Olsalazina (olsalazine sodium)

Para qué se usa Olsalazina

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.

DIPENTUM is indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine. DIPENTUM is an aminosalicylate indicated for the maintenance of remission of ulcerative colitis in adult patients who are intolerant of sulfasalazine.

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (capsule, gelatin coated, oral), Dipentum, Viatris Specialty LLC; 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.

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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 Olsalazina

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:

• Renal impairment [see Warnings and Precautions (5.1)]
• Mesalamine-induced acute intolerance syndrome [see Warnings and Precautions (5.2)]
• Hypersensitivity reactions [see Warnings and Precautions (5.3)]
• Hepatic failure [see Warnings and Precautions (5.4)]
• Severe cutaneous adverse reactions [see Warnings and Precautions (5.5)]
• Photosensitivity [see Warnings and Precautions (5.6)]
• Nephrolithiasis [see Warnings and Precautions (5.7)] The following adverse reactions have been identified from clinical studies or postmarketing reports of olsalazine.

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Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In double-blind, placebo- and active-controlled clinical trials of ulcerative colitis, discontinuations due to adverse reactions were reported in 10% of DIPENTUM-treated patients (N=441) and 7% of placebo-treated patients (N=208). Both sulfasalazine-tolerant and intolerant patients were included. The most common adverse reactions leading to discontinuation in DIPENTUM-treated patients were diarrhea/loose stools (6%), abdominal pain (1%), and rash/itching (1%). In these controlled trials, adverse reactions reported in 1% or more of patients treated with DIPENTUM and greater than placebo are provided in Table 1. Table 1 Adverse Reactions reported in at least 1% of patients in the DIPENTUM group and greater than placebo in Patients with Ulcerative Colitis in Double-Blind, Controlled Clinical Trials Adverse Reaction DIPENTUM (N=441) % Placebo (N=208) % Diarrhea 11 7 Abdominal pain/cramps 10 7 Nausea 5 4 Arthralgia/Joint Pain 4 3 Rash 2 1 Upper Respiratory Infection 2 0 Depression 2 0 Vomiting 1 0 Stomatitis 1 0 Vertigo/Dizziness 1 0 Itching 1 0 Other adverse reactions reported in clinical trials or post-marketing experience: Blood and Lymphatic System Disorders aplastic anemia, anemia, eosinophilia, hemolytic anemia, leukopenia, lymphopenia, neutropenia, pancytopenia, reticulocytosis, thrombocytopenia Cardiac Disorders chest pains, heart block second degree, myocarditis, palpitations, pericarditis, peripheral edema, shortness of breath, tachycardia A patient who developed thyroid disease 9 days after starting DIPENTUM was given propranolol and radioactive iodine and subsequently developed shortness of breath and nausea. The patient died 5 days later with signs and symptoms of acute diffuse myocarditis. Ear and Labyrinth Disorders tinnitus Eye Disorders dry eyes, vision blurred, watery eyes Gastrointestinal Disorders abdominal pain (upper), diarrhea with dehydration, dry mouth, epigastric discomfort, flare in symptoms, flatulence, increased blood in stool, pancreatitis, rectal bleeding, rectal discomfort General Disorders and Administration Site Conditions fever chills, hot flashes, irritability, pyrexia, rigors Hepatobiliary Disorders hepatic enzyme increased, hepatitis (including cholestasis, granulomatous, and non-specific, reactive), increased bilirubin Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure. Some of these cases were fatal.

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Olsalazina

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.

• Nephrotoxic Agents including Non-Steroidal Anti-inflammatory Drugs (NSAIDs): Increased risk of nephrotoxicity; monitor for changes in renal function and mesalamine-related adverse reactions. (7.1)
• Azathioprine or 6-Mercaptopurine: Increased risk of blood dyscrasias; monitor complete blood cell counts and platelet counts.

