Respuestas rápidas
- ¿Para qué se usa Amitriptilina y clordiazepóxido?
- La etiqueta aprobada por la FDA (Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., 15 de marzo de 2026) dice, en inglés: “Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. …” Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Cuáles son los efectos secundarios de Amitriptilina y clordiazepóxido?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., 15 de marzo de 2026) comienza así, en inglés: «Adverse reactions to chlordiazepoxide and amitriptyline hydrochloride are those associated with the use of either component alone. Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Other side effects occurring less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Amitriptilina y clordiazepóxido tiene una advertencia en recuadro?
- Sí. La etiqueta de la FDA de Chlordiazepoxide and Amitriptyline Hydrochloride tiene una advertencia en recuadro, la advertencia más seria de la FDA. Léala en la etiqueta completa y pregunte a su farmacéutico.
- ¿Hay escasez de Amitriptilina y clordiazepóxido?
- La FDA no indica una escasez actual para los productos de este medicamento (datos de la FDA del 30 de octubre de 2026).
- ¿Se ha retirado del mercado Amitriptilina y clordiazepóxido?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Amitriptilina y clordiazepóxido?
- 1 empresa tiene productos con receta de Amitriptilina y clordiazepóxido en el directorio NDC de la FDA, entre ellas Mylan Pharmaceuticals Inc.
Para qué se usa Amitriptilina y clordiazepóxido
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.
Chlordiazepoxide and amitriptyline hydrochloride tablets are indicated for the treatment of patients with moderate to severe depression associated with moderate to severe anxiety. The therapeutic response to chlordiazepoxide and amitriptyline hydrochloride tablets occurs earlier and with fewer treatment failures than when either amitriptyline or chlordiazepoxide is used alone. …
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (tablet, film coated, oral), Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc.; abarca 2 productos 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.
Especialidades médicas relacionadas
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.
Esta etiqueta tiene una advertencia en recuadro. Leerla en la etiqueta completa →
Amitriptilina y clordiazepóxido: lo que dice la advertencia en recuadro
Cita de la advertencia en recuadro (Boxed Warning) de la etiqueta aprobada por la FDA. Se muestra en inglés.
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; DEPENDENCE AND WITHDRAWAL REACTIONS; and SUICIDAL THOUGHTS AND BEHAVIORS
- Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required.
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Follow patients for signs and symptoms of respiratory depression and sedation (see WARNINGS and PRECAUTIONS).
- The use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing chlordiazepoxide and amitriptyline hydrochloride tablets and throughout treatment, assess each patient’s risk for abuse, misuse, and addiction (see WARNINGS).
- The continued use of benzodiazepines, including chlordiazepoxide and amitriptyline hydrochloride tablets, may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Abrupt discontinuation or rapid dosage reduction of chlordiazepoxide and amitriptyline hydrochloride tablets after continued use may precipitate acute withdrawal reactions, which can be life-threatening. To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION and WARNINGS).
- Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors (see WARNINGS). Chlordiazepoxide and amitriptyline hydrochloride tablets are not approved for use in pediatric patients (see PRECAUTIONS).
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Efectos secundarios de Amitriptilina y clordiazepóxido
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.
Adverse reactions to chlordiazepoxide and amitriptyline hydrochloride are those associated with the use of either component alone. Most frequently reported were drowsiness, dry mouth, constipation, blurred vision, dizziness and bloating. Other side effects occurring less commonly included vivid dreams, impotence, tremor, confusion and nasal congestion.
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Many symptoms common to the depressive state, such as anorexia, fatigue, weakness, restlessness and lethargy, have been reported as side effects of treatment with both chlordiazepoxide and amitriptyline hydrochloride tablets and amitriptyline. Granulocytopenia, jaundice and hepatic dysfunction of uncertain etiology have also been observed rarely with chlordiazepoxide and amitriptyline hydrochloride tablets. When treatment with chlordiazepoxide and amitriptyline hydrochloride tablets is prolonged, periodic blood counts and liver function tests are advisable. Note Included in the listing which follows are adverse reactions which have not been reported with chlordiazepoxide and amitriptyline hydrochloride. However, they are included because they have been reported during therapy with one or both of the components or closely related drugs. Cardiovascular: Hypotension, hypertension, tachycardia, palpitations, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric: Euphoria, apprehension, poor concentration, delusions, hallucinations, hypomania and increased or decreased libido. Neurologic: Incoordination, ataxia, numbness, tingling and paresthesias of the extremities, extrapyramidal symptoms, syncope, changes in EEG patterns. Anticholinergic: Disturbance of accommodation, paralytic ileus, urinary retention, dilatation of urinary tract. Allergic: Skin rash, urticaria, photosensitization, edema of face and tongue, pruritus, drug reaction with eosinophilia and systemic symptoms (DRESS). Hematologic: Bone marrow depression including agranulocytosis, eosinophilia, purpura, thrombocytopenia. Gastrointestinal: Nausea, epigastric distress, vomiting, anorexia, stomatitis, peculiar taste, diarrhea, black tongue. Endocrine: Testicular swelling and gynecomastia in the male, breast enlargement, galactorrhea and minor menstrual irregularities in the female, elevation and lowering of blood sugar levels, and syndrome of inappropriate ADH (antidiuretic hormone) secretion. Other: Headache, weight gain or loss, increased perspiration, urinary frequency, mydriasis, jaundice, alopecia, parotid swelling, hyponatremia.
