Cisatracurium besylate

Para qué se usa Cisatracurium besylate

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.

Cisatracurium besylate injection is indicated: •as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age •to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU •to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older …

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (injection, intravenous), Cisatracurium Besylate, Camber Pharmaceuticals Inc.; abarca 3 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.

La FDA tiene 19 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.

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0 de 19 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Efectos secundarios de Cisatracurium besylate

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 most common adverse reactions (0.1% to 0.4%) were bradycardia, hypotension, flushing, bronchospasm, and rash.

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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Piramal Pharma Solutions Inc. at 1-626-206-0832 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Studies Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse Reactions in Clinical Trials of Cisatracurium besylate in Surgical Patients The data presented below are based on studies involving 945 surgical patients who received Cisatracurium besylate in conjunction with other drugs in US and European clinical studies in a variety of procedures [see Clinical Studies (14.1)]. Table 3 displaysadverse reactions that occurred at a rate of less than 1%. Table 3. Adverse Reactions in Clinical Trials of Cisatracurium besylate in Surgical Patients Adverse Reaction Incidence Bradycardia 0.4% Hypotension 0.2% Flushing 0.2% Bronchospasm 0.2% Rash 0.1% Adverse Reactions in Clinical Trials of Cisatracurium besylate in Intensive Care Unit Patients The adverse reactions presented below were from studies involving 68 adult ICU patients who received Cisatracurium besylate in conjunction with other drugs in US and European clinical studies [see Clinical Studies (14.3)]. One patient experienced bronchospasm. In one of the two ICU studies, a randomized and double-blind study of ICU patients using TOF neuromuscular monitoring, there were two reports of prolonged recovery (range: 167 and 270 minutes) among 28 patients administered Cisatracurium besylate and 13 reports of prolonged recovery (range: 90 minutes to 33 hours) among 30 patients administered vecuronium. 6.2 Postmarketing Experience The following events have been identified during post-approval use of Cisatracurium besylate in conjunction with one or more anesthetic agents in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to Cisatracurium besylate: anaphylaxis, histamine release, prolonged neuromuscular block, muscle weakness, myopathy.

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. Leer la etiqueta completa en DailyMed →

Interacciones de Cisatracurium besylate

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.

Succinylcholine: May decrease time to onset of maximum neuromuscular blockade (7.1) Inhalational anesthetics, antibiotics, local anesthetics, magnesium salts, procainamide, lithium, quinidine: May potentiate or prolong neuromuscular blockade action of Cisatracurium besylate. Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.8, 7.1) Phenytoin and Carbamazepine: May shorten duration of neuromuscular blockade.

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Use peripheral nerve stimulator and monitor clinical signs of neuromuscular blockade. (5.9, 7.1) 7.1 Clinically Significant Drug Interactions Table 4 displays clinically significant drug interactions with Cisatracurium besylate. Table 4. Clinically Significant Drug Interactions with Cisatracurium besylate Drug or Drug Class Clinical Implications * Succinylcholine The use of succinylcholine prior to Cisatracurium besylate administration may decrease the time to onset of maximum neuromuscular blockade but has no effect on the duration of neuromuscular blockade. Inhalational Anesthetics Administration of inhalational anesthetics with nitrous oxide/oxygen for greater than 30 minutes to achieve 1.25 Minimum Alveolar Concentration (MAC) may prolong the duration of action of initial and maintenance doses of Cisatracurium besylate. This may potentiate the neuromuscular blockade. Antibiotics † Local anesthetics Magnesium salts Procainamide Lithium Quinidine May prolong the neuromuscular blockade action of Cisatracurium besylate Phenytoin, Carbamazepine May increase resistance to the neuromuscular blockade action of Cisatracurium besylate resulting in shorter durations of neuromuscular blockade and infusion rate requirements may be higher. * The use of peripheral nerve stimulator is strongly recommended to evaluate the level of neuromuscular blockade, to assess the need for additional doses of Cisatracurium besylate, and to determine whether adjustments need to be made to the dose with subsequent administration. † Examples: aminoglycosides, tetracyclines, bacitracin, polymyxins, lincomycin, clindamycin, colistin, sodium colistimethate 7.2 Drugs Without Clinically Significant Drug Interactions With Cisatracurium besylate In clinical studies, propofol had no effect on the duration of action or dosing requirements for Cisatracurium besylate. Cisatracurium besylate is not compatible with propofol for Y-site administration.

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Cisatracurium besylate

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.

Store Cisatracurium besylate injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product (2.1) Administer intravenously only by or under the supervision of experienced clinicians familiar with drug’s actions and possible complications (2.1) Use only if personnel and facilities for resuscitation and life support, and a Cisatracurium besylate injection, USP antagonist are immediately available (2.1) Use a peripheral …

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cisatracurium besylate 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.

