Secobarbital

Secobarbital
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Stefano Giannoni [2]

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Overview

Secobarbital is a Barbiturate that is FDA approved for the treatment of Insomnia and as Preanesthetic. Common adverse reactions include somnolence.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosages of barbiturates must be individualized with full knowledge of their particular characteristics. Factors of consideration are the patient's age, weight, and condition.

Insomnia

100 mg at bedtime.

• For the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks.

Preanesthetic

Preoperatively, 200 to 300 mg, 1 to 2 hours before surgery.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Secobarbital in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Secobarbital in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Preanesthetic

Preoperatively, 2 to 6 mg/kg, with a maximum dosage of 100 mg.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Secobarbital in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Secobarbital in pediatric patients.

Contraindications

• Hypersensitive to barbiturates.
• Patients with a history of manifest or latent porphyria,
• Marked impairment of liver function
• Marked impairment respiratory disease in which dyspnea or obstruction is evident.

Warnings

• Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient.
• The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated.
• Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs.
• Because some of the important adverse effects of sedative-hypnotics appear to be dose related, it is important to use the smallest possible effective dose, especially in the elderly.
• Complex behaviors such as "sleep-driving" (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported.
• These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose.
• Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a "sleep-driving" episode.
• Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

Habit-Forming

• Seconal Sodium may be habit-forming.
• Tolerance and psychological and physical dependence may occur with continued use.
• Patients who have psychological dependence on barbiturates may increase the dosage or decrease the dosage interval without consulting a physician and subsequently may develop a physical dependence on barbiturates. To minimize the possibility of overdosage or development of dependence, the prescribing and dispensing of sedative-hypnotic barbiturates should be limited to the amount required for the interval until the next appointment.
• The abrupt cessation after prolonged use in a person who is dependent on the drug may result in withdrawal symptoms, including delirium, convulsions, and possibly death. Barbiturates should be withdrawn gradually from any patient known to be taking excessive doses over long periods of time.

Acute or Chronic Pain

• Caution should be exercised when barbiturates are administered to patients with acute or chronic pain, because paradoxical excitement could be induced or important symptoms could be masked.

Usage in Pregnancy

• Barbiturates can cause fetal harm when administered to a pregnant woman. *Retrospective, case-controlled studies have suggested that there may be a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities.
• Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain.
• Fetal blood levels approach maternal blood levels following parenteral administration.
• Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy.
• If Seconal Sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Synergistic Effects

• The concomitant use of alcohol or other CNS depressants may produce additive CNS-depressant effects.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Secobarbital Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Secobarbital Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Secobarbital Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Barbiturates can cause fetal harm when administered to a pregnant woman. Retrospective, case-controlled studies have suggested that there may be a connection between the maternal consumption of barbiturates and a higher than expected incidence of fetal abnormalities. Barbiturates readily cross the placental barrier and are distributed throughout fetal tissues; the highest concentrations are found in the placenta, fetal liver, and brain. Fetal blood levels approach maternal blood levels following parenteral administration. Withdrawal symptoms occur in infants born to women who receive barbiturates throughout the last trimester of pregnancy. If Seconal Sodium is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Secobarbital in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Secobarbital during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Secobarbital in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Secobarbital in pediatric settings.

Geriatic Use

Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates.

Gender

There is no FDA guidance on the use of Secobarbital with respect to specific gender populations.

Race

There is no FDA guidance on the use of Secobarbital with respect to specific racial populations.

Renal Impairment

Dosage should be reduced for patients with impaired renal function

Hepatic Impairment

Dosage should be reduced for patients with hepatic disease.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Secobarbital in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Secobarbital in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Secobarbital Administration in the drug label.

Monitoring

There is limited information regarding Secobarbital Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Secobarbital and IV administrations.

Overdosage

There is limited information regarding Secobarbital overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Secobarbital Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Secobarbital Mechanism of Action in the drug label.

Structure

There is limited information regarding Secobarbital Structure in the drug label.

