012.
- G&W Labs (personal communications). August 11, 2008.
- Pharmaceutical Associates, Inc. (2007). Chloral Hydrate Oral Solution, USP [product information]. Greenville, SC, Pharmaceutical Associates, Inc.
- Hutchison, T. A., D. R. Shahan, et al., Eds. (2012. Updated periodically). Drugdex System [internet database]. Greenwood Village, CO, Thomson Healthcare.
- Yaster M, Krane, EJ, Kaplan, RF, Cote CJ et al, Eds. (1997). Pediatric Pain Management and Sedation Handbook. St. Louis, MO, Mosby.
- Taketomo CK, Hodding JH, Kraus, DM, Eds. (2009). Pediatric Dosage Handbook. Hudson, OH, Lexi-Comp.
- Donnelly, A. J., V. L. Baughman, et al., Eds. (2008). Anesthesiology and Critical Care Drug Handbook. Hudson, OH, Lexi-Comp.
- Custer JW, Rau, RE, Eds. (2009). The Harriet Lane Handbook. Philadelphia, PA, Elsevier Mosby.
- Morgan, G. E., M. S. Mikhail, et al., Eds. (2006). Clinical Anesthesiology. New York, NY, Lange.
- Anon (2012. Updated periodically). Drug Consult: Pediatric Sedation Regimens. Drugdex System [internet database]. T. A. Hutchison, D. R. Shahan and M. L. Anderson. Greenwood Village, CO, Thomson Healthcare.
- Phelps SJ, Hak EB, Crill, CM, Eds (2010). Pediatric Injectable Drugs: The Teddy Bear Book. Bethesda, Maryland, American Society of Health System Pharmacists.
- McEvoy, G. K., E. K. Snow, et al., Eds. (2012). AHFS 2012 Drug Information. Bethesda, MD, American Society of Health-System Pharmacists.
- Pagliaro LA, Pagliaro AM, Eds. (2002). Problems in Pediatric Drug Therapy. Washington, DC, American Pharmaceutical Association.
- Schulte-Uentrop L, Goepfert MS. Anesthesia or sedation for MRI in children. Curr Opin Anaesthesiol 2010; 23:513-7.
- Warden CN, Bernard PK, Kimball TR. The efficacy and safety of oral pentobarbital sedation in pediatric echocardiography. J Am Soc Echocardiogr 2010: 23:33-7.
- Krauss B, Green SM. Procedural sedation and analgesia in children. Lancet 2006;367:766-80.
- Mason KP, Prescilla R, Fontaine P, et al. Pediatric CT sedation: comparison of dexmedetomidine and pentobarbital. AJR 2011;196:194-8.
- Rooks VJ, Chung T, Connor L, et al. Comparison of oral pentobarbital sodium (Nembutal) and oral chloral hydrate for sedation of infants during radiologic imaging. AJR 2003; 180:1125-28.
- Shankar V, Deshpande, JK. Procedural sedation in the pediatric patient. Anesthesiology Clin N Am 2005; 23:635-54.
- Mason KP, Sanborn P, Zurakowski D, et al. Superiority of pentobarbital versus chloral hydrate for sedation in infants during imaging. Radiology 2004; 230:537-42.
- Mason KP, Zurakowski D, Connor L, et al. Infant sedation for MR imaging and CT: oral versus intravenous pentobarbital. Radiology 2004; 233:723-8.
- Nembutal Sodium Solution (pentobarbital sodium injection). Lake Forest, IL: Lundbeck, 2009.
- Mason KP, Zurakowski D, Zgleszewski SE, et al. High dose dexmedetomidine as the sole sedative for pediatric MRI. Pediatric Anesthesia 2008; 18:403-11.
- McMorrow SP, Abramo TJ. Dexmedetomidine Sedation: Uses in pediatric procedural sedation outside the operating room. Pediatr Emer Care 2012;28:292-9.
- Mason KP, Zgleszewski SE, Dearden JL, et al. Dexmedetomidine for pediatric sedation for computed tomography imaging studies.Anesth Analg 2006; 103:57-62.
- Precedex (dexmedetomidine injection) product information. Lake Forest, IL: Hospira; 2008.
- Mace SE, Barata IA, Cravero JP, et al. Clinical Policy: evidence based approach to pharmacologic agents used in pediatric sedation and analgesia in the emergency department. Ann Emerg Med 2004; 44:342-77.
- Ray T, Tobias JD. Dexmedetomidine for sedation during electroencephalographic analysis in children with autism, pervasive development disorders, and seizure disorders. J Clin Anesthesia 2008; 20:364-8.
- Aksu R, Kumandas S, Akin A, et al. The comparison of the effects of dexmedetomidine and midazolam sedation on electroencephalography in pediatric patients with febrile convulsion. Pediatric Anesthesia 2011; 21:373-8.
- Lubisch N, Roskos R, Berkenbosch JW. Dexmedetomidine for procedural sedation in children with autism and other behavior disorders. Pediatr Neurol 2009; 41:88-94.
Updated November 5, 2012 by Michelle Wheeler, PharmD, Drug Information Specialist. Written April 5, 2012, by Jane Chandramouli, PharmD, Drug Information Specialist. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.
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