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Medication Safety Issues
Sound-alike/look-alike issues:
Seconal® may be confused with Sectral®
Pronunciation
(see koe BAR bi tal)
U.S. Brand Names
Index Terms
Generic Available
No
Pharmacologic Category
Use: Labeled Indications
Preanesthetic agent; short-term treatment of insomnia
Restrictions
C-II
Pregnancy Risk Factor
D
Lactation
Enters breast milk/use caution (AAP rates “compatible”)
Contraindications
Hypersensitivity to barbiturates or any component of the formulation; marked hepatic impairment; dyspnea or airway obstruction; porphyria; pregnancy
Warnings/Precautions
Concerns related to adverse effects:
• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
• Hypersensitivity reactions: Postmarketing studies have indicated that the use of hypnotic/sedative agents for sleep has been associated with hypersensitivity reactions including anaphylaxis as well as angioedema.
• Paradoxical responses: May cause paradoxical responses, including agitation and hyperactivity, particularly in acute pain, chronic pain and pediatric patients.
• Sleep-related activities: An increased risk for hazardous sleep-related activities such as sleep-driving; cooking and eating food, and making phone calls while asleep have also been noted. Discontinue treatment in patients who report a sleep-driving episode.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease; may cause hypotension.
• Depression: Use with caution in patients with depression or suicidal tendencies.
• Drug abuse: Use with caution in patients with a history of drug abuse or acute alcoholism; potential for drug dependency exists. Tolerance, psychological and physical dependence may occur with prolonged use.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment.
• Respiratory disease: Use with caution in patients with respiratory disease; may cause respiratory depression.
Concurrent drug therapy issues:
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Elderly: Use with caution in the elderly; closely monitor elderly or debilitated patients for impaired cognitive or motor performance.
• Pediatrics: Use with caution in children.
Other warnings/precautions:
• Appropriate use: Symptomatic treatment of insomnia should be initiated only after careful evaluation of potential causes of sleep disturbance. Failure of sleep disturbance to resolve after 7-10 days may indicate psychiatric and/or medical illness.
• Withdrawal: Abrupt cessation may precipitate withdrawal, including status epilepticus in epileptic patients.
Adverse Reactions
Frequency not defined.
Cardiovascular: Hypotension
Central nervous system: Dizziness, lightheadedness, “hangover” effect, drowsiness, CNS depression, fever, confusion, mental depression, unusual excitement, nervousness, faint feeling, headache, insomnia, nightmares, hallucinations
Dermatologic: Exfoliative dermatitis, rash, Stevens-Johnson syndrome
Gastrointestinal: Nausea, vomiting, constipation
Hematologic: Agranulocytosis, megaloblastic anemia, thrombocytopenia, thrombophlebitis, urticaria
Local: Pain at injection site
Respiratory: Apnea, laryngospasm, respiratory depression
Postmarketing and/or case reports: Anaphylaxis, angioedema, complex sleep-related behavior (sleep-driving, cooking or eating food, making phone calls)
Metabolism/Transport Effects
Induces CYP2A6 (strong), 2C8 (strong), 2C9 (strong)
Drug Interactions
Acetaminophen: Barbiturates may increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Beta-Blockers: Barbiturates may decrease the serum concentration of Beta-Blockers. Exceptions: Atenolol; Levobunolol; Metipranolol; Nadolol. Risk C: Monitor therapy
Calcium Channel Blockers: Barbiturates may increase the metabolism of Calcium Channel Blockers. Exceptions: Clevidipine. Risk D: Consider therapy modification
