Seconal Sodium
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Questions & Answers
Side Effects & Adverse Reactions
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 (see Precautions and Dosage and Administration), 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.
1. Habit-Forming—Seconal Sodium may be habit-forming. Tolerance and psychological and physical dependence may occur with continued use (see Drug Abuse and Dependence and Pharmacokinetics under Clinical Pharmacology). 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 (see Drug Abuse and Dependence).
2. 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.
3. 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 (see Drug Abuse and Dependence). 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.
4. Synergistic Effects—The concomitant use of alcohol or other CNS depressants may produce additive CNS-depressant effects.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
A. Hypnotic, for the short-term treatment of insomnia, since it appears to lose its effectiveness for sleep induction and sleep maintenance after 2 weeks (see Clinical Pharmacology).
B. Preanesthetic
History
There is currently no drug history available for this drug.
Other Information
The barbiturates are nonselective central nervous system (CNS) depressants that are primarily used as sedative hypnotics. In subhypnotic doses, they are also used as anticonvulsants. The barbiturates and their sodium salts are subject to control under the Federal Controlled Substances Act.
Seconal Sodium® (Secobarbital Sodium Capsules, USP) is a barbituric acid derivative and occurs as a white, odorless, bitter powder that is very soluble in water, soluble in alcohol, and practically insoluble in ether. Chemically, the drug is sodium 5-allyl-5-(1-methylbutyl) barbiturate, with the molecular formula C12H17N2NaO3. Its molecular weight is 260.27. The structural formula is as follows:
Each capsule contains 100 mg (0.38 mmol) of secobarbital sodium. It also contains dimethicone, FD&C Red No. 3, FD&C Yellow No. 10, gelatin, magnesium stearate, pregelatinized starch, and titanium dioxide.
Sources
Seconal Sodium Manufacturers
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Ranbaxy Pharmaceuticals Inc.
![Seconal Sodium (Secobarbital Sodium) Capsule [Ranbaxy Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Seconal Sodium | Ranbaxy Pharmaceuticals Inc.
Dosages of barbiturates must be individualized with full knowledge of their particular characteristics. Factors of consideration are the patient’s age, weight, and condition.
Adults—As a hypnotic, 100 mg at bedtime. Preoperatively, 200 to 300 mg 1 to 2 hours before surgery.
Pediatric Patients—Preoperatively, 2 to 6 mg/kg, with a maximum dosage of 100 mg.
Special patient population—Dosage should be reduced in the elderly or debilitated because these patients may be more sensitive to barbiturates. Dosage should be reduced for patients with impaired renal function or hepatic disease.
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Marathon Pharmaceuticals, Llc
Seconal Sodium | Fresenius Kabi Usa, Llc
AdultsThe dosage recommendations for imipenem and cilastatin for injection (I.V.) represent the quantity of imipenem to be administered. An equivalent amount of cilastatin is also present in the solution. Each 125 mg, 250 mg, or 500 mg dose should be given by intravenous administration over 20 to 30 minutes. Each 750 mg or 1000 mg dose should be infused over 40 to 60 minutes. In patients who develop nausea during the infusion, the rate of infusion may be slowed.
The total daily dosage for imipenem and cilastatin for injection (I.V.) should be based on the type or severity of infection and given in equally divided doses based on consideration of degree of susceptibility of the pathogen(s), renal function, and body weight. Adult patients with impaired renal function, as judged by creatinine clearance ≤ 70 mL/min/1.73 m2, require adjustment of dosage as described in the succeeding section of these guidelines.
Intravenous Dosage Schedule for Adults with Normal Renal Function and Body Weight ≥ 70 kg
Doses cited in Table 3 are based on a patient with normal renal function and a body weight of 70 kg. These doses should be used for a patient with a creatinine clearance of ≥ 71 mL/min/1.73 m2 and a body weight of ≥ 70 kg. A reduction in dose must be made for a patient with a creatinine clearance of ≤ 70 mL/min/1.73 m2 and/or a body weight less than 70 kg. (see Tables 4 and 5).Dosage regimens in column A of Table 3 are recommended for infections caused by fully susceptible organisms which represent the majority of pathogenic species. Dosage regimens in column B of Table 3 are recommended for infections caused by organisms with moderate susceptibility to imipenem, primarily some strains of P. aeruginosa.