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Dosis de Amitriptilina y clordiazepóxido
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.
Optimum dosage varies with the severity of the symptoms and the response of the individual patient. When a satisfactory response is obtained, dosage should be reduced to the smallest amount needed to maintain the remission. The larger portion of the total daily dose may be taken at bedtime. In some patients, a single dose at bedtime may be sufficient. In general, lower dosages are recommended for elderly patients.
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Chlordiazepoxide and amitriptyline hydrochloride tablets 10 mg/25 mg are recommended in an initial dosage of 3 or 4 tablets daily in divided doses; this may be increased to 6 tablets daily as required. Some patients respond to smaller doses and can be maintained on 2 tablets daily. Chlordiazepoxide and amitriptyline hydrochloride tablets 5 mg/12.5 mg in an initial dosage of 3 or 4 tablets daily in divided doses may be satisfactory in patients who do not tolerate higher doses. Screen for Bipolar Disorder Prior to Starting Chlordiazepoxide and Amitriptyline Hydrochloride Tablets Prior to initiating treatment with chlordiazepoxide and amitriptyline hydrochloride tablets or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania (see WARNINGS: Activation of Mania or Hypomania). Discontinuation or Dosage Reduction of Chlordiazepoxide and Amitriptyline Hydrochloride Tablets To reduce the risk of withdrawal reactions, use a gradual taper to discontinue chlordiazepoxide and amitriptyline hydrochloride tablets or reduce the dosage. If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. Subsequently decrease the dosage more slowly (see WARNINGS: Dependence and Withdrawal Reactions and DRUG ABUSE AND DEPENDENCE: Dependence).
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Amitriptilina y clordiazepóxido 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.
Advise pregnant females that use of chlordiazepoxide and amitriptyline hydrochloride tablets late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in newborns (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome and Precautions, Pregnancy). Instruct patients to inform their healthcare provider if they are pregnant.
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Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy (see PRECAUTIONS: Pregnancy). Pregnancy Pregnancy Exposure Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including chlordiazepoxide and amitriptyline hydrochloride tablets, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychiatric Medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/pregnancyregistry/. Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome, and Clinical Considerations). Available data from published observational studies of pregnant women exposed to benzodiazepines do not report a clear association with benzodiazepines and major birth defects (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Fetal/Neonatal Adverse Reactions Benzodiazepines cross the placenta and may produce respiratory depression, hypotonia and sedation in neonates. Monitor neonates exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, and feeding problems. Monitor neonates exposed to chlordiazepoxide and amitriptyline hydrochloride tablets during pregnancy for signs of withdrawal. Manage these neonates accordingly (see WARNINGS: Neonatal Sedation and Withdrawal Syndrome). Data Human Data Published data from observational studies on the use of benzodiazepines during pregnancy do not report a clear association with benzodiazepines and major birth defects. Although early studies reported an increased risk of congenital malformations with diazepam and chlordiazepoxide, there was no consistent pattern noted. In addition, the majority of more recent case-control and cohort studies of benzodiazepine use during pregnancy, which were adjusted for confounding exposures to alcohol, tobacco and other medications, have not confirmed these findings.
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Amitriptilina y clordiazepóxido
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Chlordiazepoxide and amitriptyline hydrochloride tablets are contraindicated in patients with hypersensitivity to either benzodiazepines or tricyclic antidepressants. It should not be given concomitantly with a monoamine oxidase inhibitor. Hyperpyretic crises, severe convulsions and deaths have occurred in patients receiving a tricyclic antidepressant and a monoamine oxidase inhibitor simultaneously.
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When it is desired to replace a monoamine oxidase inhibitor with chlordiazepoxide and amitriptyline hydrochloride tablets, a minimum of 14 days should be allowed to elapse after the former is discontinued. Chlordiazepoxide and amitriptyline hydrochloride tablets should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. This drug is contraindicated during the acute recovery phase following myocardial infarction.
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Sobredosis de Amitriptilina y clordiazepóxido
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).
Overdosage of chlordiazepoxide and amitriptyline hydrochloride tablets, which contain a benzodiazepine (chlordiazepoxide) and a tricyclic antidepressant (amitriptyline hydrochloride), may manifest signs and symptoms related to either of its components. Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose.