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(7.2)

• Low Molecular Weight Heparins or Heparinoids: Increased risk of bleeding following neuraxial anesthesia; if possible, discontinue DIPENTUM or closely monitor for bleeding. (7.1)
• Varicella Vaccine: Avoid use for 6 weeks after vaccination. (7.4) 7.1 Nephrotoxic Agents, Including Non-Steroidal Anti-Inflammatory Drugs The concurrent use of mesalamine with known nephrotoxic agents, including non‑steroidal anti‑inflammatory drugs (NSAIDs), may increase the risk of nephrotoxicity. Monitor patients taking nephrotoxic drugs for changes in renal function and mesalamine-related adverse reactions [see Warnings and Precautions (5.1)]. 7.2 Azathioprine or 6-Mercaptopurine The concurrent use of mesalamine with azathioprine or 6‑mercaptopurine and/or any other drugs known to cause myelotoxicity (e.g., thioguanine) may increase the risk for blood disorders, bone marrow failure, and associated complications. If concomitant use of DIPENTUM and azathioprine or 6-mercaptopurine cannot be avoided, monitor blood tests, including complete blood cell counts and platelet counts. 7.3 Low Molecular Weight Heparins or Heparinoids The co-administration of salicylates and low molecular weight heparins or heparinoids may result in an increased risk of bleeding (i.e., hematomas) following neuraxial anesthesia. Discontinue DIPENTUM prior to the initiation of a low molecular weight heparin or heparinoid. If this is not possible, it is recommended to monitor patients closely for bleeding. 7.4 Varicella Vaccine Avoid DIPENTUM, and other salicylates, for six weeks after the varicella vaccine to avoid a possible increased risk of developing Reye’s syndrome. 7.5 Interference With Urinary Normetanephrine Measurements Use of DIPENTUM, which is converted to mesalamine, may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection [see Warnings and Precautions (5.8)]. Consider an alternative, selective assay for normetanephrine.

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Dosis de Olsalazina

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.

Evaluate renal function before initiating therapy with DIPENTUM [see Warnings and Precautions (5.1)]. The recommended dosage is 500 mg orally twice daily. Drink an adequate amount of fluids during treatment [see Warnings and Precautions (5.7)].

• Evaluate renal function prior to initiation of DIPENTUM and periodically while on therapy. (2, 5.1)
• The recommended dosage is 500 mg orally twice daily. (2)
• Drink an adequate amount of fluids. (2, 5.7)

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Olsalazina 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 Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety in DIPENTUM, during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). There are adverse effects on maternal and fetal outcomes associated with ulcerative colitis in pregnancy (see Clinical Considerations).

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In animal reproduction studies, there were adverse developmental effects observed after oral administration of olsalazine sodium in pregnant rats during organogenesis at doses of 5 to 20 times the maximum recommended human dose (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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and embryo/fetal risk Published data suggest that increased disease activity is associated with the risk of developing adverse pregnancy outcomes in women with ulcerative colitis. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2500 g) infants, and small for gestational age at birth. Data Human Data Published data from meta-analyses, cohort studies and case series on the use of mesalamine, the active moiety in DIPENTUM, during early pregnancy (first trimester) and throughout pregnancy have not reliably informed an association of mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is no clear evidence that mesalamine exposure in early pregnancy is associated with an increased risk in major congenital malformations, including cardiac malformations. Published epidemiologic studies have important methodological limitations which hinder interpretation of the data, including inability to control for confounders, such as underlying maternal disease, and maternal use of concomitant medications, and missing information on the dose and duration of use for mesalamine products. Animal Data Olsalazine has been shown to produce adverse fetal developmental effects including reduced fetal weights, retarded ossifications, and immaturity of the fetal visceral organs when given during organogenesis to pregnant rats at doses of 100 to 400 mg/kg (5 to 20 times the maximum recommended human dose.

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Olsalazina

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

DIPENTUM is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the excipients in DIPENTUM [see Warnings and Precautions (5.3), Description (11)]. Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of DIPENTUM. (4, 5.3)

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Olsalazina

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).

DIPENTUM is an aminosalicylate, and symptoms of salicylate toxicity include: nausea, vomiting and abdominal pain, tachypnea, hyperpnea, tinnitus, and neurologic symptoms (headache, dizziness, confusion, seizures). Severe salicylate intoxication may lead to electrolyte and blood pH imbalance and potentially to other organ (e.g., renal and liver) damage.

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There is no specific antidote for olsalazine overdose; however, conventional therapy for salicylate toxicity may be beneficial in the event of acute overdosage and may include gastrointestinal tract decontamination to prevent of further absorption. Correct fluid and electrolyte imbalance by the administration of appropriate intravenous therapy and maintain adequate renal function.

— Etiqueta de la FDA: Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Empresas que tienen este medicamento

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• Viatris Specialty LLC1 producto

Historial de aprobación de la FDA

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• Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
• Colitis ulcerativaEnfermedad que menciona la etiqueta: hospitales que la tratan
• Viatris Specialty LLCFabricante 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) — Dipentum, Viatris Specialty LLC, vigente desde el 15 de mayo 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
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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