Respuestas rápidas
- ¿Para qué se usa Anhydrous citric acid?
- La etiqueta aprobada por la FDA (Xenleta, Meitheal Pharmaceuticals Inc., 22 de julio de 2026) dice, en inglés: “XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. …” 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 Anhydrous citric acid?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Xenleta, Meitheal Pharmaceuticals Inc., 22 de julio de 2026) comienza así, en inglés: «The following clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation [see Warnings and Precautions (5.1)]. Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.3)]. Most common adverse reactions (incidence ≥2%) are: XENLETA Injection: administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache. (6.1) XENLETA Tablets: diarrhea, nausea, vomiting, hepatic enzyme elevation.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Anhydrous citric acid?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Xenleta, Meitheal Pharmaceuticals Inc., 22 de julio de 2026) comienza así, en inglés: «XENLETA Injection Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. (7.1) XENLETA Tablets Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. (7.1) Strong CYP3A inhibitors or P-gp inhibitors Avoid XENLETA. (7.1) Moderate CYP3A inhibitors or P-gp inhibitors Monitor for adverse reactions.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Anhydrous citric acid tiene una advertencia en recuadro?
- No. Ninguna de las 1 etiquetas de la FDA que encontramos para este medicamento tiene advertencia en recuadro.
- ¿Hay escasez de Anhydrous citric acid?
- 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 Anhydrous citric acid?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Anhydrous citric acid?
- 1 empresa tiene productos con receta de Anhydrous citric acid en el directorio NDC de la FDA, entre ellas Meitheal Pharmaceuticals Inc.
Para qué se usa Anhydrous citric acid
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.
XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by susceptible microorganisms. To reduce the development of drug resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. …
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (injection, solution, intravenous), Xenleta, Meitheal 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.
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.
La etiqueta citada arriba no tiene advertencia en recuadro.
Efectos secundarios de Anhydrous citric acid
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 clinically significant adverse reactions are described elsewhere in the labeling: QT Prolongation [see Warnings and Precautions (5.1)]. Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.3)]. Most common adverse reactions (incidence ≥2%) are: XENLETA Injection: administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, headache. (6.1) XENLETA Tablets: diarrhea, nausea, vomiting, hepatic enzyme elevation.
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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-888-808-5529 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. XENLETA was evaluated in two clinical trials in CABP patients (Trial 1 and Trial 2). Across the two trials, a total of 641 patients were treated with XENLETA. Trial 1 (intravenous [IV] to oral dosing switch trial) enrolled 551 adult patients, 276 randomized to XENLETA (273 received at least one dose of XENLETA) and 275 randomized to moxifloxacin (273 received at least one dose of moxifloxacin). Trial 2 (oral dosing only trial) enrolled 738 adult patients, 370 randomized to XENLETA (368 received at least one dose of XENLETA) and 368 randomized to moxifloxacin (all 368 received at least one dose of moxifloxacin). Trial 1 enrolled patients with Pneumonia Outcomes Research Team (PORT) Risk Class III-V. The mean duration of intravenous treatment was 6 days; the mean total duration of treatment was 7 days. Trial 2 enrolled patients with PORT Risk Class II-IV. The mean duration of treatment was 5 days for XENLETA and 7 days for moxifloxacin. In Trial 1 and Trial 2 (pooled), the median age of patients treated with XENLETA was 61 (range 19-97) years; 42% of patients were 65 years or older and 18% were 75 years or older. Patients were predominantly male (58%) and white (79%) and had a median body mass index (BMI) of 26.0 (range 13.0-56.8) kg/m 2. Approximately 52% of XENLETA-treated patients had creatinine clearance (CrCl) <90 mL/min. Serious Adverse Reactions and Adverse Reactions Leading to Discontinuation In Trial 1 and Trial 2 (pooled), serious adverse reactions occurred in 36/641 (5.6%) patients treated with XENLETA and 31/641 (4.8%) patients treated with moxifloxacin. Treatment was discontinued due to an adverse reaction in 21/641 (3.3%) patients treated with XENLETA and 21/641 (3.3%) patients treated with moxifloxacin. Death within 28 days occurred in 8/641 (1.2%) patients treated with XENLETA and 7/641 (1.1%) patients treated with moxifloxacin. Most Common Adverse Reactions Table 2 and Table 3 include adverse reactions occurring in ≥2% of patients receiving XENLETA in Trials 1 and 2.
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Anhydrous citric acid
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.