Pharmacodynamics

There is limited information regarding Secobarbital Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Secobarbital Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Secobarbital Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Secobarbital Clinical Studies in the drug label.

How Supplied

There is limited information regarding Secobarbital How Supplied in the drug label.

Storage

There is limited information regarding Secobarbital Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Secobarbital Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Secobarbital interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Secobarbital Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Secobarbital Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Secobarbital

File:Secobarbital.svg
Clinical data
Pregnancy category	D (USA)
Routes of administration	Oral
ATC code	N05CA06 (WHO)
Legal status
Legal status	US: Schedule II
Pharmacokinetic data
Bioavailability	?
Metabolism	Hepatic
Elimination half-life	?
Excretion	Renal
Identifiers
IUPAC name 5-(1-methylbutyl)-5-prop-2-enyl- hexahydropyrimidine-2,4,6-trione
CAS Number	76-73-3
PubChem CID	5193
DrugBank	APRD00497
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}
Chemical and physical data
Formula	C12H18N2O3
Molar mass	238.283

Secobarbital (marketed by Eli Lilly and Company under the brand names Seconal® and Tuinal) is a barbiturate derivative drug. It possesses anaesthetic, anticonvulsant, sedative and hypnotic properties. In the United Kingdom, it was known as Quinalbarbitone.

Indications

Secobarbital is indicated for:

• Treatment of epilepsy
• Temporary treatment of insomnia in patients resistant to mainstream hypnotics
• Use as a preoperative medication to produce anaesthesia and anxiolysis in short surgical, diagnostic, or therapeutic procedures which are minimally painful.

Availability

File:Secobarbital DOJ.jpg

It is available as either a free acid or a sodium salt. The free acid is a white amorphous powder that is slightly soluble in water and very soluble in ethanol. The salt is a white hygroscopic powder that is soluble in water and ethanol.

Secobarbital sodium

The sodium salt of secobarbital is classified separately from the free acid, as follows:

• CAS number: 309-43-3
• Chemical formula: C₁₂H₁₈N₂NaO₃
• Molecular weight: 260.265

Side effects

Side effects of secobarbital include:

• Somnolence
• Impaired motor functions
  • Impaired coordination
  • Impaired balance
  • Dizziness
• Anxiety
• Confusion
• Agitation, irritability, or excitability
• Headache
• Nausea
• Vomiting
• Nightmares
• Increased sensitivity to pain
• Allergic reactions
  • Difficulty breathing
  • Edema
  • Urticaria

Withdrawal

Secobarbital is a fairly addictive drug, and withdrawal symptoms can occur if long-term usage is abruptly ended. Withdrawal symptoms can include:

• Anxiety
• Death
• Insomnia
• Lack of appetite
• Seizures
• Tremors

Recreational Use

Secobarbital began to be widely abused in the 1960s and 1970s, although with the advent of benzodiazepines, they have become less commonly used.

Secobarbital has acquired many nicknames, the most common being "reds", or "red dillies" (it was originally packaged in red capsules). Another common nickname is "seccies". A less common nickname is "dolls"; this was partly responsible for the title of Jacqueline Susann's novel Valley of the Dolls, whose main characters use secobarbital and other such drugs.

Another popular brand of barbiturate pill Tuinal contained a combination of secobarbital and amobarbital but is now rarely prescribed due to problems with abuse and overdose.

Cause of Death of Charles Boyer

Two days after his wife died from cancer in 1978, Charles Boyer committed suicide with an overdose of Seconal.

Cause of Death of Bartley Crum

Bartley Crum was the attorney for some of the so-called "Hollywood Ten" who were subpoenaed to appear before the House Un-American Activities Committee in 1947. The FBI tapped Crum's phones, opened his mail, and shadowed him constantly. Labeled as subversive, he ended up losing most of his clients and, unable to cope with stress from the harassment, committed suicide in 1959 by washing down an entire bottle of Seconal with whisky.

Cause of Death of Judy Garland

Judy Garland, of "The Wizard of Oz" fame, was found dead in her bathroom by her husband Mickey Deans on June 22, 1969. The stated exact cause of death by coroner Gavin Thursdon was accidental overdose of barbiturates; her blood contained the equivalent of 10 1.5-grain Seconal capsules.

