Pentobarbital (pentobarbital sodium)

Para qué se usa Pentobarbital

Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.

Parenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section). Preanesthetics. …

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, solution, intramuscular), Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc.; abarca 1 producto del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.

Enfermedades que menciona la etiqueta

Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.

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Advertencia en recuadro

La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.

La etiqueta citada arriba no tiene advertencia en recuadro.

Efectos secundarios de Pentobarbital

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients. Because such patients may be less aware of certain 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: Nervous System: Somnolence.

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Less than 1 in 100 patients. Adverse reactions estimated to occur at a rate of less than 1 in 100 patients listed below, grouped by organ system, and by decreasing order of occurrence are: Nervous system: Agitation, confusion, hyperkinesia, ataxia, CNS depression, nightmares, nervousness, psychiatric disturbance, hallucinations, insomnia, anxiety, dizziness, thinking abnormality. 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. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-845-0689 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Leer la etiqueta completa en DailyMed →

Interacciones de Pentobarbital

Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.

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.

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Anticoagulants: Phenobarbital lowers the plasma levels of dicumarol (name previously used: bishydroxycoumarin) 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 (e.g., 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. 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. 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. 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 phenobarbital and doxycycline are administered concurrently, the clinical response to doxycycline should be monitored closely. Phenytoin, sodium valproate, valproic acid: The effect of barbiturates on the metabolism of phenytoin appears to be variable. Some investigators report an accelerating effect, while 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 appear to decrease barbiturate metabolism; therefore, barbiturate blood levels should be monitored and appropriate dosage adjustments made as indicated. Central nervous system depressants: The concomitant use of other central nervous system depressants, including other sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects. Monoamine oxidase inhibitors (MAOI): MAOI prolong the effects of barbiturates probably because metabolism of the barbiturate is inhibited. Estradiol, estrone, progesterone and other steroidal hormones: Pretreatment with or concurrent administration of phenobarbital may decrease the effect of estradiol by increasing its metabolism.

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Pentobarbital

Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.

Dosages of barbiturates must be individualized with full knowledge of their particular characteristics and recommended rate of administration. Factors of consideration are the patient's age, weight, and condition. Parenteral routes should be used only when oral administration is impossible or impractical.

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Intramuscular Administration IM injection of the sodium salts of barbiturates should be made deeply into a large muscle, and a volume of 5 mL should not be exceeded at any one site because of possible tissue irritation. After IM injection of a hypnotic dose, the patient's vital signs should be monitored. The usual adult dosage of Pentobarbital Sodium is 150 to 200 mg as a single IM injection; the recommended pediatric dosage ranges from 2 to 6 mg/kg as a single IM injection not to exceed 100 mg. Intravenous Administration Pentobarbital Sodium should not be admixed with any other medication or solution. IV injection is restricted to conditions in which other routes are not feasible, either because the patient is unconscious (as in cerebral hemorrhage, eclampsia, or status epilepticus), or because the patient resists (as in delirium), or because prompt action is imperative. Slow IV injection is essential, and patients should be carefully observed during administration. This requires that blood pressure, respiration, and cardiac function be maintained, vital signs be recorded, and equipment for resuscitation and artificial ventilation be available. The rate of IV injection should not exceed 50 mg/min for Pentobarbital Sodium. There is no average intravenous dose of Pentobarbital Sodium that can be relied on to produce similar effects in different patients. The possibility of overdose and respiratory depression is remote when the drug is injected slowly in fractional doses. A commonly used initial dose for the 70 kg adult is 100 mg. Proportional reduction in dosage should be made for pediatric or debilitated patients. At least one minute is necessary to determine the full effect of intravenous pentobarbital. If necessary, additional small increments of the drug may be given up to a total of from 200 to 500 mg for normal adults. Anticonvulsant use In convulsive states, dosage of Pentobarbital Sodium should be kept to a minimum to avoid compounding the depression which may follow convulsions. The injection must be made slowly with due regard to the time required for the drug to penetrate the blood-brain barrier. 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. Inspection Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution containers permit. Solutions for injection showing evidence of precipitation should not be used.

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Leer la etiqueta completa en DailyMed →

Pentobarbital en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

Teratogenic effects. See " Warnings - Use in Pregnancy " section 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 " section).

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Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans. In a published study, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus. In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits (See Warnings/ Pediatric Neurotoxicity, Precautions / Pediatric Use, and Animal Pharmacology and/or Toxicology).