Risk Summary The 10 mL Cisatracurium besylate injection multiple-dose vials contain the preservative benzyl alcohol. Therefore, if Cistracurium besylate injection is needed during pregnancy, consider using a benzyl alcohol-free formulation (i.e., 5 mL and 20 mL Cisatracurium besylate injection single-dose vials). Because benzyl alcohol is rapidly metabolized by a pregnant woman, benzyl alcohol exposure in the fetus is unlikely.

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However, adverse reactions have occurred in premature neonates and low birth weight infants who received intravenously administered benzyl alcohol-containing drugs [see Contraindications (4), Warnings and Precautions (5.2), and Use in Specific Populations (8.4)] There are no available clinical trial data on cisatracurium use in pregnancy to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Animal studies conducted in rats administered cisatracurium besylate during organogenesis (Gestational Day 6 to 15) found no evidence of fetal harm at 0.8 times (ventilated rats) the exposure from a human starting IV bolus dose of 0.2 mg/kg (see Data). The estimated background risk for major birth defects and miscarriage in 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Labor or Delivery The action of neuromuscular blocking agents may be enhanced by magnesium salts administered for the management of preeclampsia or eclampsia of pregnancy. Data Animal Data Two embryofetal developmental reproductive toxicity studies were conducted in rats. In a non-ventilated rat study, pregnant animals were treated with cisatracurium besylate subcutaneously twice per day from Gestational Day 6 to 15 using subparalyzing doses (2 and 4 mg/kg daily; equivalent to 6- and 12-times, respectively, the AUC exposure in humans following a bolus dose of 0.2 mg/kg IV). In the ventilated rat study, pregnant animals were treated with cisatracurium besylate intravenously once a day between Gestational Day 6 to 15 using paralyzing doses (0.5 and 1 mg/kg; equivalent to 0.4- and 0.8-times, respectively, the exposure in humans following a bolus dose of 0.2 mg/kg IV based on mg/m 2 comparison). Neither of these studies revealed maternal or fetal toxicity or malformations.

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Cisatracurium besylate

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

Cisatracurium besylate injection is contraindicated in patients with known hypersensitivity to cisatracurium. Severe anaphylactic reactions to Cisatracurium besylate injection have been reported [see Warnings and Precautions (5.4)].

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The use of 10 mL Cisatracurium besylate Injection multiple-dose vials is contraindicated for use in pediatric patients less than 1 month of age and low birth-weight infants because the formulation contains benzyl alcohol [see Warnings and Precautions (5.2) and Use in Specific Populations (8.4)] Known hypersensitivity to cisatracurium (4)

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Cisatracurium besylate

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 with neuromuscular blocking agents may result in neuromuscular blockade beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway and controlled ventilation until recovery of normal neuromuscular function is assured.

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Once recovery from neuromuscular block begins, further recovery may be facilitated by administration of a cholinesterase inhibitor (e.g., neostigmine, edrophonium) in conjunction with an appropriate cholinergic inhibitor. Cholinesterase inhibitors should not be administered when complete neuromuscular blockade is evident or suspected because the reversal of paralysis may not be sufficient to maintain a patent airway and support an appropriate level of spontaneous ventilation. Neostigmine: Administration of 0.04 to 0.07 mg/kg of neostigmine at approximately 10% recovery from neuromuscular blockade (range: 0 to 15%) produced 95% recovery of the muscle twitch response and a T 4:T 1 ratio ≥ 70% in an average of 9 to 10 minutes. The times from 25% recovery of the muscle twitch response to a T 4:T 1 ratio ≥ 70% following these doses of neostigmine averaged 7 minutes. The mean 25% to 75% recovery index following reversal was 3 to 4 minutes. Edrophonium: Administration of 1 mg/kg of edrophonium at approximately 25% recovery from neuromuscular blockade (range: 16% to 30%) produced 95% recovery and a T 4:T 1 ratio ≥ 70% in an average of 3 to 5 minutes. For providers treating patients treated with cholinesterase inhibitors: Use a peripheral nerve stimulator to evaluate recovery and antagonism of neuromuscular blockade Evaluate for evidence of adequate clinical recovery (e.g., 5-second head lift and grip strength). Support ventilation until adequate spontaneous ventilation has resumed. The onset of antagonism may be delayed in the presence of debilitation, cachexia, carcinomatosis, and the concomitant use of certain broad spectrum antibiotics, or anesthetic agents and other drugs which enhance neuromuscular block or separately cause respiratory depression [see Drug Interactions (7.1)]. Under such circumstances the management is the same as that of prolonged neuromuscular block.

