Tolmetina (tolmetin sodium)

Para qué se usa Tolmetina

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.

Carefully consider the potential benefits and risks of TOLECTIN tablets, USP and other treatment options before deciding to use TOLECTIN tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. …

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, film coated, oral), Tolectin, Poly Pharmaceuticals, 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.

La FDA tiene 6 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.

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 →

6 de 6 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Tolmetina: 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.

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS and PRECAUTIONS).
• TOLECTIN tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS).

Leer más de esta sección

Gastrointestinal Risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Tolmetina

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 adverse reactions which have been observed in clinical trials encompass observations in about 4,370 patients treated with TOLECTIN, over 800 of whom have undergone at least one year of therapy. These adverse reactions, reported below by body system, are among those typical of nonsteroidal anti-inflammatory drugs and, as expected, gastrointestinal complaints were most frequent.

Leer más de esta sección

In clinical trials with tolmetin, about 10% of patients dropped out because of adverse reactions, mostly gastrointestinal in nature. Incidence Greater Than 1%: The following adverse reactions which occurred more frequently than 1 in 100 were reported in controlled clinical trials: Gastrointestinal: nausea (11%), dyspepsia*, gastrointestinal distress*, abdominal pain*, diarrhea*, flatulence*, vomiting*, constipation, gastritis, and peptic ulcer. Forty percent of the ulcer patients had a prior history of peptic ulcer disease and/or were receiving concomitant anti-inflammatory drugs including corticosteroids, which are known to produce peptic ulceration. Body as a Whole: headache*, asthenia*, chest pain Cardiovascular: elevated blood pressure*, edema* Central Nervous System: dizziness*, drowsiness, depression Metabolic/Nutritional: weight gain*, weight loss* Dermatologic: skin irritation Special Senses: tinnitus, visual disturbance Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred. These are similar to changes reported with other nonsteroidal anti-inflammatory drugs. Urogenital: elevated BUN, urinary tract infection *Reactions occurring in 3% to 9% of patients treated with TOLECTIN. Reactions occurring in fewer than 3% of the patients are unmarked. Incidence Less Than 1%: (Causal Relationship Probable) The following adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between TOLECTIN and these adverse reactions. Gastrointestinal: gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities Body as a Whole: anaphylactoid reactions, fever, lymphadenopathy, serum sickness Hematologic: hemolytic anemia, thrombocytopenia, granulocytopenia, agranulocytosis Cardiovascular: congestive heart failure in patients with marginal cardiac function Dermatologic: urticaria, purpura, erythema multiforme, toxic epidermal necrolysis Urogenital: hematuria, proteinuria, dysuria, renal failure Incidence Less Than 1%: (Causal Relationship Unknown) Other adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing, but a causal relationship between tolmetin and the reaction could not be determined. These rarely reported reactions are being listed as alerting information for the physician since the possibility of a causal relationship cannot be excluded.

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Tolmetina

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.

ACE Inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE Inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE Inhibitors. Aspirin: As with other NSAIDs, concomitant administration of TOLECTIN sodium and aspirin is not generally recommended because of the potential of increased adverse effects.

Leer más de esta sección

Diuretics: Clinical studies, as well as post-marketing observations have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy. Lithium: NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. The in vitro binding of warfarin to human plasma proteins is unaffected by TOLECTIN, and TOLECTIN does not alter the prothrombin time of normal volunteers. However, increased prothrombin time and bleeding have been reported in patients on concomitant tolmetin and warfarin therapy. Therefore, caution should be exercised when administering tolmetin to patients on anticoagulants. Hypoglycemic Agents: In adult diabetic patients under treatment with either sulfonylureas or insulin there is no change in the clinical effects of either TOLECTIN or the hypoglycemic agents.

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Leer la etiqueta completa en DailyMed →

Dosis de Tolmetina

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.

Carefully consider the potential benefits and risks of TOLECTIN and other treatment options before deciding to use TOLECTIN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with TOLECTIN, the dose and frequency should be adjusted to suit an individual patient’s needs.

Leer más de esta sección

For the relief of rheumatoid arthritis or osteoarthritis, the recommended starting dose for adults is 400 mg three times daily (1200 mg daily), preferably including a dose on arising and a dose at bedtime. To achieve optimal therapeutic effect the dose should be adjusted according to the patient’s response after 1 or 2 weeks. Control is usually achieved at doses of 600 mg to 1800 mg daily in divided doses (generally t.i.d.). Doses larger than 1800 mg/day have not been studied and are not recommended. For the relief of juvenile rheumatoid arthritis, the recommended starting dose for pediatric patients (2 years and older) is 20 mg/kg/day in divided doses (t.i.d. or q.i.d.). When control has been achieved, the usual dose ranges from 15 to 30 mg/kg/day. Doses higher than 30 mg/kg/day have not been studied, and, therefore, are not recommended. A therapeutic response to TOLECTIN can be expected in a few days to a week. Progressive improvement can be anticipated during succeeding weeks of therapy. If gastrointestinal symptoms occur, TOLECTIN can be administered with antacids other than sodium bicarbonate. TOLECTIN bioavailability and pharmacokinetics are not significantly affected by acute or chronic administration of magnesium and aluminum hydroxides; however, bioavailability is affected by food or milk (see PRECAUTIONS: Drug-Food Interaction).

