Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide
Principio activo: BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE
Vía de administración
ORAL
Países disponibles
US
Indicaciones
INDICATIONS AND USAGE Brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup is indicated for relief of coughs and upper respiratory symptoms, including nasal congestion, associated with allergy or the common cold.
Posología
DOSAGE AND ADMINISTRATION Adults and pediatric patients 12 years of age and over: 10 mL (2 teaspoonfuls) every 4 hours. Children 6 to under 12 years of age: 5 mL (1 teaspoonful) every 4 hours. Children 2 to under 6 years of age: 2.5 mL (½ teaspoonful) every 4 hours. Infants 6 months to under 2 years of age: Dosage to be established by a physician. Do not exceed 6 doses during a 24-hour period.
Contraindicaciones
CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Do not use in the newborn, in premature infants, in nursing mothers, or in patients with severe hypertension or severe coronary artery disease. Do not use dextromethorphan in patients receiving monoamine oxidase inhibitors (MAOI) (see PRECAUTIONS - Drug Interactions ). Antihistamines should not be used to treat lower respiratory tract conditions including asthma.
Embarazo y lactancia
Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup. It is also not known whether brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed. Reproduction studies of brompheniramine maleate (a component of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup) in rats and mice at doses up to 16 times the maximum human doses have revealed no evidence of impaired fertility or harm to the fetus.
Efectos adversos
ADVERSE REACTIONS The most frequent adverse reactions to brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup are: sedation; dryness of mouth, nose and throat; thickening of bronchial secretions; dizziness. Other adverse reactions may include: Dermatologic: Urticaria, drug rash, photosensitivity, pruritus. Cardiovascular System: Hypotension, hypertension, cardiac arrhythmias, palpitation. CNS: Disturbed coordination, tremor, irritability, insomnia, visual disturbances, weakness, nervousness, convulsions, headache, euphoria, and dysphoria. G.U. System: Urinary frequency, difficult urination. G.I. System: Epigastric discomfort, anorexia, nausea, vomiting, diarrhea, constipation. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. Respiratory System: Tightness of chest and wheezing, shortness of breath. Hematologic System: Hemolytic anemia, thrombocytopenia, agranulocytosis. To report SUSPECTED ADVERSE REACTIONS, contact PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or HYPERLINK "http://www.fda.gov/medwatch" www.fda.gov/medwatch.
Fuente: OpenFDA (enlace oficial).Última actualización: 2026-05-04T10:51:52.829548+00:00. Este resumen es apoyo a la decisión clínica, no sustituye juicio profesional ni la ficha técnica oficial del laboratorio.
Editor en Jefe: Dr. Alexander Jesús Figueredo Izaguirre — RP #108356