Chloramphenicol: May decrease the metabolism of Barbiturates. Barbiturates may increase the metabolism of Chloramphenicol. Risk D: Consider therapy modification
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Contraceptive (Progestins): Barbiturates may diminish the therapeutic effect of Contraceptive (Progestins). Contraceptive failure is possible. Risk D: Consider therapy modification
Corticosteroids (Systemic): Barbiturates may increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy
CycloSPORINE: Barbiturates may increase the metabolism of CycloSPORINE. Risk D: Consider therapy modification
CYP2A6 Substrates: CYP2A6 Inducers (Strong) may increase the metabolism of CYP2A6 Substrates. Risk C: Monitor therapy
CYP2C8 Substrates (High risk): CYP2C8 Inducers (Highly Effective) may increase the metabolism of CYP2C8 Substrates (High risk). Risk C: Monitor therapy
CYP2C9 Substrates (High risk): CYP2C9 Inducers (Highly Effective) may increase the metabolism of CYP2C9 Substrates (High risk). Risk C: Monitor therapy
Disopyramide: Barbiturates may increase the metabolism of Disopyramide. Risk D: Consider therapy modification
Doxycycline: Barbiturates may decrease the serum concentration of Doxycycline. Risk D: Consider therapy modification
Etoposide: Barbiturates may increase the metabolism of Etoposide. Risk C: Monitor therapy
Etoposide Phosphate: Barbiturates may decrease the serum concentration of Etoposide Phosphate. Barbiturates may increase the metabolism, via CYP isoenzymes, of etoposide phosphate. Risk C: Monitor therapy
Felbamate: May increase the serum concentration of Barbiturates. Risk C: Monitor therapy
Griseofulvin: Barbiturates may decrease the absorption of Griseofulvin. Risk D: Consider therapy modification
LamoTRIgine: Barbiturates may increase the metabolism of LamoTRIgine. Risk D: Consider therapy modification
Meperidine: Barbiturates may enhance the CNS depressant effect of Meperidine. Risk C: Monitor therapy
Methadone: Barbiturates may increase the metabolism of Methadone. Risk D: Consider therapy modification
Oral Contraceptive (Estrogens): Barbiturates may diminish the therapeutic effect of Oral Contraceptive (Estrogens). Contraceptive failure is possible. Risk D: Consider therapy modification
Primidone: May enhance the adverse/toxic effect of Barbiturates. Primidone is converted to phenobarbital, and thus becomes additive with existing barbiturate therapy. Risk C: Monitor therapy
Propafenone: Barbiturates may increase the metabolism of Propafenone. Risk D: Consider therapy modification
Pyridoxine: May increase the metabolism of Barbiturates. Apparent in high pyridoxine doses (eg, 200 mg/day) Risk C: Monitor therapy
QuiNIDine: Barbiturates may increase the metabolism of QuiNIDine. Risk D: Consider therapy modification
Rifamycin Derivatives: May increase the metabolism of Barbiturates. Risk C: Monitor therapy
Teniposide: Barbiturates may increase the metabolism of Teniposide. Risk C: Monitor therapy
Theophylline Derivatives: Barbiturates may increase the metabolism of Theophylline Derivatives. Exceptions: Dyphylline. Risk C: Monitor therapy
Thiazide Diuretics: Barbiturates may enhance the orthostatic effect of Thiazide Diuretics. Risk C: Monitor therapy
Treprostinil: CYP2C8 Inducers (Highly Effective) may decrease the serum concentration of Treprostinil. Risk C: Monitor therapy
Tricyclic Antidepressants: Barbiturates may increase the metabolism of Tricyclic Antidepressants. Risk D: Consider therapy modification
Valproic Acid: May decrease the metabolism of Barbiturates. Barbiturates may decrease the serum concentration of Valproic Acid. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Barbiturates may increase the metabolism of Vitamin K Antagonists. Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola (may increase CNS depression).