— Etiqueta de la FDA: Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026. 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.

• Meitheal Pharmaceuticals Inc.6 productos
• Sandoz Inc3 productos
• Camber Pharmaceuticals, Inc.3 productos
• Fresenius Kabi USA, LLC3 productos
• Gland Pharma Limited3 productos
• Somerset Therapeutics, LLC3 productos
• Slate Run Pharmaceuticals, LLC3 productos
• Hikma Pharmaceuticals USA Inc.3 productos
• Caplin Steriles Limited3 productos
• Hospira, Inc.3 productos
• Zydus Pharmaceuticals USA Inc.2 productos
• Zydus Lifesciences Limited2 productos
• Eugia US LLC2 productos
• Armas Pharmaceuticals1 producto
• Avenacy, LLC1 producto

Historial de aprobación de la FDA

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

Aprobaciones de genéricos (20)

• ANDA200154Sandoz Inc · 3 de febrero de 2012
• ANDA200159Sandoz Inc · 3 de febrero de 2012
• ANDA203182Fresenius Kabi USA · 26 de febrero de 2015
• ANDA203183Fresenius Kabi USA · 26 de febrero de 2015
• ANDA203236Hospira · 30 de marzo de 2018
• ANDA203238Hospira · 30 de marzo de 2018
• ANDA206791Somerset Theraps LLC · 20 de febrero de 2019
• ANDA209132Somerset · 24 de abril de 2019
• ANDA211668Meitheal · 25 de abril de 2019
• ANDA211669Meitheal · 25 de abril de 2019
• ANDA212171Zydus Pharms · 4 de noviembre de 2019
• ANDA209144Eugia Pharma · 8 de mayo de 2020
• ANDA209665Eugia Pharma · 27 de octubre de 2020
• ANDA212432Piramal · 11 de marzo de 2022
• ANDA215516Gland · 24 de mayo de 2022
• ANDA203078Hikma · 28 de junio de 2022
• ANDA203079Hikma · 19 de abril de 2023
• ANDA217725Caplin · 9 de junio de 2023
• ANDA216538Hainan Poly · 8 de marzo de 2024
• ANDA216539Hainan Poly · 27 de agosto de 2024

Escasez

Se dejará de fabricar · actualizado el 11 de septiembre de 2026 · publicado por primera vez el 11 de septiembre de 2026

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Retiros del mercado

De los informes de la FDA, vinculados por el código NDC del producto. Un retiro suele afectar solo a lotes concretos: revise el número de lote del envase y pregunte a su farmacéutico. No deje un medicamento por su cuenta.

1. 26 de noviembre de 2025 · Clase III · En curso · D-0236-2026

   Subpotent product:out of specification assay results observed during long term stability testing.

   Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-dose 5 mL vial NDC 700 — SOMERSET THERAPEUTICS LLC

2. 26 de noviembre de 2025 · Clase III · En curso · D-0237-2026

   Subpotent product:out of specification assay results observed during long term stability testing.

   Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL), 10 x 20 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single dose 20mL vial NDC 70 — SOMERSET THERAPEUTICS LLC

3. 26 de noviembre de 2025 · Clase III · En curso · D-0238-2026

   Subpotent product:out of specification assay results observed during long term stability testing.

   Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL), 10 x 10 mL Multiple-dose Vials per carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, 10mL Multiple-dose vial, — SOMERSET THERAPEUTICS LLC

4. 27 de enero de 2021 · Clase I · Cerrado por la FDA · D-0286-2021

   Labeling: Label mix-up: Carton of Cisatracurium Besylate Injection, USP was observed to contain ten vials mislabeled as Phenylephrine Hydrochloride Injection, USP, but confirmed to contain Cisatracurium

   Cisatracurium Besylate Injection, USP, 10mg per 5mL (2 mg per mL), Single-Dose Vial (NDC 71288-712-05), packaged as 10 x 5 mL Single-Dose Vials per carton (NDC 71288-712-06), Rx only, Mfd. for Meitheal Pharmaceuticals, C — Meitheal Pharmaceuticals Inc

5. 5 de abril de 2016 · Clase II · Cerrado por la FDA · D-0819-2016

   Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.

   Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10 — Fresenius Kabi USA, LLC

Identificadores oficiales

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
• Meitheal Pharmaceuticals Inc.Fabricante o distribuidor
• Sandoz IncFabricante o distribuidor
• Camber 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

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Cisatracurium Besylate, Camber Pharmaceuticals Inc., vigente desde el 30 de abril de 2026; 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

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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