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Leer la etiqueta completa en DailyMed →

Tolmetina 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: Use of NSAIDs, including TOLECTIN, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of these risks, limit dose and duration of TOLECTIN use between about 20 and 30 weeks of gestation, and avoid TOLECTIN use at about 30 weeks of gestation and later in pregnancy (see WARNINGS: Fetal Toxicity).

Leer más de esta sección

Premature Closure of Fetal Ductus Arteriosus: Use of NSAIDs, including TOLECTIN, at about 30 weeks gestation or later in pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Oligohydramnios/Neonatal Renal Impairment: Use of NSAIDs at about 20 weeks gestation or later in pregnancy has been associated with cases of fetal renal dysfunction leading to oligohydramnios, and in some cases, neonatal renal impairment. Data from observational studies regarding other potential embryofetal risks of NSAID use in women in the first or second trimesters of pregnancy are inconclusive. In animal reproduction studies in rats and rabbits at doses up to 50 mg/kg (1.5 times the maximum clinical dose based on a body weight of 60 kg) there revealed no evidence of teratogenesis or impaired fertility due to tolmetin. However, animal reproduction studies are not always predictive of human response. Based on animal data, prostaglandins have been shown to have an important role in endometrial vascular permeability, blastocyst implantation, and decidualization. In animal studies, administration of prostaglandin synthesis inhibitors such as tolmetin, resulted in increased pre- and post-implantation loss. Prostaglandins also have been shown to have an important role in fetal kidney development. In published animal studies, prostaglandin synthesis inhibitors have been reported to impair kidney development when administered at clinically relevant doses. The estimated background risk of major birth defects and miscarriage for the indicated population(s) 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: Fetal/Neonatal Adverse Reactions: Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs in women at about 30 weeks gestation and later in pregnancy, because NSAIDs, including TOLECTIN, can cause premature closure of the fetal ductus arteriosus (see WARNINGS: Fetal Toxicity). Oligohydramnios/Neonatal Renal Impairment: If an NSAID is necessary at about 20 weeks gestation or later in pregnancy, limit the use to the lowest effective dose and shortest duration possible. If TOLECTIN treatment extends beyond 48 hours, consider monitoring with ultrasound for oligohydramnios. If oligohydramnios occurs, discontinue tolmetin sodium tablets and follow up according to clinical practice (see WARNINGS: Fetal Toxicity). Data: Human Data: There are no adequate, well controlled studies in pregnant women. TOLECTIN should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Tolmetina y la lactancia

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

Tolmetin sodium has been shown to be secreted in human milk. Because of the potential for serious adverse reactions in nursing infants from tolmetin sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Tolmetina

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

TOLECTIN tablets are contraindicated in patients with known hypersensitivity to tolmetin sodium. TOLECTIN should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS: Anaphylactoid Reactions and PRECAUTIONS: General: Preexisting Asthma).

Leer más de esta sección

TOLECTIN is contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. Leer la etiqueta completa en DailyMed →

Sobredosis de Tolmetina

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).

MANAGEMENT OF OVERDOSAGE In the event of overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage followed by the administration of activated charcoal.

— Etiqueta de la FDA: Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025. 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.

• Atland Pharmaceuticals, LLC2 productos
• Lifsa Drugs LLC1 producto
• Galt Pharmaceuticals, LLC1 producto
• Chartwell RX, LLC1 producto
• Poly Pharmaceuticals, Inc.1 producto

Historial de aprobación de la FDA

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

Aprobaciones de genéricos (3)

• ANDA073588Chartwell Rx · 31 de julio de 1992
• ANDA073393Rising · 27 de mayo de 1993
• ANDA074473Rising · 30 de agosto de 1994

Escasez

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

Base de datos de escasez de medicamentos de la FDA →

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
• Artritis reumatoideEnfermedad que menciona la etiqueta: hospitales que la tratan
• Atland Pharmaceuticals, LLCFabricante o distribuidor
• Lifsa Drugs LLCFabricante o distribuidor
• Galt Pharmaceuticals, 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) — Tolectin, Poly Pharmaceuticals, Inc., vigente desde el 30 de diciembre de 2025; 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.

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 →

Informar un error → · Información para fabricantes de medicamentos