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Leer la etiqueta completa en DailyMed →

Pentobarbital y la lactancia

Cita de la parte sobre lactancia (Nursing Mothers) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Caution should be exercised when a barbiturate is administered to a nursing woman since small amounts of barbiturates are excreted in the milk.

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Pentobarbital

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

Barbiturates are contraindicated in patients with known barbiturate sensitivity. Barbiturates are also contraindicated in patients with a history of manifest or latent porphyria.

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Leer la etiqueta completa en DailyMed →

Sobredosis de Pentobarbital

Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).

The toxic dose of barbiturates varies considerably. In general, an oral dose of 1 gram of most barbiturates produces serious poisoning in an adult. Death commonly occurs after 2 to 10 grams of ingested barbiturate. Barbiturate intoxication may be confused with alcoholism, bromide intoxication, and with various neurological disorders.

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Acute overdosage with barbiturates is manifested by CNS and respiratory depression which may progress to Cheyne-Stokes respiration, areflexia, constriction of the pupils to a slight degree (though in severe poisoning they may show paralytic dilation), oliguria, tachycardia, hypotension, lowered body temperature, and coma. Typical shock syndrome (apnea, circulatory collapse, respiratory arrest, and death) may occur. In extreme overdose, all electrical activity in the brain may cease, in which case a "flat" EEG normally equated with clinical death cannot be accepted. This effect is fully reversible unless hypoxic damage occurs. Consideration should be given to the possibility of barbiturate intoxication even in situations that appear to involve trauma. Complications such as pneumonia, pulmonary edema, cardiac arrhythmias, congestive heart failure, and renal failure may occur. Uremia may increase CNS sensitivity to barbiturates. Differential diagnosis should include hypoglycemia, head trauma, cerebrovascular accidents, convulsive states, and diabetic coma. Blood levels from acute overdosage for some barbiturates are listed in Table 1. Table 1. Concentration of Barbiturate in the Blood Versus Degree of CNS Depression Blood barbiturate level in ppm (μg/mL) * Categories of degree of depression in nontolerant persons: 1. Under the influence and appreciably impaired for purposes of driving a motor vehicle or performing tasks requiring alertness and unimpaired judgment and reaction time. 2. Sedated, therapeutic range, calm, relaxed, and easily aroused. 3. Comatose, difficult to arouse, significant depression of respiration. 4. Compatible with death in aged or ill persons or in presence of obstructed airway, other toxic agents, or exposure to cold. 5. Usual lethal level, the upper end of the range includes those who received some supportive treatment. Degree of depression in nontolerant persons* Barbiturate Onset/duration 1 2 3 4 5 Pentobarbital Fast/short ≤ 2 0.5 to 3 10 to 15 12 to 25 15 to 40 Secobarbital Fast/short ≤ 2 0.5 to 5 10 to 15 15 to 25 15 to 40 Amobarbital Intermediate/ intermediate ≤ 3 2 to 10 30 to 40 30 to 60 40 to 80 Butabarbital Intermediate/ intermediate ≤ 5 3 to 25 40 to 60 50 to 80 60 to 100 Phenobarbital Slow/long ≤ 10 5 to 40 50 to 80 70 to 120 100 to 200 Treatment of overdosage is mainly supportive and consists of the following: Maintenance of an adequate airway, with assisted respiration and oxygen administration as necessary. Monitoring of vital signs and fluid balance. Fluid therapy and other standard treatment for shock, if needed. If renal function is normal, forced diuresis may aid in the elimination of the barbiturate.

— Etiqueta de la FDA: Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Empresas que tienen este medicamento

Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.

• Sagent Pharmaceuticals1 producto
• Hikma Pharmaceuticals USA Inc.1 producto

Historial de aprobación de la FDA

• ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.

Aprobaciones de genéricos (2)

• ANDA206404Sagent Pharms Inc · 23 de mayo de 2016
• ANDA203619Hikma · 13 de noviembre de 2017

Escasez

La lista de escasez de la FDA no incluye estos productos.

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Retiros del mercado

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Identificadores oficiales

Siguientes pasos

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• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• InsomnioEnfermedad que menciona la etiqueta: hospitales que la tratan
• Sagent PharmaceuticalsFabricante o distribuidor
• Hikma Pharmaceuticals USA Inc.Fabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Pentobarbital Sodium, Hikma Pharmaceuticals USA Inc., vigente desde el 8 de marzo de 2024; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
3. Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
4. Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
6. Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.

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