Careful Administration: This product should be administered with special caution in the following patients: Pediatric patients [see Use in Children as follows]; Patients with hypertension [the symptom may worsen due to the hypertensive effect of phenylephrine]; Patients with arteriosclerosis [the symptom may worsen due to the hypertensive effect of phenylephrine]; Patients with heart disease, such as coronary insufficiency and heart failure [the symptom may worsen due to the β1 effect of phenylephrine]; Patients with diabetes [the symptom may worsen due to the gluconeogenesis-promoting effect of phenylephrine]; Patients with hyperthyroidism [sympathomimetic symptoms of palpitation and tachycardia are found in a certain percentage of patients with hyperthyroidism, and these symptoms may worsen after using this product].
Important Precautions: Because the onset of symptoms during funduscopy, including bradycardia and apnea, has been reported in low birth weight infants, this product should be administered with care, and close observation is required while using this product. [See Use in Children as follows.]
Because this product induces mydriasis or cycloplegia, patients who use this product should be cautioned against operating potentially hazardous machinery, for example, driving a car until mydriasis or cycloplegia resolves. Moreover, patients should be instructed to wear sunglasses or use other protection to avoid looking directly at sunlight or other intense light.
Use in Elderly: Generally elderly patients have declined physiological functions and this product should be administered with caution.
Use in Children: Because systemic adverse reactions tend to occur when this product is used by children, this product should be administered with care and adequate observation.
In particular, the onset of symptoms of bradycardia, apnea, and gastrointestinal hypomotility (e.g. abdominal distention, decreased amount of milk intake) has been reported in low birth weight infants; thus, the patient should be monitored. If any abnormality is observed, the use of this product should be discontinued immediately, and adequate measures should be implemented. It is recommended to dilute this product as needed before use.