TABLE 3
INTRAVENOUS DOSAGE SCHEDULE FOR ADULTS WITH NORMAL RENAL FUNCTION AND BODY WEIGHT ≥ 70 kg
Type or
Severity
of Infection
A
Fully susceptible organisms including
gram-positive and gram-negative
aerobes and anaerobes
B
Moderately susceptible organisms,
primarily some strains of P. aeruginosa
Mild
250 mg q 6 h
(TOTAL DAILY DOSE = 1 g)
500 mg q 6 h
(TOTAL DAILY DOSE = 2 g)
Moderate
500 mg q 8 h
(TOTAL DAILY DOSE = 1.5 g)
or
500 mg q 6 h
(TOTAL DAILY DOSE = 2 g)
500 mg q 6 h
(TOTAL DAILY DOSE = 2 g)
or
1 g q 8 h
(TOTAL DAILY DOSE = 3 g)
Severe, life
threatening only
500 mg q 6 h
(TOTAL DAILY DOSE = 2 g)
1 g q 8 h
(TOTAL DAILY DOSE = 3 g)
or
1 g q 6 h
(TOTAL DAILY DOSE = 4 g)
Uncomplicated
urinary tract infection
250 mg q 6 h
(TOTAL DAILY DOSE = 1 g)
250 mg q 6 h
(TOTAL DAILY DOSE = 1 g)
Complicated
urinary tract infection
500 mg q 6 h
(TOTAL DAILY DOSE = 2 g)
500 mg q 6 h
(TOTAL DAILY DOSE = 2 g)
Due to the high antimicrobial activity of imipenem and cilastatin for injection (I.V.), it is recommended that the maximum total daily dosage not exceed 50 mg/kg/day or 4 g/day, whichever is lower. There is no evidence that higher doses provide greater efficacy. However, patients over twelve years of age with cystic fibrosis and normal renal function have been treated with imipenem and cilastatin for injection (I.V.) at doses up to 90 mg/kg/day in divided doses, not exceeding 4 g/day.
Reduced Intravenous Schedule for Adults with Impaired Renal Function and/or Body Weight < 70 kgPatients with creatinine clearance of ≤ 70 mL/min/1.73 m2 and/or body weight less than 70 kg require dosage reduction of imipenem and cilastatin for injection (I.V.) as indicated in the tables below. Creatinine clearance may be calculated from serum creatinine concentration by the following equation:
To determine the dose for adults with impaired renal function and/or reduced body weight:
Choose a total daily dose from Table 3 based on infection characteristics. a) If the total daily dose is 1 g, 1.5 g, or 2 g, use the appropriate subsection of Table 4 and continue with step 3.
b) If the total daily dose is 3 g or 4 g, use the appropriate subsection of Table 5 and continue with step 3. From Table 4 or 5:a) Select the body weight on the far left which is closest to the patient's body weight (kg).b) Select the patient's creatinine clearance category.c) Where the row and column intersect is the reduced dosage regimen.TABLE 4 REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT < 70 kg
If TOTAL DAILY DOSE from TABLE 3 is:
And Body Weight
(kg)
is:
1 g/ day
1.5 g/day
2 g/day
and creatinine clearance
(mL/min/1.73 m2) is:
and creatinine clearance
(mL/min/1.73 m2) is:
and creatinine clearance
(mL/min/1.73 m2) is:
≥ 71
41 to 70
21 to 40
6 to 20
≥ 71
41 to 70
21 to 40
6 to 20
≥ 71
41 to 70
21 to 40
6 to 20
then the reduced dosage
regimen (mg) is:
then the reduced dosage
regimen (mg) is:
then the reduced dosage
regimen (mg) is:
≥ 70
250
q 6 h
250
q 8 h
250
q 12 h
250
q 12 h
500
q 8 h
250
q 6 h
250
q 8 h
250
q 12 h
500
q 6 h
500
q 8 h
250
q 6 h
250
q 12 h
60
250
q 8 h
125
q 6 h
250
q 12 h
125
q 12 h
250
q 6 h
250
q 8 h
250
q 8 h
250
q 12 h
500
q 8 h
250
q 6 h
250
q 8 h
250
q 12 h
50
125
q 6 h
125
q 6 h
125
q 8 h
125
q 12 h
250
q 6 h
250
q 8 h
250
q 12 h
250
q 12 h
250
q 6 h
250
q 6 h
250
q 8 h
250
q 12 h
40
125
q 6 h
125
q 8 h
125
q 12 h
125
q 12 h
250
q 8 h
125
q 6 h
125
q 8 h
125
q 12 h
250
q 6 h
250
q 8 h
250
q 12 h
250
q 12 h
30
125
q 8 h
125
q 8 h
125
q 12 h
125
q 12 h
125
q 6 h
125
q 8 h
125
q 8 h
125
q 12 h
250
q 8 h
125
q 6 h
125
q 8 h
125
q 12 h