Role in Death of Jimi Hendrix

Secobarbital played a role in the September 18, 1970 death of legendary rock guitarist Jimi Hendrix, who purportedly took nine Secobarbital tablets after a night of drinking wine and was later found dead in his London apartment. Hendrix' death was caused by asphyxiation, after Hendrix presumably vomited in his sleep as a result of the mixture of the excessive Secobarbital dose and alcohol.

Role in Death of Anissa Jones

Anissa Jones' fatal overdose was of a combination of cocaine, PCP, Methaqualone, and Seconal. The San Diego County coroner said it was one of the most severe cases of drug overdose ever seen in San Diego County.

Cause of Death of Carol Landis

On July 5, 1948, Carole Landis committed suicide by taking an overdose of Seconal in her Brentwood Heights, California home.

Cause of Death of Marilyn Monroe

In March 2007, an LA-based Australian writer and director named Philippe Mora uncovered previously-classified government documents regarding Marilyn Monroe's death. These documents, in turn, cited Seconal as Monroe's barbiturate of choice for her alleged suicide.

Cause of Death of Alejandra Pizarnik

Alejandra Pizarnik, an Argentine poetess, reportedly died, in 1972 at the age of 36, from a self-induced overdose of seconal.

Cause of Death of Lupe Velez

Lupe Velez, a Mexican actress who starred in many Hollywood films from 1927 to her death in 1944. On December 13, 1944 she committed suicide with an overdose of Seconal. She was 36 years old.

Use as a lethal injection

Secobarbital overdose was the most common method of implementing physician-assisted suicide (PAS) in Oregon until Eli Lilly and Company discontinued manufacturing it in May 2001, leading to a shortage of the drug. Since then, pentobarbital has dominated in Oregon PAS. Ranbaxy Laboratories Limited have experienced approval issues in their attempts to produce 100 mg secobarbital capsules, but there is no longer a shortage as of October 2006.

It is a component in the veterinary drug Somulose, used for euthanasia of horses and cattle.

External links

• Drugs.com - Secobarbital
• RxList.com - Secobarbital Consumer information.

There are also many myths surrounding this medicine, which is a very old medicine.

 If taken properly under the supervision of a doctor, this medication is relatively harmless compared to some of the new drugs made today.
  Tuinal is not seconal.  It contains seconal, and it is not made in the United States anymore.  Tuinal was 50% seconal and 50% amytal (truth serum), and is not available in the united states as a prescription drug.
 Seconal was abused many years ago, but only under certain circumstances could it be abused, number one, in combination with alcohol.
 Tuinal was abused the same way quaaludes were abused.  When combined with alcohol, it can be lethal, depending on the person.
 Also, the assisted suicide movement, made seconal very controversial.  A book was written with recipes to take one's life, one of them was to talk your doctor into prescribing it for a sleep disorder, then when a certain amount is obtained (or stored), to take them all at once.
 Also, newer medications that were patented claimed to be 'better' and 'more effective'.  The drug companies make money off of new patented drugs..
  Marilyn Monroe probably took seconal among many  drugs made at the time that were similar. but it is well known that her drug of choice was nembutal, and although that wass deemed to have caused her death, the autopsy found no traces of nembutal in her stomach, something that would occur if she  took an oversose of nembutal capsules.
 It  was widely believed she was murdered with the drug she enjoyed the most, nembutal, by an injection (fatal) from it.
 Seconal was a precription drug for decades with no regulations, but some misinformation, along with intentional and accidental deaths that showed seconal in the bloodstream, it was put on the controlled substances list passed by congress in 1971.
 This made doctors afraid to write it for patients, for fear of losing their licsense, even that was justified because unscrupulous doctors wrote it for money.
 The medication itself didn't cause danger, the misuse deliberatly made it dangerous.  People that are prescribed it for medicinal reasons and follow directions were unfairly labeled drug addicts.