Seconal Sodium

Seconal Sodium is a brand name medication included in a group of medications called Barbiturates. For more information about Seconal Sodium see its generic Secobarbital

• Marathon Pharmaceuticals, LLC

• Ranbaxy Pharmaceuticals, Inc.

Seconal Sodium is part of the drug class:

• Barbiturates

Follow all directions on your prescription label. Never take secobarbital in larger amounts, or for longer than prescribed.

Secobarbital may be habit-forming. Never share secobarbital with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.

If you take this medicine to treat insomnia: Take secobarbital only when you are getting ready for several hours of sleep. You may fall asleep very quickly after taking the medicine.

Take secobarbital on an empty stomach. Do not take the medicine right after eating a meal.

Secobarbital is for short-term use only.

Call your doctor if your insomnia symptoms do not improve, or if they get worse after using this medication for 7 to 10 nights in a row. Do not take secobarbital for longer than 2 weeks without your doctor's advice.

Do not stop using secobarbital suddenly after long-term use, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using secobarbital.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Secobarbital is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity such as driving, eating, walking, making phone calls, or having sex and later having no memory of the activity. If this happens to you, stop taking secobarbital and talk with your doctor about another treatment for your sleep disorder.

Stop using secobarbital and call your doctor at once if you have:

• unusual thoughts or behavior;

• new or worsening depression;

• confusion, hallucinations;

• anxiety, agitation; or

• thoughts of suicide or hurting yourself.

The sedative effects of secobarbital may be stronger in older adults.

Common side effects may include:

• drowsiness, feeling tired;

• "hangover" effect (drowsiness the day after a dose);

• headache, dizziness;

• memory problems;

• dry mouth;

• upset stomach; or

• feeling restless or excited (especially in children).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking secobarbital with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with secobarbital, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

General-Barbiturates may be habit-forming. Tolerance and psychological and physical dependence may occur with continuing use (see Drug Abuse and Dependence). Barbiturates should be administered with caution, if at all, to patients who are mentally depressed, have suicidal tendencies, or have a history of drug abuse.

Elderly or debilitated patients may react to barbiturates with marked excitement, depression, or confusion. In some persons, especially pediatric patients, barbiturates repeatedly produce excitement rather than depression.

In patients with hepatic damage, barbiturates should be administered with caution and initially in reduced doses. Barbiturates should not be administered to patients showing the premonitory signs of hepatic coma.

Information for Patients

"Sleep-Driving" and other complex behaviors:

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since "sleep-driving" can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other central nervous system depressants (see WARNINGS). 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.

The following information should be given to patients receiving Seconal Sodium:

1. The use of Seconal Sodium carries with it an associated risk of psychological and/or physical dependence. The patient should be warned against increasing the dose of the drug without consulting a physician. 2. Seconal Sodium may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a car or operating machinery. The patient should be cautioned accordingly. 3. Alcohol should not be consumed while taking Seconal Sodium. The concurrent use of Seconal Sodium with other CNS depressants (eg, alcohol, narcotics, tranquilizers, and antihistamines) may result in additional CNS-depressant effects.

Laboratory Tests-Prolonged therapy with barbiturates should be accompanied by periodic laboratory evaluation of organic systems, including hematopoietic, renal, and hepatic systems (see General under Precautions and Adverse Reactions).

Drug Interactions-Most reports of clinically significant drug interactions occurring with the barbiturates have involved phenobarbital. However, the application of these data to other barbiturates appears valid and warrants serial blood level determinations of the relevant drugs when there are multiple therapies.