TABLE 5 REDUCED INTRAVENOUS DOSAGE OF IMIPENEM AND CILASTATIN FOR INJECTION (I.V.) IN ADULT PATIENTS WITH IMPAIRED RENAL FUNCTION AND/OR BODY WEIGHT < 70 kg
If TOTAL DAILY DOSE from TABLE 3 is:
And Body Weight
(kg)
is:
3 g/ day
4 g/day
and creatinine clearance
(mL/min/1.73 m2) is:
and creatinine clearance
(mL/min/1.73 m2) is:
≥ 71
41 to 70
21 to 40
6 to 20
≥ 71
41 to 70
21 to 40
6 to 20
then the reduced dosage
regimen (mg) is:
then the reduced dosage
regimen (mg) is:
≥ 70
1000
q 8 h
500
q 6 h
500
q 8 h
500
q 12 h
1000
q 6 h
750
q 8 h
500
q 6 h
500
q 12 h
60
750
q 8 h
500
q 8 h
500
q 8 h
500
q 12 h
1000
q 8 h
750
q 8 h
500
q 8 h
500
q 12 h
50
500
q 6 h
500
q 8 h
250
q 6 h
250
q 12 h
750
q 8 h
500
q 6 h
500
q 8 h
500
q 12 h
40
500
q 8 h
250
q 6 h
250
q 8 h
250
q 12 h
500
q 6 h
500
q 8 h
250
q 6 h
250
q 12 h
30
250
q 6 h
250
q 8 h
250
q 8 h
250
q 12 h
500
q 8 h
250
q 6 h
250
q 8 h
250
q 12 h
Patients with creatinine clearances of 6 to 20 mL/min/1.73 m2 should be treated with imipenem and cilastatin for injection (I.V.) 125 mg or 250 mg every 12 hours for most pathogens. There may be an increased risk of seizures when doses of 500 mg every 12 hours are administered to these patients.
Patients with creatinine clearance ≤ 5 mL/min/1.73 m2 should not receive imipenem and cilastatin for injection (I.V.) unless hemodialysis is instituted within 48 hours. There is inadequate information to recommend usage of imipenem and cilastatin for injection (I.V.) for patients undergoing peritoneal dialysis.
HemodialysisWhen treating patients with creatinine clearances of ≤ 5 mL/min/1.73 m2who are undergoing hemodialysis, use the dosage recommendations for patients with creatinine clearances of 6 to 20 mL/min/1.73 m2. (See Reduced Intravenous Dosage Schedule for Adults with Impaired Renal Function and/or Body Weight < 70 kg.) Both imipenem and cilastatin are cleared from the circulation during hemodialysis. The patient should receive imipenem and cilastatin for injection (I.V.) after hemodialysis and at 12 hour intervals timed from the end of that hemodialysis session. Dialysis patients, especially those with background CNS disease, should be carefully monitored; for patients on hemodialysis, imipenem and cilastatin for injection (I.V.) is recommended only when the benefit outweighs the potential risk of seizures. (see PRECAUTIONS).
Pediatric PatientsSee PRECAUTIONS, Pediatric Patients.
For pediatric patients ≥ 3 months of age, the recommended dose for non-CNS infections is 15 to 25 mg/kg/dose administered every six hours. Based on studies in adults, the maximum daily dose for treatment of infections with fully susceptible organisms is 2 g per day, and of infections with moderately susceptible organisms (primarily some strains of P. aeruginosa) is 4 g/day. Higher doses (up to 90 mg/kg/day in older children) have been used in patients with cystic fibrosis.
For pediatric patients ≤ 3 months of age (weighing ≥ 1,500 g), the following dosage schedule is recommended for non-CNS infections:
< 1 wk of age: 25 mg/kg every 12 hrs
1 to 4 wks of age: 25 mg/kg every 8 hrs
4 wks to 3 mos. of age: 25 mg/kg every 6 hrs.Doses less than or equal to 500 mg should be given by intravenous infusion over 15 to 30 minutes. Doses greater than 500 mg should be given by intravenous infusion over 40 to 60 minutes.
Imipenem and cilastatin for injection (I.V.) is not recommended in pediatric patients with CNS infections because of the risk of seizures.
Imipenem and cilastatin for injection (I.V.) is not recommended in pediatric patients < 30 kg with impaired renal function, as no data are available.
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