Mechanism of Action
Depresses CNS activity by binding to barbiturate site at GABA-receptor complex enhancing GABA activity, depressing reticular activity system; higher doses may be gabamimetic
Pharmacodynamics/Kinetics
Onset of hypnosis: 15-30 minutes
Duration: 3-4 hours with 100 mg dose
Distribution: 1.5 L/kg; crosses the placenta; appears in breast milk
Protein binding: 45% to 60%
Metabolism: Hepatic, by microsomal enzyme system
Half-life elimination: 15-40 hours, mean: 28 hours
Time to peak, serum: Within 2-4 hours
Excretion: Urine (as inactive metabolites, small amounts as unchanged drug)
Dosage
Oral:
Children:
Preoperative sedation: 2-6 mg/kg (maximum dose: 100 mg/dose) 1-2 hours before procedure
Sedation: 6 mg/kg/day divided every 8 hours
Adults:
Hypnotic: Usual: 100 mg/dose at bedtime; range: 100-200 mg/dose
Preoperative sedation: 100-300 mg 1-2 hours before procedure
Monitoring Parameters
Blood pressure, heart rate, respiratory rate, CNS status
Patient Education
Use exactly as directed; do not increase dose or frequency or discontinue without consulting prescriber. Drug may cause physical and/or psychological dependence. While using this medication, do not use alcohol or other prescription or OTC medications (especially, pain medications, sedatives, antihistamines, or hypnotics) without consulting prescriber. Maintain adequate hydration unless instructed to restrict fluid intake. You may experience drowsiness, dizziness, or blurred vision (use caution when driving or engaging in tasks requiring alertness until response to drug is known); nausea or vomiting (small frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help); or constipation (increased exercise, fluids, fruit, or fiber may help). Report skin rash or irritation; CNS changes (confusion, depression, increased sedation, excitation, headache, insomnia, or nightmares); respiratory difficulty or shortness of breath; difficulty swallowing or feeling of tightness in throat; unusual weakness or unusual bleeding in mouth, urine, or stool; unusual swelling, especially on face or neck; or other unanticipated adverse effects. Pregnancy/breast-feeding precautions: Do not get pregnant while taking this medication. Use appropriate contraceptive measures. Consult prescriber if breast-feeding.
Geriatric Considerations
Use of this agent in the elderly is not recommended due to its long half-life and addiction potential.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Comment
In 2007, the FDA requested that all manufacturers of sedative-hypnotic drug products revise labeling to include a greater emphasis on the risks of adverse effects. These risks include severe allergic reactions (anaphylaxis, angioedema) and complex sleep-related behaviors, which may include sleep-driving (driving while not fully awake and with no memory of the event), making phone calls, and preparing and eating food while asleep.
Nursing: Physical Assessment/Monitoring
Assess effectiveness and interactions of other medications patient may be taking. Assess patient for history of addiction; long-term use can result in dependence, abuse, or tolerance and evaluate periodically for need for continued use. Be alert to possibility of anaphylaxis any time during therapy. Assess for CNS depression, abnormal thinking, and behavior changes. Monitor vital signs and respiratory status. After long-term use, taper dosage slowly when discontinuing. Oral: For inpatient use, institute safety measures. For outpatient use, monitor effectiveness and adverse reactions at beginning of therapy and periodically with long-term use. Assess knowledge/teach patient appropriate use, interventions to reduce side effects, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, as sodium: 100 mg
Pricing: U.S. (www.drugstore.com)
Capsules (Seconal)
100 mg (20): $95.99
References
Levine HL, Cohen ME, Duffner PK, et al, “Rectal Absorption and Disposition of Secobarbital in Epileptic Children,” Pediatr Pharmacol (New York), 1982, 2(1):33-8.
Monteil RA, Raybaud H, Madinier I, et al, “Occurrence of Oral Mucosal Necrosis in a Patient With Barbiturate-Induced Coma,” Oral Surg Oral Med Oral Pathol, 1991, 72(5):562-4.
Nahata MC, Starling S, and Edwards RC, “Prolonged Sedation Associated With Secobarbital in Newborn Infants Receiving Ventilatory Support,” Am J Perinatol, 1991, 8(1):35-6.
Tracqui A, Kintz P, Mangin P, et al, “A Fatality Involving Secobarbital, Nitrazepam, and Codeine,” Am J Forensic Med Pathol, 1989, 10(2):130-3.
Wolfert RR and Cox RM, “Room Temperature Stability of Drug Products Labeled for Refrigerated Storage,” Am J Hosp Pharm, 1975, 32(6):585-7.
International Brand Names
Lexi-Comp.com
Last full review/revision September 2009
Content last modified September 2009
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