XENLETA Injection Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. (7.1) XENLETA Tablets Strong or moderate CYP3A inducers or P-gp inducers Avoid XENLETA unless the benefit outweighs the risk. Monitor for reduced efficacy. (7.1) Strong CYP3A inhibitors or P-gp inhibitors Avoid XENLETA. (7.1) Moderate CYP3A inhibitors or P-gp inhibitors Monitor for adverse reactions.
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(7.1) CYP3A substrates that prolong the QT interval Concomitant use is contraindicated. (4.2, 7.2) Midazolam and other sensitive CYP3A substrates Monitor for adverse reactions. (7.2) 7.1 Effect of Other Drugs on XENLETA Strong and Moderate CYP3A Inducers or P-gp Inducers Concomitant use of oral or intravenous XENLETA with strong CYP3A4 inducers or P-gp inducers decreases lefamulin AUC and C max [see Clinical Pharmacology (12.3)], which may reduce the efficacy of XENLETA. Avoid concomitant use of XENLETA Injection and XENLETA Tablets with strong and moderate CYP3A4 inducers or P-gp inducers unless the benefit outweighs the risks. Strong and Moderate CYP3A Inhibitors or P-gp Inhibitors Concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors increases lefamulin AUC [see Clinical Pharmacology (12.3)], which may increase the risk of adverse reactions with XENLETA Tablets. Avoid concomitant use of XENLETA Tablets with strong CYP3A inhibitors or P-gp inhibitors. Monitor for adverse effects of XENLETA Tablets when administered concomitantly with moderate CYP3A inhibitors or P-gp inhibitors. 7.2 Effect of XENLETA on Other Drugs CYP3A4 Substrates Concomitant use of XENLETA Tablets with sensitive CYP3A4 substrates increases the AUC and C max of CYP3A4 substrates [see Clinical Pharmacology (12.3)], which may increase the risk of toxicities associated with cardiac conduction. Concomitant use with CYP3A substrates known to prolong the QT interval is contraindicated [see Contraindications (4.2)]. Concomitant use of sensitive CYP3A substrates with XENLETA Tablets requires close monitoring for adverse effects of these drugs (for example, alprazolam, diltiazem, verapamil, simvastatin, vardenafil). Concomitant use of XENLETA Injection with CYP3A4 substrates does not affect the exposure of CYP3A4 substrates. 7.3 Drugs that Prolong QT The pharmacodynamic interaction potential to prolong the QT interval of the electrocardiogram between XENLETA and other drugs that effect cardiac conduction is unknown. Therefore, avoid concomitant use of XENLETA Injection and XENLETA Tablets with such drugs (for example, Class IA and III antiarrhythmics, antipsychotics, erythromycin, moxifloxacin, tricyclic antidepressants).
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Anhydrous citric acid
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.
For treatment of adults with CABP, the recommended dosage of XENLETA is as follows: *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course. Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* (2.1) 5 to 7 days 600 mg orally every 12 hours.
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(2.1) 5 days Patients with Hepatic Impairment: Reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours in patients with severe hepatic impairment (Child-Pugh Class C). XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe hepatic impairment (2.2). Administration Instruction for XENLETA Tablets: Take at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). (2.3) Administration Instruction for XENLETA Injection: Infuse over 60 minutes. (2.3) See Full Prescribing Information for additional information on the administration and preparation of XENLETA Tablets and Injection. (2.4) 2.1 Recommended Dosage For treatment of adults with CABP, the recommended dosage of XENLETA is described in Table 1 below. For patients with severe hepatic impairment, dosage adjustment is required [see Dosage and Administration (2.2)]. Table 1: Dosage of XENLETA in Adult CABP Patients *With the option to switch to XENLETA Tablets 600 mg every 12 hours to complete the treatment course. Dosage Treatment Duration 150 mg every 12 hours by intravenous infusion over 60 minutes* 5 to 7 days 600 mg orally every 12 hours 5 days 2.2 Dosage Adjustment for Patients with Hepatic Impairment Monitor patients with hepatic impairment for adverse reactions associated with XENLETA Injection and Tablets throughout the treatment period [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)]. XENLETA Injection Reduce the dosage of XENLETA Injection to 150 mg infused intravenously over 60 minutes every 24 hours for patients with severe hepatic impairment (Child-Pugh Class C). No dosage adjustment of XENLETA Injection is needed for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. XENLETA Tablets XENLETA Tablets have not been studied in and are not recommended for patients with moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment. No dosage adjustment of XENLETA Tablets is needed for patients with mild hepatic impairment (Child-Pugh Class A). 2.3 Important Administration Instructions XENLETA Injection Administer XENLETA Injection by intravenous infusion over 60 minutes. Must dilute in a 250 mL solution of 10 mM citrate buffered 0.9% sodium chloride for injection supplied with XENLETA Injection before use [see Dosage and Administration (2.4)]. XENLETA Tablets Take XENLETA Tablets at least 1 hour before a meal or 2 hours after a meal. Swallow XENLETA Tablets whole with water (6 to 8 ounces). Do not crush or divide XENLETA Tablets [see Clinical Pharmacology (12.3)].