1. Anticoagulants-Phenobarbital lowers the plasma levels of dicumarol and causes a decrease in anticoagulant activity as measured by the prothrombin time. Barbiturates can induce hepatic microsomal enzymes, resulting in increased metabolism and decreased anticoagulant response of oral anticoagulants (eg, warfarin, acenocoumarol, dicumarol, and phenprocoumon). Patients stabilized on anticoagulant therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. 2. Corticosteroids-Barbiturates appear to enhance the metabolism of exogenous corticosteroids, probably through the induction of hepatic microsomal enzymes. Patients stabilized on corticosteroid therapy may require dosage adjustments if barbiturates are added to or withdrawn from their dosage regimen. 3. Griseofulvin-Phenobarbital appears to interfere with the absorption of orally administered griseofulvin, thus decreasing its blood level. The effect of the resultant decreased blood levels of griseofulvin on therapeutic response has not been established. However, it would be preferable to avoid concomitant administration of these drugs. 4. Doxycycline-Phenobarbital has been shown to shorten the half-life of doxycycline for as long as 2 weeks after barbiturate therapy is discontinued.
This mechanism is probably through the induction of hepatic microsomal enzymes that metabolize the antibiotic. If barbiturates and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely. 5. Phenytoin, Sodium Valproate, Valproic Acid-The effect of barbiturates on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, whereas others report no effect. Because the effect of barbiturates on the metabolism of phenytoin is not predictable, phenytoin and barbiturate blood levels should be monitored more frequently if these drugs are given concurrently. Sodium valproate and valproic acid increase the secobarbital sodium serum levels; therefore, secobarbital sodium blood levels should be monitored closely and appropriate dosage adjustments made as clinically indicated. 6. CNS Depressants-The concomitant use of other CNS depressants, including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects. 7. Monoamine Oxidase Inhibitors (MAOIs)-MAOIs prolong the effects of barbiturates, probably because metabolism of the barbiturate is inhibited. 8. Estradiol, Estrone, Progesterone, and Other Steroidal Hormones-Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism. There have been reports of patients treated with antiepileptic drugs (eg, phenobarbital) who become pregnant while taking oral contraceptives. An alternate contraceptive method might be suggested to women taking barbiturates.

Carcinogenesis-

1. Animal Data. Phenobarbital sodium is carcinogenic in mice and rats after lifetime administration. In mice, it produced benign and malignant liver cell tumors. In rats, benign liver cell tumors were observed very late in life. 2. Human Data-In a 29-year epidemiologic study of 9,136 patients who were treated on an anticonvulsant protocol that included phenobarbital, results indicated a higher than normal incidence of hepatic carcinoma. Previously, some of these patients had been treated with thorotrast, a drug that is known to produce hepatic carcinomas. Thus, this study did not provide sufficient evidence that phenobarbital sodium is carcinogenic in humans.
A retrospective study of 84 pediatric patients with brain tumors matched to 73 normal controls and 78 cancer controls (malignant disease other than brain tumors) suggested an association between exposure to barbiturates prenatally and an increased incidence of brain tumors.

Usage in Pregnancy-

1. Teratogenic Effects. Pregnancy Category D. See Usage in Pregnancy under Warnings. 2. Nonteratogenic Effects. Reports of infants suffering from long-term barbiturate exposure in utero included the acute withdrawal syndrome of seizures and hyperirritability from birth to a delayed onset of up to 14 days (see Drug Abuse and Dependence).

Labor and Delivery- Hypnotic doses of barbiturates do not appear to impair uterine activity significantly during labor. Full anesthetic doses of barbiturates decrease the force and frequency of uterine contractions. Administration of sedative-hypnotic barbiturates to the mother during labor may result in respiratory depression in the newborn. Premature infants are particularly susceptible to the depressant effects of barbiturates. If barbiturates are used during labor and delivery, resuscitation equipment should be available.

Data are not available to evaluate the effect of barbiturates when forceps delivery or other intervention is necessary or to determine the effect of barbiturates on the later growth, development, and functional maturity of the pediatric patient.

Nursing Mothers- Caution should be exercised when Seconal Sodium is administered to a nursing woman, because small amounts of barbiturates are excreted in the milk.

The following adverse reactions and their incidences were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of some of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.

More than 1 in 100 Patients

The most common adverse reaction estimated to occur at a rate of 1 to 3 patients per 100 is the following:
Nervous System:  Somnolence

Less than 1 in 100 Patients

Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence:
Nervous System:  Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, abnormality in thinking
Respiratory System:  Hypoventilation, apnea
Cardiovascular System:  Bradycardia, hypotension, syncope
Digestive System:  Nausea, vomiting, constipation
Other Reported Reactions:  Headache, injection site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use

Applies to secobarbital: oral capsule

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Feeling sleepy the next day.
• Dizziness.
• Headache.
• Feeling tired or weak.
• Dry mouth.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.