BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Principio activo: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
Vía de administración
ORAL
Países disponibles
US
Indicaciones
INDICATIONS AND USAGE Butalbital, Acetaminophen, and Caffeine capsules, USP are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
Posología
DOSAGE AND ADMINISTRATION 1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Contraindicaciones
CONTRAINDICATIONS This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
Embarazo y lactancia
Pregnancy Teratogenic Effects Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen, and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed. Nonteratogenic Effects Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital- containing drug during the last two months of pregnancy. Butalbital was found in the infant’s serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.
Efectos adversos
ADVERSE REACTIONS Frequently Observed The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure. Mental confusion, excitement, or depression can also occur due to intolerance, particularly in elderly or debilitated patients, or due to overdosage of butalbital. Autonomic Nervous System: dry mouth, hyperhidrosis. Gastrointestinal: difficulty swallowing, heartburn, flatulence, constipation. Cardiovascular: tachycardia. Musculoskeletal: leg pain, muscle fatigue. Genitourinary: diuresis. Miscellaneous: pruritus, fever, earache, nasal congestion, tinnitus, euphoria, allergic reactions. Several cases of dermatological reactions, including toxic epidermal necrolysis and erythema multiforme, have been reported. The following adverse drug events may be borne in mind as potential effects of the components of this product. Potential effects of high dosage are listed in the OVERDOSAGE section. Acetaminophen: allergic reactions, rash, thrombocytopenia, agranulocytosis. Caffeine: cardiac stimulation, irritability, tremor, dependence, nephrotoxicity, hyperglycemia.
Fuente: OpenFDA (enlace oficial).Última actualización: 2026-05-04T10:52:01.331157+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