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Anhydrous citric acid 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 Based on findings from animal studies, lefamulin may cause fetal harm when administered to pregnant women. There are no available data on the use of XENLETA in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
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Animal studies indicate that intravenous administration of lefamulin during organogenesis resulted in an increased incidence of prenatal mortality at mean maternal exposures 0.9 times the mean exposure in clinical patients (based on AUC 0-24h), decreased fetal body weights, apparent delay in sexual maturation that suggest treatment-related developmental delay, and malformations in rats at maternal exposures greater than 0.4 times the mean exposure in CABP patients for which the litter incidence was nonexistent in concurrent controls and rare (0 to approximately 0.3%) in historical controls. Decreased ossification was seen in fetuses at all doses in a dose-related manner, suggestive of developmental delay (see Data). The estimated 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. There is a pregnancy pharmacovigilance program for XENLETA. If XENLETA is inadvertently administered during pregnancy or if a patient becomes pregnant while receiving XENLETA, healthcare providers should report XENLETA exposure by calling 1-888-808-5529 to enroll. Data Animal Data In a prenatal and postnatal development study in rats treated from the beginning of organogenesis through lactation (Gestation Day [GD] 6 through lactation day 21), the percent of live births was reduced (87.4% compared with the concurrent control of 98.7%) in the high dose group of 100 mg/kg/day (0.9 times the mean exposure in CABP patients treated IV). Equivocal findings in that study were indicative of early post-natal mortality and apparent developmental delay that may be related to pre-natal effects. In the rat embryo-fetal development study of IV lefamulin during organogenesis (GD 6-17), findings included late resorptions in the high-dose group and malformations (cleft palate/jaw/vertebral malformations at the mid and high doses and enlarged ventricular heart chamber with a thin ventricular wall at the high dose) for which the litter incidence was nonexistent in concurrent controls and rare in historical controls (0 to approximately 0.3%). Decreased or no ossification in a number of skeletal elements in all treated groups may indicate treatment-related developmental delay at all doses. The mean exposure at the lowest dose was approximately 0.4 times the mean exposure in CABP patients treated IV.
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Anhydrous citric acid
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. (4.1) Concomitant use of XENLETA tablets with CYP3A substrates that prolong the QT interval is contraindicated.
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(4.2) 4.1 Hypersensitivity XENLETA is contraindicated in patients with known hypersensitivity to lefamulin, pleuromutilin class drugs, or any of the components of XENLETA. 4.2 CYP3A4 Substrates That Prolong the QT Interval XENLETA Tablets are contraindicated with sensitive CYP3A4 substrates that prolong the QT interval (for example, pimozide). Concomitant administration of oral XENLETA with sensitive CYP3A4 substrates may result in increased plasma concentrations of these drugs, leading to QT prolongation and cases of torsades de pointes [see Warnings and Precautions (5.1), Drug Interactions (7.2), and Clinical Pharmacology (12.3)].
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Leer la etiqueta completa en DailyMed →
Sobredosis de Anhydrous citric acid
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).
Treatment of overdose with XENLETA should consist of observation and general support measures. Lefamulin and its primary metabolite are not dialyzable.
— Etiqueta de la FDA: Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio de 2026. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Inyección, solución |
|---|---|
| Vía | Intravenosa |
| Productos con receta | 1 en el directorio NDC de la FDA |
| Nombres de marca | Citric Buffered Normal Saline |
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.1 producto
Historial de aprobación de la FDA
- NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
| Solicitud | Patrocinador | Aprobada | Cambios aprobados después |
|---|---|---|---|
| NDA211673 XENLETA | Hong Kong | 19 de agosto de 2019 | 2, el último 16 de marzo de 2021 2021: Etiquetado · 2020: Etiquetado |
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
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
- NeumoníaEnfermedad que menciona la etiqueta: hospitales que la tratan
- Meitheal 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) — Xenleta, Meitheal Pharmaceuticals Inc., vigente desde el 22 de julio 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
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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