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Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose. Critical manifestations of tricyclic antidepressant overdosage include cardiac dysrhythmias, severe hypotension, convulsions and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. Obtain an ECG and immediately initiate cardiac monitoring; hospital monitoring is required as soon as possible. Other signs of overdosage may include confusion, disturbed concentration, transient visual hallucinations, dilated pupils, agitation, hyperactive reflexes, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia or any of the symptoms listed under ADVERSE REACTIONS. Overdosage of benzodiazepines is characterized by central nervous system depression ranging from drowsiness to coma. In mild to moderate cases, symptoms can include drowsiness, confusion, dysarthria, lethargy, hypnotic state, diminished reflexes, ataxia, and hypotonia. Rarely, paradoxical or disinhibitory reactions (including agitation, irritability, impulsivity, violent behavior, confusion, restlessness, excitement, and talkativeness) may occur. In severe overdosage cases, patients may develop respiratory depression and coma. Overdosage of benzodiazepines in combination with other CNS depressants (including alcohol and opioids) may be fatal (see WARNINGS: Abuse, Misuse, and Addiction). Markedly abnormal (lowered or elevated) blood pressure, heart rate, or respiratory rate raise the concern that additional drugs and/or alcohol are involved in the overdosage. In managing benzodiazepine overdosage, employ general supportive measures, including intravenous fluids and airway management. Flumazenil, a specific benzodiazepine receptor antagonist indicated for the complete or partial reversal of the sedative effects of benzodiazepines in the management of benzodiazepine overdosage, can lead to withdrawal and adverse reactions, including seizures with chlordiazepoxide and amitriptyline hydrochloride tablets because overdosage with amitriptyline and other tricyclic and tetracyclic antidepressants increases the risk of seizures. Seizure risk is also increased in patients with long-term benzodiazepine use and physical dependency. The risk of withdrawal seizures with flumazenil use also may be increased in patients with epilepsy. Flumazenil is contraindicated in patients who have received a benzodiazepine for control of a potentially life-threatening condition (e.g., status epilepticus). Contact the Poison Help line (1-800-222-1222) or medical toxicologist for additional overdosage management recommendations.
— Etiqueta de la FDA: Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Tableta, recubierta con película |
|---|---|
| Vía | Oral |
| Productos con receta | 2 en el directorio NDC de la FDA |
Lo que pagan las farmacias (NADAC)
El Costo Promedio Nacional de Adquisición de Medicamentos (NADAC, por sus siglas en inglés) es el precio promedio que pagaron las farmacias minoristas de los EE. UU. por comprar una unidad de un medicamento (una tableta, un mL o un gramo), según una encuesta mensual de facturas de farmacias de los Centros de Servicios de Medicare y Medicaid (CMS). Los programas estatales de Medicaid lo usan para pagar a las farmacias.
Este no es el precio que usted paga. Lo que usted paga depende de su seguro médico (copago o coseguro), de su farmacia y de los descuentos, y las farmacias también cobran por despachar una receta. Pregunte a su farmacéutico o a su plan de salud cuál será su precio.
| Concentración y forma | Genérico o de marca | Pagan las farmacias |
|---|---|---|
| amitriptyline hydrochloride 14 mg · chlordiazepoxide 5 mg tableta, recubierta con película | Genérico | $1.20 por tableta |
Lista NADAC del 4 de noviembre de 2026; estos precios rigen desde el 19 de agosto de 2026. Solo se muestra cuando el código NDC de un envase coincide exactamente con la lista NADAC, y solo para esa concentración y forma: no se promedia entre concentraciones. Las concentraciones y formas que no aparecen aquí no tienen precio NADAC.
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.
- Mylan Pharmaceuticals Inc.2 productos
Historial de aprobación de la FDA
- ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
Aprobaciones de genéricos (1)
- ANDA071297Mylan Pharms Inc · 10 de diciembre de 1986
Escasez
La lista de escasez de la FDA no incluye estos productos.
Retiros del mercado
No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.
Identificadores oficiales
| RxCUI (RxNorm) | 856769, 856792 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | 66a756f2-ac77-451c-a19a-08896d73b15c |
| Etiquetas de la FDA (SPL) | 1 |
| Solicitudes de la FDA | 1 ANDA |
| Principios activos (FDA) | AMITRIPTYLINE / CHLORDIAZEPOXIDE |
Siguientes pasos
- Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
- Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
- InsomnioEnfermedad que menciona la etiqueta: hospitales que la tratan
- Mylan Pharmaceuticals Inc.Fabricante o distribuidor
- Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español
Fuentes
- Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Chlordiazepoxide and Amitriptyline Hydrochloride, Mylan Pharmaceuticals Inc., vigente desde el 15 de marzo de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- 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
- 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
- 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
- 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
- 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.
La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →
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